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March 27, 2020
Health Law Weekly

COVID-19: Developments and Updates

  • March 27, 2020

The House and Senate cleared this week an unprecedented $2 trillion stimulus package to help shore up the health care system, provide direct assistance to American workers and families, and stabilize the U.S. economy in the face of the coronavirus pandemic.

On March 25, the Senate approved by a 96-0 vote the Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) following intense bipartisan negotiations to advance a third wave of legislative measures to stem the continuing economic fallout from COVID-19. The House passed the measure March 27 by voice vote. 

The massive stimulus package, among other things, would provide

  • Checks of up to $1,200 for individuals, up to $2,400 for married couples filing jointly, and an additional $500 per child. The payment amount would be gradually reduced for income levels starting at $75,000 for individuals and $150,000 for joint filers. Individuals with income exceeding $99,000 and joint filers with income exceeding $198,000 would be ineligible for the payments. Individuals with no income and those on Social Security are eligible.
  • Expanded unemployment benefits
  • $350 billion for small business loans
  • $340 billion for efforts to stem the coronavirus outbreak, including $117 billion for hospitals and veterans’ health care, $16 billion to procure personal protective equipment (PPEs), ventilators, and other medical supplies; $11 billion for vaccines, therapeutics, diagnostics, and other preparedness needs;  $4.3 billion for the Centers for Disease Control; and $45 billion for the Federal Emergency Management disaster relief fund
  • $500 billion in loans and funding for industries and cities and states

The measure also would delay cuts to Medicaid Disproportionate Share Hospital payments and temporarily suspend Medicaid sequestration reductions.

“While this legislation is an important first step forward, more will need to be done to deal with the unprecedented challenge of this virus. We will continue to work with Congress to make sure providers on the front lines—hospitals, physicians and nurses—remain prioritized for future federal assistance as the COVID-19 pandemic spreads,” said American Hospital Association President and CEO Rick Pollack in a statement..

Agency Guidance

Centers for Medicare & Medicaid Services (CMS)

March 26—CMS continues to approve additional state Medicaid waivers under Section 1135, with the total number of approvals at 34 states nationwide as of this writing. The Section 1135 waivers give states additional flexibilities to administer their Medicaid programs during the coronavirus outbreak.

March 24—CMS provided guidance on the increased Federal Medical Assistance Percentage (FMAP) that was included in the recently enacted First Coronavirus Response Act. The statute provides a temporary 6.2 percentage point bump to each qualifying state and territory’s FMAP effective January 1, 2020 through the last day of the calendar quarter in which the public health emergency for COVID-19 terminates.

March 24—The Center for Consumer Information & Insurance Oversight (CCIIO) issued a notice that CMS will exercise enforcement discretion to permit issuers of qualified health plans and stand-alone dental plans to extend deadlines for premiums and other payments during the COVID-19 national emergency. CCIIO also issued Frequently Asked Questions noting that federal regulations don’t prohibit issuers in the individual and small group markets from giving enrollees early access to prescription drug refills or to more than a 90-day supply. Another CCIIO FAQ document strongly encouraged “all issuers to promote the use of telehealth services, including by notifying policyholders and beneficiaries of their availability, by ensuring access to a robust suite of telehealth services, including mental health and substance use disorder services, and by covering telehealth services without cost sharing or other medical management requirements.”

March 24–CMS announced in an updated list of FAQs that it will exercise enforcement discretion for submitting data to Open Payments for program year 2019 due to circumstances beyond the reporting entity’s control related to the pandemic. CMS noted it is unable to extend the statutory deadline of March 31 for submitting program year 2019 Open Payments data but will exercise enforcement discretion instead. 

March 23—Effective immediately, CMS is temporarily pausing routine inspections of nursing homes so surveyors can focus exclusively on infection control, particularly in facilities that may be at high-risk of an outbreak, according to an agency fact sheet. The new focused inspection process will target and assess if certain facilities meet standards for preventing the spread of COVID-19. CMS is urging facilities not initially inspected to self-assess their infection control performance. For the next few weeks, inspections will focus only on immediate jeopardy complaints, targeted infection control, and self-assessments.

March 22—CMS announced it is granting some exceptions and extensions for health care providers participating in Medicare quality reporting programs. The exceptions and extensions for upcoming measure reporting and data submission deadlines apply to the Quality Payment Program, Medicare Shared Savings Program, Hospital Inpatient and Outpatient Quality Reporting Programs, Hospital Readmissions Reduction Program, Home Health and Hospice Quality Reporting Programs, and the Skilled Nursing Facility Quality Reporting Program, among others.

March 22—CMS issued four new checklists to help states obtain federal waivers and implement flexibilities in their Medicaid programs. Specifically, the tools permit states to access emergency administrative relief, make temporary modifications to Medicaid eligibility and benefit requirements, relax rules to ensure that individuals with disabilities and the elderly can be effectively served in their homes, and modify payment rules to support health care providers impacted by the outbreak, the agency said.

Department of Health and Human Services (HHS)

March 24—HHS Secretary Alex Azar is asking state governors to extend the capacity of their health care workforces in the face of the pandemic by allowing health care professionals licensed or certified in other states to practice in their states either in person or through telemedicine. Azar also urged governors to waive certain statutory and regulatory standards; relax scope of practice requirements; allow physicians to supervise more health care professionals including remotely; allow for rapid certification/licensure and recertification/relicensure of certain health care professionals; modify, rescind, or waive medical malpractice polices that prevent coverage for health professionals responding to the outbreak in another state; modify laws or regulations to allow medical students to triage, diagnose, and treat patients under the supervision of licensed medical staff; and allow pharmaceutical deliveries without signatures.

March 24—HHS announced it will provide $100 million to help U.S. health care systems prepare for a surge in COVID-19 patients. The funding is authorized by the Coronavirus Preparedness and Response Supplemental Appropriations Act 2020.

Office for Civil Rights (OCR)

March 24—OCR issued guidance on how covered entities can share protected health information (PHI) with law enforcement, paramedics, other first responders, and public health authorities about individuals infected or exposed to COVID-19 without violating the Health Insurance Portability and Accountability Act (HIPAA). According to the guidance, a covered entity may disclose PHI such as an individual’s name or other identifying information without a HIPAA authorization when needed to provide treatment, when required by law, when first responders may be at risk of infection, and when disclosure is necessary to prevent or lessen a serious imminent threat.

Other Developments

March 25—A new analysis from the National Association of ACOs estimates the COVID-19 pandemic could cost Medicare between $38.5 billion and $115.4 billion over the next year, depending on the severity of disease, hospitalization rates, and other factors. The group noted that health care providers participating in payment models like Accountable Care Organizations could be particularly hard hit. According to the study, ACOs could see an increase in spending between 6% to 18% because of COVID-19. “We could see generated savings wiped out, massive penalties, and worst of all, ACOs dropping out of the program to avoid losses,” said Clif Gaus, Sc.D., NAACOS President and CEO. “In short, COVID-19 threatens to derail adoption of alternative payment models and the movement to value-based care. We need policymakers to give assurance to ACOs that they’ll take appropriate steps to provide needed protection." 

March 25—The HHS Office of Inspector General (OIG) created a portal for all information and announcements related to COVID-19. The portal can be accessed from OIG’s main website or directly at oig.hhs.gov/coronavirus. OIG is asking for feedback from individuals or entities who need clarification on its oversight authorities during the COVID-19 pandemic. OIG recognizes that in the current public health emergency, the health care industry must be focused on delivering needed patient care. As part of OIG’s mission to promote economy, efficiency, and effectiveness in HHS programs, OIG is committed to protecting patients by ensuring that health care providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns. Therefore, OIG is soliciting input from the health care community regarding the application of OIG’s administrative enforcement authorities, including the federal anti-kickback statute and civil monetary penalty provision prohibiting inducements to beneficiaries. If you have a question regarding how OIG would view an arrangement that is directly connected to the public health emergency and implicates these authorities, the question may be submitted to [email protected]. The submission should provide sufficient facts to allow for an understanding of the key parties and terms of the arrangement at issue. OIG plans to review all submissions, develop responses as appropriate to “frequently asked questions,” and make such responses publicly available on its website. The submission of a question does not obligate OIG to take action, including responding to the question, making the question public, or issuing public feedback.

March 24—The Federal Trade Commission (FTC) and the Department of Justice’s (DOJ’s) Antitrust Division issued a joint statement setting forth an expedited procedure for industry collaborations related to the COVID-19 pandemic. Under the expedited procedure, the FTC and DOJ will respond to COVID-19-related requests within seven calendar days of receiving all the information needed to vet the proposals. For more information on this announcement, see U.S. Antitrust Agencies’ COVID-19 Response: Requests for Health and Safety Cooperation posted on AHLA’s Coronavirus Pandemic Hub.

March 23—President Trump signed an executive order to help prevent hoarding of critical medical supplies such as PPE and sanitizing and disinfecting products. The order authorizes HHS “to prescribe conditions with respect to the accumulation of such resources, and to designate any material as a scarce material, or as a material the supply of which would be threatened by persons accumulating the material either in excess of reasonable demands of business, personal, or home consumption, or for the purpose of resale at prices in excess of prevailing market prices.” Pursuant to the authority granted under the executive order, HHS on March 25 designated a list of medical supplies as subject to the hoarding prevention measures, including N-95 masks, other filtering facepiece respirators, various types of ventilators, chloroquine phosphate or hydroxychloroquine HCI, disinfecting devices and sanitizing products suitable for clinical settings, and various PPE, including gloves, masks, and gowns.

March 20—The Federal Communications Commission (FCC) issued March 20 a ruling confirming that the COVID-19 pandemic constitutes an “emergency” under the Telephone Consumer Protection Act (TCPA), allowing hospitals, health care providers, state and local health officials, and other government officials to lawfully communicate information about the novel coronavirus as well as mitigation measures without violating federal law. The TCPA and FCC rules prohibit autodialed, prerecorded, or artificial voice calls and text messages to wireless telephone numbers in most circumstances. Automated voice calls and text messages to wireless numbers are allowed, however, to protect health and safety pursuant to the TCPA’s “emergency purposes” exception.

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