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March 15, 2021

Health Headlines – March 15, 2021


CMS Revises Nursing Home Guidance for Visitation Following Vaccination — On March 10, 2021, CMS revised its guidance on visitations to nursing homes in acknowledgement of the fact that millions of residents and staff in nursing facilities have received COVID-19 vaccinations in the last few months.  Although outdoor visitation remains the preferred method, CMS now recommends that facilities allow indoor visitation “at all times and for all residents” regardless of vaccination status, except for a few circumstances when visitation should be limited due to high risk of COVID-19 transmission.

Throughout the pandemic, CMS has recommended limiting visitation to nursing homes due to the threat posed by COVID-19 to nursing-home residents.  With the rollout of the vaccine, CMS has revised its guidelines, effective immediately, to allow indoor visitation.  Outdoor visitation remains the preferred method of visitation, even where the resident and visitor are fully vaccinated against COVID-19.  However, indoor visitation should be limited only in the following circumstances:

  • Indoor visitation should be limited for unvaccinated residents only if the nursing home’s COVID-19 county positivity rate is higher than 10% and less than 70% of residents in the facility are fully vaccinated.
  • Indoor visitation should be limited for residents with confirmed COVID-19 infection, whether or not they are vaccinated, until they have met the criteria to discontinue Transmission-Based Precautions.
  • Indoor visitation should be limited for residents in quarantine, whether or not they are vaccinated, until they have met criteria for release from quarantine.
  • Indoor visitation should be suspended if there is a new case of COVID-19 among residents or staff until at least one round of facility-wide testing is completed. 
    • If testing reveals no additional COVID-19 cases in other areas or units of the facility are found, then indoor visitation can resume in the other areas.  The facility should suspend visitation on the affected unit until the facility meets the criteria to discontinue outbreak testing.
    • If testing reveals one or more additional COVID-19 cases in other areas/units of the facility, then the facility should suspend visitation for all residents (vaccinated and unvaccinated), until the facility meets the criteria to discontinue outbreak testing.

CMS emphasized that compassionate-care visits, such as end-of-life care, should be permitted at all times, even in the event of the above circumstances.  CMS encourages visitors to become vaccinated when they have the opportunity, but visitors should not be required to be tested or vaccinated, or show proof of such, as a condition of visitation.  Federal and state surveyors are also not required to be vaccinated and must be permitted entry into facilities unless they exhibit signs or symptoms of COVID-19 infection.

CMS continues to recommend that facilities, residents, and families adhere to public health guidelines such as maintaining at least 6 feet between people.  However, CMS notes that if a resident is fully vaccinated, they can choose to have close contact (including touch) with their visitor while wearing a well-fitting face mask and performing hand-hygiene before and after.  Visitors should also physically distance themselves from other residents and staff in the facility.

The revised guidance, which is effective immediately, is here.

Reporter, Ariana Fuller, Los Angeles, +1 213 443 4342, afuller@kslaw.com.

U.S. Supreme Court Removes Oral Arguments Over State Medicaid Work Requirements from Calendar — On Thursday, March 11, 2021, the U.S. Supreme Court announced that it will no longer hear oral arguments that were set to occur on March 2, 2021, over D.C. Circuit Court of Appeals rulings striking down Medicaid work requirement programs in Arkansas and New Hampshire.  The announcement comes after a motion filed by the Biden DOJ requesting the hearing be taken off calendar and that the lower court rulings be vacated, and the issue be remanded back to HHS to further investigate its prior approvals of the Medicaid work requirement programs.  The announcement came without any issued comment or ruling, making it uncertain whether the Supreme Court will hear the case at a later date, or whether the Court will take any action with regards to the appellate court decisions.  The removal of this case from the March calendar reflects the latest in a series of cases before the high court that were dismissed or put on hold while the new administration reviews and reconsiders policies established under the prior administration.

The Supreme Court had granted certiorari to consider whether the U.S. Court of Appeals for the D.C. Circuit correctly vacated HHS approvals for demonstration experiments under Section 1115 of the Medicaid Act which would implement employment, job-seeking education or community volunteer engagement requirements as a condition for Medicaid coverage in Arkansas and New Hampshire.  The D.C. Circuit recognized the HHS’s authority to design and approve work experiments under Section 1115 but held that HHS failed to consider a primary objective of the Medicaid Program, coverage and access to medical care, when designing and approving the Arkansas and New Hampshire demonstrations.  The Arkansas and New Hampshire cases were consolidated before the U.S. Supreme Court as Cochran v. Gresham, U.S. No. 20-37. 

The Biden Administration has given early indication that HHS’s approvals of Medicaid work requirement programs issued under the Trump Administration would be the subject of review and reconsideration.  On January 28, 2021, President Biden signed an Executive Order directing HHS to review waivers issued under the prior administration that “may reduce coverage under or otherwise undermine Medicaid.”

Shortly after former HHS Secretary Alex Azar filed a Supreme Court brief supporting these Medicaid work requirements, on February 12, 2021, Acting CMS Administrator Elizabeth Richter sent notices to states that had received these Section 1115 waivers, including Arkansas and New Hampshire, of CMS’s intent to take steps to withdraw those approvals.  The February 12, 2021 notices stated the administration’s determination that work-related requirements would not promote the objectives of the Medicaid Program, citing the risk of unintended coverage loss as a result of the ongoing pandemic and its impact on work opportunities, access to transportation and affordable childcare. 

On February 22, 2021, Acting Solicitor General Elizabeth Prelogar filed a motion with the Supreme Court in which the Biden DOJ requested the high court remove the March hearing from its calendar in light of this change in policy, stating that these cases no longer present an appropriate context to determine the scope of HHS authority to approve demonstration policies.  The motion requested that the lower court decisions be vacated so that the issue could be remanded back to the HHS for review and determination as to how to proceed with respect to the previously issued approvals.  No decision has been made yet by the Supreme Court on DOJ’s request to vacate the D.C. Circuit decision.

President Biden’s January 28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act can be found here.  A version of the February 12, 2021 letter from CMS regarding Medicaid work requirement programs can be found here.

Reporter, Jonathan Shin, Los Angeles, +1 213 443 4334, jshin@kslaw.com.

HHS Extends Comment Period on Proposed HIPAA Rule — On January 21, 2021, the HHS Office for Civil Rights (OCR) published a notice of proposed rulemaking (the Proposed Rule) proposing modifications to the HIPAA Privacy Rule to address standards that might impede the transition to value-based care.  On March 10, 2021, OCR announced that the comment period on the Proposed Rule is being extended until May 6, 2021, from the original date of March 22, 2021.

The Proposed Rule is intended to solicit public comments on proposed modifications to the HIPAA Privacy Rule that would remove barriers to coordination of care and decrease regulatory burdens associated with compliance with patient privacy protections while continuing to protect patients’ individual health information and privacy interests.  The extension of the public comment period on the Proposed Rule is being made in conjunction with the Biden Administration’s plan to manage the federal regulatory process by providing the President’s new designees and appointees time to review all new and pending rules prior to implementation.

The Proposed Rule would change current HIPAA and HITECH Act protections in order to reduce barriers to the implementation of value-based care models by, among other things:

  • Strengthening individuals’ rights to inspect their PHI in person;
  • Shortening covered entities’ required response time to no later than 15 calendar days (from the current 30 days) with the opportunity for an extension of 15 calendar days;
  • Requiring covered entities to inform individuals that they retain their right to obtain, or direct copies of PHI to a third party, when a summary of PHI is offered in lieu of a copy;
  • Reducing the identity verification burden on individuals exercising their access rights;
  • Creating a pathway for individuals to direct the sharing of PHI in an EHR among covered health care providers and health plans, by requiring covered health care providers and health plans to submit an individual's access request to another health care provider and to receive back the requested electronic copies of the individual's PHI in an EHR;
  • Requiring covered health care providers and health plans to respond to certain records requests received from other covered health care providers and health plans when directed by individuals pursuant to the right of access;
  • Creating an exception to the “minimum necessary” standard for individual-level care coordination and case management uses and disclosures that would relieve covered entities of the minimum necessary requirement for uses by, disclosures to, or requests by, a health plan or covered health care provider for care coordination and case management activities with respect to an individual, regardless of whether such activities constitute treatment or health care operations;
  • Clarifying the scope of covered entities' abilities to disclose PHI to social services agencies, community-based organizations, home and community-based service (HCBS) providers, and other similar third parties that provide health-related services, to facilitate coordination of care and case management for individuals;
  • Replacing the privacy standard that permits covered entities to make certain uses and disclosures of PHI based on their “professional judgment” with a standard permitting such uses or disclosures based on a covered entity's good faith belief that the use or disclosure is in the best interests of the individual;
  • Expanding the ability of covered entities to disclose PHI to avert a threat to health or safety when a harm is “serious and reasonably foreseeable,” instead of the current stricter standard which requires a “serious and imminent” threat to health or safety;
  • Eliminating the requirement to obtain an individual's written acknowledgment of receipt of a direct treatment provider's Notice of Privacy Practices (NPP);
  • Modifying the content requirements of the NPP to clarify for individuals their rights with respect to their PHI and how to exercise those rights;
  • Expressly permitting disclosures to Telecommunications Relay Services (TRS) communications assistants for persons who are deaf, hard of hearing, or deaf-blind, or who have a speech disability, and modifying the definition of business associate to exclude TRS providers; and
  • Expanding the Armed Forces’ permission to use or disclose PHI to all uniformed services, which then would include the U.S. Public Health Service (USPHS) Commissioned Corps and the National Oceanic and Atmospheric Administration (NOAA) Commissioned Corps.

The full text of the Proposed Rule can be accessed here. The extension of the comment period for the Proposed Rule is noted in the Federal Register here.

Reporter, David Tassa, Los Angeles, +1 213 443 4335, dtassa@kslaw.com.

ALSO IN THE NEWS

Medicare Increases Reimbursement for COVID-19 Vaccinations – CMS announced that beginning on March 15, 2021, the Medicare payment amount for administration of the COVID-19 vaccine will increase from $28 to $40 for a single-dose vaccine. The reimbursement amount for COVID-19 vaccines requiring two doses will increase from approximately $45 to $80. The exact payment amount is dependent on the type of entity that furnishes the service, as well as the geographic location. The press release may be found here.

King & Spalding Webinar — Issues Facing California Healthcare Providers: Class Action Litigation in the Wake of the COVID-19 Pandemic and Developing Legislation — King & Spalding will host a webinar on Wednesday, March 17, 2021, from 9:00 am PT to 10:00 am PT. This webinar serves as the second session of the California Healthcare Roundtable Series to discuss recent developments in class action litigation targeting healthcare providers.  Over the last 10 years, healthcare providers have been subjected to increasing numbers of high-stakes class action lawsuits on a variety of issues. The COVID-19 pandemic has only given additional fuel to these class action and representative lawsuits and expanded the issues that form the basis of plaintiffs’ allegations.  To register for the event, click here.

King & Spalding Webinar — The Growing Liability Issues Facing Florida Healthcare Facilities in 2021 — More than 10,000 residents and staff of Florida nursing homes have died from COVID-19. The Florida Legislature is considering limited immunity provisions, but Florida plaintiff lawyers are already working to leverage the weaknesses in any potential legislation. King & Spalding will host a series of webinars to discuss what Florida healthcare facilities need to know about the current legal environment at both the state and national levels so they can take appropriate precautions and plan for the coming year. The first installment is Wednesday, March 17, 2021, from 12:00 pm ET to 1:00 pm ET and focuses on Florida law on COVID-related tort liability. The second installment is Wednesday, March 24, 2021, from 12:30 pm ET to 1:30 pm ET and addresses potential COVID-related False Claims Act liability. The third installment is Wednesday, March 31, 2021, from 12:00 pm ET to 1:00 pm ET and focuses on post-COVID-19 jury trials. RSVP by March 16, 2021 by emailing Angie Yeary at ayeary@kslaw.com.