NY State Senate Bill 2021-S9276

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
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Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
May 12, 2022	referred to health

2021-S9276 (ACTIVE) - Details

See Assembly Version of this Bill:: A216
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §230-f, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2019-2020: A7745
2023-2024: S2942, A3729

2021-S9276 (ACTIVE) - Summary

Enacts provisions authorizing retail clinics to provide certain services; directs the commissioner of health to enact regulations imposing certain standards and restrictions.

2021-S9276 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S9276

SPONSOR: RIVERA
 
TITLE OF BILL:

An act to amend the public health law, in relation to retail clinics

 
PURPOSE OR GENERAL IDEA OF BILL:

To limit the services that may be offered by a health care practice that
is operated within a retail business space or is labeled, branded or
marketed by a retail business entity.

 
SUMMARY OF SPECIFIC PROVISIONS:

The bill adds a new Public Health Law § 230-e to define "retail clinics"
as professional health care practices that operate within the space of a
retail business, such as a pharmacy or a store open to the general
public; or is labeled, branded, advertised or marketed with the name or
symbol of a retail business; or is labeled, branded, advertised or
marketed with the name or symbol of a business other than the health
care practice itself. The definition excludes facilities that only

provide healthcare to employees of a retail business, as well as pharma-
cy and ophthalmic dispensing and ophthalmologic or optometric services
provided in connection with ophthalmic dispensing. Current restrictions
on referrals considered self-dealing would apply.

Retail clinics will be limited to episodic services that do not require
multiple visits, such as minor acute conditions, episodic prevention and
wellness services such as immunizations, and treatment of minor inju-
ries. They will not treat children under age two. They will be required
to have access to walk-ins and extended business hours. Retail clinics
will not treat any patient for the same condition or illness more than
three times in a year.

The Commissioner of Health will make regulations requiring accredi-
tation; provide guidelines for advertising, and signage that
prescriptions and supplies do not need to be purchased on-site; issue
guidelines for informed consent, record keeping, referral, continuity of
care, case reporting; and address design, construction, fixtures, and
equipment.

The regulations will promote and strengthen primary care by requiring
retail clinics to inquire of each patient whether he or she has a prima-
ry care provider and for those who do not, provide a list drawn from a
searchable website list of primary care providers maintained by the
Department of Health which will include providers who serve Medicaid,
low-income and uninsured patients, and people with disabilities, and
identify cultural and linguistic capabilities.

Retail clinics will refer patients and transmit records to patients'
primary care and other health care providers; and report to data
required by the department, provided that such reporting shall comply
with all privacy laws related to patient data; and participate in the
statewide health information network of New York (SHIN-NY).

Retail clinics already in operation are given an additional year to
comply with accreditation requirements. If a retail clinic fails to

comply with the law or regulations, the department will take enforcement
actions under title two of article one of the Public Health Law.

The Commissioner may consult with a workgroup including representatives
of health care consumers and representatives of professional societies
of appropriate health care professionals, including those in primary
care and other specialties.

A retail clinic shall provide treatment without discrimination as to
source of payment.

The department will post an annual report on its website showing
locations of retail clinics, which clinics are located in medically
underserved areas and analysis as to whether retail clinics have
improved access to health care in underserved areas, with recommenda-
tions or other information the department may deem necessary.

The bill does not authorize any form of ownership or organization of a
retail clinic or practice of any profession that would not otherwise be
legal, and does not expand the scope of practice of any health care
practitioner. The host business entity of a retail clinic shall not,
directly or indirectly, by contract, policy, communication, incentive or
otherwise, influence or seek to influence any clinical decision, policy
or practice of any health care practitioner providing any health care
service in the retail clinic, including prescribing or recommending
drugs, devices or supplies.

 
JUSTIFICATION:

Retail clinics already exist in several locations throughout New York
State. One concern is that high-profile retail branding may influence
clinical judgment, such as prescribing, or skew public perception of the
value of a retail clinic's services to the detriment of primary care
providers who instead choose a normal neighborhood location.

Today there is nothing to limit the scope of services offered by a
retail clinic. Around the country, they are becoming what claim to be
full-service medical practices. With the marketing power and capital
support they receive, they would out-compete more conventional prac-
tices. Health care would become increasingly dominated by corporate-
controlled providers. As retail entities become merged with insurers,
health care providers will become controlled by health insurers.
Curtailing retail clinics is necessary to prevent this scenario.

New York law does not permit business corporations to actually own
health care practices or health care providers. However, a corporation
can rent them space. The corporation can provide marketing, rent equip-
ment, provide management support, provide electronic health record
systems, etc. Combined with the power of a commercial landlord, the
corporation virtually owns the retail clinic, undermining professional
independence. This makes it all the more compelling to limit the scope
of what these clinics are allowed to do.

The consolidation of pharmacies and insurers, with pharmacy benefit
managers influencing clinical decisions and costs adds concern that
without sufficient regulation, retail clinics become the final link in a
vertically integrated closed loop. Even if the host business is only
renting space to the practice, the proximity and branding may blur how
the practice is perceived. Patients deserve unfettered power to consent
to or refuse treatment, and purchase prescribed drugs or supplies at
their own discretion, free of the overwhelming influence that retailers
seek to exert over the public.

This bill will ensure that all retail clinics are operated according to
set standards that assure convenience, clinical autonomy, and support
rather than detract from regional primary care.

Family practice and primary care are already stressed by a health care
system that is still too driven by hospitals, specialists, drug manufac-
turers, and insurers. Population health improves when access to needed
care is available and timely, which retail clinics can offer, and even
more so when such care is connected to systems that offer continuity and
follow-up, which this bill will assure.

 
PRIOR LEGISLATIVE HISTORY:

New legislation

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
180 days after enactment.

2021-S9276 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9276
 
                             I N  S E N A T E
 
                               May 12, 2022
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law, in relation to retail clinics
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  The  public health law is amended by adding a new section
 230-f to read as follows:
   § 230-F. RETAIL CLINICS. 1. AS USED IN THIS SECTION,  "RETAIL  CLINIC"
 MEANS A FACILITY OR PORTION OF A FACILITY THAT IS OPERATED BY ANY ENTITY
 THAT  IS AUTHORIZED UNDER THE LAWS OF THIS STATE TO PROVIDE PROFESSIONAL
 SERVICES TO THE PUBLIC AND THAT PROVIDES HEALTH CARE SERVICES OR  TREAT-
 MENT  PROVIDED BY A HEALTH CARE PRACTITIONER LICENSED, CERTIFIED, REGIS-
 TERED OR AUTHORIZED TO PRACTICE UNDER TITLE EIGHT OF THE EDUCATION  LAW,
 ACTING  WITHIN  HIS OR HER LAWFUL SCOPE OF PRACTICE, THAT:  (A) OPERATES
 WITHIN THE SPACE OF A RETAIL BUSINESS OPERATION, SUCH AS A PHARMACY OR A
 STORE OPEN TO THE GENERAL PUBLIC; (B) IS LABELED, BRANDED, ADVERTISED OR
 MARKETED WITH THE NAME OR SYMBOL OF A RETAIL BUSINESS ENTITY; OR (C)  IS
 LABELED,  BRANDED,  ADVERTISED  OR MARKETED WITH THE NAME OR SYMBOL OF A
 BUSINESS ENTITY, OTHER THAN A BUSINESS ENTITY THAT PROVIDES HEALTH  CARE
 SERVICES  OR  TREATMENT PROVIDED AT THE FACILITY. HOWEVER, A FACILITY OR
 PORTION OF A FACILITY SHALL NOT BE DEEMED TO BE A RETAIL  CLINIC  IF  IT
 ORDINARILY  IS USED ONLY FOR PROVIDING HEALTH CARE SERVICES TO EMPLOYEES
 OF THE RETAIL BUSINESS OPERATION.  A FACILITY SHALL NOT BE DEEMED TO  BE
 A  RETAIL  CLINIC  IF  THE  HEALTH CARE SERVICE UNDER TITLE EIGHT OF THE
 EDUCATION LAW IT PROVIDES IS LIMITED TO PHARMACY OR OPHTHALMIC  DISPENS-
 ING  AND  OPHTHALMOLOGIC  OR  OPTOMETRIC SERVICES PROVIDED IN CONNECTION
 WITH OPHTHALMIC DISPENSING.
   2. THE TREATMENTS AND SERVICES THAT MAY BE PROVIDED BY A RETAIL CLINIC
 SHALL BE LIMITED TO THE PROVISION OF TREATMENT AND SERVICES TO  PATIENTS
 FOR  ACUTE  EPISODIC ILLNESS OR CONDITION; EPISODIC PREVENTIVE TREATMENT
 AND SERVICES SUCH AS IMMUNIZATIONS; OPHTHALMIC DISPENSING AND OPHTHALMO-
 LOGIC OR OPTOMETRIC SERVICES  PROVIDED  IN  CONNECTION  WITH  OPHTHALMIC
 DISPENSING;  OR  TREATMENT  AND SERVICES FOR MINOR INJURIES THAT ARE NOT
 REASONABLY LIKELY TO BE LIFE-THREATENING  OR  POTENTIALLY  DISABLING  OR
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD00379-01-1
 S. 9276                             2

 HAVE  COMPLICATIONS IF AMBULATORY CARE WITHIN THE CAPACITY OF THE RETAIL
 CLINIC IS PROVIDED; BUT THE TREATMENTS AND SERVICES PROVIDED BY A RETAIL
 CLINIC SHALL NOT INCLUDE  MONITORING  OR  TREATMENT  AND  SERVICES  OVER
 MULTIPLE VISITS OVER PROLONGED PERIODS.
   3.  A RETAIL CLINIC SHALL BE DEEMED TO BE A "HEALTH CARE PROVIDER" FOR
 THE PURPOSES OF TITLE TWO-D OF THIS ARTICLE. A PRESCRIBER PRACTICING  IN
 A RETAIL CLINIC SHALL NOT BE DEEMED TO BE IN THE EMPLOY OF A PHARMACY OR
 PRACTICING  IN  A  HOSPITAL  FOR  PURPOSES OF SUBDIVISION TWO OF SECTION
 SIXTY-EIGHT HUNDRED SEVEN OF THE EDUCATION LAW.
   4. (A) THE COMMISSIONER SHALL MAKE REGULATIONS  SETTING  FORTH  OPERA-
 TIONAL  AND  PHYSICAL  PLANT  STANDARDS FOR RETAIL CLINICS, WHICH MAY BE
 DIFFERENT FROM THE REGULATIONS OTHERWISE APPLICABLE  TO  DIAGNOSTIC  AND
 TREATMENT CENTERS, INCLUDING, BUT NOT LIMITED TO:
   (I) REQUIRING THAT RETAIL CLINICS ATTAIN AND MAINTAIN ACCREDITATION BY
 AN  APPROPRIATE  ACCREDITING  ENTITY  APPROVED  BY  THE COMMISSIONER AND
 REQUIRING TIMELY REPORTING TO THE DEPARTMENT IF A  RETAIL  CLINIC  LOSES
 ITS ACCREDITATION;
   (II)  DESIGNATING  OR LIMITING THE TREATMENTS AND SERVICES THAT MAY BE
 PROVIDED, INCLUDING LIMITING THE SCOPE OF  SERVICES  TO  THE  FOLLOWING,
 PROVIDED  THAT  SUCH  SERVICES SHALL NOT INCLUDE MONITORING OR TREATMENT
 AND SERVICES OVER MULTIPLE VISITS OR PROLONGED PERIODS:
   (A) THE PROVISION OF TREATMENT AND  SERVICES  TO  PATIENTS  FOR  MINOR
 ACUTE EPISODIC ILLNESSES OR CONDITIONS;
   (B)  EPISODIC  PREVENTION AND WELLNESS TREATMENTS AND SERVICES SUCH AS
 IMMUNIZATIONS;
   (C) OPHTHALMIC DISPENSING AND OPHTHALMOLOGIC  OR  OPTOMETRIC  SERVICES
 PROVIDED IN CONNECTION WITH OPHTHALMIC DISPENSING;
   (D)  TREATMENT AND SERVICES FOR MINOR INJURIES THAT ARE NOT REASONABLY
 LIKELY TO BE LIFE THREATENING OR POTENTIALLY DISABLING OR  HAVE  COMPLI-
 CATIONS  IF  AMBULATORY CARE WITHIN THE CAPACITY OF THE RETAIL CLINIC IS
 PROVIDED;
   (E) PROHIBITING THE PROVISION  OF  SERVICES  TO  PATIENTS  TWENTY-FOUR
 MONTHS OF AGE OR YOUNGER;
   (III)  REQUIRING  RETAIL CLINICS TO ACCEPT WALK-INS AND OFFER EXTENDED
 BUSINESS HOURS;
   (IV) SETTING FORTH GUIDELINES FOR ADVERTISING AND SIGNAGE, WHICH SHALL
 INCLUDE  SIGNAGE  INDICATING  THAT  PRESCRIPTIONS  AND  OVER-THE-COUNTER
 SUPPLIES MAY BE PURCHASED BY A PATIENT FROM ANY BUSINESS AND DO NOT NEED
 TO BE PURCHASED ON-SITE;
   (V)  SETTING  FORTH  GUIDELINES  FOR INFORMED CONSENT, RECORD KEEPING,
 REFERRAL FOR TREATMENT AND CONTINUITY OF CARE,  CASE  REPORTING  TO  THE
 PATIENT'S   PRIMARY   CARE  OR  OTHER  HEALTH  CARE  PROVIDERS,  DESIGN,
 CONSTRUCTION, FIXTURES, AND EQUIPMENT.
   (B) SUCH REGULATIONS ALSO SHALL PROMOTE AND STRENGTHEN PRIMARY CARE BY
 REQUIRING RETAIL CLINICS TO:
   (I) INQUIRE OF EACH PATIENT WHETHER HE  OR  SHE  HAS  A  PRIMARY  CARE
 PROVIDER;
   (II)  MAINTAIN  AND  REGULARLY  UPDATE  A  LIST  OF LOCAL PRIMARY CARE
 PROVIDERS AND PROVIDE SUCH LIST TO EACH PATIENT WHO INDICATES THAT HE OR
 SHE DOES NOT HAVE A PRIMARY CARE PROVIDER.  SUCH  ROSTER  (A)  SHALL  BE
 DRAWN  FROM A LIST OF PRIMARY CARE PROVIDERS MAINTAINED AND PERIODICALLY
 UPDATED BY THE DEPARTMENT ON ITS WEBSITE (IN SEARCHABLE FORM)  INCLUDING
 THE  INFORMATION  REQUIRED  IN CLAUSES (B) AND (C) OF THIS SUBPARAGRAPH,
 LOCATED IN THE ZIP CODE AREA AND ADJACENT ZIP CODE AREAS OF  THE  RETAIL
 CLINIC,  AND  MAY INCLUDE ADDITIONAL PRIMARY CARE PROVIDERS ADDED BY THE
 RETAIL CLINIC; (B) SHALL IDENTIFY PREFERRED PROVIDERS WHO HAVE  ACHIEVED
 S. 9276                             3

 RECOGNITION  AS  A PATIENT CENTERED MEDICAL HOME (PCMH) OR OTHER SIMILAR
 DESIGNATION AND A DESCRIPTION OF WHAT SUCH DESIGNATION  MEANS;  AND  (C)
 SHALL INCLUDE FEDERALLY QUALIFIED HEALTH CENTERS AND OTHER PROVIDERS WHO
 SERVE MEDICAID, LOW-INCOME AND UNINSURED PATIENTS, AND PEOPLE WITH DISA-
 BILITIES  AND  SHALL  IDENTIFY CULTURAL AND LINGUISTIC CAPABILITIES WHEN
 AVAILABLE;
   (III) REFER PATIENTS TO THEIR PRIMARY CARE PROVIDERS OR  OTHER  HEALTH
 CARE PROVIDERS WHERE APPROPRIATE;
   (IV)  TRANSMIT  BY  ELECTRONIC  MEANS  WHENEVER  POSSIBLE,  RECORDS OF
 SERVICES TO PATIENTS' PRIMARY CARE PROVIDERS;
   (V) DECLINE TO TREAT ANY PATIENT FOR THE  SAME  CONDITION  OR  ILLNESS
 MORE THAN THREE TIMES IN A YEAR; AND
   (VI)  REPORT  TO THE DEPARTMENT RELEVANT DATA, AS MAY BE DEEMED NECES-
 SARY BY THE  DEPARTMENT,  RELATED  TO  SERVICES  PROVIDED  AND  PATIENTS
 SERVED,  PROVIDED THAT SUCH REPORTING SHALL COMPLY WITH ALL PRIVACY LAWS
 RELATED TO PATIENT DATA.
   (C) RETAIL CLINICS ALREADY IN OPERATION AT THE TIME THIS SECTION TAKES
 EFFECT MUST COMPLY WITH ACCREDITATION REQUIREMENTS UNDER  THIS  SUBDIVI-
 SION WITHIN ONE YEAR AFTER THE EFFECTIVE DATE OF THIS SECTION.
   (D)  THE  DEPARTMENT  SHALL  ROUTINELY REVIEW THE COMPLIANCE BY RETAIL
 CLINICS WITH THE PROVISIONS OF THIS SECTION AND IF A RETAIL CLINIC FAILS
 TO COMPLY WITH THE PROVISIONS OF THIS SECTION,  OR  REGULATIONS  ADOPTED
 PURSUANT  TO  THIS  SECTION,  THE DEPARTMENT SHALL HAVE THE AUTHORITY TO
 TAKE ENFORCEMENT ACTIONS UNDER TITLE TWO OF ARTICLE ONE OF THIS CHAPTER.
   (E) IN MAKING REGULATIONS UNDER THIS  SECTION,  THE  COMMISSIONER  MAY
 CONSULT  WITH A WORKGROUP INCLUDING, BUT NOT LIMITED TO, REPRESENTATIVES
 OF HEALTH CARE CONSUMERS AND REPRESENTATIVES OF  PROFESSIONAL  SOCIETIES
 OF  APPROPRIATE  HEALTH  CARE  PROFESSIONALS, INCLUDING THOSE IN PRIMARY
 CARE AND OTHER SPECIALTIES.
   5. A RETAIL CLINIC SHALL PROVIDE TREATMENT WITHOUT  DISCRIMINATION  AS
 TO SOURCE OF PAYMENT.
   6.  THE  DEPARTMENT SHALL PROVIDE AN ANNUAL REPORT WHICH IT SHALL MAKE
 AVAILABLE ON ITS WEBSITE; THE REPORT SHALL INCLUDE LOCATIONS  OF  RETAIL
 CLINICS  IN  THE  STATE  AND SHALL INDICATE WHICH CLINICS ARE LOCATED IN
 MEDICALLY UNDERSERVED AREAS; SUCH REPORT SHALL ALSO INCLUDE AN  ANALYSIS
 AS  TO  WHETHER  RETAIL  CLINICS  HAVE IMPROVED ACCESS TO HEALTH CARE IN
 UNDERSERVED AREAS, RECOMMENDATIONS RELATED THERETO AND ANY OTHER  INFOR-
 MATION THE DEPARTMENT MAY DEEM NECESSARY.
   7.  THIS SECTION DOES NOT AUTHORIZE ANY FORM OF OWNERSHIP OR ORGANIZA-
 TION OF A RETAIL CLINIC OR PRACTICE OF ANY  PROFESSION  THAT  WOULD  NOT
 OTHERWISE  BE  LEGAL,  AND  DOES NOT EXPAND THE SCOPE OF PRACTICE OF ANY
 HEALTH CARE PRACTITIONER. WHERE ANY REGULATION UNDER THIS SECTION  WOULD
 AFFECT  THE  SCOPE OF PRACTICE THAT MAY BE PROVIDED IN A RETAIL CLINIC A
 HEALTH CARE PRACTITIONER LICENSED, REGISTERED, CERTIFIED  OR  AUTHORIZED
 TO PRACTICE UNDER TITLE EIGHT OF THE EDUCATION LAW, THE REGULATION SHALL
 BE MADE IN CONSULTATION WITH THE COMMISSIONER OF EDUCATION.
   8.  THE HOST BUSINESS ENTITY OF A RETAIL CLINIC SHALL NOT, DIRECTLY OR
 INDIRECTLY, BY CONTRACT, POLICY, COMMUNICATION, INCENTIVE OR  OTHERWISE,
 INFLUENCE OR SEEK TO INFLUENCE ANY CLINICAL DECISION, POLICY OR PRACTICE
 OF ANY HEALTH CARE PRACTITIONER PROVIDING ANY HEALTH CARE SERVICE IN THE
 RETAIL  CLINIC,  INCLUDING PRESCRIBING OR RECOMMENDING DRUGS, DEVICES OR
 SUPPLIES. THIS SUBDIVISION SHALL NOT PRECLUDE THE HOST  BUSINESS  ENTITY
 FROM  ESTABLISHING,  CONSISTENT  WITH  THIS  SECTION AND APPLICABLE LAW,
 LIMITATIONS ON OR REQUIREMENTS AS TO THE SCOPE OF HEALTH  CARE  SERVICES
 TO  BE PROVIDED IN THE RETAIL CLINIC OR ACTIVITIES TO ASSURE MAINTAINING
 QUALITY STANDARDS OF HEALTH CARE SERVICES.  AS  USED  IN  THIS  SECTION,
 S. 9276                             4
 
 "HOST  BUSINESS  ENTITY"  MEANS ANY RETAIL BUSINESS ORGANIZATION, RETAIL
 BUSINESS ENTITY OR BUSINESS ENTITY WITHIN WHOSE SPACE THE RETAIL  CLINIC
 IS  LOCATED  OR  WITH WHOSE NAME OR SYMBOL THE RETAIL CLINIC IS LABELED,
 BRANDED, ADVERTISED OR MARKETED.
   § 2. This act shall take effect on the one hundred eightieth day after
 it  shall have because a law. Effective immediately, the commissioner of
 health shall make regulations and take other actions  reasonably  neces-
 sary to implement this act on that date.

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Senate Bill S9276

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

2021-S9276 (ACTIVE) - Details

2021-S9276 (ACTIVE) - Summary

2021-S9276 (ACTIVE) - Sponsor Memo

2021-S9276 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S9276

Share this bill

Sponsored By

Gustavo Rivera

Archive: Last Bill Status - In Senate Committee Health Committee

2021-S9276 (ACTIVE) - Details

2021-S9276 (ACTIVE) - Summary

2021-S9276 (ACTIVE) - Sponsor Memo

2021-S9276 (ACTIVE) - Bill Text download pdf

Comments