The National Health Service (Primary Medical Services) (Miscellaneous Amendments and Transitional Provisions) Regulations 2013

Made: 15th February 2013

Laid before Parliament: 27th February 2013

Coming into force: 1st April 2013

The Secretary of State for Health makes the following Regulations in exercise of the powers conferred by sections 83, 85, 86(4), 88, 89, 90, 91, 93, 94, 97(6), 259 and 272(7) and (8) of the National Health Service Act 2006[^f00001].

PART 1 — GENERAL

Citation, commencement and interpretation

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PART 2 — AMENDMENT OF THE GMS CONTRACTS REGULATIONS

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Amendment of regulation 2

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Substitution of regulation 3

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Amendment of regulation 4

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Amendment of regulation 5

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Amendment of regulation 6

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Amendment of regulation 7

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Amendment of regulation 9

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Amendment of regulation 10

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Amendment of regulation 14

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Amendment of regulation 15

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Amendment of regulation 17

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Amendment of regulation 18

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Insertion of new regulation 20A

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Amendment of regulation 22

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Substitution of regulation 23

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Amendment of regulation 24

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Amendment of regulation 26

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Omission of regulation 26A and insertion of new regulation 26B

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Amendment of regulation 27

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Amendment of regulation 31

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Omission of regulation 32 and Schedule 7

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Amendment of Schedule 2

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Amendment of Schedule 3

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Amendment of Schedule 5

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Amendment of Schedule 6

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Amendment of Schedule 10

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Transitional provision

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PART 3 — AMENDMENTS OF THE PMS AGREEMENT REGULATIONS

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Amendment of regulation 2

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Substitution of regulation 3

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Amendment of regulation 5

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Amendment of regulation 6

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Amendment of regulation 7

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Amendment of regulation 8

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Amendment of regulation 9

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Amendment of regulation 11

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Insertion of new regulation 11A

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Amendment of regulation 13

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Substitution of regulation 14

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Amendment of regulation 15

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Amendment of regulation 16

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Substitution of regulation 18

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Omission of regulation 18A and insertion of new regulation 18B

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Amendment of regulation 19

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Omission of regulation 21 and Schedule 6

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Amendment to Schedule 3

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Amendment of Schedule 4

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Amendment of Schedule 5

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Omission of Schedule 7

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Amendment of Schedule 10

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Transitional provisions

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PART 4 — MISCELLANEOUS AMENDMENTS

National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004

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• (1) The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004[^f00031] are amended as follows.

• (2) In Schedule 2 (drugs, medicines and other substances that may be ordered only in certain circumstances)—

• (a) in column 1, omit the entry for “Cyanocobalamin Tablets” and the adjacent part which relates to the description of the patient (column 2) and the specified purpose (column 3);

• (b) for the entry for “Oseltamivir (Tamiflu)” which is referred to in column 1, in the part which relates to the description of the patient (as mentioned in column 2), in paragraph (1A) and (2A), for “are part of a Primary Care Trust’s antivirals distribution service.”, substitute “are part of an antiviral distribution service provided by the Board, Public Health England or a Local Authority.”[^f00032]; and

• (c) for the entry for “Zanamivir (Relenza)” which is referred to in column 1, in the part which relates to “patient” (as mentioned in column 2), in paragraph (2) for “are part of a Primary Care Trust’s antivirals distribution service.”, substitute “are part of an antiviral distribution service provided by the Board, Public Health England or a Local Authority.”.

Primary Medical Services (Sale of Goodwill and Restrictions on Sub-contracting) Regulations 2004

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• (1) The Primary Medical Services (Sale of Goodwill and Restrictions on Sub-contracting) Regulations 2004[^f00033] are amended as follows.

• (2) In regulation 2 (interpretation)—

• (a) in paragraph (1)—

• (i) after the definition of “the 1977 Act” insert—

• “the 2006 Act” means the National Health Service Act 2006;
• “the 2012 Act” means the Health and Social Care Act 2012;

• (ii) for the definition of “APMS contractor”, substitute—

• means a person with whom the Board has made arrangements under section 83(2) (primary medical services) of the 2006 Act for the provision of primary medical services or as a consequence of a scheme made under section 300 (transfer schemes) of the 2012 Act is a party to such arrangements;

• (iii) for the definition of “GMS contractor”, substitute—

• means a person with whom the Board has entered into a general medical services contract under section 84 (general medical services contracts: introductory) of the 2006 Act or a default contract or as a consequence of a scheme made under section 300 of the 2012 Act is a party to such contracts;

; and

• (iv) for the definition of “PMS contractor”, substitute—

• means a person with whom the Board has entered into a section 92 arrangement or as a consequence of a scheme made under section 300 of the 2012 Act is a party to a section 92 arrangement;

• (b) in paragraph (2), for sub-paragraph (a), substitute—

(a) recorded by the Board as being on the contractor’s or performer’s list of patients or on a list of patients maintained by the Board in respect of the contractor or performer; and

• (3) Immediately after regulation 2, insert—

(2A) For the purposes of section 259(1) of the 2006 Act (sale of medical practices), the relevant area means the area which forms the area team area of the Board in which the performers or providers who are specified in regulation 3(1) (prohibition on the sale of goodwill in certain primary medical services practices) have provided or performed services at any time in accordance with arrangements or contract at that time.

SCHEDULE 1 — Transitional provisions relating to GMS contracts

Application of Schedule 1

1

This Schedule applies to a GMS contract which is entered into before the appointed day, and the parties to the contract on or after the appointed day are the Contractor and the Board as a consequence of a property scheme transfer made under section 300 of the 2012 Act.

Interpretation

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In this Schedule—

• “2012 Act” means the Health and Social Care Act 2012[^f00034];

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

• “the appointed day” means 1st April 2013;

• “the Board” means the National Health Service Commissioning Board [^f00035];

• “contractor” means— in relation to a period before the appointed day, a party to a GMS contract, other than the Primary Care Trust; or in relation to a period on or after the appointed day, a party to the GMS contract, other than the Board;

• “GMS contract” means a contract entered into in accordance with section 84 of the 2006 Act [^f00036];

• “out of hours services” has the same meaning as in regulation 2 (interpretation) of the GMS Contracts Regulations;

• “Primary Care Trust” means the Primary Care Trust which was established and which subsisted immediately before the coming into force of section 34 (abolition of Primary Care Trusts) of the 2012 Act;

• “Strategic Health Authority” means the Strategic Health Authority which was established and which subsisted immediately before the coming into force of section 33 (abolition of Strategic Health Authorities) of the 2012 Act.

General transitional provisions relating to the terms of a GMS contract

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• (1) The Contractor and the Board must as soon as is reasonably practicable on or after the appointed day, enter into discussions with each other with a view to agreeing variations to the GMS contract in order to ensure that the contract complies with the GMS Contracts Regulations on or after the appointed day.

• (2) Where the terms of the GMS contract have not been varied so as to include the terms which have the same effect as those terms specified in these Regulations, the GMS contract is deemed to have been so varied only to the extent that such terms are to have the same effect as those terms specified in these Regulations which have effect on or after the appointed day.

• (3) The Contractor and the Board may not agree any variation to the GMS contract that is contrary to the GMS Contracts Regulations on or after the appointed day.

Continuing validity of forms

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A form supplied by a Primary Care Trust continues to be a valid form in relation to the Board until it is cancelled or withdrawn by the Board.

Notification of reasons by a Primary Care Trust in respect of entering into contracts

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Where a Primary Care Trust has given notification to a person under regulation 6 (reasons) of the GMS Contracts Regulations before the appointed day, the notification and the written views contained in that notification are to be treated, on or after that day, as notification by the Board and the written views of the Board.

Appeals relating to eligibility to enter into a contract

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A person who has been served notice pursuant to regulation 6 of the GMS Contracts Regulations before the appointed day may on or after that day appeal to the First-tier Tribunal against the decision of the Primary Care Trust and that appeal must be treated as an appeal against a decision of the Board.

Finance

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Any right that a Primary Care Trust had to set off against any amount payable to the contractor under the term that gives effect to regulation 22 (finance) of the GMS Contracts Regulations immediately before the appointed day, must be treated as a right of the Board under the term that gives effect to that regulation on or after the appointed day.

Opt outs of additional and out of hours services

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• (1) Subject to the following provisions of this paragraph, a notification or approval given, or an agreement made, by a Primary Care Trust in accordance with the term of the contract that gives effect to—

• (a) regulation 17 (opt outs of additional and out of hours services) of the GMS Contracts Regulations;

• (b) regulation 31(3)(b) (out of hours services) of the GMS Contracts Regulations; or

• (c) paragraph 4 (out of hours opt outs where the opt out notice is served after 30th September 2004) of Schedule 3 to the GMS Contracts Regulations,

in respect of a period that commences on or after the appointed day, must be regarded for the purposes of the term of the GMS contract that give effect to that regulation or that paragraph as a notification or approval given, or agreement made, by the Board and is binding on the Board as if such notification or approval were given, or agreement were made, by it.

• (2) Where a contractor informs the relevant Primary Care Trust that it wishes to withdraw an out of hours opt out notice where it has been approved by the Primary Care Trust and the Primary Care Trust has not agreed to the withdrawal before the appointed day, the Board may, if it considers it appropriate, agree to the withdrawal of the out of hours opt out notice as if it had approved the notice.

Continuing application of published guidance and other documents

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Where as a consequence of paragraph 11 (standards for out of hours services) or 125 (compliance with legislation and guidance) of Schedule 6 to the GMS Contracts Regulations a contractual term in a GMS contract requires a contractor to meet requirements set out in a document or have regard to, or comply with, guidance published before the appointed day which has effect immediately before that day, that contractual term continues to apply in respect of such documents and guidance on or after the appointed day—

• (a) as if references to a Primary Care Trust or Strategic Health Authority in that document or guidance were to the Board; and

• (b) until such time as the Board, or as the case may be, the Secretary of State, cancels or withdraws the document or guidance.

Arrangements for GP Registrars

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A contractor which employs a GP Registrar in accordance with paragraph 64 (arrangements for GP Registrars) of Schedule 6 to the GMS Contracts Regulations immediately before the appointed day must continue to employ that GP Registrar and may only vary the terms and conditions to the extent necessary to comply with that paragraph and any other relevant provision relating to the 2006 Act which have effect on or after the appointed day.

Sub-contracting of clinical matters

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• (1) A notification made to a Primary Care Trust by a contractor under the term of contract that had the same effect as the provision in sub-paragraph (1) of paragraph 69 (sub-contracting of clinical matters) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day, must be treated as notification to the Board.

• (2) Notwithstanding a Primary Care Trust’s request for further information in accordance with the term of the GMS contract that had the same effect as the provision in paragraph 69(4) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day, the Board may request such further information from the contractor relating to the proposed sub-contract if it considers it necessary in order to deal with the matter.

• (3) Where a Primary Care Trust served notice of objection to the sub-contract in accordance with the term of the contract that had the same effect as the provision in paragraph 69(5) of the GMS Contracts Regulations as in force immediately before the appointed day, that notice and the reasons for objection is deemed to be notice of objection by, and reasons of, the Board.

• (4) Where a Primary Care Trust has not objected to a proposed sub-contract and the 28 day period referred to in the term of the contract that had the same effect as the provision in paragraph 69(5) of the GMS Contracts Regulations as in force immediately before the appointed day has elapsed on or after that date, the Board and the contractor are deemed as having agreed a variation of the contract in accordance with paragraph 69(8) of the GMS Contracts Regulations as in force on or after the appointed day.

Sub-contracting of out of hours services

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• (1) A written approval given by a Primary Care Trust to a contractor in respect of the term of the contract that had the same effect as the provision in paragraph 70(1) (sub-contracting of out of hours services) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day, must be treated as an approval given by the Board.

• (2) An application for approval made by a contractor to a Primary Care Trust under the term of the contract that has the same effect as the provisions in paragraph 70(1) and (3) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day which is pending, must be treated as an application made to the Board.

• (3) Notwithstanding a Primary Care Trust’s request for further information in accordance with the term of the contract that has the same effect as the provision in paragraph 70(4) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day, the Board may request such further information from the contractor relating to the proposed arrangements if it considers it necessary in order to deal with the matter.

• (4) Where a Primary Care Trust informed the contractor by notice of its decision in accordance with the term of the contract that had the same effect as the provision in paragraph 70(7) of the GMS Contracts Regulations as in force immediately before the appointed day, that notice and (where it refuses an application) the statement of reasons for refusal is to be deemed as notice by, and (where there has been a refusal) the statement of reasons for refusal of, the Board.

Withdrawal and variation of approval relating to sub-contracting out of hours services

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The Board may, at any stage, serve notice on a contractor withdrawing or varying an approval which was given by a Primary Care Trust in accordance with the term of the contract that had the same effect as paragraph 70(3) of the GMS Contracts Regulations as in force immediately before the appointed day, and for the purposes of the term of the contract that has the same effect as paragraphs 71 (withdrawal and variation of approval under paragraph 70) and 72 of the GMS Contracts Regulations, the approval is deemed to be approval by the Board.

Records, information, notifications and rights of entry

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• (1) Where a Primary Care Trust gave consent, authorisation or notification or made a request under a term of the GMS contract that had the same effect as the provisions in Part 5 (records, information, notification and rights of entry) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day, such consent, authorisation, notification or request is deemed to be that of the Board for the purposes of the application of the terms of the GMS contract that have the same effect as the provisions in Part 5 of Schedule 6 to the GMS Contracts Regulations on or after the appointed day.

• (2) The reference to a request and authorisation in paragraph (1) respectively includes any inquiries made in writing from the Primary Care Trust and appointments made by the Primary Care Trust in accordance with the terms of the GMS contract that have the same effect as the provisions in paragraph 79 (inquiries about prescriptions and referrals) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day.

Leaflets

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• (1) This paragraph applies where a contractor has compiled a practice leaflet which complies with the requirements of paragraph 76 (practice leaflet) of Schedule 6 to the GMS Contracts Regulations immediately before the appointed day.

• (2) Notwithstanding the requirements in paragraph 76 of Schedule 6 to the GMS Contracts Regulations as in force on or after the appointed day, a contractor must review its practice leaflet and make any amendments necessary so as to include the information specified in Schedule 10 to the GMS Contracts Regulations (information to be included in practice leaflets) not later than 1st July 2013.

Complaints

16

• (1) This paragraph applies where an investigation of a complaint under the procedure referred to in paragraph 92 of Schedule 6 to the GMS Contracts Regulations is not completed before the appointed day.

• (2) A complaint of a kind referred to in paragraph (1) must continue to be dealt with in accordance with the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009[^f00037]—

• (a) as if any reference to a Primary Care Trust in a document or form relating to the complaint were a reference to the Board; and

• (b) in respect of a complaint received prior to 1st April 2009, the contractor—

• (i) must deal with the complaint as far as it is able, in accordance with those Regulations; and

• (ii) may if it is unable to comply with those Regulations as a consequence of the length of time it has taken to deal with the complaint vary the procedure only to the extent that it is necessary in order to dispose of the matter in a just manner.

Co-operation with investigations

17

The contractor must continue to co-operate with an investigation of a complaint which is on-going immediately before the appointed day in accordance with the terms of the GMS contract that give effect to paragraph 97 of Schedule 6 to the GMS Contracts Regulations as in force on or after the appointed day as if any act or omission by, or reference to, a Primary Care Trust or Strategic Health Authority were an act or omission by, or reference to, the Board.

Disputes

18

• (1) Any dispute arising out of or in connection with a GMS contract in respect of a contractor and Primary Care Trust that is on-going immediately before the appointed day is deemed to be a dispute in respect of that contractor and the Board.

• (2) The terms of the contract which had the same effect as the provisions in Part 7 of Schedule 6 to the GMS Contracts Regulations as in force on or after the appointed day continue to apply to the dispute as if references to—

• (a) subject to paragraph (c), “Primary Care Trust” were to the “Board”;

• (b) “the parties” mean to the contractor and the Board; and

• (c) “the Local Medical Committee for the area of the Primary Care Trust” were to “the Local Medical Committee for the area of the Primary Care Trust which was established and subsisted immediately before 1st April 2013”.

Variation and termination of GMS contracts

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• (1) This paragraph applies where a Primary Care Trust or a contractor has taken any steps in accordance with or in connection with a matter referred to in any of the provisions in Part 8 (variation and termination of contracts) of Schedule 6 to the GMS Contracts Regulations before the appointed day and had it not been for the coming into force of section 34 (abolition of Primary Care Trusts) of the 2012 Act that matter would continue to fall to the Primary Care Trust to be dealt with in accordance with Part 8.

• (2) Any action taken or omission by a Primary Care Trust in accordance with or in connection with any of the provisions in Part 8 of Schedule 6 to the GMS Contracts Regulations is deemed to be action taken or omitted by the Board for the purposes of the continuity of the application of those provisions that have effect on or after the appointed day.

• (3) Where an agreement has been reached between a contractor and a Primary Care Trust in accordance with or in connection with the provisions in Part 8 of Schedule 6 to the GMS Contracts Regulations before the appointed day, that agreement is deemed to be an agreement made by that contractor and the Board.

• (4) Where notice has been given by the contractor to the Primary Care Trust or notice has been given by the Primary Care Trust to the contractor in accordance with or in connection with the provisions in Part 8 of Schedule 6 to the GMS Contracts Regulations, that notice is deemed to have been given by that contractor to the Board, or as the case may be, notice given by the Board to that contractor.

• (5) Notwithstanding the above paragraphs, the Board may, if it thinks necessary or desirable in order to dispose of a matter justly, review a decision or action taken that it is deemed to have made or taken as a consequence of this paragraph.

Consultation with the Local Medical Committee

20

Where a Primary Care Trust consulted the Local Medical Committee before the appointed day in accordance with the term of the contract that had the same effect as paragraph 120 (consultation with the Local Medical Committee) of Schedule 6 to the GMS Contracts Regulations as in force immediately before the appointed day, the Local Medical Committee, if it has not responded to the Primary Care Trust, must respond to the Board and treat the consultation as a consultation by the Board.

Supplementary transitional provision

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• (1) Subject to the preceding provisions in this Schedule, any act or omission by, or in relation to, a Primary Care Trust before the appointed day in respect of—

• (a) the exercise of any functions of the Primary Care Trust under Part 4 of the 2006 Act; or

• (b) any rights or liabilities of the Primary Care Trust transferred as a consequence of a property transfer scheme made under section 300 of the 2012 Act,

in relation to a GMS contract, is deemed to have been an act or omission of, or in relation to the Board.

• (2) Anything which, when these Regulations take effect, is in the process of being done by, or in relation to, the Primary Care Trust in respect of, or in connection with—

• (a) the exercise by the Primary Care Trust of any of its functions under Part 4 of the 2006 Act; or

• (b) any rights or liabilities of the Primary Care Trust transferred as a consequence of a property transfer scheme made under section 300 of the 2012 Act,

is deemed to have effect as if done by, or in relation to, and may be continued by, or in relation to, the Board.

• (3) Where it is necessary for the contractor or the Board—

• (a) to take account of a period of time; or

• (b) to calculate a period of time which is required in accordance with the GMS Contracts Regulations as in force on or after the appointed day,

any period of time that occurred before the appointed day and which is relevant to the matter under consideration is to be taken into account or used in order to calculate any time period for the purposes of that consideration or applying provisions in these Regulations on or after the appointed day only if that period of time could have been taken into account or used in a calculation of a time period in respect of those mirror provisions as in force immediately before the appointed day.

SCHEDULE 2 — Transitional provisions relating to PMS agreements

Application of Schedule 2

1

This Schedule applies to a PMS agreement which is entered into before the appointed day, and the parties to the agreement on or after the appointed day are the Contractor and the Board as a consequence of a property scheme transfer made under section 300 of the 2012 Act.

Interpretation

2

In this Schedule—

• “2012 Act” means the Health and Social Care Act 2012[^f00038];

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

• “the appointed day” means 1st April 2013;

• “the Board” means the National Health Service Commissioning Board;

• “contractor” means— in relation to a period before the appointed day, a party to a PMS agreement, other than the Primary Care Trust; or in relation to a period on or after the appointed day, a party to a PMS agreement, other than the Board;

• “out of hours services” has the same meaning as in regulation 2 (interpretation) of the PMS Agreements Regulations;

• “PMS agreement” means an agreement entered into in accordance with section 92 of the 2006 Act[^f00039];

• “Primary Care Trust” means the Primary Care Trust which was established and which subsisted immediately before the coming into force of section 34 (abolition of Primary Care Trusts) of the 2012 Act; and

• “relevant body” means— in a case where the contractor is a party to a PMS agreement with a Primary Care Trust, that Primary Care Trust, and in a case where the contractor is a party to a PMS agreement with a Strategic Health Authority, that Authority; and

• “Strategic Health Authority” means the Strategic Health Authority which was established and which subsisted immediately before the coming into force of section 33 (abolition of Strategic Health Authorities) of the 2012 Act.

General Transitional provision relating to the terms of a PMS agreement

3

• (1) The Contractor and the Board must as soon as is reasonably practicable on or after the appointed day, enter into discussions with each other with a view to agreeing variations to the PMS agreement in order to ensure that the agreement complies with the PMS Agreements Regulations on or after the appointed day.

• (2) Where the terms of the PMS agreement have not been varied so as to include the terms which have the same effect as those terms specified in these Regulations, the PMS agreement is deemed to have been so varied only to the extent that such terms are to have the same effect as those terms specified in these Regulations that have effect on or after on or after the appointed day.

• (3) The Contractor and the Board may not agree any variation to the PMS agreement that is contrary to the PMS Agreements Regulations on or after the appointed day.

Continuing validity of forms

4

A form supplied by a relevant body continues to be a valid form in relation to the Board until it is cancelled or withdrawn by the Board.

Notification of reasons by a relevant body in respect of entering into agreements

5

Where a relevant body has given notification to a person under regulation 6 (reasons) of the PMS Agreements Regulations before the appointed day, the notification and the written views contained in that notification are to be treated, on or after that day, as notification by the Board and the written views of the Board.

Appeals relating to eligibility to enter into a PMS agreement

6

A person who has been served notice pursuant to regulation 6 of the PMS Agreements Regulations before the appointed day may on or after that day appeal to the First-tier Tribunal against the decision of the relevant body and that appeal must be treated as an appeal against a decision of the Board.

Finance

7

Any right that a relevant body had to set off against any amount payable to the contractor under the term that gives effect to regulation 13 (finance) of the PMS Agreements Regulations immediately before the appointed day, must be treated as a right of the Board under the term that gives effect to that regulation on or after the appointed day.

Opt outs of out of hours services

8

• (1) Subject to the following provisions of this paragraph, a notification or approval given, or an agreement made, by a Primary Care Trust in accordance with the term of the agreement that gives effect to—

• (a) regulation 16 (opt outs of out of hours services) of the PMS Agreements Regulations; or

• (b) paragraph 1 (out of hours opt outs where the opt out notice is served after 30th September 2004) of Schedule 4 to the PMS Agreements Regulations,

in respect of a period that commences on or after the appointed day, must be regarded for the purposes of the term of the PMS agreement that gives effect to that regulation or that paragraph as a notification or approval given, or agreement made, by the Board and is binding on the Board as if such notification or approval were given, or agreement were made, by it.

• (2) Where a contractor informs the relevant Primary Care Trust that it wishes to withdraw an out of hours opt out notice where it has been approved by the Primary Care Trust and the Primary Care Trust has not agreed to the withdrawal before the appointed day, the Board may, if it considers it appropriate, agree to the withdrawal of the out of hours opt out notice as if it had approved the notice.

Right to a general medical services contract

9

Where notice is given to a relevant body prior to the appointed day in accordance with regulation 19 (right to a general medical services contract) of the PMS Agreements Regulations as in force immediately before the appointed day, that notice must be treated as notice given to the Board for the purposes of the application of that regulation as in force on or after the appointed day.

Arrangements for GP Registrars

10

A contractor which employs a GP Registrar in accordance with paragraph 63 (arrangements for GP Registrars) of Schedule 5 to the PMS Agreements Regulations immediately before the appointed day must continue to employ that GP Registrar and may only vary the terms and conditions to the extent necessary to comply with that paragraph and any other relevant provision relating to the 2006 Act which have effect on or after the appointed day.

Continuing application of published guidance and other documents

11

Where as a consequence of paragraph 9 (standards for out of hours services) or 115 (compliance with legislation and guidance) of Schedule 5 to the PMS Agreements Regulations a contractual term in a PMS agreement requires a contractor to meet requirements set out in a document or have regard to, or comply with, guidance published before the appointed day which has effect immediately before that day, that contractual term continues to apply in respect of such documents and guidance on or after the appointed day—

• (a) as if references to a Primary Care Trust or Strategic Health Authority in that document or guidance were to the Board; and

• (b) until such time as the Board, or as the case may be, the Secretary of State, cancels or withdraws the document or guidance.

Sub-contracting of clinical matters

12

• (1) Where a contractor has informed a relevant body that it has sub-contracted its rights and has provided the relevant information in accordance with paragraph 69 (sub-contracting of clinical matters) of Schedule 5 to the PMS Agreements Regulations as in force immediately before the appointed day, the contractor is deemed to have informed the Board and provided the Board with the relevant information.

• (2) Notwithstanding paragraph (1), the Board may request from the contractor such further information relating to the proposed sub-contract if it considers it necessary in order to deal with the matter.

Records, information, notifications and rights of entry

13

• (1) Where a Primary Care Trust has given consent, authorisation or notification or made a request under a term of the contract that has the same effect of the provisions in Part 5 (records, information, notification and rights of entry) of Schedule 5 to the PMS Agreements Regulations as in force immediately before the appointed day, such consent, authorisation, notification or request is deemed to be that of the Board for the purposes of the application of the terms of the contract that have the same effect as the provisions in Part 5 of Schedule 5 to the PMS Agreements Regulations on or after the appointed day.

• (2) The reference to a request and authorisation in paragraph (1) respectively includes any inquiries made in writing from the Primary Care Trust and appointments made by the Primary Care Trust in accordance with the terms of the PMS agreement that have the same effect as the provisions in paragraph 75 (inquiries about prescriptions and referrals) of Schedule 5 to the PMS Agreements Regulations as in force immediately before the appointed day.

Leaflets

14

• (1) This paragraph applies where a contractor has compiled a practice leaflet which complies with the requirements of paragraph 72 (contractor’s leaflet) of Schedule 5 to the PMS Agreements Regulations immediately before the appointed day.

• (2) Notwithstanding the requirements in paragraph 72 of Schedule 5 to the PMS Agreements Regulations as in force on or after the appointed day, a contractor must review its practice leaflet and make any amendments necessary so as to include the information specified in Schedule 10 to the PMS Agreements Regulations (information to be included in practice leaflets) not later than 1st July 2013.

Complaints

15

• (1) This paragraph applies where an investigation of a complaint under the procedure referred to in paragraph 86 of Schedule 5 to the PMS Agreements Regulations is not completed before the appointed day.

• (2) A complaint of a kind referred to in paragraph (1) must continue to be dealt with in accordance with the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009[^f00040]—

• (a) as if any reference to a relevant body in a document or form relating to the complaint were a reference to the Board; and

• (b) in respect of a complaint received prior to 1st April 2009, the contractor—

• (i) must deal with the complaint as far as it is able, in accordance with those Regulations; and

• (ii) may if it is unable to comply with those Regulations as a consequence of the length of time it has taken to deal with the complaint vary the procedure only to the extent that it is necessary in order to dispose of the matter in a just manner.

Co-operation with investigations

16

The contractor must continue to co-operate with an investigation of a complaint which is on-going immediately before the appointed day in accordance with the terms of the PMS agreement that give effect to paragraph 91 of Schedule 5 to the PMS Agreements Regulations as in force on or after the appointed day as if any act or omission by, or reference to, a relevant body, Primary Care Trust or Strategic Health Authority were an act or omission by, or reference to the Board.

Disputes

17

• (1) Any dispute arising out of or in connection with a PMS agreement in respect of a contractor and relevant body that is on-going immediately before the appointed day is deemed to be a dispute in respect of that contractor and the Board.

• (2) The terms of the PMS agreement which have the same effect as the provisions in Part 7 of Schedule 5 to the PMS Agreements Regulations as in force on or after the appointed day apply to the dispute as if any act, omission by, or in relation to, the relevant body is an act, omission by, or in relation to the Board.

Variation and termination of PMS agreements

18

• (1) This paragraph applies where a relevant body or a contractor has taken any steps in accordance with or in connection with a matter referred to in any of the provisions in Part 8 (variation and termination of agreements) of Schedule 5 to the PMS Agreements Regulations before the appointed day and had it not been for the coming into force of section 33 (abolition of Strategic Health Authorities) or section 34 (abolition of Primary Care Trusts) of the 2012 Act that matter would continue to fall to the relevant body to be dealt with in accordance with Part 8.

• (2) Any action taken or omission by a relevant body in accordance with or in connection with any of the provisions in Part 8 of Schedule 5 to the PMS Agreements Regulations is deemed to be action taken or omitted by the Board for the purposes of the continuity of the application of those provisions that have effect on or after the appointed day.

• (3) Where an agreement has been reached between a contractor and a relevant body in accordance with or in connection with the provisions in Part 8 of Schedule 5 to the PMS Agreements Regulations before the appointed day, that agreement is deemed to be an agreement made by that contractor and the Board.

• (4) Where notice has been given by the contractor to the relevant body or notice has been given by the relevant body to the contractor in accordance with or in connection with the provisions in Part 8 of Schedule 5 to the PMS Agreements Regulations, that notice is deemed to have been given by that contractor to the Board, or as the case may be, notice given by the Board to that contractor.

• (5) Notwithstanding the above paragraphs, the Board may, if it thinks necessary or desirable in order to dispose of a matter justly, review a decision or action taken that it is deemed to have made or taken as a consequence of this paragraph.

Supplementary transitional provision

19

• (1) Subject to the preceding provisions in this Schedule, any act or omission by, or in relation to, the relevant body before the appointed day in respect of—

• (a) the exercise of any functions of the relevant body under Part 4 of the 2006 Act; or

• (b) any rights or liabilities of the relevant body transferred as a consequence of a property transfer scheme made under section 300 of the 2012 Act,

in relation to section 92 arrangements, is deemed to have been an act or omission of, or in relation to the Board.

• (2) Anything which, when these Regulations take effect, is in the process of being done by, or in relation to, the relevant body in respect of, or in connection with—

• (a) the exercise by the relevant body of any of its functions under Part 4 of the 2006 Act; or

• (b) any rights or liabilities of the relevant body transferred as a consequence of a property transfer scheme made under section 300 of the 2012 Act,

is deemed to have effect as if done by, or in relation to, and may be continued by, or in relation to, the Board.

• (3) Where it is necessary for the contractor or the Board—

• (a) to take account of a period of time; or

• (b) to calculate a period of time which is required in accordance with the PMS Agreements Regulations as in force on or after the appointed day,

any period of time that occurred before the appointed day and which is relevant to the matter under consideration is to be taken into account or used in order to calculate any time period for the purposes of that consideration or applying provisions in these Regulations on or after the appointed day only if that period of time could have been taken into account or used in a calculation of a time period in respect of those mirror provisions as in force immediately before the appointed day.

Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — Department of Health — 15th February 2013

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations amend the National Health Service (General Medical Services Contracts) Regulations 2004 (“the GMS Contracts Regulations”), the National Health Service (Personal Medical Services Agreements) Regulations 2004 (“the PMS Agreements Regulations”), the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 (“the Prescription of Drugs Regulations”) and the Primary Medical Services (Sales of Goodwill and Restrictions on Sub-contracting) Regulations 2004 (“the Sale of Goodwill Regulations”). These Regulations largely make amendments which are as a consequence of the transfer of primary medical services contracts and agreements to the National Health Service Commissioning Board (“the Board”) from Primary Care Trusts and as a consequence of the abolition of Strategic Health Authorities and Primary Care Trusts upon the coming into force of sections 33 and 34 of the Health and Social Care Act 2012 (c.7) (“the 2012 Act”). These Regulations also make other minor amendments to the GMS Contracts Regulations, PMS Agreements Regulations and the Prescription of Drugs Regulations.

Part 2 contains amendments to the GMS Contracts Regulations. The majority of these amendments are made in consequence of the transfer of GMS contracts from Primary Care Trusts to the Board, the abolition of Primary Care Trusts and Primary Care Trust’s areas. In addition, minor amendments are made as a consequence of amendments to Part 4 of the National Health Service Act 2006 (c.41) by section 202(1) (medical services: minor amendments) of the 2012 Act coming into force. However–

• regulation 12 amends regulation 15 of the GMS Contracts Regulations to ensure that a contractor under its contractual terms is not required to provide essential services during any period in respect of which the Care Quality Commission has suspended the contractor as a service provider. Regulation 3 makes a consequential amendment by the insertion of a new definition of “service provider” into regulation 2 of the GMS Contracts Regulations;

• regulation 15 inserts a new provision into the GMS Contracts Regulations providing that contracts are to contain a term requiring a contractor to be a member of a clinical commissioning group and requiring a contractor to appoint one individual to act on its behalf. Regulation 3 makes a consequential amendment by the insertion of a new definition of “CCG” into regulation 2 of the GMS Contracts Regulations;

• regulation 20 omits the provisions relating to the Patient Choice Scheme that comes to an end on 31st March 2013. A new Patient Choice Extension Scheme is established and a variation of contractual terms in respect of entering into arrangements under that scheme are provided for by new regulation 26B which is inserted into the GMS Contracts Regulations by regulation 20. Regulation 3 makes a consequential amendment by the insertion of a new definition of “Patient Choice Extension Scheme” into regulation 2 of the GMS Contracts Regulations;

• Regulation 27 makes additional amendments to Schedule 6 to the GMS Contracts Regulations– paragraphs (33), (34) and (36) make amendments in relation to electronic prescriptions which are required as a consequence of the National Health Service IT infrastructure changes which include the electronic system that enables the transmission of digitally signed prescriptions and prescription messages to dispensing contractors. Regulation 3 makes consequential amendments; paragraph (41) makes an updating amendment as a consequence of changes relating to postgraduate education and training and requirements relating to the medical performers list which is established and maintained by the Board; paragraph (42) amends paragraph 64 of Schedule 6 and paragraph 86 inserts a new paragraph 121B into Schedule 6 as a consequence of the newly established Special Health Authority known as Health Education England; paragraph (43) amends paragraph 65 of Schedule 6 as a consequence of chiropodists and podiatrists and physiotherapists being able to be recorded on the register maintained under article 5 of the Health and Social Work Professions Order 2001 as independent prescribers. paragraphs (60) and (61) respectively omit paragraph 91A and insert a new paragraph 91B as a consequence of the abolition of local involvement networks and the establishment of Local Healthwatch organisations in accordance with section 222(2A) of the Local Government and Public Involvement in Health Act 2007 (c.28) as amended by section 183(2) of the 2012 Act.

Schedule 1 makes transitional provisions in respect of GMS contracts which are transferred from Primary Care Trusts to the Board on 1st April 2013.

Part 3 and Schedule 2 make amendments to the PMS Agreements Regulations and transitional provision relating to agreements made under those Regulations which mirror those made to the GMS Contracts Regulations.

Part 4 makes miscellaneous amendments. Regulation 54 amends the Prescription of Drugs Regulations–

• (a) to omit the entry for Cyanocobalamin Tablets from the list of drugs that may be ordered in respect of specified persons in certain circumstances, and

• (b) in respect of the circumstances in which Oseltamivir and Zanamivir may be ordered for a person as part of an antiviral distribution service as a consequence of the abolition of Primary Care Trusts, the establishment of the Board and Public Health England and the public health functions of Local Authorities.

Regulation 55 amends the Sale of Goodwill Regulations as a consequence of the abolition of Primary Care Trusts and Strategic Health Authorities.

Footnotes

[^f00001]: 2006. c.41. By virtue of section 271(1) of the Act, the powers conferred by these sections are exercisable by the Secretary of State only in relation to England. Section 83 is amended by section 55(1) of, and paragraph 30 of Schedule 4 to, the Health and Social Care Act 2012 (c.7) (“the 2012 Act”); section 86 is amended by section 55(1) of, and paragraph 32 of Schedule 4 to, the 2012 Act; section 89 is amended by sections 28(1), 55(1) and 202(2) of, and paragraph 34 of Schedule 4 to, the 2012 Act; section 91 is amended by section 55(1) of, and paragraph 35 of Schedule 4 to, the 2012 Act; section 93 is amended by sections 55(1) and 202(3) of, and paragraph 37 of Schedule 4 to, the 2012 Act; section 94 is amended by sections 28(2) and 55(1) of, and paragraph 38 of Schedule 4 to, the 2012 Act; section 97 is amended by section 55(1) of, and paragraph 41 of Schedule 4 to, the 2012 Act and section 259 is amended by section 55(1) of, and paragraph 132 of Schedule 4 to, the 2012 Act. See also section 275(1) for the definition of “prescribed” and “regulations”.

[^f00031]: S.I. 2004/629. Relevant amending instruments are S.I. 2004/3215, 2009/2230, 2010/2389 and 2011/680 and 1043.

[^f00032]: Public Health England is an Executive Agency of the Department of Health.

[^f00033]: S.I. 2004/906. There are no amendments.

[^f00034]: 2012 c.7.

[^f00035]: The National Health Service Commissioning Board is established by section 1H of the 2006 Act. Section 1H is inserted by section 9 of the 2012 Act.

[^f00036]: Section 84 is amended by section 55(1) of, and paragraph 31 of Schedule 4 to, the 2012 Act.

[^f00037]: S.I.2009/309; amending instruments are S.I. 2009/1768, 2012/1909 and 2013/235.

[^f00038]: 2012 (c.7).

[^f00039]: Section 92 is amended by section 55(1) of, and paragraph 36 of Schedule 4 to, the 2012 Act.

[^f00040]: S.I.2009/309; amending instruments are S.I. 2009/1768, 2012/1909 and 2013/235.

Editorial notes

[^key-226162c68ac5987486a244032b43379a]: Reg. 54 in force at 1.4.2013, see reg. 1(1)

[^key-828056aea8f3f3ecd8f84ad1d3c06102]: Reg. 55 in force at 1.4.2013, see reg. 1(1)

[^key-010bf3d8b6be608cc0439d4e354f5057]: Sch. 1 para. 1 in force at 1.4.2013, see reg. 1(1)

[^key-63ba249e65804576a133c4cf4f52004a]: Sch. 1 para. 2 in force at 1.4.2013, see reg. 1(1)

[^key-9d5496712fc5fdfce80ea6b0dbcb6adb]: Sch. 1 para. 3 in force at 1.4.2013, see reg. 1(1)

[^key-63b6493075cb83467d05757ea53f82f1]: Sch. 1 para. 4 in force at 1.4.2013, see reg. 1(1)

[^key-904e71b85b052ff5d3dfeb2e258b94bf]: Sch. 1 para. 5 in force at 1.4.2013, see reg. 1(1)

[^key-617f4e4a27f5ee616ea4daa7df247de4]: Sch. 1 para. 6 in force at 1.4.2013, see reg. 1(1)

[^key-d8689ec30ffeaefc38d8c65cad9a8d31]: Sch. 1 para. 7 in force at 1.4.2013, see reg. 1(1)

[^key-8341a0c85ff5228e0c8cf3fa3586babf]: Sch. 1 para. 8 in force at 1.4.2013, see reg. 1(1)

[^key-a6d57fa86911b171dd4f8f647b49e510]: Sch. 1 para. 9 in force at 1.4.2013, see reg. 1(1)

[^key-89b7c0b459b384ff3d272ec72f278755]: Sch. 1 para. 10 in force at 1.4.2013, see reg. 1(1)

[^key-0a8ee4886339e6c1573e7be735636cb6]: Sch. 1 para. 11 in force at 1.4.2013, see reg. 1(1)

[^key-5c27a8ba0f5930c47e54f8117013cab0]: Sch. 1 para. 12 in force at 1.4.2013, see reg. 1(1)

[^key-594454175e9b0e8320246558c293f718]: Sch. 1 para. 13 in force at 1.4.2013, see reg. 1(1)

[^key-e0ef06e5323a528af7e92a60c0f75401]: Sch. 1 para. 14 in force at 1.4.2013, see reg. 1(1)

[^key-93fdad8d2a91904050301c0726da7ba1]: Sch. 1 para. 15 in force at 1.4.2013, see reg. 1(1)

[^key-5c9986ef46a83849e65031beb1c2bd59]: Sch. 1 para. 16 in force at 1.4.2013, see reg. 1(1)

[^key-d88b23e82618b0bb36fd85304a669dd5]: Sch. 1 para. 17 in force at 1.4.2013, see reg. 1(1)

[^key-479c97439ae593bf1213e9fca444c590]: Sch. 1 para. 18 in force at 1.4.2013, see reg. 1(1)

[^key-ccbcccc7b444611a830913b1b1179632]: Sch. 1 para. 19 in force at 1.4.2013, see reg. 1(1)

[^key-3c43f944008764baec788526b6bc1ce8]: Sch. 1 para. 20 in force at 1.4.2013, see reg. 1(1)

[^key-d3a5cbe9d95cf05ff07f8fa78c45ec10]: Sch. 1 para. 21 in force at 1.4.2013, see reg. 1(1)

[^key-358d3d4217329cd9e40691aec4b57be9]: Sch. 2 para. 1 in force at 1.4.2013, see reg. 1(1)

[^key-61fe6ba46fe671208ac6a9dcf36985cb]: Sch. 2 para. 2 in force at 1.4.2013, see reg. 1(1)

[^key-70c8d252ec16eddeb052f91005baab66]: Sch. 2 para. 3 in force at 1.4.2013, see reg. 1(1)

[^key-12c3375d3d4cfdb68eb6a4e48315a0de]: Sch. 2 para. 4 in force at 1.4.2013, see reg. 1(1)

[^key-ff9be1aaf0031d39c380846122fb4384]: Sch. 2 para. 5 in force at 1.4.2013, see reg. 1(1)

[^key-1676fcb06aba606e387eff2709c05873]: Sch. 2 para. 6 in force at 1.4.2013, see reg. 1(1)

[^key-a1dd907d9f18c6ddfe4c350add818462]: Sch. 2 para. 7 in force at 1.4.2013, see reg. 1(1)

[^key-36c5170ace490c6bb711c427898b0917]: Sch. 2 para. 8 in force at 1.4.2013, see reg. 1(1)

[^key-5c888196941d028bef1a759243414233]: Sch. 2 para. 9 in force at 1.4.2013, see reg. 1(1)

[^key-4e6d846484f6601fa144e88a71c1a1f7]: Sch. 2 para. 10 in force at 1.4.2013, see reg. 1(1)

[^key-18a620088d99fa31931920a8ac8b5ede]: Sch. 2 para. 11 in force at 1.4.2013, see reg. 1(1)

[^key-3f0f56eb8f8e3cdb8635988557b2bd37]: Sch. 2 para. 12 in force at 1.4.2013, see reg. 1(1)

[^key-f5372e4a88b0008dd522b01b0c549651]: Sch. 2 para. 13 in force at 1.4.2013, see reg. 1(1)

[^key-9b5e2bd9624a2d95c99981b70e632b35]: Sch. 2 para. 14 in force at 1.4.2013, see reg. 1(1)

[^key-2e2d5fb934a733949e573179534d1a2a]: Sch. 2 para. 15 in force at 1.4.2013, see reg. 1(1)

[^key-f497ef9f74ed407b98385476a5ed9ed4]: Sch. 2 para. 16 in force at 1.4.2013, see reg. 1(1)

[^key-ab3efab435307486568b38cde939e256]: Sch. 2 para. 17 in force at 1.4.2013, see reg. 1(1)

[^key-354f5f82994919616ccbdfb125cc0f78]: Sch. 2 para. 18 in force at 1.4.2013, see reg. 1(1)

[^key-3a245572a8dce8f26bf853c2070b852f]: Sch. 2 para. 19 in force at 1.4.2013, see reg. 1(1)

[^key-3dc94884398982dbd8f8da70d38231cb]: Pt. 1 revoked (7.12.2015) by The National Health Service (Personal Medical Services Agreements) Regulations 2015 (S.I. 2015/1879), reg. 1(2), Sch. 4 (with regs. 2, 88)

[^key-cfa7927bdbdc68737d55add91faf09bd]: Pt. 2 revoked (7.12.2015) by The National Health Service (General Medical Services Contracts) Regulations 2015 (S.I. 2015/1862), reg. 1(2), Sch. 5 Table (with reg. 2)

[^key-406945236b16d88d3ff063bf41f4386e]: Pt. 3 revoked (7.12.2015) by The National Health Service (Personal Medical Services Agreements) Regulations 2015 (S.I. 2015/1879), reg. 1(2), Sch. 4 (with regs. 2, 88)