Bill Text: NY A01411 | 2015-2016 | General Assembly | Amended
Bill Title: Enacts provisions authorizing retail clinics and limited services clinics to provide certain services and directs the commissioner of health to enact regulations imposing certain standards and restrictions.
Spectrum: Moderate Partisan Bill (Democrat 21-5)
Status: (Introduced - Dead) 2016-06-09 - print number 1411b [A01411 Detail]
Download: New_York-2015-A01411-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 1411--B 2015-2016 Regular Sessions IN ASSEMBLY January 12, 2015 ___________ Introduced by M. of A. PAULIN, GOTTFRIED, BENEDETTO, LINARES, RODRIGUEZ, STIRPE, QUART, McDONALD, CRESPO, CROUCH, MURRAY, SIMON, PICHARDO, ARROYO, COOK, TITONE, DUPREY, SKOUFIS, DINOWITZ -- Multi-Sponsored by -- M. of A. HIKIND, HOOPER, LUPARDO, LUPINACCI, MARKEY, McDONOUGH, PERRY, SEPULVEDA, WRIGHT -- read once and referred to the Committee on Health -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee -- reported and referred to the Committee on Codes -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee AN ACT to amend the public health law, in relation to retail clinics and limited services clinics The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The public health law is amended by adding a new section 2 230-e to read as follows: 3 § 230-e. Retail clinics. 1. As used in this section, "retail clinic" 4 means a facility or portion of a facility that is operated by any entity 5 that is authorized under the laws of this state to provide professional 6 services to the public and that provides health care services or treat- 7 ment provided by a health care practitioner licensed, certified, regis- 8 tered or authorized to practice under title eight of the education law, 9 acting within his or her lawful scope of practice, that: (a) operates 10 within the space of a retail business operation, such as a pharmacy or a 11 store open to the general public; (b) is labeled, branded, advertised or 12 marketed with the name or symbol of a retail business entity; or (c) is 13 labeled, branded, advertised or marketed with the name or symbol of a 14 business entity, other than a business entity that provides health care 15 services or treatment provided at the facility. However, a facility or 16 portion of a facility shall not be deemed to be a retail clinic if it 17 ordinarily is used only for providing health care services to employees 18 of the retail business operation. A facility shall not be deemed to be EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD04863-07-6A. 1411--B 2 1 a retail clinic if the health care service under title eight of the 2 education law it provides is limited to pharmacy or ophthalmic dispens- 3 ing and ophthalmologic or optometric services provided in connection 4 with ophthalmic dispensing. 5 2. The treatments and services that may be provided by a retail clinic 6 shall be limited to the provision of treatment and services to patients 7 for acute episodic illness or condition; episodic preventive treatment 8 and services such as immunizations; ophthalmic dispensing and ophthalmo- 9 logic or optometric services provided in connection with ophthalmic 10 dispensing; or treatment and services for minor injuries that are not 11 reasonably likely to be life-threatening or potentially disabling or 12 have complications if ambulatory care within the capacity of the retail 13 clinic is provided; but the treatments and services provided by a retail 14 clinic shall not include monitoring or treatment and services over 15 multiple visits over prolonged periods. 16 3. A retail clinic shall be deemed to be a "health care provider" for 17 the purposes of title two-D of this article. A prescriber practicing in 18 a retail clinic shall not be deemed to be in the employ of a pharmacy or 19 practicing in a hospital for purposes of subdivision two of section 20 sixty-eight hundred seven of the education law. 21 4. (a) The commissioner shall make regulations setting forth opera- 22 tional and physical plant standards for retail clinics, which may be 23 different from the regulations otherwise applicable to diagnostic and 24 treatment centers, including, but not limited to: 25 (i) requiring that retail clinics attain and maintain accreditation by 26 an appropriate accrediting entity approved by the commissioner and 27 requiring timely reporting to the department if a retail clinic loses 28 its accreditation; 29 (ii) designating or limiting the treatments and services that may be 30 provided, including limiting the scope of services to the following, 31 provided that such services shall not include monitoring or treatment 32 and services over multiple visits or prolonged periods: 33 (A) the provision of treatment and services to patients for minor 34 acute episodic illnesses or conditions; 35 (B) episodic prevention and wellness treatments and services such as 36 immunizations; 37 (C) ophthalmic dispensing and ophthalmologic or optometric services 38 provided in connection with ophthalmic dispensing; 39 (D) treatment and services for minor injuries that are not reasonably 40 likely to be life threatening or potentially disabling or have compli- 41 cations if ambulatory care within the capacity of the retail clinic is 42 provided; 43 (E) prohibiting the provision of services to patients twenty-four 44 months of age or younger; 45 (iii) requiring retail clinics to accept walk-ins and offer extended 46 business hours; 47 (iv) setting forth guidelines for advertising and signage, which shall 48 include signage indicating that prescriptions and over-the-counter 49 supplies may be purchased by a patient from any business and do not need 50 to be purchased on-site; 51 (v) setting forth guidelines for informed consent, record keeping, 52 referral for treatment and continuity of care, case reporting to the 53 patient's primary care or other health care providers, design, 54 construction, fixtures, and equipment. 55 (b) Such regulations also shall promote and strengthen primary care by 56 requiring retail clinics to:A. 1411--B 3 1 (i) inquire of each patient whether he or she has a primary care 2 provider; 3 (ii) maintain and regularly update a list of local primary care 4 providers and provide such list to each patient who indicates that he or 5 she does not have a primary care provider. Such roster (A) shall be 6 drawn from a list of primary care providers maintained and periodically 7 updated by the department on its website (in searchable form) including 8 the information required in clauses (B) and (C) of this subparagraph, 9 located in the zip code area and adjacent zip code areas of the retail 10 clinic, and may include additional primary care providers added by the 11 retail clinic; (B) shall identify preferred providers who have achieved 12 recognition as a patient centered medical home (pcmh) or other similar 13 designation and a description of what such designation means; and (C) 14 shall include federally qualified health centers and other providers who 15 serve medicaid, low-income and uninsured patients, and people with disa- 16 bilities and shall identify cultural and linguistic capabilities when 17 available; 18 (iii) refer patients to their primary care providers or other health 19 care providers where appropriate; 20 (iv) transmit by electronic means whenever possible, records of 21 services to patients' primary care providers; 22 (v) decline to treat any patient for the same condition or illness 23 more than three times in a year; and 24 (vi) report to the department relevant data, as may be deemed neces- 25 sary by the department, related to services provided and patients 26 served, provided that such reporting shall comply with all privacy laws 27 related to patient data. 28 (c) Retail clinics already in operation at the time this section takes 29 effect must comply with accreditation requirements under this subdivi- 30 sion within one year after the effective date of this section. 31 (d) The department shall routinely review the compliance by retail 32 clinics with the provisions of this section and if a retail clinic fails 33 to comply with the provisions of this section, or regulations adopted 34 pursuant to this section, the department shall have the authority to 35 take enforcement actions under title two of article one of this chapter. 36 (e) In making regulations under this section, the commissioner may 37 consult with a workgroup including, but not limited to, representatives 38 of health care consumers and representatives of professional societies 39 of appropriate health care professionals, including those in primary 40 care and other specialties. 41 5. A retail clinic shall provide treatment without discrimination as 42 to source of payment. 43 6. The department shall provide an annual report which it shall make 44 available on its website; the report shall include locations of retail 45 clinics in the state and shall indicate which clinics are located in 46 medically underserved areas; such report shall also include an analysis 47 as to whether retail clinics have improved access to health care in 48 underserved areas, recommendations related thereto and any other infor- 49 mation the department may deem necessary. 50 7. This section does not authorize any form of ownership or organiza- 51 tion of a retail clinic or practice of any profession that would not 52 otherwise be legal, and does not expand the scope of practice of any 53 health care practitioner. Where any regulation under this section would 54 affect the scope of practice that may be provided in a retail clinic a 55 health care practitioner licensed, registered, certified or authorizedA. 1411--B 4 1 to practice under title eight of the education law, the regulation shall 2 be made in consultation with the commissioner of education. 3 8. The host business entity of a retail clinic shall not, directly or 4 indirectly, by contract, policy, communication, incentive or otherwise, 5 influence or seek to influence any clinical decision, policy or practice 6 of any health care practitioner providing any health care service in the 7 retail clinic, including prescribing or recommending drugs, devices or 8 supplies. This subdivision shall not preclude the host business entity 9 from establishing, consistent with this section and applicable law, 10 limitations on or requirements as to the scope of health care services 11 to be provided in the retail clinic or activities to assure maintaining 12 quality standards of health care services. As used in this section, 13 "host business entity" means any retail business organization, retail 14 business entity or business entity within whose space the retail clinic 15 is located or with whose name or symbol the retail clinic is labeled, 16 branded, advertised or marketed. 17 § 2. Section 2801-a of the public health law is amended by adding a 18 new subdivision 17 to read as follows: 19 17. (a) A diagnostic or treatment center that is a retail clinic under 20 section two hundred thirty-e of this chapter, where the retail business 21 organization, retail business entity or business entity within whose 22 space the retail clinic is located is a pharmacy registered under arti- 23 cle one hundred thirty-seven of the education law, or established within 24 space used by an employer for providing health care services to its 25 employees, may be owned or operated by a legal entity formed under the 26 laws of New York: 27 (i) that is, or is owned and controlled by, the applicable business 28 entity under paragraph (a), (b) or (c) of subdivision one of section two 29 hundred thirty-e of this chapter or, in the case of a limited services 30 clinic providing health care services to an employer's employees, the 31 employer to whose employees it provides health care services; 32 (ii) whose stockholders or members, as applicable, may include other 33 than natural persons; 34 (iii) whose principal stockholders and members, as applicable, and 35 controlling persons comply with all applicable requirements of this 36 section; and 37 (iv) that demonstrates, to the satisfaction of the public health and 38 health planning council, sufficient experience and expertise in deliver- 39 ing high quality health care services, and a commitment to operate 40 limited services clinics in medically underserved areas of the state. 41 (b) A diagnostic and treatment center under this subdivision shall be 42 referred to in this subdivision as a "limited services clinic". 43 (c) For purposes of this subdivision, the public health and health 44 planning council shall adopt and amend rules and regulations, notwith- 45 standing any inconsistent provision of this section, to address any 46 matter it deems pertinent to the establishment of limited services clin- 47 ics; provided that such rules and regulations shall include, but not be 48 limited to, provisions governing or relating to: 49 (i) any direct or indirect changes or transfers of ownership interests 50 or voting rights in such entities or their stockholders or members, as 51 applicable; 52 (ii) providing for public health and health planning council approval 53 of any change in controlling interests, principal stockholders, control- 54 ling persons, parent company or sponsors; 55 (iii) oversight of the operator and its shareholders or members, as 56 applicable, including local governance of the limited services clinics;A. 1411--B 5 1 (iv) relating to the character and competence and qualifications of, 2 and changes relating to, the directors and officers of the operator and 3 its principal stockholders, controlling persons, parent company or spon- 4 sors; and 5 (v) in determining whether to approve additional limited services 6 clinic locations for the operator, the department shall consider whether 7 the operator has fulfilled its commitment to operate limited services 8 clinics in medically underserved areas of the state. 9 (d) The following provisions of this section shall not apply to limit- 10 ed services clinics: 11 (i) paragraph (a) of subdivision three of this section; 12 (ii) paragraph (b) of subdivision three of this section, relating to 13 stockholders and members other than principal stockholders and principal 14 members; 15 (iii) paragraph (c) of subdivision four of this section, relating to 16 the disposition of stock or voting rights; and 17 (iv) paragraph (e) of subdivision four of this section, relating to 18 the ownership of stock or membership. 19 (e) A limited services clinic shall be deemed to be a "health care 20 provider" for the purposes of title two-D of article two of this chap- 21 ter. A prescriber practicing in a limited services clinic shall not be 22 deemed to be in the employ of a pharmacy or practicing in a hospital for 23 purposes of subdivision two of section sixty-eight hundred seven of the 24 education law. 25 (f) The commissioner shall promulgate regulations setting forth opera- 26 tional and physical plant standards for limited services clinics, which 27 may be different from the regulations otherwise applicable to diagnostic 28 or treatment centers, including, but not limited to: 29 (i) requiring that limited services clinics attain and maintain 30 accreditation by an appropriate accrediting entity approved by the 31 commissioner and requiring timely reporting to the department if a 32 limited services clinic loses its accreditation; 33 (ii) designating or limiting the treatments and services that may be 34 provided, including limiting the scope of services to the following, 35 provided that such services shall not include monitoring or treatment 36 and services over multiple visits or prolonged periods: 37 (A) the provision of treatment and services to patients for minor 38 acute episodic illnesses or conditions; 39 (B) episodic prevention and wellness treatments and services such as 40 immunizations; 41 (C) ophthalmic dispensing and ophthalmologic or optometric services 42 provided in connection with ophthalmic dispensing; 43 (D) treatment and services for minor injuries that are not reasonably 44 likely to be life threatening or potentially disabling or have compli- 45 cations if ambulatory care within the capacity of the retail clinic is 46 provided; 47 (E) prohibiting the provision of services to patients twenty-four 48 months of age or younger; 49 (iii) requiring limited services clinics to accept walk-ins and offer 50 extended business hours; 51 (iv) guidelines for advertising and signage, disclosure of ownership 52 interests, informed consent, record keeping, referral for treatment and 53 continuity of care, case reporting to the patient's primary care or 54 other health care providers, design, construction, fixtures, and equip- 55 ment; signage shall also be required to indicate that prescriptions andA. 1411--B 6 1 over-the-counter supplies may be purchased by a patient from any busi- 2 ness and do not need to be purchased on-site; and 3 (v) where a limited services clinic is a retail clinic, not treating 4 any patient for the same condition or illness more than three times in a 5 year. 6 (g) Such regulations also shall promote and strengthen primary care by 7 requiring limited service clinics to: 8 (i) inquire of each patient whether he or she has a primary care 9 provider; 10 (ii) maintain and regularly update a list of local primary care 11 providers and provide such list to each patient who indicates that he or 12 she does not have a primary care provider. Such roster (A) shall be 13 drawn from a list of primary care providers maintained and periodically 14 updated by the department on its website (in searchable form) including 15 the information required in clauses (B) and (C) of this subparagraph, 16 located in the zip code area and adjacent zip code areas of the retail 17 clinic, and may include additional primary care providers added by the 18 retail clinic; (B) shall identify preferred providers who have achieved 19 recognition as a patient centered medical home (pcmh) or other similar 20 designation and a description of what such designation means; and (C) 21 shall include federally qualified health centers and other providers who 22 serve medicaid, low-income and uninsured patients, and people with disa- 23 bilities and shall identify cultural and linguistic capabilities when 24 available; 25 (iii) refer patients to their primary care providers or other health 26 care providers where appropriate; 27 (iv) transmit by electronic means whenever possible, records of 28 services to patients' primary care providers; 29 (v) in the case of a limited services clinic that is a retail clinic, 30 decline to treat any patient for the same condition or illness more than 31 three times in a year; and 32 (vi) report to the department relevant data, as may be deemed neces- 33 sary by the department, related to services provided and patients 34 served, provided that such reporting shall comply with all privacy laws 35 related to patient data. 36 (h) Each limited services clinic shall use its best efforts to execute 37 participation agreements with health information organizations, also 38 known as qualified entities, pursuant to which the limited services 39 clinic agrees to participate in the statewide health information network 40 of New York (SHIN-NY). 41 (i) A limited services clinic shall provide treatment without discrim- 42 ination as to source of payment. 43 (j) The host business entity of a limited services clinic shall not, 44 directly or indirectly, by contract, policy, communication, incentive or 45 otherwise, influence or seek to influence any clinical decision, policy 46 or practice of any health care practitioner providing any health care 47 service in the retail clinic, including prescribing or recommending 48 drugs, devices or supplies. This subdivision shall not preclude the host 49 business entity from establishing, consistent with this section and 50 applicable law, limitations on or requirements as to the scope of health 51 care services to be provided in the retail clinic or activities to 52 assure maintaining quality standards of health care services. As used in 53 this section, "host business entity" means the retail business organiza- 54 tion, retail business entity or business entity within whose space the 55 limited services clinic is located or the employer for whose employees 56 it provides health care services.A. 1411--B 7 1 § 3. This act shall take effect on the one hundred eightieth day after 2 it shall have become a law; provided that effective immediately, the 3 commissioner of health shall make regulations and take other actions 4 reasonably necessary to implement the provisions of the public health 5 law enacted by this act when they take effect.
