Bill Text: NY A01046 | 2019-2020 | General Assembly | Introduced
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: Strong Partisan Bill (Democrat 30-2)
Status: (Introduced - Dead) 2020-01-08 - referred to health [A01046 Detail]
Download: New_York-2019-A01046-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 1046 2019-2020 Regular Sessions IN ASSEMBLY January 14, 2019 ___________ Introduced by M. of A. PAULIN, GOTTFRIED, BENEDETTO, RODRIGUEZ, STIRPE, QUART, CRESPO, CROUCH, SIMON, PICHARDO, ARROYO, COOK, DINOWITZ, PRET- LOW, RAMOS, LAVINE, SIMOTAS, SEAWRIGHT, HEVESI, ENGLEBRIGHT, BARRETT, MAGNARELLI, BICHOTTE, BLAKE, TITUS, RICHARDSON, JEAN-PIERRE, D'URSO -- Multi-Sponsored by -- M. of A. LUPARDO, McDONOUGH, PERRY, WRIGHT -- read once and referred to the Committee on Health 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 19 a retail clinic if the health care service under title eight of the 20 education law it provides is limited to pharmacy or ophthalmic dispens- 21 ing and ophthalmologic or optometric services provided in connection 22 with ophthalmic dispensing. 23 2. The treatments and services that may be provided by a retail clinic 24 shall be limited to the provision of treatment and services to patients EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD00610-01-9A. 1046 2 1 for acute episodic illness or condition; episodic preventive treatment 2 and services such as immunizations; ophthalmic dispensing and ophthalmo- 3 logic or optometric services provided in connection with ophthalmic 4 dispensing; or treatment and services for minor injuries that are not 5 reasonably likely to be life-threatening or potentially disabling or 6 have complications if ambulatory care within the capacity of the retail 7 clinic is provided; but the treatments and services provided by a retail 8 clinic shall not include monitoring or treatment and services over 9 multiple visits over prolonged periods. 10 3. A retail clinic shall be deemed to be a "health care provider" for 11 the purposes of title two-D of this article. A prescriber practicing in 12 a retail clinic shall not be deemed to be in the employ of a pharmacy or 13 practicing in a hospital for purposes of subdivision two of section 14 sixty-eight hundred seven of the education law. 15 4. (a) The commissioner shall make regulations setting forth opera- 16 tional and physical plant standards for retail clinics, which may be 17 different from the regulations otherwise applicable to diagnostic and 18 treatment centers, including, but not limited to: 19 (i) requiring that retail clinics attain and maintain accreditation by 20 an appropriate accrediting entity approved by the commissioner and 21 requiring timely reporting to the department if a retail clinic loses 22 its accreditation; 23 (ii) designating or limiting the treatments and services that may be 24 provided, including limiting the scope of services to the following, 25 provided that such services shall not include monitoring or treatment 26 and services over multiple visits or prolonged periods: 27 (A) the provision of treatment and services to patients for minor 28 acute episodic illnesses or conditions; 29 (B) episodic prevention and wellness treatments and services such as 30 immunizations; 31 (C) ophthalmic dispensing and ophthalmologic or optometric services 32 provided in connection with ophthalmic dispensing; 33 (D) treatment and services for minor injuries that are not reasonably 34 likely to be life threatening or potentially disabling or have compli- 35 cations if ambulatory care within the capacity of the retail clinic is 36 provided; 37 (E) prohibiting the provision of services to patients twenty-four 38 months of age or younger; 39 (iii) requiring retail clinics to accept walk-ins and offer extended 40 business hours; 41 (iv) setting forth guidelines for advertising and signage, which shall 42 include signage indicating that prescriptions and over-the-counter 43 supplies may be purchased by a patient from any business and do not need 44 to be purchased on-site; 45 (v) setting forth guidelines for informed consent, record keeping, 46 referral for treatment and continuity of care, case reporting to the 47 patient's primary care or other health care providers, design, 48 construction, fixtures, and equipment. 49 (b) Such regulations also shall promote and strengthen primary care by 50 requiring retail clinics to: 51 (i) inquire of each patient whether he or she has a primary care 52 provider; 53 (ii) maintain and regularly update a list of local primary care 54 providers and provide such list to each patient who indicates that he or 55 she does not have a primary care provider. Such roster (A) shall be 56 drawn from a list of primary care providers maintained and periodicallyA. 1046 3 1 updated by the department on its website (in searchable form) including 2 the information required in clauses (B) and (C) of this subparagraph, 3 located in the zip code area and adjacent zip code areas of the retail 4 clinic, and may include additional primary care providers added by the 5 retail clinic; (B) shall identify preferred providers who have achieved 6 recognition as a patient centered medical home (pcmh) or other similar 7 designation and a description of what such designation means; and (C) 8 shall include federally qualified health centers and other providers who 9 serve medicaid, low-income and uninsured patients, and people with disa- 10 bilities and shall identify cultural and linguistic capabilities when 11 available; 12 (iii) refer patients to their primary care providers or other health 13 care providers where appropriate; 14 (iv) transmit by electronic means whenever possible, records of 15 services to patients' primary care providers; 16 (v) decline to treat any patient for the same condition or illness 17 more than three times in a year; and 18 (vi) report to the department relevant data, as may be deemed neces- 19 sary by the department, related to services provided and patients 20 served, provided that such reporting shall comply with all privacy laws 21 related to patient data. 22 (c) Retail clinics already in operation at the time this section takes 23 effect must comply with accreditation requirements under this subdivi- 24 sion within one year after the effective date of this section. 25 (d) The department shall routinely review the compliance by retail 26 clinics with the provisions of this section and if a retail clinic fails 27 to comply with the provisions of this section, or regulations adopted 28 pursuant to this section, the department shall have the authority to 29 take enforcement actions under title two of article one of this chapter. 30 (e) In making regulations under this section, the commissioner may 31 consult with a workgroup including, but not limited to, representatives 32 of health care consumers and representatives of professional societies 33 of appropriate health care professionals, including those in primary 34 care and other specialties. 35 5. A retail clinic shall provide treatment without discrimination as 36 to source of payment. 37 6. The department shall provide an annual report which it shall make 38 available on its website; the report shall include locations of retail 39 clinics in the state and shall indicate which clinics are located in 40 medically underserved areas; such report shall also include an analysis 41 as to whether retail clinics have improved access to health care in 42 underserved areas, recommendations related thereto and any other infor- 43 mation the department may deem necessary. 44 7. This section does not authorize any form of ownership or organiza- 45 tion of a retail clinic or practice of any profession that would not 46 otherwise be legal, and does not expand the scope of practice of any 47 health care practitioner. Where any regulation under this section would 48 affect the scope of practice that may be provided in a retail clinic a 49 health care practitioner licensed, registered, certified or authorized 50 to practice under title eight of the education law, the regulation shall 51 be made in consultation with the commissioner of education. 52 8. The host business entity of a retail clinic shall not, directly or 53 indirectly, by contract, policy, communication, incentive or otherwise, 54 influence or seek to influence any clinical decision, policy or practice 55 of any health care practitioner providing any health care service in the 56 retail clinic, including prescribing or recommending drugs, devices orA. 1046 4 1 supplies. This subdivision shall not preclude the host business entity 2 from establishing, consistent with this section and applicable law, 3 limitations on or requirements as to the scope of health care services 4 to be provided in the retail clinic or activities to assure maintaining 5 quality standards of health care services. As used in this section, 6 "host business entity" means any retail business organization, retail 7 business entity or business entity within whose space the retail clinic 8 is located or with whose name or symbol the retail clinic is labeled, 9 branded, advertised or marketed. 10 § 2. Section 2801-a of the public health law is amended by adding a 11 new subdivision 17 to read as follows: 12 17. (a) A diagnostic or treatment center that is a retail clinic under 13 section two hundred thirty-e of this chapter, where the retail business 14 organization, retail business entity or business entity within whose 15 space the retail clinic is located is a pharmacy registered under arti- 16 cle one hundred thirty-seven of the education law, or established within 17 space used by an employer for providing health care services to its 18 employees, may be owned or operated by a legal entity formed under the 19 laws of New York: 20 (i) that is, or is owned and controlled by, the applicable business 21 entity under paragraph (a), (b) or (c) of subdivision one of section two 22 hundred thirty-e of this chapter or, in the case of a limited services 23 clinic providing health care services to an employer's employees, the 24 employer to whose employees it provides health care services; 25 (ii) whose stockholders or members, as applicable, may include other 26 than natural persons; 27 (iii) whose principal stockholders and members, as applicable, and 28 controlling persons comply with all applicable requirements of this 29 section; and 30 (iv) that demonstrates, to the satisfaction of the public health and 31 health planning council, sufficient experience and expertise in deliver- 32 ing high quality health care services, and a commitment to operate 33 limited services clinics in medically underserved areas of the state. 34 (b) A diagnostic and treatment center under this subdivision shall be 35 referred to in this subdivision as a "limited services clinic". 36 (c) For purposes of this subdivision, the public health and health 37 planning council shall adopt and amend rules and regulations, notwith- 38 standing any inconsistent provision of this section, to address any 39 matter it deems pertinent to the establishment of limited services clin- 40 ics; provided that such rules and regulations shall include, but not be 41 limited to, provisions governing or relating to: 42 (i) any direct or indirect changes or transfers of ownership interests 43 or voting rights in such entities or their stockholders or members, as 44 applicable; 45 (ii) providing for public health and health planning council approval 46 of any change in controlling interests, principal stockholders, control- 47 ling persons, parent company or sponsors; 48 (iii) oversight of the operator and its shareholders or members, as 49 applicable, including local governance of the limited services clinics; 50 (iv) relating to the character and competence and qualifications of, 51 and changes relating to, the directors and officers of the operator and 52 its principal stockholders, controlling persons, parent company or spon- 53 sors; and 54 (v) in determining whether to approve additional limited services 55 clinic locations for the operator, the department shall consider whetherA. 1046 5 1 the operator has fulfilled its commitment to operate limited services 2 clinics in medically underserved areas of the state. 3 (d) The following provisions of this section shall not apply to limit- 4 ed services clinics: 5 (i) paragraph (a) of subdivision three of this section; 6 (ii) paragraph (b) of subdivision three of this section, relating to 7 stockholders and members other than principal stockholders and principal 8 members; 9 (iii) paragraph (c) of subdivision four of this section, relating to 10 the disposition of stock or voting rights; and 11 (iv) paragraph (e) of subdivision four of this section, relating to 12 the ownership of stock or membership. 13 (e) A limited services clinic shall be deemed to be a "health care 14 provider" for the purposes of title two-D of article two of this chap- 15 ter. A prescriber practicing in a limited services clinic shall not be 16 deemed to be in the employ of a pharmacy or practicing in a hospital for 17 purposes of subdivision two of section sixty-eight hundred seven of the 18 education law. 19 (f) The commissioner shall promulgate regulations setting forth opera- 20 tional and physical plant standards for limited services clinics, which 21 may be different from the regulations otherwise applicable to diagnostic 22 or treatment centers, including, but not limited to: 23 (i) requiring that limited services clinics attain and maintain 24 accreditation by an appropriate accrediting entity approved by the 25 commissioner and requiring timely reporting to the department if a 26 limited services clinic loses its accreditation; 27 (ii) designating or limiting the treatments and services that may be 28 provided, including limiting the scope of services to the following, 29 provided that such services shall not include monitoring or treatment 30 and services over multiple visits or prolonged periods: 31 (A) the provision of treatment and services to patients for minor 32 acute episodic illnesses or conditions; 33 (B) episodic prevention and wellness treatments and services such as 34 immunizations; 35 (C) ophthalmic dispensing and ophthalmologic or optometric services 36 provided in connection with ophthalmic dispensing; 37 (D) treatment and services for minor injuries that are not reasonably 38 likely to be life threatening or potentially disabling or have compli- 39 cations if ambulatory care within the capacity of the retail clinic is 40 provided; 41 (E) prohibiting the provision of services to patients twenty-four 42 months of age or younger; 43 (iii) requiring limited services clinics to accept walk-ins and offer 44 extended business hours; 45 (iv) guidelines for advertising and signage, disclosure of ownership 46 interests, informed consent, record keeping, referral for treatment and 47 continuity of care, case reporting to the patient's primary care or 48 other health care providers, design, construction, fixtures, and equip- 49 ment; signage shall also be required to indicate that prescriptions and 50 over-the-counter supplies may be purchased by a patient from any busi- 51 ness and do not need to be purchased on-site; and 52 (v) where a limited services clinic is a retail clinic, not treating 53 any patient for the same condition or illness more than three times in a 54 year. 55 (g) Such regulations also shall promote and strengthen primary care by 56 requiring limited services clinics to:A. 1046 6 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) in the case of a limited services clinic that is a retail clinic, 23 decline to treat any patient for the same condition or illness more than 24 three times in a year; and 25 (vi) report to the department relevant data, as may be deemed neces- 26 sary by the department, related to services provided and patients 27 served, provided that such reporting shall comply with all privacy laws 28 related to patient data. 29 (h) Each limited services clinic shall use its best efforts to execute 30 participation agreements with health information organizations, also 31 known as qualified entities, pursuant to which the limited services 32 clinic agrees to participate in the statewide health information network 33 of New York (SHIN-NY). 34 (i) A limited services clinic shall provide treatment without discrim- 35 ination as to source of payment. 36 (j) The host business entity of a limited services clinic shall not, 37 directly or indirectly, by contract, policy, communication, incentive or 38 otherwise, influence or seek to influence any clinical decision, policy 39 or practice of any health care practitioner providing any health care 40 service in the retail clinic, including prescribing or recommending 41 drugs, devices or supplies. This subdivision shall not preclude the host 42 business entity from establishing, consistent with this section and 43 applicable law, limitations on or requirements as to the scope of health 44 care services to be provided in the retail clinic or activities to 45 assure maintaining quality standards of health care services. As used in 46 this section, "host business entity" means the retail business organiza- 47 tion, retail business entity or business entity within whose space the 48 limited services clinic is located or the employer for whose employees 49 it provides health care services. 50 § 3. This act shall take effect on the one hundred eightieth day after 51 it shall have become a law; provided that effective immediately, the 52 commissioner of health shall make regulations and take other actions 53 reasonably necessary to implement the provisions of the public health 54 law enacted by this act when they take effect.
