The Massachusetts Medical Society is disappointed in the legislature’s insistence on modification of existing regulations on limited service clinics and concerned about the impact of the proposed regulations on public health. The MMS supported the Department in its development and implementation of the current limited service clinic regulations. The existing regulations are unique in their comprehensive approach to public protection and addressing the concerns of delivering health care in a retail store setting. It is regrettable that the legislature, through the inclusion of four sentences in Chapter 224, has required that this model regulatory framework must be significantly undermined. It is particularly regrettable that the legislative language appears to envision access to care in a manner inconsistent with the goals of increased efficiency, accountable care, patient centered medical homes and team based comprehensive preventive services which were the main goals of Chapter 224.
In spite of its minimal length, the legislative language contains significant limitations on care provided in limited service clinics. The MMS is concerned that these limitations are not reflected in the proposed regulations. Emphasis seems to be on statutory requirements that the DPH “promote the availability of limited services clinics as a point of access for health care services within the full scope of a nurse practitioner” . The statute also specifically excludes allowing the clinic to serve as a patient’s primary care provider or make referrals to unaffiliated specialists. The definition of limited services states that they must be “within the scope of practice of a nurse practitioner using available facilities and equipment, including shared toilet facilities for point-of care testing”.
These statutory limitations realistically reflect the limited role the retail clinics serve in providing ambulatory care. In the definitions section of the regulations there should be some clarification of what type of clinical samples may be obtained in a shared toilet facility.
Point-of-care Testing means the analysis of clinical specimens at the site of patient care, in order to provide immediate results to the health care provider. Examples of point-of-care tests include blood glucose tests, urine strip tests and other tests that do not require submission of the specimens to an outside laboratory.
Drawing blood would not be appropriate in a shared toilet facility. The MMS is concerned that the Department is eliminating requirements that limited service clinics list the services they provide in their application process since the Department’s review and approval is dependent upon the equipment and facilities available in each site. The statute specifically references available facilities. Such facilities and equipment will vary from applicant to applicant and responsible review of applications for licensing requires a connection between equipment, facilities and services. The MMS supports the retention or expansion of existing regulatory language requiring specification of available facilities and a direct connection to services offered rather than a deletion of this requirement.
The MMS understands the Department in its use of a statutory definition of a primary care provider in its regulations. Although the language used comes from Chapter 224, it is not connected to the sections promoting limited service clinics and nurse practitioners. It comes from language amending insurance coverage requirements. As such, it provides a firm basis on which the Department may build a regulatory framework consistent with the public interest. The MMS suggests that the Department include language requiring limited service clinics to refrain from serving as a primary care provider as the statutory language requires. However, serving as a primary care provider goes beyond being a designated primary care provider by an insurer. The services of a primary care provider include providing routine wellness visits, immunizations, physicals and each element of the comprehensive services a patient centered medical home should provide. The MMS believes the regulations should reflect legislative language prohibiting serving as a primary care provider by specifying that limited service clinics should provide episodic treatment of minor issues when access to a primary care provider is unavailable rather than offering comprehensive services or a preventive or general diagnostic nature.
The statutory definition of a primary care provider includes general medical care for common health care problems, supervision, coordination, prescribes or otherwise provides or proposes health care services, initiates referrals for specialist care and maintains continuity of care within the scope of practice. The Department should consider how best in regulations to reconcile the statutory requirements that limited service clinics not provide such services.
Other Specific Issues
Anesthesia
The MMS is concerned that the proposed regulations delete the word local from the anesthesia sections of the specific services listing. Does this mean that limited services clinics may apply local anesthetics? If so, the circumstances under which such anesthetics could be used should be specified. If the intent is to allow local anesthesia for biopsies or other surgical and diagnostic services the MMS is opposed to such expansion of services, particularly in connection with removal of requirements related to physical plant and equipment specification in applications. This is an area requiring clarification.
Application for a License
The requirement that license applicants submit information under pains and penalties of perjury is removed. There is no statutory basis for this change. Other health care license application, including medical licenses, are subject to such a standard. The MMS suggests this language be retained in section .102.
Limited Service List
In section 140.103(F) The MMS requests that requirements for a list of services be submitted as is currently required as opposed to a description of services as proposed. Additionally, the MMS suggests that the following sentence be retained. “The Department shall review and approve only those services that it determines the applicant may appropriately provide in the limited services clinic and shall list such services on the clinic license.” This existing language should be retained to reflect the statutory language discussed above which ties services to available facilities and equipment.
140.1001 Policies and Procedures for Limited Services Clinics
This section’s changes raise significant concerns. The Department has chosen to add the statutory prohibition of serving as a primary care provider with no indication of what it means to be a primary care provider. Additionally the following language is deleted:
“ (1) The limited services clinic shall provide only those services indicated on its licensure application and approved by the Department.
(2) No limited services clinic may provide any service for which it is not licensed.
(3) No limited services clinic may provide childhood immunizations (excluding influenza vaccine) unless such clinic is a satellite of or is otherwise affiliated with a licensed health care practitioner or entity that provides primary care to the patient seeking such immunization.
(4) No limited services clinic may provide treatment to children younger than 24 months old.
These deleted provisions are important public protections which should be maintained. Particularly number 3 seems to be the kind of specific language that defines how a clinic may not serve as a primary care provider. These provisions should be expanded not deleted.
Guidelines
This section changes the requirement for clinics to develop practice guidelines to requirements that clinics utilize guidelines. This may be a deference to large corporate guidelines where one size fits all nationally. Such deference is inconsistent with Massachusetts laws regarding supervision of nurse practitioners. Nurse practitioners who order tests and therapeutics or who prescribe must practice under mutually developed guidelines with their supervising physician. This requirement is under attack by some parties but it is still required under law and regulation. The MMS is very concerned that the Department is ignoring its own regulations on prescribing as well as the requirements of regulations of the nursing and medicine board.
Similarly clinics should develop rather than simply utilize guidelines for determining when services are beyond the scope of its staff. Scope of practice varies both by state and by the training of nurse practitioners . Supervising guidelines also may limit an individual nurse practitioner’s scope of practice. National commercial guidelines are not adequate.
Referral to Physicians
The MMS is concerned that existing requirements requiring the development of policies and procedures requiring the referral of repeat customers to primary care practitioners have been gutted to only require policies regarding such referrals. This is inconsistent with the statutory prohibition on serving as a primary care provider and is a significant reduction in the protections existing regulations give to the public. The word requiring should be maintained in section (F)(1).
(I) Required Disclosures
The MMS must object to the changes in this section which eliminate requirements on clinics to prominently post their services and replace them with a requirement to prominently disclose the services available. Disclosure is an act taken upon request. We are not sure how one prominently responds to a request. In any case, posting of services, is of value to the public. Mandated disclosure in a retail setting is of little value to consumers. Replacement of posting also makes unclear the means of clinic compliance with the retained regulatory requirement in this section of notice that a patient should go to their primary care provider for services beyond those offered on site. The MMS suggests that posting requirements remain unchanged.
The MMS supports addition of requirements prohibiting advertizing or implying in any way that a limited services clinic is a primary care provider but we support retention of existing language prohibiting assertion that a full range of medical services are available.
Summary
The MMS appreciates the work the Department has done in attempting to restructure its regulations in a manner that is consistent with legislative requirements. However, the Department has a core role as a licensing agency for health care facilities. Nurse practitioners have a history of working within settings where they serve as part of a team with supervising physicians, peer support, credentialing requirements, risk management and multiple systems to prevent error and protect patients. Many work in not for profit settings and in settings with limitations on sale of good to patients or self-referral limitations. Most of these established systems are not available in retail clinics. The Department must step up to fulfill its role of protection of the public even as it follows the mandates of the legislature. Four sentences in a 349 page law should not divert the Department from its historic role and mission.
