|
| |
|
(6) | Monitor must grant an application under this section if— |
| |
(a) | having regard to the matters in subsection (4), it is satisfied that the |
| |
criterion in subsection (3) is met, and |
| |
(b) | it is satisfied that the commissioner carried out consultation in |
| |
accordance with subsection (2)(a). |
| 5 |
(7) | Where Monitor grants an application under this section, it must give notice of |
| |
the designation of the service concerned to— |
| |
(a) | the commissioner, and |
| |
(b) | every relevant person. |
| |
(8) | A notice under subsection (7) given to a provider of a service for the purposes |
| 10 |
of the NHS must explain the right of appeal conferred by section 70. |
| |
(9) | Where the applicant under this section is the National Health Service |
| |
Commissioning Board, the relevant persons are— |
| |
(a) | the Secretary of State, |
| |
(b) | the Care Quality Commission and its Healthwatch England committee, |
| 15 |
(c) | every local authority in whose area the service is provided for the |
| |
| |
(d) | every local Healthwatch organisation in whose area the service is |
| |
provided for those purposes, |
| |
(e) | every person who, in pursuance of arrangements with the Board, |
| 20 |
provides the services for the purposes of the NHS, and |
| |
(f) | such other persons as the Board considers appropriate. |
| |
(10) | Where the applicant under this section is a commissioning consortium, the |
| |
| |
(a) | every local authority in whose area the service is provided for the |
| 25 |
| |
(b) | every local Healthwatch organisation in whose area the service is |
| |
provided for those purposes, |
| |
(c) | every person who, in pursuance of arrangements with the consortium, |
| |
provides the service for the purposes of the NHS, and |
| 30 |
(d) | such other persons as the consortium considers appropriate. |
| |
(11) | Where the applicant under this section is the Secretary of State, or a person |
| |
acting on the Secretary of State’s behalf, by virtue of section 13U of the National |
| |
Health Service Act 2006, the relevant persons are— |
| |
(a) | the Healthwatch England committee of the Care Quality Commission, |
| 35 |
(b) | every local authority, |
| |
(c) | every local Healthwatch organisation in whose area the service in |
| |
| |
(d) | the National Health Service Commissioning Board, and |
| |
(e) | such other persons as the Secretary of State or person acting on the |
| 40 |
Secretary of State’s behalf considers appropriate. |
| |
70 | Appeals to the Tribunal |
| |
(1) | An appeal by a provider of a designated service against Monitor’s decision to |
| |
designate that service lies to the First-tier Tribunal. |
| |
(2) | A person may bring an appeal under this section only if— |
| 45 |
(a) | the person has made a complaint under section 71(8), and |
| |
|
| |
|
| |
|
(b) | Monitor has notified the person of its decision on the complaint. |
| |
(3) | The grounds for an appeal under this section are that the decision to make the |
| |
| |
(a) | based on an error of fact, |
| |
| 5 |
| |
(4) | On an appeal under this section, the First-tier Tribunal may confirm Monitor’s |
| |
decision or direct that it is not to have effect. |
| |
71 | Reviews and removals of designations |
| |
(1) | The commissioner of a designated service must, during the relevant period, |
| 10 |
review the designation so as to establish whether, having regard to the matters |
| |
in subsection (4) of that section, it is satisfied that the criterion in subsection (3) |
| |
of that section continues to be met. |
| |
(2) | The relevant period is— |
| |
(a) | for the first review under subsection (1), the period— |
| 15 |
(i) | beginning with the expiry of the period of one year after the |
| |
date of the notice under section 69(7), and |
| |
(ii) | ending with the expiry of the period of ten years after that date, |
| |
| |
(b) | for a subsequent review under subsection (1), the period— |
| 20 |
(i) | beginning with the expiry of the period of one year after the |
| |
date on which the previous review under that subsection was |
| |
| |
(ii) | ending with the expiry of the period of ten years after that date. |
| |
(3) | The commissioner of a designated service may (whether or not in consequence |
| 25 |
of a review under subsection (1)) apply to Monitor for the removal of the |
| |
| |
(4) | The commissioner may make the application only if— |
| |
(a) | it has consulted the relevant persons, and |
| |
(b) | having regard to the matters in subsection (4) of section 69, it is satisfied |
| 30 |
that the criterion in subsection (3) of that section is no longer met. |
| |
(5) | An application under subsection (3) must be accompanied by copies of the |
| |
responses the commissioner received to the consultation under subsection |
| |
| |
(6) | Monitor must grant an application under subsection (3) if— |
| 35 |
(a) | having regard to the matters in subsection (4) of section 69, it is satisfied |
| |
that the criterion in subsection (3) of that section is no longer met, and |
| |
(b) | it is satisfied that the commissioner carried out consultation in |
| |
accordance with subsection (4)(a). |
| |
(7) | Where Monitor grants an application under subsection (3), it must give notice |
| 40 |
of the removal of the designation to— |
| |
(a) | the commissioner, and |
| |
(b) | every relevant person. |
| |
|
| |
|
| |
|
(8) | Monitor may, on a complaint by a provider of a designated service, remove a |
| |
designation under section 69 if— |
| |
(a) | it has consulted the commissioner who applied for the designation, and |
| |
(b) | having regard to the matters in subsection (4) of section 69, it is satisfied |
| |
that the criterion in subsection (3) of that section is no longer met. |
| 5 |
(9) | A complaint under subsection (8) must be made before the end of the period of |
| |
28 days beginning with the day on which the designation is made. |
| |
(10) | Where Monitor removes a designation on a complaint under subsection (8), it |
| |
must give notice of the removal of the designation to— |
| |
(a) | the provider who made the complaint, |
| 10 |
(b) | the commissioner who applied for the designation, and |
| |
(c) | every relevant person. |
| |
(11) | The relevant persons for the purposes of this section are the persons who are |
| |
the relevant persons for the purposes of section 69. |
| |
72 | Designations affecting more than one commissioner |
| 15 |
(1) | The National Health Service Commissioning Board must make arrangements |
| |
for facilitating agreement between commissioning consortia as to— |
| |
(a) | whether to apply for designation of a service under section 69; |
| |
(b) | which consortium is to apply for designation of a service under that |
| |
section (and is accordingly, if the application is granted, to have power |
| 20 |
to review and apply for the removal of the designation). |
| |
(2) | Where commissioning consortia fail to reach agreement on a matter in |
| |
pursuance of arrangements under subsection (1), the National Health Service |
| |
Commissioning Board may determine the matter; and the consortia concerned |
| |
must comply with that determination. |
| 25 |
(3) | Regulations may make provision as to the determination of matters on which |
| |
commissioning consortia fail to reach agreement in pursuance of arrangements |
| |
| |
(4) | Where regulations under subsection (3) are in force, the power conferred on the |
| |
National Health Service Commissioning Board by subsection (2) must be |
| 30 |
exercised in accordance with the regulations. |
| |
| |
(1) | Monitor must publish guidance on— |
| |
(a) | applying for designation of a service under section 69; |
| |
(b) | reviewing a designation under section 71; |
| 35 |
(c) | applying for removal of a designation under that section. |
| |
(2) | Before publishing guidance under this section, Monitor must— |
| |
(a) | consult the persons in subsection (3), and |
| |
(b) | obtain the approval of the National Health Service Commissioning |
| |
| 40 |
(3) | The persons to be consulted are— |
| |
(a) | the Secretary of State, |
| |
(b) | the Care Quality Commission and its Healthwatch England committee, |
| |
|
| |
|
| |
|
(c) | every local authority in England, |
| |
(d) | every commissioning consortium, |
| |
(e) | every licence holder, and |
| |
(f) | such other persons as Monitor considers appropriate. |
| |
(4) | Monitor must give each consultee notice of the duration of the consultation |
| 5 |
period in relation to the proposed guidance; and for that purpose the |
| |
consultation period is the period of 28 days beginning with the day after that |
| |
on which the notice is given. |
| |
(5) | Monitor may revise guidance under this section and, if it does so, must publish |
| |
| 10 |
| |
| |
| |
74 | Requirement for health service providers to be licensed |
| |
(1) | Any person who provides a health care service for the purposes of the NHS |
| 15 |
must hold a licence under this Chapter. |
| |
(2) | Regulations may make provision for the purposes of this Chapter for |
| |
determining, in relation to a service provided by two or more persons acting in |
| |
different capacities, which of those persons is to be regarded as the person who |
| |
| 20 |
75 | Deemed breach of requirement to be licensed |
| |
(1) | This section applies where a licence holder— |
| |
(a) | in providing a health care service for the purposes of the NHS, carries |
| |
on a regulated activity (within the meaning of Part 1 of the Health and |
| |
Social Care Act 2008), but |
| 25 |
(b) | is not registered under Chapter 2 of Part 1 of that Act in respect of the |
| |
carrying on of that activity. |
| |
(2) | The licence holder is to be regarded as providing the service in breach of the |
| |
requirement under section 74 to hold a licence. |
| |
| 30 |
(1) | Regulations (referred to in this section and section 77 as “exemption |
| |
regulations”) may provide for the grant of exemptions from the requirement in |
| |
section 74(1) in respect of— |
| |
(a) | a prescribed person or persons of a prescribed description; |
| |
(b) | the provision of a prescribed health care service or a health care service |
| 35 |
of a prescribed description. |
| |
(2) | Exemption regulations may grant an exemption— |
| |
(a) | either generally or to the extent prescribed; |
| |
(b) | either unconditionally or subject to prescribed conditions; |
| |
|
| |
|
| |
|
(c) | indefinitely, for a prescribed period or for a period determined by or |
| |
| |
(3) | Conditions subject to which an exemption may be granted include, in |
| |
particular, conditions requiring a person providing a service pursuant to the |
| |
| 5 |
(a) | to comply with any direction given by Monitor about such matters as |
| |
are specified in the exemption or are of a description so specified, |
| |
(b) | except to the extent that Monitor otherwise approves, to do, or not to |
| |
do, such things as are specified in the exemption or are of a description |
| |
so specified (or to do, or not to do, such things in a specified manner), |
| 10 |
| |
(c) | to refer for determination by Monitor such questions arising under the |
| |
exemption as are specified in the exemption or are of a description so |
| |
| |
(4) | Before making exemption regulations the Secretary of State must give |
| 15 |
| |
| |
(b) | the National Health Service Commissioning Board, and |
| |
(c) | the Care Quality Commission and its Healthwatch England committee. |
| |
(5) | The Secretary of State must also publish the notice under subsection (4). |
| 20 |
(6) | The notice under subsection (4) must— |
| |
(a) | state that the Secretary of State proposes to make exemption |
| |
regulations and set out their proposed effect, |
| |
(b) | set out the Secretary of State’s reasons for the proposal, and |
| |
(c) | specify the period (“the notice period”) within which representations |
| 25 |
with respect to the proposal may be made. |
| |
(7) | The notice period must be not less than 28 days beginning with the day after |
| |
that on which the notice is published under subsection (4). |
| |
(8) | Where an exemption is granted to a person, the Secretary of State— |
| |
(a) | must give the person notice of the exemption, and |
| 30 |
(b) | must publish the exemption. |
| |
77 | Exemption regulations: supplementary |
| |
(1) | Regulations may revoke exemption regulations by which an exemption was |
| |
granted to a person, or amend such regulations by which more than one |
| |
exemption was so granted so as to withdraw any of the exemptions— |
| 35 |
(a) | at the person’s request, |
| |
(b) | in accordance with any provision of the exemption regulations by |
| |
which the exemption was granted, or |
| |
(c) | if the Secretary of State considers it to be inappropriate for the |
| |
exemption to continue to have effect. |
| 40 |
(2) | Regulations may revoke exemption regulations by which an exemption was |
| |
granted to persons of a prescribed description, or amend such regulations by |
| |
which more than one exemption was so granted so as to withdraw any of the |
| |
| |
(a) | in accordance with any provision of the exemption regulations by |
| 45 |
which the exemption was granted, or |
| |
|
| |
|
| |
|
(b) | if the Secretary of State considers it to be inappropriate for the |
| |
exemption to continue to have effect. |
| |
(3) | The Secretary of State may by direction withdraw an exemption granted to |
| |
persons of a description prescribed in exemption regulations for any person of |
| |
| 5 |
(a) | at the person’s request, |
| |
(b) | in accordance with any provision of the exemption regulations by |
| |
which the exemption was granted, or |
| |
(c) | if the Secretary of State considers it to be inappropriate for the |
| |
exemption to continue to have effect in the case of the person. |
| 10 |
(4) | Subsection (5) applies where the Secretary of State proposes to— |
| |
(a) | make regulations under subsection (1)(b) or (c) or (2), or |
| |
(b) | give a direction under subsection (3)(b) or (c). |
| |
(5) | The Secretary of State must— |
| |
(a) | consult the following about the proposal— |
| 15 |
| |
(ii) | the National Health Service Commissioning Board; |
| |
(iii) | the Care Quality Commission and its Healthwatch England |
| |
| |
(b) | where the Secretary of State is proposing to make regulations under |
| 20 |
subsection (1)(b) or (c), give notice of the proposal to the person to |
| |
whom the exemption was granted; |
| |
(c) | where the Secretary of State is proposing to make regulations under |
| |
subsection (2), publish the notice. |
| |
| 25 |
(a) | state that the Secretary of State proposes to make the regulations or give |
| |
the direction (as the case may be), |
| |
(b) | set out the Secretary of State’s reasons for the proposal, and |
| |
(c) | specify the period within which representations with respect to the |
| |
| 30 |
| |
78 | Application for licence |
| |
(1) | A person seeking to hold a licence under this Chapter must make an |
| |
| |
(2) | The application must be made in such form, and contain or be accompanied by |
| 35 |
such information, as Monitor requires. |
| |
| |
(1) | Monitor must set and publish the criteria which must be met by a person in |
| |
order for that person to be granted a licence under this Chapter. |
| |
(2) | Monitor may revise the criteria and, if it does so, must publish them as revised. |
| 40 |
(3) | Before setting or revising the criteria, Monitor must obtain the approval of the |
| |
| |
|
| |
|