President Trump signed the Families First Coronavirus Response Act, H.R. 6201, on March 18th, 2020 after it passed in the Senate without amendment. The Act, Public Law 116-127, has become known as “Phase II” of the legislative response to COVID-19. As discussed in Health Headlines for the week of March 16, 2020, the Phase II law expands paid leave for certain workers, mandating two weeks of paid sick leave and up to three months of paid family and medical leave, while excluding certain health care providers and emergency responders. The Phase II law also provides that testing will be covered by private insurers and government payors without cost-sharing payments. On Thursday, March 19, 2020, Senate Republicans introduced the “Coronavirus Aid, Relief, and Economic Security Act” or the “CARES Act”, S. 3548, which has become known as the “Phase III” legislative response. The CARES Act remains a work in progress after twice failing procedural votes in the Senate yesterday and today, but a draft of the bill reveals the types of relief that might be included in the final version. We also anticipate that a supplemental appropriations package will be included as a component of CARES. The most recent draft included $75 million to “reimburse, through grants or other mechanisms, eligible health care providers for health care related expenses or lost revenues that are directly attributable to coronavirus.

The general purpose of the CARES Act is to support the U.S. healthcare system during the COVID-19 public health emergency and to provide relief to individuals and businesses. In the most recent version of the CARES Act, which was unveiled on Sunday, most of the provisions that specifically apply to the healthcare industry are located in Division A, Title III. These generally include (1) provisions intended to mitigate shortages of medical supplies, drugs and devices, (2) provisions intended to increase access to care and the availability of healthcare services, and (3) various changes with respect to Medicare and Medicaid services and reimbursement. Set forth below is a summary of these provisions. Although these provisions remain subject to ongoing negotiations, they are illustrative of the types of relief that may be included in the final bill.

Summary of Draft Healthcare Relief Provisions

• Medical Supplies, Drugs, and Devices

• Clarifying the Strategic National Stockpile (SNS) include certain types of medical supplies such as personal protective equipment and supplies necessary for administering drugs, vaccines, and diagnostic tests.
• Granting liability protection for manufacturers of personal respiratory protective devices where such devices are determined to be a priority for use during a public health emergency. Note, however, that the CARES Act does not address how devices that are permitted during the current crisis that would otherwise be considered sub-standard should be treated after the crisis has ended (i.e., steps that manufacturers and providers will need to take to identify and remove sub-standard devices from circulation at some point in the future).
• Requiring the FDA to prioritize and expedite reviews of drug applications and inspections to mitigate emergency drug shortages.
• Adding new reporting requirements for drug manufacturers to submit information regarding interruptions in supply and requiring manufacturers to adopt risk management plans to ensure adequate supply.
• Adding new requirements for medical device manufacturers to report shortages of devices or related components during a public health emergency.
• Access to Healthcare Services
• Requiring insurers to pay providers either a contracted rate or a cash price posted by a provider (if no contracted rate exists) for COVID-19 tests covered at no cost to patients. Providers that do not post their cash price for the test on their website are subject to civil monetary penalties.
• Requiring insurers to cover any COVID-19 vaccine that meets certain qualifications without imposing any cost-sharing on patients.
• Providing $1.32 billion for FY2020 for community health centers for testing and treating COVID-19.
• Reauthorizing certain Health Resources and Services Administration (HRSA) grant programs intended to promote telehealth and strengthen rural community health.
• Establishing a “Ready Reserve Corps” to ensure availability of trained physicians and nurses during public health emergencies.
• Shielding volunteer health care professionals from liability for harm caused in the course of providing services during the COVID-19 public health emergency, subject to certain exceptions including, among others, gross negligence, willful misconduct, and services rendered under the influence of alcohol or intoxicating drugs.
• Expanding the authority of the Secretary of HHS with respect to assignments of members of the National Health Service Corps during the COVID-19 public health emergency.
• Requiring HHS to issue guidance within 180 days regarding the sharing of protected health information (PHI) under HIPAA during the COVID-19 public health emergency, and also revising confidentiality and disclosure requirements for records relating to substance use disorder.
• Reauthorizing certain health professions workforce development programs, requiring HHS to develop a comprehensive workforce development plan.
• Permitting a high-deductible health plan (HDHP) with a health savings account (HSA) to cover telehealth services for patients who have not yet reached their deductibles.
• Allowing Federally qualified health centers and rural health clinics to provide telehealth during the COVID-19 public health emergency.
• Medicare and Medicaid Services and Reimbursement
• Waiving requirements for face-to-face visits between Medicare home dialysis patients and physicians during the COVID-19 public health emergency.
• Permitting the use of telehealth for a face-to-face encounter prior to recertifying eligibility for hospice care under Medicare during the COVID-19 public health emergency.
• Allowing physician assistants, nurse practitioners, and certain other professionals to order home health services for Medicare and Medicaid beneficiaries.
• Temporarily suspending Medicare sequestration from May 1 through December 31, 2020.
• Increasing the Medicare add-on payment for COVID-19 patients by 20% during the emergency.
• Waiving the requirement under Medicare for an inpatient rehabilitation facility (IRF) to provide at least 3 hours of therapy per day.
• Requiring HHS to exercise enforcement discretion during the emergency with respect to (i) the payment adjustment for a long-term care hospital (LTCH) that does not have a discharge payment percentage of at least 50% and (ii) LTCH exclusion criteria from the site-neutral inpatient prospective payment system (IPPS) payment rate.
• Revising payment rates for durable medical equipment (DME) under Medicare during the COVID-19 emergency.
• Providing for COVID-19 vaccines to be covered under Medicare Part B without any cost sharing.
• Requiring Medicare and Medicare Advantage prescription drug plans to allow for refills of covered Part D drugs for up to a three-month supply during the COVID-19 emergency.
• Permitting State Medicaid programs to pay for direct support professionals to provide personal assistance services to individuals with disabilities during hospital stays.
• Extending the Medicare work geographic index floor to January 1, 2022.
• Delaying scheduled reductions of disproportionate-share hospital (DSH) payments.

A copy of the most recent draft version of the CARES Act, which was current as of Sunday, March 22, is available in two parts: the first is available here and the second here.