Last week was a very busy one for those following the legal side of the novel coronavirus (“COVID-19”), as lots of new measures are being released to address the impacts of the virus on health care entities and other businesses across the country. Here are just a few of the healthcare-related highlights.
Guidance on the Definition of Health Care Provider
Late on Friday afternoon (March 27), the U.S. Department of Labor (“DOL”) issued additions to its guidance related to the Families First Coronavirus Response Act ("FFCRA"), explaining its paid sick leave and expanded Family and Medical Leave Act (“FMLA”) benefits. One of the most important issues requiring clarification for our hospital and health center clients was the definition of “health care providers.” This issue is critical because, under the FFCRA, employers of health care providers are entitled to exclude those providers from the benefits that are offered generally to employees.
Before Friday’s release, the only existing guidance for who counted as a “health care provider” could be found in the Code of Federal Regulations ("CFR") provisions relating back to traditional FMLA protections. According to the CFR,
Health care provider means:
(1) The Act defines health care provider as:
(i) A doctor of medicine or osteopathy who is authorized to practice medicine or surgery (as appropriate) by the State in which the doctor practices; or
(ii) Any other person determined by the Secretary to be capable of providing health care services.
(2) Others “capable of providing health care services” include only:
(i) Podiatrists, dentists, clinical psychologists, optometrists, and chiropractors (limited to treatment consisting of manual manipulation of the spine to correct a subluxation as demonstrated by X-ray to exist) authorized to practice in the State and performing within the scope of their practice as defined under State law;
(ii) Nurse practitioners, nurse-midwives, clinical social workers and physician assistants who are authorized to practice under State law and who are performing within the scope of their practice as defined under State law;
(iii) Christian Science Practitioners listed with the First Church of Christ, Scientist in Boston, Massachusetts. Where an employee or family member is receiving treatment from a Christian Science practitioner, an employee may not object to any requirement from an employer that the employee or family member submit to examination (though not treatment) to obtain a second or third certification from a health care provider other than a Christian Science practitioner except as otherwise provided under applicable State or local law or collective bargaining agreement.
(iv) Any health care provider from whom an employer or the employer’s group health plan’s benefits manager will accept certification of the existence of a serious health condition to substantiate a claim for benefits; and
(v) A health care provider listed above who practices in a country other than the United States, who is authorized to practice in accordance with the law of that country, and who is performing within the scope of his or her practice as defined under such law.
The obvious problem with this limited definition was that it is like trying to fit a square peg into a round hole. This definition is meant to establish which medical professionals are capable of authoring medical opinions and reports to support an employee’s request for FMLA leave. The definition has nothing to do with establishing what personnel is essential to maintaining and operating a hospital or health care practice.
With the latest DOL guidance, however, we have a much broader definition of “health care provider”:
For the purposes of employees who may be exempted from paid sick leave or expanded family and medical leave by their employer under the FFCRA, a health care provider is anyone employed at any doctor’s office, hospital, health care center, clinic, post-secondary educational institution offering health care instruction, medical school, local health department or agency, nursing facility, retirement facility, nursing home, home health care provider, any facility that performs laboratory or medical testing, pharmacy, or any similar institution, employer, or entity. This includes any permanent or temporary institution, facility, location, or site where medical services are provided that are similar to such institutions.
This definition includes any individual employed by an entity that contracts with any of the above institutions, employers, or entities institutions to provide services or to maintain the operation of the facility. This also includes anyone employed by any entity that provides medical services, produces medical products, or is otherwise involved in the making of COVID-19 related medical equipment, tests, drugs, vaccines, diagnostic vehicles, or treatments. This also includes any individual that the highest official of a state or territory, including the District of Columbia, determines is a health care provider necessary for that state’s or territory’s or the District of Columbia’s response to COVID-19.
To minimize the spread of the virus associated with COVID-19, the DOL encouraged employers “to be judicious when using this definition to exempt health care providers from the provisions of the FFCRA.” In its release, the DOL also took steps to define “emergency responder” under the FFCRA.
Expanding Access to Qualified Providers
On March 23, 2020, West Virginia Governor Jim Justice issued Executive Order 10-20, which amended many provisions of his earlier Executive Order 7-20. Through Executive Order 10-20, Governor Justice has attempted to increase and expand the access West Virginians have to qualified providers during this health crisis. Under West Virginia Code § 15-5-6, the Governor is authorized “to suspend the provisions of any regulatory statute prescribing the procedures for conduct of state business or the orders, rules of any state agency, if strict compliance therewith would in any way prevent, hinder or delay necessary action in coping with the emergency.”
Among those regulations that Executive Order 10-20 suspends are (i) the requirement that any person practicing or offering to practice as a registered nurse ("RN") or advanced practice registered nurse (“APRN”) have a license issued by the West Virginia Board of Registered Professional Nurses (W.Va. Code § 30-7-2), with the exception of those with pending complaints, investigations, consent orders, board orders, or pending disciplinary proceedings, and provided the RN or APRN is licensed in another state; (ii) the requirement that RN and APRN licenses have a renewal period requirement (W.Va. Code §30-7-8); (iii) the requirement for supervision or presence of any other healthcare provider when anesthesia is administered by a certified registered nurse anesthetist (W.Va. Code §30-7-15); (iv) the requirement for APRN authorization for prescriptive authority, collaborative requirements for prescriptive authority, prescriptive formulary limitations, prescriptive refill and supply limitations, and other prescriptive limitations including continuing education and renewal requirements (W.Va. Code §§ 30-7-15a-c); and (v) the requirement that RNs and APRNs furnish completion of continuing education, including drug diversion and veterans’ mental health, for licensure or licensure renewal (W.Va. Code §30-1-7a).
Additionally, Executive Order 10-20 deleted and replaced sections within the Governor’s prior order which limited patients’ access to retired or inactive allopathic physicians and surgeons (W.Va. Code §§ 30-3-13(a) and 30-3-12(h)(j)); to telemedicine providers licensed in other states (W.Va. Code §§ 30-3-13a(b)(2) and 30-3-13(b)); and to retired or inactive osteopathic physicians and surgeons (W.Va. Code §§ 30-14-1 and 30-14-10(a), (c), (d)). The Executive Order also suspended the requirement that telemedicine be performed by video only (W.Va. Code §§ 30-14-12d(c) and 30-3-13a(c).
Temporary Medicare Enrollment Privileges
Last week, the Centers for Medicare & Medicaid Services ("CMS") established new toll-free hotlines for practitioners (both physicians and non-physicians) to enroll and receive temporary billing privileges under Medicare. Additionally, certain prescreening requirements, including fingerprint-based criminal background checks and site visits, also have been temporarily waived, and all revalidation requirements have been postponed for now. Further, CMS will continue to expedite pending and new applications – 7 days for clean online applications and 14 days for clean paper applications. For answers to frequently asked questions and a list of the hotline numbers, health care providers can click on this CMS link.
Suspension of Joint Commission Surveys
Last week, the Joint Commission suspended all regular, onsite surveying activities of hospitals and other health care organizations. The Joint Commission said it expected the surveys to be on hold at least until the end of April, but plans are underway for the handling of a longer suspension if the COVID-19 outbreak continues past April. For hospitals with expiring accreditations, their accreditations will be extended without any disruption of the hospital’s status as an accredited facility. This decision was made with the support of CMS, which has said hospitals’ Medicare payment status will not be affected by the suspension of surveying activities during the pandemic. In the meantime, the Joint Commission recommends that all hospitals, nursing homes, and other facilities have, review, and modify, where necessary, plans for managing the increased numbers of infectious patients, as set forth in Infection Control Standard 01.06.01.
Extension of MIPS Reporting Deadline
The 2019 data reporting deadline for the Merit-based Incentive Payment System (“MIPS”) was set for March 31, 2020. In light of the ongoing health emergency related to COVID-19, CMS has agreed to extend this deadline to April 30, 2020. MIPS-eligible providers who do not submit their MIPS data by this new deadline will qualify for the automatic “extreme and uncontrollable circumstances” policy and will receive a neutral payment adjustment for the 2021 payment year.
New Guidance regarding Treatment Services Covered by 42 CFR Part 2
Over the last few years, medical providers have worked hard to meet the heightened confidentiality requirements of 42 C.F.R. Part 2, relating to the treatment of patients with substance use disorder (“SUD”). As the current health crisis continues to deepen, providers of SUD treatment services have grown increasingly concerned regarding their ability to meet the needs of those patients. Both CDC and West Virginia guidelines have encouraged social distancing – as evidenced by Governor Justice’s recent stay-at-home order – and the suspension of non-essential health care services. Never has the need for telehealth services been greater than it is now.
For those without adequate telehealth technology, providers are offering telephonic consultations to patients. This process is allowable under the emergency provisions approved by Governor Justice’s Executive Orders. However, these procedures also limit a provider’s ability to obtain the patient’s written consent for the disclosure of SUD records, as required by 42 C.F.R. Part 2. In response to these concerns and the fear that providers would be forced to discontinue services, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) has issued guidance to ensure that substance use disorder treatment services are uninterrupted during the public health emergency. Based on this guidance, if a provider determines that a medical emergency exits, the provider may use and disclose patient identifying information without violating the restrictions of 42 C.F.R. Part 2.
Under these emergency circumstances, the disclosure of the information is permissible to another medical personnel, without patient consent, to the extent necessary to address a bona fide medical emergency. In such cases, SUD treatment providers will want to carefully document, not only the support for their determination that a bona fide medical emergency exists, but also the reasons the patient’s prior informed consent could not be obtained. Any information disclosed to the medical personnel treating the emergency may be redisclosed by that personnel for treatment purposes, as needed.
Need Assistance? Bowles Rice is Here to Help
COVID-19 has resulted in an unprecedented time of stress and confusion, and it is perfectly natural to feel overwhelmed when employees have so many questions. When trying to navigate all these complicated issues, it can be a relief to know that Bowles Rice LLP is there to provide comprehensive and experienced legal advice. Bowles Rice has assembled a COVID-19 Response Team that can answer all your questions and help your organization devise strategies in response to the seemingly ever-changing landscape caused by this pandemic.