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

1

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

PART 2 — AMENDMENT OF THE GMS CONTRACTS REGULATIONS

2

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

Amendment of regulation 2

3

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

Substitution of regulation 3

4

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

Amendment of regulation 4

5

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

Amendment of regulation 5

6

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

Amendment of regulation 6

7

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

Amendment of regulation 7

8

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

Amendment of regulation 9

9

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

Amendment of regulation 10

10

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

Amendment of regulation 14

11

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

Amendment of regulation 15

12

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

Amendment of regulation 17

13

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

Amendment of regulation 18

14

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

Insertion of new regulation 20A

15

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

Amendment of regulation 22

16

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

Substitution of regulation 23

17

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

Amendment of regulation 24

18

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

Amendment of regulation 26

19

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

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

20

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

Amendment of regulation 27

21

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

Amendment of regulation 31

22

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

Omission of regulation 32 and Schedule 7

23

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

Amendment of Schedule 2

24

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

Amendment of Schedule 3

25

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

Amendment of Schedule 5

26

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

Amendment of Schedule 6

27

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

Amendment of Schedule 10

28

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

Transitional provision

29

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

PART 3 — AMENDMENTS OF THE PMS AGREEMENT REGULATIONS

30

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

Amendment of regulation 2

31

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

Substitution of regulation 3

32

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

Amendment of regulation 5

33

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

Amendment of regulation 6

34

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

Amendment of regulation 7

35

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

Amendment of regulation 8

36

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

Amendment of regulation 9

37

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

Amendment of regulation 11

38

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

Insertion of new regulation 11A

39

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

Amendment of regulation 13

40

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

Substitution of regulation 14

41

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

Amendment of regulation 15

42

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

Amendment of regulation 16

43

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

Substitution of regulation 18

44

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

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

45

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

Amendment of regulation 19

46

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

Omission of regulation 21 and Schedule 6

47

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

Amendment to Schedule 3

48

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

Amendment of Schedule 4

49

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

Amendment of Schedule 5

50

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

Omission of Schedule 7

51

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

Amendment of Schedule 10

52

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

Transitional provisions

53

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

PART 4 — MISCELLANEOUS AMENDMENTS

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

54

• (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

55

• (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

2

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

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 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

4

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

5

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

6

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

7

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

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 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

9

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

10

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

11

• (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

12