PART 1 GENERAL

Citation, commencement and application

1. —(1) These Regulations may be cited as the National Health Service (Personal Dental Services Agreements) Regulations 2005 and shall come into force on 1st January 2006.

(2) These Regulations apply in relation to England only .

Interpretation

2. —(1) In these Regulations—

“ the Act ” means the National Health Service Act 1977;

“ the 2006 Act ” means the National Health Service Act 2006;

“ the 2012 Act ” means the Health and Social Care Act 2012;

“ the 1990 Act ” means the National Health Service and Community Care Act 1990;

“ additional services ” means one or more of—

“ adjudicator ” means the Secretary of State or a person or persons appointed by the Secretary of State under section 4(5) of the 1990 Act (NHS contracts) or paragraph 55(4) of Schedule 3 (NHS dispute resolution procedure);

“ advanced mandatory services ” means any primary dental service that would fall within the services described in regulation 14 of the GDS Contracts Regulations, but by virtue of the high level of facilities, experience or expertise required in respect of a particular patient, is provided as a referral service;

“ agreement ” means, except where the context otherwise requires, an agreement for primary dental services made under section 28C of the Act;

“ Band 1 course of treatment ” means a course of treatment, including a course of treatment consisting of urgent treatment, provided to a patient in respect of which a Band 1 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;

“ Band 2 course of treatment ” means a course of treatment provided to a patient in respect of which a Band 2 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;

“ Band 3 course of treatment ” means a course of treatment provided to a patient in respect of which a Band 3 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;

“ banded course of treatment ” means , subject to regulation 14C, a Band 1, Band 2 or Band 3 course of treatment;

“ bank holiday ” means any day that is specified or proclaimed as a bank holiday in England pursuant to section 1 of the Banking and Financial Dealings Act 1971 ;

...

“ bridge ” means a fixed or removable bridge which takes the place of any teeth;

“ capitated patient ” has the meaning given in regulation 14C;

“ Capitation and Quality Scheme Agreement ” means an agreement containing such terms and conditions relating to the provision of primary dental services as are required by, and which is made in accordance with, directions given by the Secretary of State under section 8 of the National Health Service Act 2006;

“ Capitation and Quality Scheme 2 Agreement ” means an agreement containing such terms and conditions relating to the provision of primary dental services as are required by, and which is made in accordance with, directions given by the Secretary of State under section 114A of the 2006 Act;

“ case assessment ”, in respect of an orthodontic course of treatment, means a clinical examination of the patient, including the taking of such radiographs, colour photographs and models as are required in order to determine what orthodontic treatment (if any) is to be provided to the patient;

“ CDS prototype contractor ” means a contractor who has elected to enter into a prototype agreement under which primary dental services are secured for, and provided to, persons who cannot easily access such services;

“ charge exempt course of treatment ” means a course of treatment that involves the examination and assessment of a patient leading to—

which, by virtue of regulation 3(2)(d) or (e) of the NHS Charges Regulations, is provided free of charge to the patient;

“ charity trustee ” means one of the persons having the general control and management of the administration of a charity;

“ child ” means a person who has not attained the age of 16 years;

“ complete ”, in relation to—

“ contractor ” means a person other than NHS England , who is a party to the agreement ;

“ course of treatment ” means—

by, unless the context otherwise requires, one or more providers of primary dental services, except that it does not include the provision of any orthodontic services or dental public health services and, where the course of treatment is an interim care course of treatment provided under a prototype agreement or a Capitation and Quality Scheme 2 Agreement in the context of regulation 12A of the NHS Charges Regulations (charges in respect of primary dental services provided under a prototype agreement or under a Capitation and Quality Scheme 2 Agreement) , it does not include the treatment mentioned in sub-paragraph (a);

“ dental appliance ” means a denture or bridge and for the purposes of this definition, a denture includes an obturator;

“ dental care professional ” means a person whose name is included in the register of dental care professionals or on the appropriate roll for dental auxiliaries established in accordance with Part II of the Dental Auxiliaries Regulations 1986 ;

“ dental performers list ”, means the list of dental practitioners maintained by NHS England in accordance with regulations made under section 106 of the 2006 Act;

“ dental public health services ” means services provided by the contractor by virtue of section 16CB(4)(c) of the Act (dental public health);

“ Dentists Act ” means the Dentists Act 1984 ;

“ Dentists Act Order ” means the Dentists Act 1984 (Amendment) Order 2005 ;

“ Dentists Register ” means the register maintained by the General Dental Council pursuant to section 14 of the Dentists Act (the dentists register and the registrar);

“ domiciliary services ” means a course of treatment, or part of a course of treatment, provided at a location other than—

“ exempt person ” means a person who is, by virtue of either Schedule 12ZA to the Act (dental charging: exemptions) or the NHS Charges Regulations, exempt from the need to pay an NHS Charge in respect of the services he has received under the agreement;

“ family member ” means—

“ FHSAA ” means the Family Health Services Appeal Authority constituted under section 49S of the Act (the Family Health Services Appeal Authority);

“ financial year ” means the period of 12 months ending with 31st March in any year;

“ GDS Contracts Regulations ” means the National Health Service (General Dental Services Contracts) Regulations 2005 ;

“ health care professional ” has the same meaning as in section 28M of the Act (persons eligible to enter into GDS contracts) and “ health care profession ” shall be construed accordingly;

“health service body” has, unless the context otherwise requires, the meaning given to it in section 4(2) of the 1990 Act (NHS contracts);

“ licensing body ” means any body that licenses or regulates any profession;

“ listed ”, in relation to drugs, medicines or appliances, means such drugs, medicines or appliances as are included in a list for the time being approved by the Secretary of State for the purposes of section 41(1)(c) of the Act (arrangements for pharmaceutical services);

“ mandatory services ” means the services described in regulation 14 of the GDS Contracts Regulations;

“ mobile surgery ”, except where expressly provided otherwise in these Regulations, means any vehicle in which services under the agreement are to be provided;

“ national disqualification ” means—

“ NHS Charge ” means a charge made to the patient for provision of services pursuant to the NHS Charges Regulations;

“ NHS Charges Regulations ” means the National Health Service (Dental Charges) Regulations 2005 ;

“ NHS contract ” has the meaning assigned to it in section 4 of the 1990 Act;

“ NHS dispute resolution procedure ” means the procedure for disputes specified in paragraphs 55 and 56 of Schedule 3;

“ NHS England ” means the body corporate established under section 1H of the 2006 Act;

“ NHS Tribunal ” means the Tribunal constituted under section 46 of the Act for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001 and in relation to Wales only until 26th August 2002 ;

“ normal surgery hours ” means the times at which the contractor has agreed with NHS England (and specified in the agreement) that the surgery will be open to patients for the provision of services;

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“ orthodontic appliance ” means a device used in the mouth to move or immobilise the teeth in order to correct or prevent malocclusion;

“ orthodontic course of treatment ” means—

“ orthodontic services ” means the provision of orthodontic courses of treatment or the services referred to in paragraph 5(2) of Schedule 1 (repairs);

“ orthodontic treatment ” means treatment of, or treatment to prevent, malocclusion of the teeth and jaws, and irregularities of the teeth;

“ parent ”, in relation to any child, means a parent or other person who has parental responsibility for that child;

“ patient ” means, unless the context otherwise requires, a person to whom the contractor is providing services under the agreement;

“ patient record ” means a form supplied by NHS England for the purpose of maintaining a record of treatment, and may include an electronic form;

“ practice premises ”, except where expressly provided otherwise in these Regulations, means an address specified in the agreement as one at which services are to be provided under the agreement but does not include a mobile surgery;

“ prescriber ” means a dental practitioner who is either engaged or employed by the contractor or is a party to the agreement;

“ primary care list ” means—

“ Primary Care Trust ” means, except where the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to an agreement;

“ prison ” includes a young offender institution but not a secure training centre or a naval, military or air force prison, and for the purposes of this definition—

“ private ”, in the context of services or treatment, means otherwise than under the agreement or Part 1 of the Act, and “ privately ” shall be construed accordingly;

“ professional registration number ” means the number against a dental practitioner's name in the Dentists Register;

“ prototype agreement ” means an agreement temporarily varied as part of the Prototype Agreements Scheme which contains—

“ the Prototype Directions ” means the National Health Service (Dental Services) (Prototype Agreements) Directions 2015;

“ the Prototype SFE ” means the Prototype Agreements Scheme Statement of Financial Entitlements;

“ referral notice ” means the notice referred to in paragraph 10(2)(a) of Schedule 3 (referral to another contractor, a hospital or other relevant service provider for advanced mandatory, domiciliary or sedation services);

“ referral service ” means one or more of advanced mandatory services, domiciliary services or sedation services provided by the contractor to a patient who has, during a course of treatment, been referred to the contractor by—

for the provision of one or more of those services as part of that course of treatment;

“ referral treatment plan ” means a treatment plan provided pursuant to paragraph 2(1) of Schedule 1 or that plan as varied in accordance with paragraph 2(2) of that Schedule;

“ register of dental care professionals ” means the register maintained by the General Dental Council under section 36B of the Dentists Act (the dental care professionals register);

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“ sedation services ” means a course of treatment provided to a patient during which the contractor administers one or more drugs to a patient, which produce a state of depression of the central nervous system to enable treatment to be carried out, and during and in respect of that period of sedation—

“ trauma ” means damage to teeth, gingival tissues or alveoli caused by a force arising outside the mouth, resulting in mobility, luxation, subluxation or fracture of the hard tissues or injury to the soft tissues;

“ unit of dental activity ” means the unit of activity which is in the agreement used to—

mandatory services and advanced mandatory services provided under the agreement;

“ unit of orthodontic activity ” means the unit of activity which is in the agreement used to—

orthodontic services provided under the agreement;

“ urgent treatment ” means a course of treatment that consists of one or more of the treatments listed in Schedule 4 to the NHS Charges Regulations (urgent treatment under Band 1 charge) that are provided to a person in circumstances where—

“ working day ” means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday.

(2) In these Regulations—

(a) the use of the term it in relation to the contractor shall be deemed to include a reference to a contractor that is an individual dental practitioner or two or more persons contracting together to provide services under an agreement and related expressions shall be construed accordingly; and

(b) references to forms supplied by NHS England to contractors includes electronic forms and forms which are generated electronically, but does not include prescription forms.

(3) In these Regulations, where reference is made to an announcement or advice of NHS England that relates to a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially serious risk to human health,

it is to that announcement or advice, which may be withdrawn at any time, as amended from time to time.

PART 2 CONTRACTORS

Conditions: introductory

3. Subject to the provision of any scheme made by the Secretary of State under section 300 (transfer schemes) or any order made under section 303 (power to make consequential provision) of the 2012 Act, NHS England may only enter into an agreement if the conditions set out in—

(a) regulation 4; and

(b) in the case of an agreement to be entered into with a dental corporation on or after the coming into force for all purposes of article 39 of the Dentists Act Order (substitution of sections 43 and 44), regulation 5,

are met.

General conditions relating to all agreements

4. —(1)NHS England may make an agreement with an individual falling within section 28D(1)(b) to (d) if that individual does not fall within paragraph (3).

(2)NHS England may make an agreement with a person only if—

(a) in the case of a dental corporation, that dental corporation, or any director, chief executive or secretary of that corporation; or

(b) in the case of a company limited by shares, that company limited by shares, or any director, chief executive or secretary of that company; or

(c) in the case of a limited liability partnership, that limited liability partnership, or any member of that partnership,

does not fall within paragraph (3).

(3) A person falls within this paragraph if—

(a) he or it (in the case of a dental corporation, a company limited by shares, or a limited liability partnership) is the subject of a national disqualification;

(b) subject to paragraph (4), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;

(c) within the period of five years prior to the date the agreement is to be commenced or, if earlier, the date on which the agreement is to be signed—

(i) he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body, unless he has subsequently been employed by that health service body or another health service body and paragraph (5) applies to him or that dismissal was the subject of a finding of unfair dismissal by any competent tribunal or court; or

(ii) he or it has been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively) unless his or its name has subsequently been included in such a list;

(d) he has been convicted in the United Kingdom of—

(i) murder; or

(ii) a criminal offence other than murder, committed on or after 14th December 2001, and has been sentenced to a term of imprisonment of over six months;

(e) subject to paragraph (6), he has been convicted outside the United Kingdom of an offence—

(i) which would, if committed in England and Wales, constitute murder; or

(ii) committed on or after 14th December 2001, which would if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months;

(f) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995(offences against children under the age of 17 years to which special provisions apply) committed on or after 1st April 2006;

(g) he or it has—

(i) been made bankrupt or had sequestration of his estate awarded or is a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986) applies unless ... he has been discharged from the bankruptcy or the sequestration or the bankruptcy order has been annulled;

(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A , or a debt relief restrictions order or interim debt relief restrictions order under Schedule 4ZB, to the Insolvency Act 1986 unless that order has ceased to have effect or has been annulled; or

(iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it;

(h) an administrator, administrative receiver or receiver is appointed in respect of it;

(i) he has within the period of five years prior to the date the agreement is to be commenced or, if earlier, the date on which the agreement is to be signed—

(i) been removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated;

(ii) been removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of the Court of Session to deal with management of charities), or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session), from being concerned in the management or control of any body; or

(iii) been subject to a disqualification order under the Company Directors Disqualification Act 1986 , the Companies (Northern Ireland) Order 1986 or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order).

(4) A person shall not fall within paragraph (3)(b) where NHS England is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and it does not make that person unsuitable to be—

(a) a party to an agreement;

(b) a director, chief executive or secretary of a dental corporation, in the case of an agreement with a dental corporation;

(c) a director, chief executive or secretary of a company limited by shares, in the case of an agreement with a company limited by shares; or

(d) a member of a limited liability partnership, in the case of an agreement with a limited liability partnership.

(5) Where a person has been employed as a member of a health care profession any subsequent employment must also be as a member of that profession.

(6) A person shall not fall within paragraph (3)(e) where NHS England is satisfied that the conviction does not make the person unsuitable to be—

(a) a party to an agreement;

(b) a director, chief executive or secretary of a dental corporation, in the case of an agreement with a dental corporation;

(c) a director, chief executive or secretary of a company limited by shares, in the case of an agreement with a company limited by shares; or

(d) a member of a limited liability partnership, in the case of an agreement with a limited liability partnership.

(7) For the purposes of paragraph (3)(c)(i), a health service body includes a Strategic Health Authority or a Primary Care Trust which was established before the coming into force of sections 33 and 34 of the 2012 Act.

Additional conditions relating to agreements with dental corporations or companies limited by shares

5. —(1) Subject to paragraph (2), it is a condition in the case of an agreement to be entered into with a dental corporation or a company limited by shares on or after the date of the coming into force of article 39 of the Dentists Act Order, that no—

(a) offence has been or is being committed under section 43 of the Dentists Act; or

(b) financial penalty has been imposed under section 43B or 44 of the Dentists Act.

(2) Paragraph (1) shall not apply if NHS England is satisfied that any offence under section 43 or penalty imposed under section 43B or 44 of the Dentists Act does not make a dental corporation or a company limited by shares unsuitable to be a contractor, whether by virtue of the time that has elapsed since any conviction or penalty was imposed, or otherwise.

Reasons

6. —(1) Where NHS England is of the view that the conditions in regulation 4 or 5 for entering into an agreement are not met it shall notify in writing the person or persons intending to enter into the agreement of its view and its reasons for that view and of his, its, or their right of appeal under regulation 7.

(2)NHS England shall also notify in writing of its view and its reasons for that view to—

(a) a director, chief executive or secretary of a dental corporation;

(b) a director, chief executive or secretary of a company limited by shares; or

(c) the members of a limited liability partnership,

who is, or are, notified under paragraph (1) where its reasons for the decision relates to that person or persons.

Appeal

7. A person who has been served with a notice under regulation 6(1) may appeal to the First-tier Tribunal against the decision of NHS England that the conditions in regulation 4 or 5 are not met ... .

PART 3 PRE-AGREEMENT DISPUTE RESOLUTION

Pre-agreement disputes

8. —(1) Subject to paragraphs (2) and (3), if in the course of negotiations intending to lead to an agreement the prospective parties to that agreement are unable to agree on a particular term of the agreement, either party may, subject to paragraph (2), refer the dispute to the Secretary of State to consider and determine the matter.

(2) Both parties to the prospective agreement must make every reasonable effort to communicate and co-operate with each other with a view to resolving a dispute arising during the course of negotiations, before referring the dispute for determination under paragraph (1).

(3) Disputes referred to the Secretary of State in accordance with paragraph (1), or section 4(4) of the 1990 Act, shall be considered and determined in accordance with the provisions of paragraphs 55(4) to 55(13) and 56(1) of Schedule 3, and paragraph (4) (where it applies) of this regulation.

(4) In the case of a dispute referred to the Secretary of State under paragraph (1), the determination—

(a) may specify terms to be included in the proposed agreement;

(b) may require NHS England to proceed with the proposed agreement, but may not require the proposed contractor to proceed with the proposed agreement; and

(c) shall be binding upon the prospective parties to the agreement.

PART 4 HEALTH SERVICE BODY STATUS

Health service body status

9.—(1) A contractor shall be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date it makes an agreement unless—

(a) in the case of an agreement with a single individual, that individual;

(b) in the case of an agreement with a dental corporation, that corporation;

(c) in the case of a company limited by shares, that company; or

(d) in the case of a limited liability partnership, that partnership,

object in a written notice served on NHS England at any time prior to the agreement being made.

(2) Where a contractor is to be regarded as a health service body for the purposes of section 4 of the 1990 Act pursuant to paragraph (1), any change in the parties comprising the contractor shall not affect the health service body status of the contractor.

(3) If, pursuant to paragraph (1) or (4), a contractor is to be regarded as a health service body, that fact shall not affect the nature of, or any rights or liabilities arising under, any other agreement or contract with a health service body entered into by that contractor before the date on which the contractor is to be so regarded.

(4) A contractor may at any time request a variation of the agreement to include or remove provision from the agreement that the agreement is an NHS contract, and if it does so—

(a) NHS England shall agree to the variation; and

(b) the procedure in paragraph 60(1) of Schedule 3 (variation of a contract: general) shall apply.

(5) Where, pursuant to paragraph (4), NHS England agrees to a variation of the agreement, the contractor shall—

(a) be regarded; or

(b) subject to paragraph (7), cease to be regarded,

as a health service body for the purposes of section 4 of the 1990 Act from the date that variation takes effect pursuant to paragraph 60(1) of Schedule 3.

(6) Subject to paragraph (7), a party or parties who were to be regarded as a health service body pursuant to paragraphs (1) or (4), as the case may be, shall cease to be a health service body for the purposes of section 4 of the 1990 Act if the agreement is terminated.

(7) Where a contractor ceases to be a health service body pursuant to—

(a) paragraph (5) or (6), it shall continue to be regarded as a health service body for the purposes of being a party to any other NHS contract entered into after it became a health service body but before the date on which the contractor ceased to be a health service body (for which purposes it ceases to be such a body on the termination of that NHS contract);

(b) paragraph (5), where it or NHS England —

(i) has referred any matter to the NHS dispute resolution procedure before it ceases to be a health service body, or

(ii) refers any matter to the NHS dispute resolution procedure, in accordance with paragraph 54(1)(a) of Schedule 3, after it ceases to be a health service body,

the contractor is to continue to be treated as a health service body (and accordingly the agreement is to continue to be regarded as an NHS contract) for the purposes of the consideration and determination of the dispute; or

(c) paragraph (6), it shall continue to be regarded as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced—

(i) before the termination of the agreement; or

(ii) after the termination of the agreement, whether in connection with, or arising out of, the termination of the agreement or otherwise,

for which purposes it ceases to be such a body on the conclusion of that procedure.

PART 5 AGREEMENTS: REQUIRED TERMS

NHS contracts

10. If the contractor is to be regarded as a health service body, the agreement must state that it is an NHS contract.

Additional services

11. If the agreement includes the provision of additional services, it must contain in relation to each such service as is included in the agreement, terms that have the same effect as those specified in Schedule 1 in so far as they are relevant to that service.

Agreements: general

12. —(1) An agreement must specify—

(a) the services to be provided by the contractor;

(b) the duration of the agreement;

(c) to whom such services are to be provided; and

(d) the postal address of each of the premises to be used by the contractor or any sub-contractor for the provision of such services, or, if the contractor is to provide services from a mobile surgery, that fact.

(2) The premises referred to in paragraph (1)(d) do not include any place in which a patient is residing.

Units of dental activity

13. —(1) Subject to regulation 20C , where an agreement includes the provision of mandatory or advanced mandatory services, the agreement must specify the number of units of dental activity to be provided by the contractor—

(a) where the agreement begins on 1st April, in each financial year or, by virtue of the duration of the agreement, part financial year; or

(b) where the agreement begins on a date other than 1st April, in the remainder of the financial year in which the agreement begins, and in each financial year thereafter.

(2) Subject to regulation 20C , an agreement must contain terms which have the effect of those specified in Part 1 of Schedule 2 in relation to the calculation of the number of units of dental activity that the contractor has provided under the agreement.

Units of orthodontic activity

14. —(1) Where an agreement includes the provision of orthodontic services, the agreement must specify the number of units of orthodontic activity to be provided by the contractor—

(a) where the agreement begins on 1st April, in each financial year or, by virtue of the duration of the agreement, part financial year; or

(b) where the agreement begins on a date other than 1st April, in the remainder of the financial year in which the agreement begins, and in each financial year or part financial year thereafter.

(2) Where paragraph (1) applies, the agreement must also contain terms which have the effect of those specified in Part 2 of Schedule 2 in relation to the calculation of how many units of orthodontic activity a contractor has provided under the agreement.

Units of dental activity for contractors who elect to enter into a prototype agreement

14A.—(1) Subject to paragraph (3), where a contractor has elected to enter into a prototype agreement, the prototype agreement must specify the number of units of dental activity to be provided by the contractor—

(a) where the prototype agreement begins on 1st April, in each financial year; or

(b) where the prototype agreement begins on a date other than 1st April, in the remainder of the financial year in which the prototype agreement begins, and in each financial year thereafter.

(2) A prototype agreement must contain terms which have the effect of those specified in Schedule 2A in relation to the calculation of the number of units of dental activity to be provided by the contractor under the prototype agreement.

(3) This regulation does not apply where the contractor is a CDS prototype contractor.

Capitated patient figures for contractors who elect to enter into a prototype agreement

14B. Where a contractor has elected to enter into a prototype agreement, except where the contractor is a CDS prototype contractor, the prototype agreement must specify the number of patients to whom the contractor is expected to have provided primary dental services (known as the capitated patient figure) by the end of each financial year.

Capitated patients

14C.—(1) Subject to paragraph (3), where a contractor has elected to enter into a prototype agreement, on any day (“the relevant day”) a patient is a capitated patient if that patient has been provided with a banded course of treatment by the contractor (C1) within a period of three years immediately preceding that day, provided that—

(a) the banded course of treatment has not been provided by a foundation trainee;

(b) the patient has not been referred to C1 for the banded course of treatment by another primary dental servicescontractor; and

(c) the patient was not subsequently provided with a banded course of treatment before the relevant day by another primary dental servicescontractor (C2), unless the patient was referred to C2 by C1 for that banded course of treatment.

(2) For the purposes of this regulation—

(a) a banded course of treatment does not include the provision of an urgent course of treatment; and

(b) “foundation trainee” has the meaning given in Section 12 of the General Dental Services Statement of Financial Entitlements 2013 (glossary of terms).

(3) This regulation does not apply where the contractor is a CDS prototype contractor.

Under-provision of units of dental activity or units of orthodontic activity

15. —(1) The agreement shall provide that NHS England shall not, pursuant to Part 9 of Schedule 3 (variation and termination of agreements), be entitled to take any action for breach of a term of the agreement giving effect to regulation 13 or 14 (including termination of the agreement) where paragraph (2) applies.

(2) Subject to paragraph (4), this paragraph applies where the contractor has failed to provide—

(a) the number of units of dental activity; or

(b) the number of units of orthodontic activity,

it is contracted to provide pursuant to a term of the agreement giving effect to regulation 13 or 14 where—

(i) that failure amounts to 4 per cent or less of the total number of units of dental activity or units of orthodontic activity that ought to have been provided; and

(ii) the contractor agrees to provide and does so provide the units it has failed to provide within such period as NHS England specifies in writing, such period to consist of not less than 60 days.

(3) Paragraphs (1) and (2) shall not prevent NHS England from taking action under Part 9 of Schedule 3 for breach of contract (including terminating the agreement) on other grounds.

(4) In the case of an agreement with a duration period of less than 12 months, the period of 60 days in paragraph (2)(ii) may not apply if NHS England considers it not appropriate or considers that another period of less than 60 days should apply.

Domiciliary services and sedation services

16. Where an agreement includes the provision of domiciliary services or sedation services, the agreement must specify the number of courses of treatment that the contractor is—

(a) to provide; or

(b) to contribute to where provided as a referral service,

that involve the provision of domiciliary services or sedation services—

(i) where the contract begins on 1st April, in each financial year; or

(ii) where the contract begins on a date other than 1st April, in the remainder of the financial year in which the contract begins, and in each financial year thereafter for which the contract continues.

Finance

17. —(1) Subject to regulation 20C , the agreement must contain a term which has the effect of requiring—

(a) NHS England to make payments to the contractor under the agreement promptly and in accordance with both the terms of the agreement and any other conditions relating to the payment contained in directions given by the Secretary of State under section 28E(3A) of the Act (personal medical or dental services: regulations);

(b) the contractor to make payments promptly to NHS England and in accordance with both the terms of the agreement and any other conditions relating to the payment contained in directions given by the Secretary of State under section 17 (Secretary of State's directions: exercise of functions) or 28E(3A) of the Act.

(2) The obligation referred to in paragraph (1) is subject to any right the Relevant Body has to set off against an amount payable to the contractor an amount that—

(a) is owed by the contractor to NHS England under the agreement;

(b) has been paid to the contractor owing to an error or in circumstances when it was not due; or

(c) NHS England may withhold from the contractor in accordance with the terms of the agreement or any other applicable provisions contained in directions given by the Secretary of State under section 28E(3A).

(3) Subject to regulation 20C , the agreement must contain a term to the effect that where, pursuant to directions under section 17 or 28E(3A) of the Act, NHS England is required to make a payment to a contractor under an agreement but subject to conditions, those conditions are to be a term of the agreement.

Publication of information about earnings

17A.—(1) Using the information that it has obtained to make the payments to contractors mentioned in regulation 17(1)(a), NHS England must publish the information specified in paragraph (2).

(2) The information specified in this paragraph is, in respect of each agreement—

(a) the number of dental performers who during the previous financial year performed services under the agreement;

(b) a figure representing the aggregate net pensionable earnings in respect of the previous financial year of those dental performers under the agreement, taking into account the amount by which the employing authority of those performers would reduce those earnings to take account of expenses; and

(c) an average figure of net pensionable earnings of each performer based on the figures referred to in sub-paragraphs (a) and (b).

(3) In relation to the financial year ending on 31st March 2015, the information specified in paragraph (2) must be published by 31st May 2016; and for each subsequent financial year, it must be published before the end of the financial year following the financial year to which the information relates.

(4) The NHSBSA is directed to perform NHS England’s functions under this regulation, and must publish the information on its website in such form and such manner as it sees fit.

(5) For the purposes of this regulation, net pensionable earnings are to be calculated in accordance with paragraph 3(2B) (meaning of pensionable earnings) of Schedule 2 (medical and dental practitioners) to the National Health Service Pension Scheme Regulations 1995, regulation 3.A.7(4) (meaning of pensionable earnings) of the National Health Service Pension Scheme Regulations 2008 and paragraph 3 (dental practitioner) of Schedule 10 (practitioner income) to the National Health Service Pension Scheme Regulations 2015.

(6) For the purposes of this regulation—

“ dental performer ” means a dental practitioner whose name is included in the dental performers list;

“ employing authority ” has the meaning given in—

“ the NHSBSA ” means the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG).

Fees, charges and financial interests of the contractor

18. —(1) The agreement must contain terms relating to fees, charges and financial interests which have the same effect as those set out in paragraphs (2) to (4).

(2) The contractor shall not, either itself or through any other person, demand or accept a fee or other remuneration for its own or another's benefit from—

(a) any patient of its for the provision of any treatment under the agreement, except as otherwise provided in the NHS Charges Regulations; or

(b) any person who has requested services under the agreement for himself or a family member, as a prerequisite to providing services under the agreement to that person or his family member.

(3) The agreement must contain a term that—

(a) only permits the contractor to collect from any patient of its any charge that that patient is required to pay by virtue of the NHS Charges Regulations, in accordance with the requirements of those Regulations; and

(b) provides for obligations imposed on the contractor by virtue of the NHS Charges Regulations to be terms of the agreement.

(4) The agreement must contain a term that requires the contractor in making a decision—

(a) as to what services to recommend or provide to a patient who has sought services under the agreement; or

(b) to refer a patient for other services by another contractor, hospital or other relevant service provider under Part 1 of the Act,

to do so without regard to its own financial interests.

(5) The term “patient” in paragraph (3) shall have the same meaning as in regulation 2(1) of the NHS Charges Regulations.

Arrangements on termination

19. An agreement shall make suitable provision for arrangements on termination of an agreement including the consequences (whether financial or otherwise) of the agreement ending.

Other contractual terms

20. —(1) Subject to regulation 20C , an agreement must, unless it is of a type or nature to which a particular provision does not apply, contain other terms which have the same effect as those specified in Schedule 3 except paragraphs 55(4) to 55(13) and 56 and Schedule 5.

(2) The paragraphs specified in paragraph (1) shall have effect in relation to the matters set out in those paragraphs.

(3) Where an agreement does not commence on 1st April in any financial year or the duration of an agreement is less than 12 months, there must be a contractual term—

(a) specifying the date and periods for the purposes of a mid-year review of the services provided; and

(b) which, other than as to the date and periods, have similar effect as those specified in paragraphs 58(3) to (8) and 59 of Schedule 3 in respect of the requirement and procedure for carrying out mid-year reviews.

Variation of contractual terms in respect of election to enter into a Capitation and Quality Scheme Agreement

20A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of contractual terms in respect of election to enter into a Capitation and Quality Scheme 2 Agreement

20B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Variation of contractual terms in respect of election to enter into a prototype agreement

20C.—(1) Subject to paragraph (6), this regulation applies where the contractor and NHS England elect to enter into a prototype agreement.

(2) Where this regulation applies, the terms of the agreement which have the same effect as the provisions specified in paragraph (3) must be varied in accordance with paragraphs (4) and (5) with effect from the day on which the prototype agreement commences and for the period ending at the end of the day which is the date of termination of the prototype agreement, which must be no later than 31st March 2022 .

(3) The provisions specified in this paragraph are—

(a) regulation 13 (units of dental activity);

(b) regulation 15 (under provision of units of dental activity or units of orthodontic activity), in relation to units of dental activity only;

(c) regulation 17 (finance);

(d) Part 1 of Schedule 2 (units of dental activity); and

(e) in Schedule 3 (other contractual terms)—

(i) paragraph 33(2) (patient records), which is a contractor’s discretion to keep patient records in electronic form,

(ii) paragraph 58 (mid-year reviews), and

(iii) paragraph 61(1)(a) and (3)(a) (variation of an agreement: activity under the agreement), which relate to units of dental activity.

(4) The agreement must include terms that have the effect of temporarily releasing the contractor and NHS England from all of the obligations, conditions, payments, rights and liabilities relating to those terms (and only those terms) which have the same effect as the provisions specified in paragraph (3), including any right to enforce those terms.

(5) The agreement must also include terms that have the effect of providing that, immediately after the date of the termination of the prototype agreement, the terms of the agreement that subsisted between the parties immediately before—

(a) in the case of a contractor who held both a Capitation and Quality Scheme Agreement and a Capitation and Quality Scheme 2 Agreement, the Capitation and Quality Scheme Agreement commenced;

(b) in the case of a contractor who held a Capitation and Quality Scheme 2 Agreement but not a Capitation and Quality Scheme Agreement, the Capitation and Quality Scheme 2 Agreement commenced; or

(c) if neither sub-paragraph (a) nor (b) applies, the prototype agreement commenced,

and from which the parties were temporarily released in accordance with paragraph (4), must apply from the day after the date of termination, and all obligations, conditions, payments, rights and liabilities relating to those terms are to be enforceable from that day.

(6) Sub-paragraphs (b) and (d) of paragraph (3) do not apply where the contractor is a CDS prototype contractor.

Suspension of agreement terms or of enforcement of agreement terms while a disease is or in anticipation of a disease being imminently pandemic etc.

20D.—(1) Any term that is part of an agreement (including a prototype agreement) as a consequence of action taken under this Part or by agreement between the parties is temporarily not part of that agreement, in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii), in the following circumstances—

(a) as a consequence of a disease being, or in anticipation of a disease being imminently—

(i) pandemic, and

(ii) a serious risk or potentially a serious risk to human health,

NHS England with the agreement of the Secretary of State has made an announcement in respect of the prioritisation of services to be provided in, or in any part of, England as part of the health service;

(b) the prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;

(c) as part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that contractors are not to comply with a specified type of term of personal dental servicesagreements (including prototype agreements)—

(i) in the area to which the announcement relates,

(ii) in the particular circumstances specified in the announcement, and

(iii) during the period specified in the announcement; and

(d) the contractor is situated in the area to which the announcement relates and compliance with the term (it being of the specified type) would, but for the effect of this paragraph, be a requirement of the contractor’s agreement.

(2)NHS England must not take enforcement action, as provided for in an agreement (including a prototype agreement), in respect of a breach of a term of the agreement in the following circumstances—

(a) as a consequence of a disease being, or in anticipation of a disease being imminently—

(i) pandemic, and

(ii) a serious risk or potentially a serious risk to human health,

NHS England with the agreement of the Secretary of State has made an announcement in respect of the prioritisation of services to be provided in, or in any part of, England as part of the health service;

(b) the prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;

(c) as part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that contractors need not comply with a specified type of term of personal dental servicesagreements (including prototype agreements)—

(i) in the area to which the announcement relates,

(ii) in the particular circumstances specified in the announcement, and

(iii) during the period specified in the announcement; and

(d) the contractor—

(i) is situated in the area to which the announcement relates, and

(ii) has not complied with the term (it being of the specified type) in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii).

PART 6 RIGHT TO A GENERAL DENTAL SERVICES CONTRACT

Right to a general dental services contract

21. —(1) A contractor which is providing mandatory services and which wishes a general dental services contract to be entered into pursuant to this regulation shall notify NHS England in writing at least three months before the date on which it wishes the general dental services contract to be entered into.

(2) A notice under paragraph (1) shall—

(a) state that the contractor wishes to terminate the agreement and the date on which the contractor wishes the agreement to terminate which must be at least three months after the date of service of the notice;

(b) subject to paragraph (3), give the name or names of the person or persons whom the contractor wishes NHS England to enter into a general dental services contract with; and

(c) confirm that the person or persons so named meet the conditions set out in section 28M of the Act (persons eligible to enter into GDS contracts) and regulations 4 and 5 (where applicable) of the GDS Contracts Regulations or, where the contractor is not able so to confirm, the reason why it is not able to do so and confirmation that the person or persons immediately prior to entering into the general dental services contract will meet those conditions.

(3) A person's name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement.

(4)NHS England shall acknowledge receipt of the notice served under paragraph (1) within the period of seven days beginning on the day that it received the notice.

(5) Provided that the conditions set out in section 28M of the Act and regulations 4 and 5 (where applicable) of the GDS Contracts Regulations are met, NHS England shall enter into a general dental services contract with the person or persons named in the notice served under paragraph (1).

(6) In addition to the terms required by the Act and the GDS Contracts Regulations, a general dental services contract entered into pursuant to this regulation shall provide for—

(a) the general dental services contract to commence immediately after the termination of the agreement;

(b) the same services to be provided under the general dental services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree;

(c) the contractor to complete any course of treatment or orthodontic course of treatment that were not complete immediately before the agreement was terminated—

(i) in accordance with the terms of the general dental services contract in so far as those terms correspond with the terms of the agreement immediately before it was terminated, and

(ii) subject to such terms of the general dental services contract that permits the termination of a course of treatment or orthodontic course of treatment; and

(d) unless the parties otherwise agree—

(i) subject to paragraph (ii), the same number of units of dental activity or units of orthodontic activity (as the case may be) specified in the agreement in a term giving effect to regulation 13 or 14 to be provided under the general dental services contract;

(ii) where the general dental services contract is to begin on a day other than 1st April, the contractor to provide under that contract during the remainder of that financial year any units of dental activity or units of orthodontic activity that the contractor would have been obliged to provide in that financial year under the agreement but had not yet provided immediately before the general dental services contract begins;

(e) unless the parties otherwise agree—

(i) subject to paragraph (ii), the same number of courses of treatment involving the provision of sedation services or domiciliary services specified in the agreement in a term giving effect to regulation 16 to be provided under the general dental services contract;

(ii) where the general dental services contract is to begin on a day other than 1st April, the contractor under that contract to provide or contribute to during the remainder of that financial year any courses of treatment involving the provision of sedation services or domiciliary services that the contractor would have been obliged to provide or contribute to in that financial year under the agreement but had not yet provided or contributed to immediately before the general dental services contract begins;

(f) in respect of a course of treatment or orthodontic course of treatment falling within sub-paragraph (c), the contractor to ensure that a patient who is not an exempt person only pays one NHS Charge in respect of that course of treatment or orthodontic course of treatment; and

(g) the contractor to comply with the term of the general dental services contract giving effect to paragraph 12 of Schedule 3 to the GDS Contracts Regulations (repair or replacement of restorations) in respect of any patients to whom it provided treatment under its agreement, in addition to patients to whom it provides treatment under the general dental services contract.

(7) An agreement shall terminate on the date stated in the notice given by the contractor under paragraph (1) unless a different date is agreed by the contractor and NHS England or no general dental services contract is entered into by NHS England pursuant to this regulation.

(8) Where there is a dispute as to whether or not a person satisfies the conditions set out in section 28M of the Act or regulation 4 or 5 of the GDS Contracts Regulations, the contractor may appeal to the First-tier Tribunal and NHS England shall be the respondent.

(9) Any other dispute relating to this regulation shall be determined by the Secretary of State in accordance with regulation 8(3) and (4) of the GDS Contracts Regulations (pre-contract disputes).

(10) The parties to a dispute referred to the Secretary of State in accordance with paragraph (9) shall be the contractor and NHS England .

PART 7 TRANSITIONAL PROVISION

Commencement of agreement

22. The agreement shall provide for services to be provided under it from any date after 31st March 2006.

Regulation 11

SCHEDULE 1 NHS England’s ADDITIONAL SERVICES

PART 1 ADVANCED MANDATORY SERVICES, DOMICILIARY SERVICES AND SEDATION SERVICES

Provision of advanced mandatory services, domiciliary services and sedation services by the contractor

1. —(1) A contractor which provides domiciliary services or sedation services under the agreement may only provide those services—

(a) to a person to whom it is providing an entire course of treatment, during that course of treatment; or

(b) as a referral service.

(2) A contractor may only provide advanced mandatory services under the agreement as a referral service.

(3) In this paragraph, “ entire course of treatment ” means a course of treatment provided by only the contractor.

Referral services

2. —(1) A contractor which provides one or more of the additional services specified in paragraph 1 as a referral service shall, at the time of the first examination of the patient, ensure that the patient is provided with a referral treatment plan on a form supplied for that purpose by NHS England which shall specify—

(a) the name of the patient;

(b) the name of the contractor;

(c) the particulars of the places where the patient will receive the referral service to be provided to him by the contractor;

(d) the telephone number at which the contractor may be contacted during its normal surgery hours;

(e) details of the services which are at the date of that examination considered to be necessary for the contractor to provide having regard to the reason for the referral; and

(f) any proposals the contractor may have for private services as an alternative to the services proposed under the agreement, including particulars of the cost to the patient if he were to accept the provision of private services.

(2) Where the services included in the referral treatment plan need to be varied for clinical reasons, the contractor shall provide the patient with a revised referral treatment plan in accordance with sub-paragraph (1).

(3) The contractor shall, subject to the termination of, or being unable to complete a course of treatment in accordance with paragraph 7(5) or (6) of Schedule 3 (course of treatment), provide the services which are detailed in the referral treatment plan, or where a revised treatment plan is provided pursuant to sub-paragraph (2), pursuant to that revised treatment plan.

(4) This paragraph shall not apply where a patient has been referred to the contractor for advanced mandatory services limited only to examination and advice, and the contractor only provides examination and advice in respect of that patient.

Sedation services

3. The contractor shall only provide sedation services to a patient in accordance with the recommendations contained in the report of the Standing Dental Advisory Committee entitled “Conscious Sedation in the Provision of Dental Care” , in so far as those recommendations and guidelines are relevant to—

(a) the type of sedation being administered; and

(b) the patient to whom the sedation is being administered.

PART 2 ORTHODONTIC SERVICES

Patients to whom orthodontic services may be provided

4. —(1) An agreement that includes the provision of orthodontic services shall specify that orthodontic services may be provided to—

(a) only persons who are under the age of 18 years at the time of the case assessment;

(b) only persons who have attained the age of 18 years at the time of the case assessment; or

(c) persons falling within paragraph (a) or (b).

(2) Where an agreement specifies the matters referred to in sub-paragraph (1)(b) or (1)(c), it shall in addition specify the circumstances in which orthodontic services may be provided to a person over the age of 18 years at the time of a case assessment.

(3) The contractor shall only provide orthodontic treatment to a person who is assessed by the contractor following a case assessment as having a treatment need in—

(a) grade 4 or 5 of the Dental Health Component of the Index of Orthodontic Treatment Need , or

(b) grade 3 of the Dental Health Component of that Index with an Aesthetic Component of 6 or above,

unless the contractor is of the opinion, and has reasonable grounds for its opinion, that orthodontic treatment should be provided to a person who does not have such a treatment need by virtue of the exceptional circumstances of the dental and oral condition of the person concerned.

(4) In a case where a person does not have a treatment need but the contractor has reasonable grounds for its opinion that orthodontic treatment should be provided to that person because of the exceptional circumstances of the dental and oral condition of that person, such treatment as is referred to in sub-paragraph (3) may be provided.

Orthodontic course of treatment

5. —(1) Subject to sub-paragraph (2), the contractor shall provide orthodontic services to a patient by providing to that patient an orthodontic course of treatment.

(2) The contractor may provide orthodontic services that are not provided by virtue of an orthodontic course of treatment where—

(a) it provides a repair to an orthodontic appliance of a person; and

(b) the orthodontic course of treatment in which that orthodontic appliance was provided is being provided by another contractor, hospital or relevant service provider under Part 1 of the Act.

(3) The contractor shall use its best endeavours to ensure that an orthodontic course of treatment is completed within a reasonable time from the date on which the orthodontic treatment plan was written in accordance with paragraph 6(1).

(4) If an orthodontic course of treatment is—

(a) terminated before it has been completed; or

(b) otherwise not completed within a reasonable time,

any further orthodontic services to be provided to that patient under the agreement must be provided as a new orthodontic course of treatment.

(5) An orthodontic course of treatment may only be terminated by—

(a) the contractor—

(i) when the circumstances referred to in paragraph 3(1) of Schedule 3 (violent patients) occur and notice that it will no longer provide services has been given to NHS England ;

(ii) where the patient has refused to pay a charge in the circumstances referred to in paragraph 4 of Schedule 3 (refusal to pay NHS Charges prior to the commencement of, or during, treatment); or

(iii) where, in the reasonable opinion of the contractor, there has been an irrevocable breakdown in the relationship between the patient and that contractor and notice of such a breakdown has been given to the patient and NHS England ;

(b) the patient; or

(c) a person specified in paragraph 1(2) of Schedule 3 acting on the patient's behalf.

Orthodontic treatment plans

6. —(1) Where the contractor has, following a case assessment, determined that orthodontic treatment should be provided to a patient, it shall, at the time of that case assessment, ensure that the patient is provided with an orthodontic treatment plan on a form supplied for that purpose by the Relevant Body which shall specify—

(a) the name of the patient;

(b) the name of the contractor;

(c) particulars of the places where the patient will receive orthodontic treatment;

(d) the telephone number at which the contractor may be contacted during normal surgery hours;

(e) details of the orthodontic treatment which is, at the date of the examination, considered necessary to secure the oral health of the patient;

(f) the NHS Charge, if any, in respect of those services if provided pursuant to the agreement; and

(g) subject to paragraph 11 of Schedule 3 (mixing of services provided under the contract with private services), any proposals the contractor may have for private services as an alternative to the services proposed under the agreement, including particulars of the cost to the patient if he were to accept the provision of private services.

(2) If the patient, having considered the treatment plan provided pursuant to sub-paragraph (1), decides to accept the provision of private services in place of orthodontic services under the agreement, the contractor shall ensure that the patient signs the treatment plan in the appropriate place to indicate that he has understood the nature of private services to be provided and his acceptance of those private services.

(3) Where, for clinical reasons, the services included in the orthodontic treatment plan under sub-paragraph (1) need to be varied, the contractor shall provide the patient with a revised orthodontic treatment plan in accordance with that sub-paragraph.

(4) Subject to paragraphs 5(4) and (5), the contractor shall provide the orthodontic services which are detailed in the orthodontic treatment plan provided pursuant to sub-paragraph (1) or, where the orthodontic treatment plan is revised, pursuant to the revised orthodontic treatment plan.

Monitoring outcomes

7. —(1) The agreement shall require the contractor to monitor, in accordance with this paragraph, the outcome of the orthodontic treatment it provides.

(2) The contractor shall, in respect of orthodontic courses of treatment it provides in which orthodontic treatment is provided following the case assessment, monitor the outcome of that orthodontic treatment in accordance with sub-paragraph (3).

(3) The contractor shall monitor the outcome of orthodontic treatment in accordance with “Methods to determine outcome of orthodontic treatment in terms of improvement and standards” in respect of—

(a) where the total number of cases is 20 or fewer, all the cases of orthodontic courses of treatment it provides; or

(b) where the total number of orthodontic courses of treatment provided is greater than 20—

(i) 20 of the cases; and

(ii) in addition, 10 per cent of the number of cases over 20,

of orthodontic courses of treatment it provides.

(4) The agreement shall specify the period of time which is relevant for calculating the number of orthodontic courses of treatment that need to be monitored in accordance with this paragraph.

(5) As part of its monitoring of the outcome of orthodontic treatment under paragraph (2), the contractor shall, in respect of the patients whose courses of treatment are monitored calculate a peer assessment rating of the patient's study casts—

(a) taken at or after the case assessment but prior to the commencement of orthodontic treatment; and

(b) taken at the completion of the orthodontic course of treatment,

using either Clinical Outcome Monitoring Program software or by applying the methodology set out in “An introduction to Occlusal Indices” .

(6) In sub-paragraph (5), “ peer assessment rating ” means an index of treatment standards in which individual scores for the components of alignment and occlusion are summed to calculate an overall score comparing pre- and post- treatment .

Completion of orthodontic courses of treatment

8. —(1) The contractor shall indicate on the form supplied to NHS England pursuant to paragraph 39 of Schedule 3 (notification of a course of treatment) whether or not the orthodontic course of treatment was completed.

(2) If NHS England requests in writing that the contractor provides reasons for the failure to complete one or more orthodontic courses of treatment, the contractor shall, within such period as NHS England may specify, provide the reasons for that failure.

(3) If NHS England —

(a) determines that the number of orthodontic courses of treatment provided by the contractor which have not been completed is excessive; and

(b) does not consider that the reasons given by the contractor for the failure to complete the orthodontic courses of treatment are satisfactory,

it shall be entitled to exercise its powers under paragraph 71 of Schedule 3 on the grounds that the contractor is not, pursuant to paragraph 5(3) of this Schedule , using its best endeavours to ensure orthodontic courses of treatment are completed.

Regulations 13 and 14

SCHEDULE 2 PROVISION OF SERVICES: UNITS OF DENTAL ACTIVITY AND UNITS OF ORTHODONTIC ACTIVITY

PART 1 UNITS OF DENTAL ACTIVITY

1. —(1) Where the contractor provides-—

(a) a Band 1 or Band 3 course of treatment; or

(b) a sub-band of a Band 2 course of treatment as set out in Part 1A of this Schedule,

the contractor provides the number of units of dental activity specified in the appropriate row of Table A.

(2) Where a banded course of treatment is commenced but not completed for whatever reason, the appropriate number of units of dental activity provided shall be calculated on the basis of the components of the course of the treatment which has been—

(a) completed;

(b) commenced but not completed.

(3) Where a patient is referred by the contractor for advanced mandatory services to another provider of primary dental services, the appropriate number of units of dental activity provided by—

(a) that contractor; and

(b) the other provider of primary dental services, if that provider is also a contractor,

must be calculated on the basis of the components of the course of treatment which they actually provide, notwithstanding that the treatment constitutes a single banded course of treatment for charging purposes.

2. Where the contractor provides a charge exempt course of treatment, the contractor provides the number of units of dental activity specified in the appropriate row of Table B.

PART 1A Band 2 courses of treatment – sub-bands

Sub-band 2a treatments

2A. The following Band 2 courses of treatments are within sub-band 2a—

(a) non-surgical periodontal treatment including root-planing, deep scaling, irrigation of periodontal pockets and subgingival curettage and all necessary scaling and polishing;

(b) surgical periodontal treatment, including gingivectomy, gingivoplasty or removal of an operculum;

(c) surgical periodontal treatment, including raising and replacement of a mucoperiostal flap, curettage, root planing and bone resection;

(d) free gingival grafts;

(e) sealant restorations;

(f) pulpotomy;

(g) apicectomy;

(h) transplantation of teeth;

(i) oral surgery including surgical removal of cyst, buried root, unerupted tooth, impacted tooth or exostosed tooth and alveolectomy;

(j) soft tissue surgery in relation to the buccal cavity and lips;

(k) frenectomy, frenoplasty and frenotomy;

(l) relining and rebasing dentures including soft linings;

(m) addition of tooth, clasp, labial or buccal flange to dentures;

(n) splints (other than laboratory fabricated splints) in relation to periodontally compromised teeth and in connection with external trauma;

(o) bite raising appliances (other than laboratory fabricated appliances);

(p) permanent fillings in amalgam, composite resin, synthetic resin, glass ionomer, compomers, silicate or silico-phosphate, including acid etch retention, if delivered to less than 3 teeth in single course of treatment;

(q) extraction of one or two teeth; and

(r) endodontic treatment of any retained deciduous teeth.

Sub-band 2b treatments

2B. The following Band 2 courses of treatments are within sub-band 2b—

(a) permanent fillings in amalgam, composite resin, synthetic resin, glass ionomer, compomers, silicate or silico-phosphate, including acid etch retention, if delivered to 3 or more teeth in single course of treatment;

(b) endodontic treatment of any permanent teeth, excluding molar teeth; and

(d) extraction of three or more teeth.

Sub-band 2c treatments

2C. The Band 2 course of treatment within sub-band 2c is endodontic treatment of permanent molar teeth.

PART 2 UNITS OF ORTHODONTIC ACTIVITY

3. —(1) Where the contractor provides an orthodontic course of treatment to a patient that solely consists of a case assessment, the contractor provides 1.0 unit of orthodontic activity.

(2) Where the contractor provides an orthodontic course of treatment to a patient aged under 10 years that consists of—

(a) a case assessment; and

(b) the provision of orthodontic treatment following the case assessment,

the contractor provides 4.0 units of orthodontic activity.

(3) Where the contractor provides an orthodontic course of treatment to a patient aged between 10 and 17 years of age that consists of—

(a) a case assessment; and

(b) the provision of orthodontic treatment to the patient following the case assessment,

the contractor provides 21.0 units of orthodontic activity.

(4) Where the contractor provides an orthodontic course of treatment to a patient who is aged 18 years or over that consists of—

(a) a case assessment; and

(b) the provision of orthodontic treatment to the patient,

the contractor provides 23.0 units of orthodontic activity.

(5) Where the contractor—

(a) provides a repair to an orthodontic appliance of a patient; and

(b) the orthodontic course of treatment in which that orthodontic appliance was provided is being provided by another contractor, hospital or relevant service provider under Part 1 of the Act,

the contractor provides 0.8 units of orthodontic activity.

Regulation 14A

SCHEDULE 2A PROVISION OF SERVICES: UNITS OF DENTAL ACTIVITY WHERE A CONTRACTOR HAS ELECTED TO ENTER INTO A PROTOTYPE AGREEMENT

1. —(1) Where a contractor holding a Blend A prototype agreement provides a banded course of treatment, for the purposes of the agreement the contractor is to be regarded as providing the number of units of dental activity specified in the appropriate row of Table A.

(2) Where a contractor holding a Blend B prototype agreement provides a banded course of treatment, for the purposes of the agreement the contractor is to be regarded as providing the number of units of dental activity specified in the appropriate row of Table B.

(3) Where a banded course of treatment is commenced under a prototype agreement but not completed for whatever reason, the appropriate number of units of dental activity provided is to be calculated on the basis of the components of the course of the treatment which have been —

(a) completed; and

(b) commenced but not completed.

(4) Where a patient is referred by the contractor for advanced mandatory services to another provider of primary dental services, the appropriate number of units of dental activity provided by—

(a) that contractor; and

(b) the other provider of primary dental services, if that provider is also a contractor,

must be calculated on the basis of the components of the course of treatment which each contractor actually provides, notwithstanding that the treatment constitutes a single banded course of treatment for charging purposes.

(5) Where the contractor provides a charge exempt course of treatment, for the purposes of the prototype agreement the contractor provides the number of units of dental activity specified in the appropriate row of Table C.

(6) For the purposes of this paragraph, “Blend A prototype agreement” and “Blend B prototype agreement” have the same meaning as in the Prototype SFE.

(7) This Schedule does not apply where the contractor is a CDS prototype contractor.

Regulation 20

SCHEDULE 3 OTHER CONTRACTUAL TERMS

PART 1 PATIENTS

Persons to whom mandatory services or additional services are to be provided

1. —(1) Subject to sub-paragraphs (3) and (5), the contractor may agree to provide mandatory or additional services under the agreement to any person if a request is made for such services by—

(a) the person who requires the services; or

(b) a person specified in sub-paragraph (2), on behalf of the person who requires those services.

(2) For the purposes of sub-paragraph (1)(b), a request for services may be made—

(a) on behalf of any child by—

(i) either parent;

(ii) a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989 ; or

(iii) a person duly authorised by a voluntary organisation by which the child is being accommodated under the provisions of that Act; or

(b) on behalf of any adult who is incapable of making such an application, or authorising such an application to be made on their behalf, by a relative or the primary carer of that person.

(3) The contractor may refuse to provide mandatory or additional services in relation to a person falling outside a specified group of persons only where the contract provides for the contractor to provide such services to a specified group.

(4) The contractor shall only refuse to provide services under the agreement to a person if it has reasonable grounds for doing so which do not relate to—

(a) a person’s age, sex (reassigned or otherwise), religion or belief, sexual orientation, race, cultural and linguistic background, any disability they may have, or medical or dental condition; or

(b) a person's decision or intended decision to accept private services in respect of himself or a family member.

(5) Sub-paragraph (1) does not apply—

(a) where the contractor is providing mandatory or additional services in a prison; or

(b) in any event to dental public health services.

Patient preference of practitioner

2. —(1) Where the contractor has agreed to provide services to a patient, it shall—

(a) notify the patient (or, in the case of a child or incapable adult, the person who made the application on their behalf) of the patient's right to express a preference to receive services from a particular performer; and

(b) record in writing any such preference expressed by or on behalf of the patient.

(2) The contractor shall endeavour to comply with any reasonable preference expressed under sub-paragraph (1) but need not do so if the preferred performer—

(a) has reasonable grounds for refusing to provide services to the patient; or

(b) does not routinely perform the services required by the patient within the practice.

(3) This paragraph does not apply—

(a) where the contractor is providing mandatory or additional services in a prison; or

(b) in any event to dental public health services.

Violent patients

3. —(1) Where—

(a) a patient of the contractor has committed an act of violence or behaved in such a way against any persons specified in sub-paragraph (2) as a consequence of which that person has feared for his safety; and

(b) the contractor has reported the incident to the police,

the contractor may notify NHS England that it will no longer provide services to that patient under the agreement.

(2) The persons referred to in sub-paragraph (1) are—

(a) any party to the agreement who is an individual;

(b) any member of the contractor's staff;

(c) a person engaged by the contractor to perform or assist in the performance of services under the agreement; or

(d) any other person present—

(i) on the practice premises; or

(ii) in the place where services were provided to the patient under the agreement.

(3) Notification under sub-paragraph (1) may be given by any means including telephone, fax or email but if not given in writing shall subsequently be confirmed in writing within seven days (and for this purpose a faxed or email notification is not a written one).

(4) The time at which the contractor notifies NHS England shall be the time at which it makes the telephone call or sends or delivers the notification to NHS England .

(5)NHS England shall—

(a) acknowledge in writing receipt of the notice from the contractor under sub-paragraph (1); and

(b) take all reasonable steps to inform the patient concerned as soon as is reasonably practicable.

Patients who refuse to pay NHS charges prior to the commencement of, or during, treatment

4. The contractor may—

(a) refuse to begin a course of treatment; or

(b) terminate a course of treatment prior to its completion,

if the contractor has, in accordance with the NHS Charges Regulations, requested that the patient pay a charge in respect of that course of treatment or orthodontic course of treatment, and that patient has failed to pay that charge.

Irrevocable breakdown in relationship between contractor and patient

5. Where—

(a) in the reasonable opinion of the contractor, there has been an irrevocable breakdown in the relationship between the patient and that contractor; and

(b) notice of such a breakdown has been given to the patient by the contractor,

the contractor may notify NHS England that it will no longer provide services to that patient under the agreement.

Friends and Family Test

5A.—(1) The contractor must give all patients who use the contractor's practice the opportunity to provide feedback about the service received from the practice through the Friends and Family Test.

(2) The contractor must—

(a) report the results of completedFriends and Family Tests to NHS England ; and

(b) publish the results of such completed tests,

in the manner approved by NHS England .

(3) In this paragraph, “Friends and Family Test” means the arrangements that the contractor is required by NHS England to implement to enable its patients to provide anonymous feedback about the patient experience at the contractor’s practice.

PART 2 PROVISION OF SERVICES

Mandatory services

6. Where the agreement provides for a contractor to provide mandatory services, the contractor must provide—

(a) urgent treatment, at such times as are agreed with NHS England and specified in the agreement; and

(b) all other mandatory services during normal surgery hours.

Course of treatment

7. —(1) Except in the case of orthodontic services and dental public health services, the contractor shall provide mandatory and additional services to a patient by providing to that patient a course of treatment.

(2) The contractor shall use its best endeavours to ensure that a course of treatment is completed, and that it is so completed within a reasonable time from the date on which—

(a) the treatment plan was written in accordance with paragraph 8(1); or

(b) where a treatment plan is not required pursuant to that paragraph, the initial examination and assessment of the patient took place.

(3) Where a contractor provides urgent treatment to a patient, the urgent treatment provided shall constitute a single course of treatment and no other services shall be provided during that course of treatment.

(4) If a course of treatment is—

(a) terminated before it has been completed; or

(b) otherwise not completed within a reasonable time,

any further services to be provided to that patient under the agreement must be provided as a new course of treatment.

(5) A course of treatment may only be terminated by—

(a) the contractor—

(i) when the circumstances referred to in paragraph 3(1) of this Schedule (violent patient) occur and notice that it will no longer provide services has been given to NHS England ;

(ii) where the patient has refused to pay a charge in the circumstances referred to in paragraph 4 of this Schedule (refusal to pay NHS Charges during treatment); or

(iii) where, in the reasonable opinion of the contractor, there has been an irrevocable breakdown in the relationship between the patient and the contractor and notice of such a breakdown has been given to the patient and NHS England ;

(b) the patient; or

(c) a person specified in paragraph 1(2) acting on the patient's behalf.

(6) If a contractor is unable to complete the course of the treatment which has been commenced for reasons beyond its control, it shall give notice to NHS England of the extent of the treatment so provided and the reason for his inability to complete the remainder.

Treatment plans

8. —(1) Subject to sub-paragraph (5), where the contractor agrees to provide a course of treatment to a patient, it shall, at the time of the initial examination and assessment of that patient, ensure that the patient is provided with a treatment plan on a form supplied for that purpose by NHS England which shall specify—

(a) the name of the patient;

(b) the name of the contractor;

(c) particulars of the places where the patient will receive services;

(d) the telephone number at which the contractor may be contacted during normal surgery hours;

(e) details of the services (if any) which are, at the date of the examination, considered necessary to secure the oral health of the patient;

(f) the NHS charge, if any, in respect of those services if provided pursuant to the agreement; and

(g) any proposals the contractor may have for private services as an alternative to the services proposed under the agreement, including particulars of the cost to the patient if he were to accept the provision of private services.

(2) If the patient, having considered the treatment plan provided pursuant to sub-paragraph (1), decides to accept the provision of private services in place of all or part of services under the agreement, the contractor shall ensure that the patient signs the treatment plan in the appropriate place to indicate that he has understood the nature of private services to be provided and his acceptance of those services.

(3) Where the services included in the treatment plan under this paragraph need to be varied, the contractor shall provide the patient with a revised treatment plan in accordance with sub-paragraph (1).

(4) Subject to paragraph 7(5), the contractor shall provide the services which are detailed in the treatment plan, or where the treatment plan is revised, the revised treatment plan.

(5) The obligation to provide a treatment plan under this paragraph shall not apply to a Band 1 course of treatment or a charge exempt course of treatment unless—

(a) the contractor is providing privately any part of that course of treatment pursuant to paragraph 11; or

(b) the patient has requested that he be provided with written details of the course of treatment to be provided or that has been provided to him, whether or not he specifically requests a treatment plan.

(6) Where a patient requests the contractor to provide him with a summary of the care and treatment provided under the treatment plan because he intends to receive services from another contractor, the contractor shall provide him with such a summary as he considers appropriate (including details of the care and treatment which could not easily be observed on visual examination).

(7) The summary referred to in sub-paragraph (6) shall be supplied to the patient on a form supplied for that purpose by NHS England within 28 days of that request.

(8) Where, by virtue of this paragraph, a person is required to include anything in a treatment plan or a summary, or to ensure a patient signs a treatment plan, but as a consequence of a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, for the period specified in the announcement, that requirement is to be waived or modified in the manner specified in the announcement, that requirement is waived or is as modified in the specified manner for the specified period.

(9)Modifications under sub-paragraph (8) may include modifications imposing requirements on a person other than the person who, but for the announcement, would be required to include anything in a treatment plan or a summary or to ensure a patient signs a treatment plan.

(10) An announcement under sub-paragraph (8) may be withdrawn or amended at any time.

Completion of courses of treatment

9. —(1) The contractor shall indicate on the form supplied by NHS England pursuant to paragraph 39 whether the course of treatment was completed, and if the course of treatment was not completed, provide the reason for the failure to complete the course of treatment.

(2) If NHS England —

(a) determines that the number of courses of treatment provided by the contractor which have not been completed is excessive; and

(b) does not consider that the reasons given by the contractor for the failure to complete the courses of treatment are satisfactory,

it shall be entitled to exercise its powers under paragraph 59(2) on the grounds that the contractor is not, pursuant to paragraph 7(2), using its best endeavours to ensure courses of treatment are completed.

Referral to another contractor, a hospital or other relevant service provider for advanced mandatory, domiciliary or sedation services

10. —(1) Where a patient requires advanced mandatory services, domiciliary services or sedation services that are not provided under the agreement by the contractor, it shall, if the patient agrees, refer that patient in accordance with sub-paragraph (2) for the provision of a referral service by an alternative contractor, a hospital or other relevant service provided under Part 1 of the Act.

(2) In referring a patient pursuant to sub-paragraph (1), the contractor shall provide—

(a) to the patient being referred, a referral notice on a form supplied for that purpose by NHS England ... which shall specify the services detailed on the treatment plan which will be carried out by the alternative contractor, hospital or other relevant service provider; and

(b) to the alternative contractor, hospital or other relevant service provider, either at the time of referral or as soon as reasonably practicable thereafter—

(i) a copy of the treatment plan provided to the patient pursuant to paragraph 8;

(ii) a copy of the referral notice; and

(iii) a statement of the amount paid to it, or due to be paid to it, by the patient under the NHS Charges Regulations in respect of the course of treatment during which the referral is made.

(3) Where the patient notifies the contractor, whether verbally or in writing, that he does not wish to be referred to the alternative contractor, hospital or other relevant service provider selected by the contractor, the contractor shall, if requested to do so by the patient, use its best endeavours to refer the patient to another suitable contractor, hospital or other relevant service provider under Part 1 of the Act for the provision of the referral service.

Mixing of services provided under the agreement with private services

11. —(1) Subject to sub-paragraph (2) and the requirements in paragraphs 2 (referral services) and 6 (orthodontic treatment plans) of Schedule 1 and paragraph 8(1)(g) of this Schedule, a contractor may, with the consent of the patient, provide privately any part of a course of treatment or orthodontic course of treatment for that patient, including in circumstances where that patient has been referred to the contractor for a referral service.

(2) A contractor may—

(a) not provide privately or under the agreement treatment that involves the administration of general anaesthesia or the provision of sedation; and

(b) in the case of an orthodontic course of treatment provide—

(i) the case assessment wholly privately or wholly under the agreement; and

(ii) the orthodontic treatment wholly privately or wholly under the agreement.

(3) A contractor shall not, with a view to obtaining the agreement of a patient to undergo services privately—

(a) advise a patient that the services which are necessary in his case are not available from the contractor under the agreement; or

(b) seek to mislead the patient about the quality of the services available under the agreement.

(4) In sub-paragraph (2)(a), “ provision of sedation ” means the provision of one or more drugs to a patient in order to produce a state of depression of the central nervous system to enable treatment to be carried out.

Repair or replacement of restorations

12. —(1) Subject to sub-paragraph (5), where a restoration specified in sub-paragraph (2) needs to be repaired or replaced the contractor shall repair or replace the restoration at no charge to the patient.

(2) The restorations referred to in sub-paragraph (1) are any filling, root filling, inlay, porcelain veneer or crown provided by the contractor to a patient in the course of providing services under the agreement, including referral services, which, within the relevant period, has to be repaired or replaced to secure oral health.

(3) The repair or replacement of a restoration specified in sub-paragraph (2) is a banded course of treatment for the purposes of calculating the number of units of dental activity and paragraph 1 of Schedule 2 shall apply notwithstanding that no charge is made or recovered in accordance with the NHS Charges Regulations.

(4) The band in which the restoration specified in sub-paragraph (2) falls shall be determined in accordance with the NHS Charges Regulations and if such restoration falls within a Band 2 course of treatment, the applicable sub-band for the purpose of calculating the appropriate number of units of dental activity shall be determined in accordance with Parts 1 and 1A of Schedule 2 .

(5) Sub-paragraph (1) shall not apply where—

(a) within the relevant period, a person other than the contractor has provided treatment on the tooth in respect of which the restoration was provided;

(b) the contractor advised the patient at the time of the restoration and indicated on the patient record that—

(i) the restoration was intended to be temporary in nature; or

(ii) in its opinion, a different form of restoration was more appropriate to secure oral health but, notwithstanding that advice, the patient nevertheless requested the restoration which was provided;

(c) in the opinion of the contractor, the condition of the tooth in respect of which the restoration was provided is such that the restoration cannot satisfactorily be repaired or replaced and different treatment is now required; or

(d) the repair or replacement is required as a result of trauma.

(6) In this paragraph “ the relevant period ” means the 12 month period beginning on the date on which the restoration was provided, and ceasing twelve months after that date.

Premises, facilities and equipment

13. —(1) The contractor shall ensure that the premises used for the provision of services under the agreement are—

(a) suitable for the delivery of those services; and

(b) sufficient to meet the reasonable needs of the contractor's patients.

(2) The obligation in sub-paragraph (1) includes providing proper and sufficient waiting-room accommodation for patients.

(3) The contractor shall provide, in relation to all of the services to be provided under the agreement, such other facilities and equipment as are necessary to enable it to properly perform that service.

(4) In this paragraph, “ premises ” includes a mobile surgery.

Telephone services

14. —(1) The contractor shall not be a party to any contract or other arrangement under which the number for telephone services to be used by—

(a) patients to contact the practice for any purpose related to the agreement; or

(b) any other person to contact the practice in relation to services provided as part of the health service,

starts with the digits 087, 090 or 091 or consists of a personal number, unless the service is provided free to the caller.

(2) In this paragraph, “ personal number ” means a telephone number which starts with the number 070 followed by a further 8 digits.

National Institute for Clinical Excellence guidance

15. The contractor shall provide services under the agreement in accordance with any relevant guidance that is issued by the National Institute for Clinical Excellence , in particular the guidance entitled “Dental recall - Recall interval between routine dental examinations” .

Infection control

16. The contractor shall ensure that it has appropriate arrangements for infection control and decontamination.

Treatment under general anaesthesia: prohibition

17. —(1) Subject to sub-paragraph (2), the contractor shall not provide any services under the agreement that involve the provision of general anaesthesia.

(2) Where the contractor is NHS England , an NHS Foundation Trust or an NHS Trust, that contractor may provide general anaesthesia in accordance with guidance issued by the General Dental Council in “Standards for Dental Professions” .

PART 3 SUPPLY OF DRUGS AND PRESCRIBING

General

18. The contractor shall ensure that any prescription form for listed drugs, medicines or appliances issued by a prescriber complies as appropriate with the requirements in this Part.

Supply of drugs

19. —(1) A presciber may supply to a patient such listed drugs, medicines or appliances as are required for immediate use before the issue of a prescription for such drugs, medicines or appliances in accordance with paragraph 20.

(2) A prescriber may personally administer to a patient any drug or medicine required for the treatment of that patient.

Issue of prescription forms

20. —(1) A prescriber shall order listed drugs, medicines or appliances (other than those supplied under paragraph 19) as are needed for the treatment of any patient to whom it is providing services under the agreement by issuing to the patient a prescription form.

(2) The prescription form shall—

(a) be signed by the prescriber; and

(b) be issued separately to each patient to whom the contractor is providing services under the agreement,

and a separate prescription form shall be issued for each patient.

(3) For the purposes of this paragraph, “prescription form” means a form that is supplied for the purposes of paragraph (1) by NHS England .

Excessive prescribing

21. The contractor shall not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of that patient.

PART 4 PERSONS WHO PERFORM SERVICES

Dental Practitioners

22. A dental practitioner may perform dental services under the contract provided—

(a) that dental practitioner is included in the dental performers list held by NHS England ; and

(b) that dental practitioner’s inclusion in that list is not subject to a suspension.

Dental care professionals

23. —(1) Prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act (professions complementary to dentistry)—

(a) a dental hygienist; or

(b) a dental therapist,

may perform dental services under the agreement provided he is enrolled in the appropriate register established in accordance with the Dental Auxiliaries Regulations 1986 .

(2) Upon the coming into force of the first regulations under section 36A(2) of the Dentists Act—

(a) a dental hygienist;

(b) a dental therapist; or

(c) a professional or member of a class as specified in regulations made under section 36A(2) of the Dentists Act,

may perform dental services under the agreement provided he is—

(i) a dental care professional; and

(ii) his registration in the dental care professional register established under section 36B of the Dentists Act is not subject to a suspension.

Performers: further requirements

24. —(1) No health care professional or other person other than one to whom paragraph 23 applies shall perform clinical services under the agreement unless he is appropriately registered with his relevant professional body and his registration is not subject to a suspension.

(2) Where—

(a) the registration of a dental practitioner, dental care professional or other health care professional; or

(b) a dental practitioner's inclusion in the dental performers list held by NHS England ,

is subject to conditions, the contractor shall ensure compliance with those conditions in so far as they are relevant to the agreement.

(3) No health care professional or other person shall perform any clinical services under the agreement unless he has such clinical experience and training as are necessary to enable him properly to perform such services.

Conditions for employment and engagement: dental practitioners performing dental services

25.—(1) A contractor must not employ or engage a dental practitioner to perform dental services under the contract unless the contractor has checked that the practitioner meets the requirements in paragraph 22.

(2) Where the employment or engagement of a dental practitioner is urgently needed and it is not possible to check the matters referred to in paragraph 22 in accordance with sub-paragraph (1)(b) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to seven days whilst such checks are undertaken.

Conditions for employment and engagement: persons performing dental services other than dental practitioners

26. —(1) The contractor shall not employ or engage a dental care professional to perform dental services unless it has taken reasonable steps to satisfy itself that he has the clinical experience and training necessary to enable him to properly perform dental services and—

(a) prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act, the contractor has checked that his name is on the roll of the appropriate register established in accordance with the Dental Auxiliaries Regulations 1986; and

(b) from the coming into force of the first regulations under section 36A(2) of the Dentists Act, the contractor has checked that—

(i) his name is included in the register of dental care professionals; and

(ii) his registration in the dental care professional register is not subject to a suspension.

(2) Where the employment or engagement of a person specified in sub-paragraph (1) is urgently needed and it is not possible to check the references referred to in sub-paragraph (1) (where it applies) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to seven days whilst such checks are undertaken.

(3) When considering a person's experience and training for the purposes of sub-paragraph (1), the contractor shall have regard in particular to—

(a) any post-graduate or post-registration qualification held by that person; and

(b) any relevant training undertaken by him and any relevant clinical experience gained by him.

Conditions for employment and engagement: all persons performing dental services

27. —(1) The contractor shall not employ or engage a person to perform dental services under the agreement unless—

(a) that person has provided two clinical references that relate to two recent posts (which may include any current post) exercising the profession in which he seeks employment or engagement with the contractor which lasted for three months or more without a significant break, or where this is not possible, that person has provided a full explanation and alternative referees; and

(b) the contractor has checked and is satisfied with the references.

(2) Where the employment or engagement of a person falling within sub-paragraph (1) is urgently needed and it is not possible for the contractor to check the references in accordance with sub-paragraph (1)(b) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to 14 days whilst his references are checked and considered, and for an additional period of a further seven days if the contractor believes the person supplying those references is ill, on holiday or otherwise temporarily unavailable.

(3) Where the contractor employs or engages the same person on more than one occasion within a period of three months, it may rely on the references provided on the first occasion, provided that those references are not more than 12 months old.

Conditions for employment or engagement: persons assisting in the provision of services under the agreement

28. —(1) Before employing or engaging any person to assist it in the provision of services under the agreement, the contractor shall take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which he is to be employed or engaged.

(2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 25 to 27.

(3) When considering the competence and suitability of any person for the purpose of sub-paragraph (1), the contractor shall have regard, in particular, to—

(a) that person's academic and vocational qualifications;

(b) his education and training; and

(c) his previous employment or work experience.

Training

29. —(1) The contractor shall ensure that for any dental practitioner or dental care professional who is—

(a) performing dental services under the contract; or

(b) employed or engaged to assist in the performance of such services,

arrangements are in place for the purpose of maintaining and updating his skills and knowledge in relation to the services which he is performing or assisting in performing.

(2) The contractor shall afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee's competence.

Level of skill

30. The contractor shall carry out its obligations under the contract with reasonable care and skill.

Appraisal and assessment

31. The contractor shall ensure that any dental practitioner performing services under the agreement—

(a) participates in the appraisal system (if any) provided by NHS England ; and

(b) co-operates with NHS England in relation to patient safety.

Sub-contracting of clinical matters

32. —(1) The contractor shall not sub-contract any of its rights or duties under the agreement to any person in relation to clinical matters unless—

(a) it has taken reasonable steps to satisfy itself that—

(i) it is reasonable in all the circumstances; and

(ii) that the person is qualified and competent to provide the service; and

(b) it is satisfied in accordance with paragraphs 79 and 80 that the sub-contractor holds adequate insurance.

(2) Where the contractor sub-contracts any of its rights or duties under the agreement in relation to clinical matters, it shall—

(a) inform NHS England of the sub-contract as soon as is reasonable practicable; and

(b) provide NHS England with such information in relation to the sub-contract as it reasonably requests.

(3) Where the contractor sub-contracts clinical services in accordance with sub-paragraph (1), the parties to the agreement shall be deemed to have agreed a variation to the agreement which has the effect of adding to the list of the contractor's premises any premises which are to be used by the sub-contractor for the purpose of the sub-contract and paragraph 60 shall not apply.

(4) A contract with a sub-contractor must prohibit the sub-contractor from sub-contracting the clinical services it has agreed with the contractor to provide.

PART 5 RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY

Patient records

33. —(1) The contractor shall ensure that a full, accurate and contemporaneous record is kept in the patient record in respect of the care and treatment given to each patient under the agreement, including treatment given to a patient who is referred to the contractor.

(2) The patient record may be kept in electronic form.

(3) The patient record shall include details of any private services (to the extent that it is provided with services under the agreement) and shall be kept with—

(a) a copy of any treatment plan or referral treatment plan given to the patient pursuant to paragraph 2 of Schedule 1 (referral services) or paragraph 8 of this Schedule;

(b) all radiographs, photographs and study casts taken or obtained by it as part of the services provided to that patient;

(c) where an orthodontic course of treatment has been provided to a patient, a copy of the orthodontic treatment plan;

(d) where information is to be submitted to NHS England ... in accordance with paragraph 39 and that information is submitted or collated electronically—

(i) the written declaration form in respect of exemption under paragraph 1(1) of Schedule 12ZA to the Act duly made and completed in accordance with regulations made under section 79 of, and paragraph 7(a) to Schedule 12ZA to, that Act; and

(ii) a note of the evidence in support of that declaration; and

(e) the statement concerning any custom-made devices provided by any person as a consequence of regulation 15 of the Medical Devices Regulations 2002(procedures for custom-made devices) in respect of services being provided to that patient.

(4) The patient record and the items referred to in sub-paragraph (3) shall be retained for a period of two years beginning with—

(a) the date on which—

(i) a course of treatment or orthodontic course of treatment is terminated; or

(ii) a course of treatment or an orthodontic course of treatment is completed; or

(b) in respect of courses of treatment or orthodontic courses of treatment not falling within paragraph (a)(i) or (a)(ii) the date by which no more services can be provided as part of that course of treatment or orthodontic course of treatment by virtue of paragraph 5(4)(b) of Schedule 1 or paragraph 7(4)(b) of this Schedule.

(5) Nothing in this paragraph shall affect any property right which the contractor may have in relation to the records, radiographs, photographs and study models referred to in this paragraph.

Confidentiality of personal data

34. The contractor shall nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.

Patient information

35. —(1) The contractor shall ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access—

(a) in respect of its practice based quality assurance system referred to in paragraph 78, a written statement relating to its commitment to the matters referred to in paragraph 78(4);

(b) such information relating to NHS Charges as is supplied by NHS England for the purposes of providing information to patients; and

(c) information about the complaints procedure which it operates in accordance with Part 6, giving the name and title of the person nominated by the contractor in accordance with paragraph 50(2)(a).

(2) The contractor shall—

(a) compile a document (in this paragraph called a “patient information leaflet”) which shall include the information specified in Schedule 4;

(b) review its patient information leaflet at least once in every period of 12 months and make any amendments necessary to maintain its accuracy; and

(c) make available a copy of the leaflet, and any subsequent updates, to its patients and prospective patients.

(3) The requirements in sub-paragraph (2) do not apply to any contractor to the extent that it provides services to persons detained in prison.

Information about the contractor’s practice

35A.—(1) The contractor must ensure that a comprehensive and accurate profile in respect of its practice is provided to NHS England for the purpose of display on the NHS.uk website.

(2) The contractor must review the information contained in the profile referred to in paragraph (1) at least once in every period of 90 days from the date the profile is provided in accordance with paragraph (1).

(3) If, on such a review, it appears to the contractor that any of that information is inaccurate or incomplete, the contractor must provide NHS England with an updated profile in respect of its practice.

Provision of and access to information: NHS England

36. —(1) The contractor shall, at the request of NHS England —

(a) produce to NHS England or to a person authorised in writing by NHS England in such format, and at such intervals or within such time, as NHS England specifies; or

(b) allow NHS England , or a person authorised in writing by it to access,

the information specified in sub-paragraph (2).

(2) The information specified for the purposes of sub-paragraph (1) is—

(a) any information which is reasonably required by NHS England for the purposes of or in connection with the agreement; and

(b) any other information which is reasonably required in connection with NHS England’s functions,

and includes the contractor's patient records.

Requests for information from Patients' Forums

37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inquiries about prescriptions and referrals

38. —(1) A contractor shall, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from NHS England concerning—

(a) any prescription form issued by a prescriber;

(b) the considerations by reference to which prescribers issue such forms;

(c) the referral by or on behalf of the contractor of any patient for any other services provided under the Act; or

(d) the considerations by which the contractor makes such referrals or provides for them to be made on its behalf.

(2) An inquiry referred to in sub-paragraph (1) may only be made for the purpose either of obtaining information to assist NHS England to discharge its functions or of assisting the contractor in the discharge of its obligations under the agreement.

(3) The contractor shall not be obliged to answer any inquiry referred to in sub-paragraph (1) unless it is made—

(a) in the case of sub-paragraph (1)(a) or (1)(b), by an appropriately qualified health care professional; or

(b) in the case of sub-paragraph (1)(c) or (1)(d), by an appropriately qualified dental practitioner,

appointed in either case by NHS England to assist it in the exercise of its functions under this paragraph and the person produces, on request, written evidence that he is authorised by NHS England to make such inquiry on its behalf.

Notification of a course of treatment, orthodontic course of treatment etc.

39. —(1) Subject to paragraph (2), the contractor shall, within two months of the date upon which—

(a) it completes a course of treatment in respect of mandatory or additional services;

(b) it completes a case assessment in respect of an orthodontic course of treatment that does not lead to a course of treatment;

(c) it provides an orthodontic appliance following a case assessment in respect of orthodontic treatment;

(d) it completes a course of treatment in respect of orthodontic treatment;

(e) it completes a course of treatment in respect of mandatory services or additional services or orthodontic course of treatment is terminated; or

(f) in respect of courses not falling with sub-paragraph (d) or (e), no more services can be provided by virtue of paragraph 5(4)(b) of Schedule 1 (orthodontic course of treatment) or paragraph 7(4)(b) of this Schedule,

subject to sub-paragraph (5), send to NHS England by means of electronic submission , the information specified in paragraph (3).

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The information referred to in sub-paragraphs (1) and (2) comprise of —

(a) details of the patient to whom it provides services;

(b) details of the services provided (including any appliances provided) to that patient;

(c) details of any NHS Charge payable and paid by that patient; and

(d) in the case of a patient who is exempt from NHS Charges, the information required under sub-paragraph (4).

(4) In the case of a patient who is exempt from NHS Charges, the contractor must provide NHS England (or a person authorised on NHS England's behalf) with—

(a) such details of that exemption as NHS England may reasonably request; and

(b) the written declaration.

(5)NHS England may accept submission of the information mentioned in sub-paragraph (2) in paper form in such exceptional circumstances as NHS England may reasonably determine.

(6) In this regulation, ‘electronic submission’ means the submission of information electronically via a computer system approved by NHS England .

Annual report and review

40. —(1)NHS England shall provide to the contractor an annual report relating to the agreement which shall contain the same categories of information for all persons who hold agreements with NHS England .

(2) Once NHS England has provided the report referred to in sub-paragraph (1), NHS England shall arrange with the contractor an annual review of its performance in relation to the agreement.

(3)NHS England shall prepare a draft record of the review referred to in sub-paragraph (2) for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

(4) A copy of the final record referred to in sub-paragraph (3) shall be sent to the contractor.

Notifications to NHS England

41. —(1) In addition to any requirements of notification elsewhere in these Regulations, the contractor shall notify NHS England in writing, as soon as reasonably practicable, of—

(a) any serious incident that, in the reasonable opinion of the contractor, affects or is likely to affect the contractor's performance of its obligations under the agreement; or

(b) any circumstances which give rise to NHS England’s right to terminate the agreement under paragraph 68 or 69(1).

(2) The contractor shall, unless it is impracticable for it to do so, notify NHS England in writing within 28 days of any occurrence requiring a change in the information about it published by NHS England in accordance with regulations made under section 16CA(3) of the Act (primary dental services).

(3) The contractor shall give notice in writing to NHS England when a dental practitioner who is performing or will perform services under the agreement—

(a) leaves the contractor, and the date upon which he left; or

(b) is employed or engaged by the contractor,

which shall include the name of the dental practitioner who has left, or who has been employed or engaged, together with his professional registration number.

Notice provisions specific to an agreement with a dental corporation

42. Where a dental corporation is a party to the agreement, it shall give notice in writing to NHS England forthwith when—

(a) it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

(b) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the contractor;

(c) circumstances arise which would enable the court to make a winding up order in respect of the contractor; or

(d) the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts).

Notice provisions specific to an agreement with a company limited by shares

42A.—(1) Where a company limited by shares is a party to the agreement, it shall give notice in writing to NHS England forthwith when—

(a) it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

(b) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the contractor;

(c) circumstances arise which would enable the court to make a winding up order in respect of the contractor;

(d) the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts); or

(e) changes take place in relation to the ownership of shares in the company.

(2) A notice under sub-paragraph (e) must—

(a) provide the name of any person ceasing to own a share in the company;

(b) provide the name of any new person acquiring a share in the company; and

(c) confirm that following any changes in share ownership, that the company continues to meet the conditions in section 108(1A) of the 2006 Act.

Notice provisions specific to an agreement with a limited liability partnership

42B.—(1) Where a limited liability partnership is a party to an agreement it shall give notice to NHS England forthwith when—

(a) it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

(b) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the contractor;

(c) circumstances arise which would enable the court to make a winding up order in respect of the contractor;

(d) the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts); or

(e) any membership changes are notified in accordance with section 9 of the Limited Liability Partnership Act 2000 (registration of membership changes) to the registrar (within the meaning of that Act) in relation to a person who becomes or ceases to be a member or designated member (within the meaning of that Act) and the notice must specify the date on which that person becomes or ceases to be a member or designated member (as the case may be).

(2) A notice under sub-paragraph (e) must confirm—

(a) that any new member joining the partnership meets the conditions imposed by regulation 4 (general conditions relating to all agreements); and

(b) following the membership changes, that sub-sections 108(1B) or 108(1C) of the 2006 Act continue to apply to the partnership.

Notifications to patients following a variation of the agreement

43. Where the agreement is varied in accordance with Part 9 of this Schedule and, as a result of that variation there is to be a change in the range of services provided by the contractor, the contractor shall ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access, written details of that change.

Notification provisions specific to prototype agreements

43A. Where the contractor has elected to enter into a prototype agreement, except for CDS prototype contractors, the contractor shall —

(a) send to NHS England details of any private treatment provided to a capitated patient attending the practice, in electronic form, whether or not this treatment is associated with services that are provided under the prototype agreement; and

(b) provide to all patients attending for treatment at its practice a privacy notice in a form approved by NHS England notifying them about the obligation referred to in sub-paragraph (a).

Entry and inspection by NHS England

44. —(1) Subject to—

(a) the conditions in sub-paragraph (2); and

(b) sub-paragraph (3),

the contractor shall allow persons authorised in writing by NHS England to enter and inspect the practice premises at any reasonable time.

(2) The conditions referred to in sub-paragraph (1)(a) are that—

(a) reasonable notice of the intended entry has been given;

(b) written evidence of the authority of the person seeking entry is produced to the contractor on request; and

(c) entry is not made to any premises or part of the premises used as residential accommodation without the consent of the resident.

(3) Where the contractor is providing services under the agreement in a prison, the contractor shall not be obliged to comply with sub-paragraph (1), or paragraph ... 46, if—

(a) the contractor has used its best endeavours to allow NHS England ... or the Care Quality Commission to enter and inspect the practice premises; but

(b) entry and inspection has been prevented by the prison authorities despite the contractor's best endeavours.

(4) In this paragraph “ practice premises ” includes a mobile surgery.

Entry and inspection by members of Patients' Forums

45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entry and inspection by the Care Quality Commission

46. Subject to paragraph 44(3), the contractor shall allow persons authorised by the Care Quality Commission to enter and inspect the premises in accordance with section 62 of the Health and Social Care Act 2008 (entry and inspection).

Entry and viewing by Local Healthwatch organisations

46A. The contractor must comply with the requirement to allow an authorised representative to enter and view premises and observe the carrying-on of activities on those premises in accordance with regulations made under section 225 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors) of the Local Government and Public Involvement Health Act 2007.

PART 5A COMPLAINTS RECEIVED ON OR AFTER 1ST APRIL 2009

46B. As regards complaints relating to any matter reasonably connected with the provision of services under the agreement which are received on or after 1st April 2009, the contractor must have in place a complaints procedure which meets the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009.

PART 6 COMPLAINTS

Complaints procedure

47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Making of complaints

48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Period for making complaints

49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Further requirements for complaints procedures

50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Co-operation with investigations

51. —(1) The contractor ... shall co-operate with—

(a) any investigation of a complaint in relation to any matter reasonably connected with the provision of services under the agreement undertaken by—

(i) NHS England ; and

(ii) the Health Service Commissioner ; and

(b) any investigation of a complaint by an NHS body or local authority which relates to a patient or former patient of the contractor.

(2) In sub-paragraph (1)—

“ NHS body ” means NHS England , an NHS trust, an NHS foundation trust, ... a Local Health Board, a Health Board, a Health and Social Services Board, a Health and Social Services Trust or, a Health Board or Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978 ;

“ local authority ” means—

“ Health Service Commissioner ” means the person appointed Health Service Commissioner for England in accordance with section 1 of, and Schedule 1 to, the Health Service Commissioners Act 1993.

(3) The co-operation required by sub-paragraph (1) includes—

(a) answering questions reasonably put to the contractor by NHS England ;

(b) providing any information relating to the complaint reasonably required by NHS England ; and

(c) attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given) if the contractor's presence at the meeting is reasonably required by NHS England .

Provision of information

52. The contractor ... shall inform NHS England , at such intervals as NHS England requires, of the number of complaints it has received under the procedure established in accordance with this Part.

PART 7 DISPUTE RESOLUTION

Local resolution of agreement disputes

53. In the case of any dispute arising out of, or in connection with, the agreement, the contractor and NHS England must make every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

Dispute resolution: non-NHS contracts

54.—(1) In the case of an agreement that is not an NHS contract, any dispute arising out of or in connection with the agreement, except matters dealt with under the complaints procedure pursuant to Part 6, may be referred for consideration and determination to the Secretary of State—

(a) if it relates to a period when the contractor was a health service body, by the contractor or by NHS England ; or

(b) in any other case, by the contractor or, if the contractor agrees in writing, by NHS England .

(2) In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—

(a) the procedure to be followed is the NHS dispute resolution procedure; and

(b) the parties agree to be bound by any determination made by the adjudicator.

NHS dispute resolution procedure

55. —(1) The procedure specified in the following sub-paragraphs and paragraph 56 applies in the case of any dispute arising out of or in connection with the agreement which is referred to the Secretary of State—

(a) in accordance with section 4(3) of the 1990 Act (where the agreement is an NHS contract); or

(b) in accordance with paragraph 54(1) (where the agreement is not an NHS contract).

(2) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) shall send to the Secretary of State a written request for dispute resolution which shall include or be accompanied by—

(a) the names and addresses of the parties to the dispute;

(b) a copy of the agreement; and

(c) a brief statement describing the nature and circumstances of the dispute.

(3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of three years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.

(4) Where the dispute relates to an agreement which is not an NHS contract, the Secretary of State may determine the matter herself or, if she considers it appropriate, appoint a person or persons to consider and determine it .

(5) Before reaching a decision as to who should determine the dispute, either under sub-paragraph (4) or under section 4(5) of the 1990 Act, the Secretary of State shall, within the period of seven days beginning with the date on which a matter was referred to her, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.

(6) The Secretary of State shall give, with the notice given under sub-paragraph (5), to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred to dispute resolution.

(7) The Secretary of State shall give a copy of any representations received from a party to the other party and shall in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

(8) Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (5) or (7), the Secretary of State shall, if she decides to appoint a person or persons to hear the dispute—

(a) inform the parties in writing of the name of the person or persons whom she has appointed; and

(b) pass to the person or persons so appointed any documents received from the parties under or pursuant to paragraph (2), (5) or (7).

(9) For the purpose of assisting him in his consideration of the matter, the adjudicator may—

(a) invite representatives of the parties to appear before him to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which he wishes them to give special consideration; or

(b) consult other persons whose expertise he considers will assist him in his consideration of the matter.

(10) Where the adjudicator consults another person under sub-paragraph (9)(b), he shall notify the parties accordingly in writing and, where he considers that the interests of any party might be substantially affected by the result of the consultation, he shall give to the parties such opportunity as he considers reasonable in the circumstances to make observations on those results.

(11) In considering the matter, the adjudicator shall consider—

(a) any written representations made in response to a request under sub-paragraph (5), but only if they are made within the specified period;

(b) any written observations made in response to a request under sub-paragraph (7), but only if they are made within the specified period;

(c) any oral representations made in response to an invitation under sub-paragraph (9)(a);

(d) the results of any consultation under sub-paragraph (9)(b); and

(e) any observations made in accordance with an opportunity given under sub-paragraph (10).

(12) In this paragraph, “ specified period ” means such period as the Secretary of State shall specify in the request, being not less than two, nor more than four weeks, beginning with the date on which the notice referred to is given, but the Secretary of State may, if she considers that there is good reason for doing so, extend any such period (even after it has expired) and, where she does so, a reference in this paragraph to the specified period is to the period as so extended.

(13) Subject to the other provisions of this paragraph and paragraph 56, the adjudicator shall have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

Determination of dispute

56. —(1) The adjudicator shall record his determination and the reasons for it in writing and shall give notice of the determination (including a record of the reasons) to the parties.

(2) In the case of any dispute referred for determination in accordance with paragraph 54(1), subsection (8) of section 4 of the 1990 Act shall apply as that subsection applies in the case of any dispute referred for determination in accordance with subsection (3) of section 4 of that Act.

Interpretation of Part 7

57. —(1) In this Part, “ any dispute arising out of, or in connection with, the agreement ” includes any dispute arising out of, or in connection with, the termination of the agreement.

(2) Any term of the agreement that makes provision in respect of the requirements in this Part shall survive even where the agreement has terminated.

PART 8 MID-YEAR REVIEW OF ACTIVITY UNDER AGREEMENTS

Mid-year reviews

58. —(1) This paragraph and paragraph 59 apply where services are to be provided under the agreement from 1st April in any financial year.

(2) In this paragraph and paragraph 59, references to requirements to provide units of dental activity or units of orthodontic activity are to such requirements under the terms of the agreement giving effect to regulation 13 (units of dental activity) or 14 (units of orthodontic activity).

(3)NHS England shall, by 31st October in each financial year, determine the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

that the contractor has provided between 1st April and 30th September of that financial year based on the data provided to it by virtue of paragraph 39.

(4) Where NHS England determines under sub-paragraph (3) that the contractor has, between 1st April and 30th September, provided less than 30 per cent of the total number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

that it is required to provide in that financial year, sub-paragraph (5) shall apply.

(5) Where this sub-paragraph applies, NHS England may—

(a) notify the contractor that it is concerned about the level of activity provided under the agreement in the first half of the financial year, setting out—

(i) the number of units of dental activity or units of orthodontic activity (as the case may be) that it has determined that the contractor has provided; and

(ii) the percentage of the total number of units of dental activity or units of orthodontic activity (as the case may be) required to be provided during the financial year that the number in sub-paragraph (i) represents; and

(b) require in that notification that the contractor participate in a mid-year review of its performance in relation to the agreement with NHS England .

(6) Where a mid-year review is required by NHS England under sub-paragraph (5), NHS England and the contractor shall discuss at that review—

(a) any written evidence the contractor puts forward to demonstrate that it has performed a greater number of units of dental activity or units of orthodontic activity during the first half of the financial year than those notified to it pursuant to sub-paragraph (5)(a)(i); and

(b) any reasons that the contractor puts forward for the level of activity in the first half of the financial year.

(7)NHS England shall prepare a draft record of the mid-year review for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

(8) A copy of the final record of the mid-year review shall be sent to the contractor.

Action NHS England can take following a mid-year review

59. —(1) Where, following the mid-year review and the provision of the final record of that review to the contractor, NHS England , having taken account of any evidence or reasons put forward by the contractor at that review, nevertheless has serious concerns that the contractor is unlikely to provide the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

that it is required to provide by the end of the financial year, NHS England shall be entitled to take either or both of the steps specified in paragraph (2).

(2)NHS England may—

(a) require the contractor to comply with a written plan drawn up by NHS England to ensure that the level of activity during the remainder of the financial year is such that the contractor will provide the number of units of dental activity or units of orthodontic activity it is required to provide; or

(b) withhold monies payable under the agreement.

(3) The maximum amount that may be withheld under sub-paragraph (2)(b) is—

(a) the amount that is payable under the agreement in respect of the number of units of dental activity or units of orthodontic activity required to be provided in a financial year, less

(b) the amount that would be payable under the agreement as a relevant proportion of that amount if the contractor provided in the whole of the financial year only twice the number of units of dental activity or orthodontic activity that it provided between 1st April and 30th September.

(4) Nothing in this paragraph shall prevent NHS England and the contractor agreeing to vary the contract in accordance with paragraph 61 to adjust—

(a) the level of activity to be provided under the agreement; or

(b) the monies to be paid by NHS England to the contractor under the agreement.

(5) Where NHS England withholds monies pursuant to paragraph (2), it shall ensure that it pays the withheld monies to the contractor as soon as possible following the end of the financial year where the contractor has—

(a) provided the number of units of dental activity or units of orthodontic activity required to be provided; or

(b) failed to provide that number of units of dental activity or units of orthodontic activity, but that failure amounts to 4 per cent or less of the total number of units of dental activity or units of orthodontic activity that ought to have been provided during that financial year (and therefore regulation 15 applies).

PART 9 VARIATION AND TERMINATION OF AGREEMENTS

60. —(1) Subject to paragraph 32(3), no amendment or variation shall have effect unless it is in writing and signed by or on behalf of NHS England and the contractor.

(2) In addition to the specific provision made in paragraphs 61A and 73, NHS England may vary the agreement without the contractor's consent where it—

(a) is reasonably satisfied that it is necessary to vary the agreement so as to comply with the Act, any regulations made pursuant to that Act, or any direction given by the Secretary of State pursuant to that Act; and

(b) notifies the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect,

and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect shall be not less than 14 days after the date on which the notice under paragraph (b) is served on the contractor.

Variation of an agreement: activity under the agreement

61. —(1) Where the contractor or NHS England is of the opinion that there needs to be a variation to the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

to be provided under the agreement, sub-paragraphs (2) and (3) shall apply.

(2) The contractor or NHS England shall notify the other party to the agreement in writing of its opinion of the need for a variation, specifying in that notice the variation that it considers necessary, together with its reasons.

(3) Following service of the notice referred to in sub-paragraph (2), both parties shall use their best endeavours to communicate and co-operate with each other with a view to determining what (if any) variation should be made to the number of—

(a) units of dental activity; or

(b) units of orthodontic activity,

and any related variations to the agreement, including to the monies to be paid to the contractor under the agreement, and shall where appropriate effect the variation in accordance with paragraph 60.

Variation of an agreement: rebasing for persistent under performance

61A.—(1) In this paragraph—

“ contracted activity ” means the number of units of dental activity or units of orthodontic activity the contractor is required to provide under the agreement,

“ Covid years ” means the financial years ending on 31st March 2021 and 31st March 2022,

“ rebasing ” means a permanent variation of the agreement pursuant to sub-paragraph (2) and “rebase” is to be read accordingly,

“ rebasing date ” means the date, notified by NHS England under a rebasing notice, from which the rebasing takes effect,

“ rebasing notice ” means a notice in writing sent by NHS England to the contractor, notifying the contractor of the wording of a proposed rebasing and the rebasing date,

“ relevant financial years ” means any three consecutive financial years, save for the Covid years, which—

(2) If all the conditions in sub-paragraph (3) are met, NHS England may rebase the agreement to—

(a) reduce the contracted activity, and

(b) carry out any related variations of the agreement, including in relation to the monies to be paid to the contractor under the agreement,

but the rebasing must not result in the contracted activity being reduced to less than the highest number of units of dental or orthodontic activity provided by the contractor in any one of the relevant financial years.

(3) The conditions referred to in sub-paragraph (2) are—

(a) in respect of each relevant financial year—

(i) NHS England invited the contractor to participate in a mid-year review of its performance under the agreement, pursuant to paragraph 58(5)(b), whether the contractor has engaged with this procedure or not,

(ii) the contractor provided less than 96% of contracted activity,

(iii) there have not been force majeure circumstances under the agreement, which have caused the under delivery pursuant to sub-paragraph (ii),

(iv) NHS England issued a breach notice to the contractor by reason of under delivery pursuant to sub-paragraph (ii), which has not been set aside, and no formal dispute is pending in respect of the circumstances that have given rise to the breach notice, and

(b) NHS England has not been able to agree with the contractor a permanent variation of the agreement under paragraph 61(3).

(4) If NHS England decides to rebase a contract—

(a) it must serve a rebasing notice on the contractor and allow a minimum of 28 days, starting with the day the rebasing notice is served on the contractor, before taking any action pursuant to that notice, and

(b) it must specify in the rebasing notice a rebasing date it considers appropriate, which must be no earlier than 1st April in the financial year immediately following the financial year in which the rebasing notice is served on the contractor .

Termination by agreement

62.NHS England and the contractor may agree in writing to terminate the agreement, and if the parties so agree, they shall agree the date upon which that termination should take effect and any further terms upon which the agreement should be terminated.

Termination on the death of an individual

63. —(1) Where the agreement is with a single individual and that individual dies, the agreement shall terminate at the end of the period of 28 days after the date of his death unless, before the end of that period—

(a) subject to sub-paragraph (2), NHS England has agreed in writing with that individual's personal representatives that the agreement should continue for a further period, not exceeding 6 months after the end of the period of 28 days ; and

(b) that individual's personal representatives have confirmed in writing to NHS England that they are employing or engaging one or more dental practitioners to assist in the provision of dental services under the agreement throughout the period for which it continues.

(2) Where NHS England is of the opinion that another individual may wish to enter into an agreement in respect the mandatory services which were provided by the deceased, the 6 month period referred to in sub-paragraph (1)(a) may be extended by a period not exceeding six months as may be agreed.

(3) Sub-paragraph (1) does not affect any other rights to terminate the agreement which NHS England may have under paragraphs 67 to 71.

Termination by the contractor

64. —(1) A contractor may terminate the agreement by serving notice in writing on NHS England at any time.

(2) Where a contractor serves notice pursuant to sub-paragraph (1), the agreement shall terminate three months after the date on which the notice is served (“ the termination date ”), save that if the termination date is not the last calendar day of a month, the agreement shall instead terminate on the last calendar day of the month in which the termination date falls.

(3) This paragraph and paragraph 65 are without prejudice to any other rights to terminate the agreement that the contractor may have.

Late payment notices

65. —(1) The contractor may give notice in writing (a “late payment notice”) to NHS England if NHS England has failed to make any payments due to the contractor in accordance with a term of the agreement that has the effect specified in regulation 17, and the contractor shall specify in the late payment notice the payments that NHS England has failed to make in accordance with that regulation.

(2) Subject to sub-paragraph (3), the contractor may, at least 28 days after having served a late payment notice, terminate the agreement by a further written notice if NHS England has still failed to make the payments that were due to the contractor and that were specified in the late payment notice served on NHS England pursuant to sub-paragraph (1).

(3) If, following receipt of a late payment notice, NHS England refers the matter to the NHS dispute resolution procedure within 28 days of the date upon which it is served with the late payment notice, and it notifies the contractor in writing that it has done so within that period of time, the contractor may not terminate the agreement pursuant to sub-paragraph (2) until—

(a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits the contractor to terminate the agreement; or

(b) NHS England ceases to pursue the NHS dispute resolution procedure,

(c) whichever is the sooner.

Termination by NHS England : general provisions

66.NHS England may only terminate the agreement in accordance with the provisions in this Part.

Termination by NHS England : notice

67. —(1)NHS England may terminate the agreement by serving notice in writing on the contractor at any time.

(2) Where a notice is served pursuant to sub-paragraph (1), the agreement shall terminate on the date provided for in the agreement.

Termination by NHS England for the provision of untrue etc. information

68.NHS England may serve notice in writing on the contractor terminating the agreement forthwith, or from such date as may be specified in the notice if, after the agreement has been entered into, it comes to the attention of NHS England that written information provided to it by the contractor before the agreement was entered into in relation to the conditions set out in regulation 4 or 5 (and compliance with those conditions) was, when given, untrue or inaccurate in a material respect.

Termination by NHS England on grounds of suitability etc.

69. —(1)NHS England may serve notice in writing on the contractor terminating the agreement forthwith, or from such date as may be specified in the notice if—

(a) in the case of an agreement with an individual as a party, that individual;

(b) in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(c) in the case of a company limited by shares, any director, chief executive or secretary of that company; or

(d) in the case of a limited liability partnership, any member of that partnership.

(2) A person falls within this sub-paragraph if—

(a) he or it is the subject of a national disqualification;

(b) subject to sub-paragraph (3), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation or a suspension on the grounds of ill-health) from practising by any licensing body anywhere in the world;

(c) subject to sub-paragraph (4), he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless before NHS England has served a notice terminating the agreement pursuant to this paragraph, he is employed by the health service body that dismissed him or by another health service body;

(d) he or it is removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively) unless his name has subsequently been included in such a list;

(e) he has been convicted in the United Kingdom of—

(i) murder; or

(ii) a criminal offence other than murder, committed on or after 14th December 2001, and has been sentenced to a term of imprisonment of over six months;

(f) subject to sub-paragraph (5), he has been convicted outside the United Kingdom of an offence—

(i) which would, if committed in England and Wales, constitute murder; or

(ii) committed on or after 14th December 2001, which would if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months;

(g) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995(offences against children under the age of 17 years to which special provisions apply);

(h) he or it has—

(i) been made bankrupt or had sequestration of his estate awarded or is a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986) applies unless ... he has been discharged from the bankruptcy or the sequestration or the bankruptcy order has been annulled;

(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A , or a debt relief restrictions order or interim debt relief restrictions order under Schedule 4ZB, to the Insolvency Act 1986 , unless that order has ceased to have effect or has been annulled;

(iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it; or

(iv) been wound up under Part 4 of the Insolvency Act 1986;

(i) there is—

(i) an administrator, administrative receiver or receiver appointed in respect of it; or

(ii) an administration order made in respect of it under Schedule B1 to the Insolvency Act 1986 ;

(j) he has been—

(i) removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated; or

(ii) removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of the Court of Session to deal with management of charities) or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session) , from being concerned in the management or control of any body;

(k) he is subject to a disqualification order under the Company Directors Disqualification Act 1986 , the Companies (Northern Ireland) Order 1986 or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); or

(l) he has refused to comply with a request by NHS England for him to be medically examined on the ground that it is concerned that he is incapable of adequately providing services under the agreement.

(3)NHS England shall not terminate the agreement pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make the person unsuitable to be—

(a) a contractor; ...

(b) in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(c) in the case of a company limited by shares, any director, chief executive or secretary of that company; or

(d) in the case of a limited liability partnership, any member of that partnership.

(4)NHS England shall not terminate the agreement pursuant to sub-paragraph (2)(c)—

(a) until a period of at least three months has elapsed since the date of the dismissal of the person concerned; or

(b) if, during the period of time specified in paragraph (a), the person concerned brings proceedings in any competent tribunal or court in respect of his dismissal, until proceedings before that tribunal or court are concluded,

and NHS England may only terminate the agreement at the end of the period specified in paragraph (b) if there is no finding of unfair dismissal.

(5)NHS England shall not terminate the agreement pursuant to sub-paragraph (2)(f) where it is satisfied that the conviction does not make the person unsuitable to be—

(a) a contractor; ...

(b) in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(c) in the case of a company limited by shares, any director, chief executive or secretary of that company; or

(d) in the case of a limited liability partnership, any member of that partnership.

Termination by NHS England : patient safety and material financial loss

70.NHS England may serve notice in writing on the contractor terminating the agreement forthwith or with effect from such date as may be specified in the notice if—

(a) the contractor has breached the agreement and as a result of that breach, the safety of the contractor's patients is at serious risk if the agreement is not terminated; or

(b) the contractor's financial situation is such that NHS England considers that NHS England is at risk of material financial loss.

Termination by NHS England : remedial notices and breach notices

71. —(1) Where a contractor has breached the agreement other than as specified in paragraphs 68 to 70 and the breach is capable of remedy, NHS England shall, before taking any action it is otherwise entitled to take by virtue of the agreement, serve a notice on the contractor requiring it to remedy the breach (“remedial notice”).

(2) A remedial notice shall specify—

(a) details of the breach;

(b) the steps the contractor must take to the satisfaction of NHS England in order to remedy the breach; and

(c) the period during which the steps must be taken (“ the notice period ”).

(3) The notice period shall, unless NHS England is satisfied that a shorter period is necessary to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss,

be no less than 28 days from the date that notice is given.

(4) Where NHS England is satisfied that the contractor has not taken the required steps to remedy the breach by the end of the notice period, NHS England may terminate the agreement with effect from such date as NHS England may specify in a further notice to the contractor.

(5) Where a contractor has breached the agreement otherwise than as specified in paragraphs 68 to 70 and the breach is not capable of remedy, NHS England may serve notice on the contractor requiring the contractor not to repeat the breach (“breach notice”).

(6) If, following a breach notice or a remedial notice, the contractor—

(a) repeats the breach that was the subject of the breach notice or the remedial notice; or

(b) otherwise breaches the agreement resulting in either a remedial notice or a further breach notice,

NHS England may serve notice on the contractor terminating the agreement with effect from such date as may be specified in that notice.

(7)NHS England shall not exercise its right to terminate the agreement under sub-paragraph (6) unless it is satisfied that the cumulative effect of the breaches is such that NHS England considers that to allow the agreement to continue would be prejudicial to the efficiency of the services to be provided under the agreement.

(8) If the contractor is in breach of any obligation and a breach notice or a remedial notice in respect of that default has been given to the contractor, NHS England may withhold or deduct monies which would otherwise be payable under the agreement in respect of that obligation which is the subject of the default.

Termination by NHS England : additional provisions specific to contracts with dental corporations, companies limited by shares and limited liability partnerships

72. —(1) Where a party to the agreement is a dental corporation, company limited by shares, or limited liability partnership , if NHS England becomes aware that the dental corporation, company limited by shares, or limited liability partnership is carrying on any business which NHS England considers to be detrimental to the contractor's performance of its obligations under the agreement—

(a) NHS England shall be entitled to give notice to the contractor requiring that the dental corporation, company limited by shares, or limited liability partnership ceases carrying on that business before the end of a period of not less than 28 days beginning on the day on which the notice is given (“ the notice period ”); and

(b) if the contractor has not satisfied NHS England that the dental corporation, company limited by shares, or limited liability partnership has ceased carrying on that business by the end of the notice period, NHS England may, by a further written notice, terminate the agreement forthwith or from such date as may be specified in the notice.

(2) Where the contractor is a dental corporation or company limited by shares and on or after the coming into force for all purposes of article 39 of the Dentists Act Order during the existence of the agreement—

(a) the majority of the directors of the dental corporation or company limited by shares cease to be either dental practitioners or dental care professionals;

(b) the dental corporation or company limited by shares has been convicted of an offence under section 43(1) of the Dentists Act (directors of bodies corporate); or

(c) the dental corporation or company limited by shares , or a director or former director of that dental corporation or company limited by shares , has had a financial penalty imposed on it or him by the General Dental Council pursuant to section 43B (financial penalties in relation to bodies corporate) or 44 (further financial penalties on bodies corporate) of the Dentists Act,

NHS England may, by written notice, terminate the agreement if it considers that as a consequence the dental corporation or company limited by shares is no longer suitable to be a contractor.

(3) Where the contractor is a company limited by shares and the company ceases—

(a) to be a company limited by shares; or

(b) to satisfy the conditions in section 108(1A) of the 2006 Act,

NHS England shall serve notice in writing on the contractor terminating the contract forthwith.

(4) Where the contractor is a limited liability partnership and—

(a) the partnership ceases to be a limited liability partnership; or

(b) section 108(1B) or (1C) of the 2006 Act ceases to apply in respect of that partnership,

NHS England shall serve notice in writing on the contractor terminating the contract forthwith.

Agreement sanctions

73. —(1) In this paragraph and paragraph 74, “ agreement sanction ” means—

(a) termination of specified reciprocal obligations under the agreement;

(b) suspension of specified reciprocal obligations under the agreement for a period of up to six months; or

(c) withholding or deducting monies otherwise payable under the agreement.

(2) Where NHS England is entitled to terminate the agreement pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72, it may instead impose any of the agreement sanctions if NHS England is reasonably satisfied that the agreement sanction to be imposed is appropriate and proportionate to the circumstances which provide grounds for NHS England to terminate the agreement.

(3) If NHS England decides to impose an agreement sanction, it must notify the contractor of the agreement sanction that it proposes to impose, the date upon which that sanction will be imposed and provide in that notice an explanation of the effect of the imposition of that sanction.

(4) Subject to paragraph 74, NHS England shall not impose the agreement sanction until at least 28 days after it has served notice on the contractor pursuant to sub-paragraph (3) unless it is satisfied that it is necessary to do so in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss.

(5) Where NHS England imposes an agreement sanction, it shall be entitled to charge the contractor the reasonable costs of additional administration that NHS England has incurred in order to impose, or as a result of imposing, the agreement sanction.

Agreement sanctions and the NHS dispute resolution procedure

74. —(1) If there is a dispute between NHS England and the contractor in relation to an agreement sanction that NHS England is proposing to impose, NHS England shall not, subject to sub-paragraph (4), impose the proposed agreement sanction except in the circumstances specified in sub-paragraph (2).

(2) If the contractor refers the dispute relating to the agreement sanction to the NHS dispute resolution procedure within 28 days beginning on the date on which NHS England served notice on the contractor in accordance with paragraph 73(3) (or such longer period as may be agreed in writing with NHS England ), and notifies NHS England in writing that it has done so, NHS England shall not impose the agreement sanction unless—

(a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits NHS England to impose the agreement sanction; or

(b) the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(3) If the contractor does not invoke the NHS dispute resolution procedure within the time specified in sub-paragraph (2), NHS England shall be entitled to impose the agreement sanction forthwith.

(4) If NHS England is satisfied that it is necessary to impose the agreement sanction before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss,

NHS England shall be entitled to impose the agreement sanction forthwith, pending the outcome of that procedure.

Termination and the NHS dispute resolution procedure

75. —(1) Where NHS England is entitled to serve written notice on the contractor terminating the agreement pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72, it shall, in the notice served on the contractor pursuant to those provisions, specify a date on which the agreement terminates that is not less than 28 days after the date on which NHS England has served that notice on the contractor unless sub-paragraph (2) applies.

(2) This sub-paragraph applies if NHS England is satisfied that a period less than 28 days is necessary in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss.

(3) In a case falling with sub-paragraph (1), where—

(a) the exceptions in sub-paragraph (2) do not apply;

(b) the contractor invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and

(c) the contractor notifies NHS England in writing that it has done so,

the agreement shall not terminate at the end of the notice period but instead shall only terminate in the circumstances specified in sub-paragraph (4).

(4) The agreement shall only terminate if and when—

(a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits NHS England to terminate the agreement; or

(b) the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(5) If NHS England is satisfied that it is necessary to terminate the agreement before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the contractor's patients; or

(b) protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and NHS England shall be entitled to confirm, by written notice to be served on the contractor, that the agreement will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72.

PART 10 MISCELLANEOUS

Evidence of exemption under the Act

76. —(1) Subject to sub-paragraph (2), the contractor shall ensure that it requests, in respect of a person who makes a declaration relating to exemption under paragraph 1(1) of Schedule 12ZA to the Act, evidence in support of that declaration.

(2) The contractor shall ensure that—

(a) a note of the type of evidence submitted is made; or

(b) in the case where no evidence is submitted, a note of that fact is made.

(3) Sub-paragraphs (1) and (2) do not apply where the contractor is satisfied that the person in respect of whom the declaration is made is under the age of 18 years.

Clinical governance arrangements

77. —(1) Subject to paragraph (2), the contractor shall comply with such clinical governance arrangements as NHS England may establish in respect of contractors providing services under an agreement.

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The contractor shall nominate a person who manages services under the agreement to have responsibility for ensuring compliance with clinical governance arrangements.

(4) In this paragraph, “ clinical governance arrangements ” means arrangements through which the contractor endeavours to continuously improve the quality of its services and safeguard high standards of care by creating an environment in which clinical excellence can flourish.

Duty as to education and training

77A. The contractor must co-operate with the Secretary of State in the discharge of the Secretary of State's duty under section 1F of the 2006 Act (duty as to education and training), or co-operate with NHS England where NHS England is discharging that duty by virtue of section 97 of the Care Act 2014 .

Quality assurance system

78. —(1) The contractor shall establish and operate a practice based quality assurance system which is applicable to all persons specified in sub-paragraph (2).

(2) The specified persons are—

(a) any dental practitioner who performs services under the agreement; and

(b) any other person employed or engaged by the contractor to perform or assist in the performance of services under the agreement.

(3) A contractor shall ensure that in respect of its practice based quality assurance system, it has nominated a person (who need not be connected with the contractor's practice) to be responsible for operating that system.

(4) In this paragraph, “ a practice based quality assurance system ” means one which comprises a system to ensure that—

(a) effective measures of infection control are used;

(b) all legal requirements relating to health and safety in the workplace are satisfied;

(c) all legal requirements relating to radiological protection are satisfied; and

(d) any requirements of the General Dental Council in respect of the continuing professional development of dental practitioners are satisfied.

Insurance: negligent performance

79. —(1) The contractor shall at all times have in force in relation to it an indemnity arrangement which provides appropriate cover .

(2) The contractor shall not sub-contract its obligations to provide clinical services under the agreement unless it has satisfied itself that the sub-contractor has in force in relation to it an indemnity arrangement which provides appropriate cover .

(3) In this paragraph—

(a) “ indemnity arrangement ” means a contract of insurance or other arrangement made for the purpose of indemnifying the contractor;

(aa) “ appropriate cover ” means cover against liabilities that may be incurred by the contractor in the performance of clinical services under the agreement, which is appropriate, having regard to the nature and extent of the risks in the performance of such services; and

(b) a contractor or sub-contractor shall be regarded as having in force in relation to it an indemnity arrangement if there is an indemnity arrangement in force in relation to an employee of its in connection with clinical services which that employee provides under the agreement or, as the case may be, sub-contract.

Public liability insurance

80. —(1) The contractor shall at all times hold adequate public liability insurance in relation to liabilities to third parties arising under or in connection with the agreement which are not covered by an indemnity arrangement referred to in paragraph 79(1).

(2) In this paragraph, “ indemnity arrangement ” has the same meaning as in paragraph 79.

Gifts

81. —(1) The contractor shall keep a register of gifts which are given to any of the persons specified in sub-paragraph (2) by or on behalf of—

(a) a patient;

(b) a relative of a patient; or

(c) any person who provides or wishes to provide services to the contractor or its patients in connection with the agreement,

and have, in its reasonable opinion, an individual value of more than £100.00.

(2) The persons referred to in sub-paragraph (1) are—

(a) the contractor;

(b) where the agreement is with a dental corporation , a director, chief executive or secretary of the corporation;

(ba) where the agreement is with a company limited by shares, a director, chief executive or secretary of the company;

(bb) where the agreement is with a limited liability partnership, a member of the partnership;

(c) any person employed by the contractor for the purposes of the agreement;

(d) any dental practitioner engaged by the contractor for the purposes of the agreement;

(e) any spouse or civil partner of a contractor (where the contractor is an individual) or of a person specified in paragraphs (b) to (d); or

(f) any person whose relationship with the contractor (where the contractor is an individual) or with a person specified in paragraphs (b) to (d) has the characteristics of the relationship between husband and wife or civil partners.

(3) Sub-paragraph (1) does not apply where—

(a) there are reasonable grounds for believing that the gift is unconnected with services provided or to be provided by the contractor;

(b) the contractor is not aware of the gift; or

(c) in a case falling within sub-paragraph (1)(c), the contractor is not aware that the donor wishes to provide services to the contractor.

(4) The contractor shall take reasonable steps to ensure that it is informed of gifts which fall within sub-paragraph (1) and which are given to any of the persons specified in sub-paragraph (2)(b) to (2)(f).

(5) The register referred to in sub-paragraph (1) shall include the following information—

(a) the name of the donor;

(b) in a case where the donor is a patient, the patient's National Health Service number or, if the number is not known, his address;

(c) in any other case, the address of the donor;

(d) the nature of the gift;

(e) the estimated value of the gift; and

(f) the name of the person or persons who received the gift.

(6) The contractor shall make the register available to NHS England on request.

Compliance with legislation and guidance

82. The contractor shall—

(a) comply with all relevant legislation; and

(b) have regard to all relevant guidance issued by NHS England and the Secretary of State.

Third party rights

83. The agreement shall not create any right enforceable by any person not a party to it.

Signing of documents

84. —(1) In addition to any other requirements relating to such documents whether in these Regulations or otherwise, the contractor shall ensure that the documents specified in paragraph (2) include—

(a) the name and clinical profession of the professional who signed the document; and

(b) the name of the contractor on whose behalf it is signed.

(2) The documents referred to in sub-paragraph (1) are—

(a) forms that are required to be completed pursuant to these Regulations, where such forms require a signature;

(b) prescription forms; and

(c) any other clinical documents.

Regulation 20 and paragraph 35 of Schedule 3

SCHEDULE 4 PATIENT INFORMATION LEAFLET

A patient leaflet shall include—

1. The name of the party or parties comprising the contractor.

2. In the case of an agreement with a dental corporation —

(a) the names of the directors, chief executive and secretary of that corporation , in so far as those positions exist in relation to the dental corporation ; and

(b) the address of the corporation's registered office.

2A. In the case of an agreement with a company limited by shares—

(a) whether or not it is a company limited by shares;

(b) the names of the directors, chief executive and secretary of the company, in so far as those positions exist in relation to the company; and

(c) the address of the company's registered office.

2B. In the case of an agreement with a limited liability partnership—

(a) whether or not it is a limited liability partnership;

(b) the names of the members of the partnership; and

(c) the registered premises address of the limited liability partnership.

3. The full name of each person performing services under the agreement.

4. In the case of each person performing dental services under the agreement, his professional qualifications.

5. Whether the contractor undertakes the teaching or training of persons who provide dental services or who intend to do so.

6. The address of each of the practice premises.

7. The contractor's telephone and fax numbers and the address of its website (if any).

8. Whether the practice premises have suitable access for disabled patients and, if not, the alternative arrangements for providing services to such patients.

9. How to request services as a patient.

10. The rights of a patient to express a preference of practitioner in accordance with paragraph 2 of Schedule 3 and the means of expressing such a preference.

11. The services available under the agreement.

12. The normal surgery days and hours of the practice.

13. The arrangements for dental services for the hours and days that fall outside normal surgery hours (whether or not provided by the contractor) and how the patient may contact such services.

14. If the services in paragraph 13 are not provided by the contractor, the fact that NHS England referred to in paragraph 20 is responsible for commissioning the services.

15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16. How patients may make a complaint or comment on the provision of services.

17. The rights and responsibilities of the patient, including keeping appointments.

18. The action that may be taken where a patient is violent or abusive to the contractor, its staff, persons present on the practice premises or in the place where treatment is provided under the agreement or other persons specified in paragraph 3(2) of Schedule 3.

19. Details of who has access to patient information (including information from which the identity of the individual can be ascertained) and the patient's rights in relation to disclosure of such information.

20. The name, postal and website address and telephone number of NHS England with which the contractor is a party to the agreement.

21. The full name, postal, email and website address, and telephone number of NHS England .

Regulation 20

SCHEDULE 5 MODIFICATION OF PATIENT PROVISIONS WHERE THE CONTRACTOR IS A PRIMARY CARE TRUST

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .