Health Law Blog - Healthcare Legal Issues

Archive for April, 2020

CMS State Goals in the COVID-19 Pandemic

Thursday, April 30th, 2020

CMS has identified its general goals during the COVID-19 pandemic on a few occasions. The most recent was in the April 30, 2020 press release in which CMS introduces new regulatory waivers to assist providers as they emerge from the pandemic. CMS’ identified goals have included:

  1. To ensure that local hospitals and health systems have the capacity to handle COVID-19 patients through temporary expansion sites (also known as the CMS Hospital Without Walls initiative);
  2. To expand at-home and community-based testing to minimize transmission of COVID-19;
  3. To expand the healthcare workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the local community or other states;
  4. To increase access to telehealth for Medicare patients so they can get care from their physicians and other clinicians while staying safely at home; and
  5. put patients over paperwork by giving providers, healthcare facilities, Medicare Advantage and Part D plans, and states temporary relief from many reporting and audit requirements so they can focus on patient care.

The Joint Commission COVID-19 Information Page for Health Care Providers

Thursday, April 23rd, 2020

The Joint Commission has issued a Coronavirus (COVID-19) guidance page for hospitals and other organizations who are accredited through that organization. The page contains a letter and a video from the CEO of the Joint Commission, Mark R. Chassin, MD, FACP, MPP, MPH.

the joint commission covid-19 guidance

The Joint Commission Offers Useful Resources on the COVID-19 Pandemic.

The page also contains a variety of statements from the Joint Commission, Frequently Asked Questions about the Joint Commission’s statement on use of face masks brought from home, a statement on universal masking, a public statement on the shortage of critical equipment.

The page contains an interesting section highlighting stories from health care workers who are working on the front lines of the battle against the virus.

The Joint Commission page contains topical coverage of a variety of COVID-19 issues that are being faced by health care providers. The Joint Commission offers some really good content. There are informative articles, videos, training material and a wide variety of resources related to the COVID-19 virus, organized by category.

Some of the information on the Joint Commission site includes:

Visit the Joint Commission COVID-19 Resource Page, but plan to spend a while over there. There is a lots of really nice content.

For continual coverage of COVID-19 Legal Issues, Visit our Coronavirus Resources and Blog

When is a Referral Mandate for Employed Physicians Permitted under the Stark Law?

Wednesday, April 22nd, 2020

When Employed Physicians be Required to Make Referrals for Designated Health Services

Referral Requirements Employed PhysiciansThe Stark Law Regulations include a provision that dictates the conditions under which an employer of a physician may mandate referrals for designated health services.  Certain specific conditions must be met if an employer wishes to require its employed physicians to make referrals to the employer’s designated health services.  Many institutions assume that an employer may always require an employed physician to make referrals to its ancillary services.  That assumption is not correct.

The Stark regulations provides that a physician’s compensation from a bona fide employer or under a managed care contract or other contract for personal services may be conditioned on the physician’s referrals to a particular provider, practitioner, or supplier.    There are a number of specific requirements that must be present to permit referral requirements including:

  1.  The required referrals can only relate to the physician’s services covered by the scope of the employment or the contract.
  2. The referral requirement must be reasonably necessary to effectuate the legitimate business purposes of the compensation arrangement.
  3. The physician’s compensation must be set in advance for the term of the agreement requiring referrals.
  4.  The physician’s compensation must be consistent with fair market value for services performed (that is, the payment may not take into account the volume or value of anticipated or required referrals).
  5. The arrangement must otherwise comply with an applicable exception under Sec. 411.355 or Sec. 411.357.
  6.  The requirement to make referrals to a particular provider, practitioner, or supplier is set forth in a written agreement signed by the parties.
  7. The requirement to make referrals to a particular provider, practitioner, or supplier may not apply if the patient expresses a preference for a different provider.
  8. The referral requirement may not apply to cases where the patient’s insurer determines the provider, practitioner, or supplier;.
  9. The referral requirement may not apply where the referral is not in the patient’s best medical interests in the judgment of the referring physician.
  10. There can be no requirement that an employed physician make referrals that relate to services that are not provided by the physician under the scope of his or her employment or contract.

This scenario most commonly applies in cases where a hospital or health system employs a physician and requires direction of referrals to the system’s designated health services.  It is not uncommon to see a health system contractually require employed doctors to refer to the hospital or ancillary services of the hospital.  The Stark Law permits the employing hospital to require referrals subject to these conditions.  It is also common to see referral requirements without including in the contract the various conditions that must be present to permit the direction of referrals.  The Stark Law would cast a shadow over a compensation arrangement with an employed physician that requires referrals without subjecting the referrals to the conditions set forth in the Stark regulations.  Failing to subject the required referrals to the Stark Law conditions would seem to make the compensation arrangement illegal.  Any referral made to the hospital’s designated health services may be tainted and reimbursement arising from the illegally required referrals would be prohibited.

Stark Law Provisions Relating to Referral Requirements of Employed Physicians

The following is the exact wording of the portion of the Stark Law that established the various conditions that must be met in order to permit the provider of designated health services to require employed physician’s to refer to its DHS.

42 C.F.R. § 411.354(d)(4)

(4) A physician’s compensation from a bona fide employer or under a managed care contract or other contract for personal services may be conditioned on the physician’s referrals to a particular provider, practitioner, or supplier, provided that the compensation arrangement meets all of the following conditions. The compensation arrangement:
(i) Is set in advance for the term of the agreement.
(ii) Is consistent with fair market value for services performed (that is, the payment does not take into account the volume or value of anticipated or required referrals).(iii) Otherwise complies with an applicable exception under §411.355 or §411.357.(iv) Complies with both of the following conditions:

(A) The requirement to make referrals to a particular provider, practitioner, or supplier is set forth in a
written agreement signed by the parties.

(B) The requirement to make referrals to a particular provider, practitioner, or supplier does not apply if the patient expresses a preference for a different provider, practitioner, or supplier; the patient’s insurer determines the provider, practitioner, or supplier; or the referral is not in the patient’s
best medical interests in the physician’s judgment.

(v) The required referrals relate solely to the physician’s services covered by the scope of the employment or the contract, and the referral requirement is reasonably necessary to effectuate
the legitimate business purposes of the compensation arrangement. In no event may the physician be required to make referrals that relate to services that are not provided by the physician under the scope of his or her employment
or contract.

Complying with HIPAA and Beyond during COVID-19

Wednesday, April 22nd, 2020

Safeguarding Patient Health Information in an Emergency Situation

Even in an emergency situation such as that presented by the COVID-19 pandemic, covered entities must continue to meet their obligations under federal and state laws protecting confidentiality of patient health care information, to implement reasonable safeguards to protect patient information against intentional or unintentional impermissible uses and disclosures. They must continue to comply with the administrative, physical, and technical safeguards of the security rule and privacy rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Covered Entities must continue to comply with HIPAA and other confidentiality laws during the COVID-19 pandemic. Certain emergency provisions may apply in applicable state and federal regulations.

The obligation to conduct periodic HIPAA security assessments continues, even during the existence of an emergency or natural disaster. The obligation to meet the requirements of state laws protecting special status health information such as mental health records and drug and alcohol rehabilitation records, also continues through a pandemic.

Each of the bodies of regulations that apply to patient health information contain certain specific provisions that can apply during a pandemic. For example, HIPAA permits disclosures to public health authorities and others where it is necessary for purposes of controlling the spread of the virus or to otherwise protect the public from harm. These exceptions permit disclosures that may be in the public good for purposes of addressing the emergency situation. The emergency exceptions do not provide blanket exemption from assuring compliance with applicable regulations.


HIPAA Applies Only to Covered Entities and Business Associates, But Other Laws May Apply More Broadly

The HIPAA Privacy Rule applies to disclosures made by employees, volunteers, and other members of a covered entity’s or business associate’s workforce. HIPAA does not apply to others, such as some emergency workers, law enforcement, fire responders, and other first responders who may be involved in the course of a patient’s health care episode. But you should be aware that other laws, such as laws protecting confidentiality of mental health treatment information and substance/alcohol rehabilitation records, may be applicable and will normally be more protective of patient confidentiality than HIPAA. Covered entities include health plans, health care clearinghouses, and most health care providers. Business associates generally are persons or entities that are not inside the organization and who perform functions or activities on behalf of, or provide certain services to, a covered entity that involve creating, receiving, maintaining, or transmitting protected health information.


Business associates also include subcontractors of other business associates that create, receive, maintain, or transmit protected health information. The HIPAA privacy rules do not apply to disclosures made by entities or other persons who are not covered entities or business associates. (although such persons or entities are free to follow the standards on a voluntary basis if desired). There may be other state or federal rules that apply.
A business associate of a covered entity may make disclosures permitted by the HIPAA rules, including those that are available in the case of an emergency.


Although HIPAA may not apply to law enforcement and others who may come into possession of information concerning the health care of an individual, other federal and state laws apply more broadly and extend beyond covered entities and business associates. For example, the regulations applicable to substance and alcohol abuse records are subject to laws prohibiting any party who receives the protected information from the provider to comply with a prohibition against redisclosure. Even though law enforcement and other first responders may not be covered entities or business associates as defined in HIPAA, the provisions of 42 CFR Part 2, the federal regulations providing confidentiality protection for substance and alcohol abuse treatment records, and possibly state laws protecting mental health records, may impose an obligation on law enforcement and other non-covered entities, to maintain the confidentiality of the information that they receive.


We previously released a blog article describing some of the Emergency Provisions available under HIPAA.

Coronavirus Checklist for Nursing Homes and Hospitals

Thursday, April 16th, 2020


Follow the links below to download from the CDC.

A coronavirus preparedness checklist for hospitals, including long-term acute care hospitals are available from the CDC.

Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings:

Strategies to Prevent the Spread of COVID-19 in Long-Term Care Facilities (LTCF):

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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