COVID-19: Updates and Developments (Week of April 4)
- April 10, 2020
Lawmakers and the administration this week focused on providing additional interim relief to small businesses to help ease the ongoing fallout of the COVID-19 pandemic, but the Senate failed April 9 to quickly advance the measure through unanimous consent.
The recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act included an unprecedented $2 trillion stimulus package, but lawmakers and the administration have argued more funding is needed for small businesses.
Treasury Secretary Steve Mnuchin asked congressional leaders on April 7 for an additional $250 billion in funding for small business loans through the Paycheck Protection Program (PPP), which was included in the CARES Act.
House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Charles Schumer (D-NJ) are seeking at least double that amount in additional funding, including $100 billion for hospitals and health systems, $150 billion for state and local governments, and an increase in food assistance for families.
Pelosi said the additional funding is an interim step ahead of a fourth, broader stimulus measure. “CARES 2 must provide transformational relief as the American people weather this assault on their lives and livelihoods,” she said.
Senate Majority Leader Mitch McConnell (R-KY), however, has signaled Republicans aren’t ready to dive into another major piece of stimulus legislation at this point. “I think first, we need to see what the effect of the current bill is,” McConnell said.
Democrats blocked McConnell’s effort to swiftly clear the additional $250 billion in funding for the PPP in the Senate on April 9. In remarks on the Senate floor, McConnell accused Democrats of holding the supplemental funding for the PPP hostage to broader negotiations on a fourth stimulus package.
Pelosi in an interview with the Washington Post continued to argue for adding $250 billion to the interim measure, and to focus relief on minority-owned companies and others struggling to secure loans.
Schumer, along with Senate Democratic Committee leaders, earlier in the week also unveiled the COVID-19 “Heroes Fund,” which would provide “pandemic premium pay” for recruiting and retaining essential workers. The fund would include up to a $25,000 bump in annual pay for essential workers, equivalent to a raise of $13 per hour from the start of the public health emergency until December 31, 2020, and a $15,000 essential worker recruitment incentive. Under the measure, essential workers include those working in health care, grocery stores, and transit.
Meanwhile, the Department of Health and Human Services (HHS) began distributing an initial $30 billion in relief funding of the $100 billion set aside in the CARES Act for health care providers. HHS said the funding will be used to support health care expenses or lost revenue resulting from the coronavirus and to pay for testing and treatment provided to uninsured Americans.
Agency Action
Department of Health and Human Services
April 8—HHS authorized licensed pharmacists to order and administer COVID-19 tests, including serology tests authorized by the Food and Drug Administration. HHS said that pharmacists are “well-positioned” to help expand COVID-19 testing. “The vast majority of Americans live close to a retail or independent community-based pharmacy. That proximity reduces travel to testing locations, which is an important mitigation measure,” HHS noted. The agency also said pharmacists qualify as “covered persons” under the Public Readiness and Emergency Preparedness Act (PREP Act) and absent willful misconduct would have immunity from claims arising from the administration of COVID-19 tests.
April 8—HHS awarded $1.3 billion to 1,387 health centers across the country for preventing, testing, and treating COVID-19 and maintaining or increasing capacity and staffing. The funding is being made available through the Health Resources and Services Administration under the CARES Act.
April 8—HHS inked a deal with DuPont to expedite the delivery of personal protective equipment to health care workers. Under the agreement, DuPont will deliver 450,000 Tyvek® suits to the United States from its manufacturing facility in Hanoi, Vietnam. HHS said it expects to receive 2.25 million TYVEK suits over the next five weeks with an option to continue purchasing up to a total of 4.5 million TYVEK suits.
April 8—HHS entered into a $489.4 million contract with General Motors to deliver 30,000 ventilators to the Strategic National Stockpile by the end of August. HHS said the contract is the first for ventilator production under the Defense Production Act (DPA). HHS later announced a second, $646.7 million contract with Phillips for ventilator production under the DPA. The contract requires Phillips to deliver 43,000 ventilators to the Strategic National Stockpile by the end of December.
April 6—The Centers for Disease Control and Prevention (CDC) is providing $186 million in funding to state and local public health authorities to support their COVID-19 response efforts, HHS announced. CDC plans to provide the supplemental funding to “hot zones” with the highest number of reported COVID-19 cases to support activities including lab equipment, supplies, staffing, shipping, infection control, surge staffing, monitoring of individuals, and data management. CDC will use existing networks to reach out to state and local jurisdictions to access this initial funding, HHS said.
Centers for Medicare & Medicaid Services (CMS)
April 9—CMS issued April 9 new waivers aimed at maximizing flexibilities for health care providers to expand their workforces for a surge in COVID-19 patients. CMS said the new waivers focus on reducing supervision, licensure, and certification requirements so that doctors, nurses, and other clinicians can be hired and put to work quickly. Under the waivers, physicians can directly care for patients at rural hospitals, across state lines, via telehealth using phones, radio, or online communications, CMS said. The waivers also allow nurse practitioners to perform some medical exams at skilled nursing facilities, and occupational therapists to perform initial assessments on certain homebound patients. “It’s all hands on deck during this crisis,” said CMS Administrator Seema Verma. “All frontline medical professionals need to be able to work at the highest level they were trained for. CMS is making sure there are no regulatory obstacles to increasing the medical workforce to handle the patient surge during the COVID pandemic.”
April 8—CMS issued updated infection control guidance for health care providers to prevent the spread of COVID-19. The updated guidance includes new instructions for dialysis facilities, which treat patients with End-Stage Renal Disease, a patient population that may be particularly susceptible to COVID-19. The updated guidance opens the door for dialysis facilities to provide more services in patients’ homes or in long term care facilities. CMS also provided updated or new guidance for a broad range of health care settings, including hospitals, outpatient settings, and residential facilities. CMS also updated guidance related to the Emergency Medical Treatment and Labor Act (EMTALA), including expanded recommendations on screening and visitation restrictions, staff screening and testing, and return-to-work policies. The revised guidance includes a detailed discussion of patient triage, appropriate medical screening and treatment, the use of alternate testing sites, and telehealth, CMS said.
April 9—CMS has distributed $51 billion in advance and accelerated payments to health care providers and suppliers across the country, the agency announced. CMS said it has reduced the timeframe for processing accelerated or advanced payments requests from three to four weeks to four to six days. The agency has approved roughly 21,000 of more than 32,000 requests from health care providers and suppliers for the payments. CMS previously used the advance and accelerated payment program on a much smaller scale for natural disasters like hurricanes. The payments are loans that suppliers and providers must pay back. The funding is separate than the $100 billion made available to health care providers under the CARES Act.
April 7—CMS has now approved 49 Medicaid waivers under Section 1135. The Section 1135 waivers give states additional flexibilities to administer their Medicaid programs during the coronavirus outbreak. CMS recently approved waivers for Maine, the U.S. Virgin Islands, and Nevada, among others.
April 3—CMS issued guidance for ambulatory surgical centers (ASCs) temporarily enrolling as hospitals during the COVID-19 public health emergency. As part of efforts to increase hospital capacity, CMS previously announced that ASCs already enrolled in Medicare could enroll as hospitals to provide inpatient and outpatient services.
Office for Civil Rights (OCR)
April 9—OCR issued a notice of enforcement discretion that it will not impose penalties under the Health Insurance Portability and Accountability Act (HIPAA) on covered entities or business associates that participate in good faith in operating COVID-19 testing sites during the public health emergency. The exercise of enforcement discretion is effective immediately and retroactive to March 13. The move is specifically aimed at ensuring expanded availability of testing in communities, including at mobile, drive-through, or walk-up sites.
April 8—OCR resolved its compliance review of Alabama after the state removed ventilator rationing guidelines that allegedly discriminated on the basis of disability. OCR issued last week a bulletin reminding covered entities that they must continue to comply with federal civil rights laws. OCR enforces the Americans with Disabilities Act, Section 504 of the Rehabilitation Act, the Age Discrimination Act, and Section 1557 of the Affordable Care Act. OCR initiated a compliance review following a complaint filed by the Alabama Disabilities Advocacy Program and the The Arc of the United States that Alabama had incorporated 2010 guidelines into its emergency operations plan that allegedly allowed for denying ventilator services to individuals based on disability and age. OCR said it was concerned that the 2010 criteria could result in discrimination against individuals with disabilities or based on age for ventilator services. OCR communicated with state officials, who agreed to remove all links to the 2010 criteria from state websites and to clarify that the criteria are not in effect and will not be added in the future. “OCR commends Alabama for quickly disavowing problematic triage plans and coming into compliance with federal civil rights laws within days of being contacted by our office,” said OCR Director Roger Severino. In a statement, Alabama Department of Public Health, State Health Officer, Dr. Scott Harris said, “All people deserve compassion and equal respect, and with this in mind, the allocation of care cannot discriminate based on race, color, national origin, disability, age, sex, exercise of conscience or religion. This includes the use of ventilators during medical emergencies in addressing the needs of at-risk populations in Alabama.”
Drug Enforcement Administration (DEA)
April 7—The Drug Enforcement Administration (DEA) issued a final order increasing annual quotas on Schedule II controlled substances that are in high demand due to COVID-19. The final order increases the 2020 Aggregate Production Quotas by 15% for certain substances needed for COVID-19 treatment, including fentanyl, morphine, hydromorphone, codeine, ephedrine, pseudoephedrine, and certain controlled substance intermediates that are essential to their production. DEA also is increasing the annual cap for methadone “to ensure that opioid treatment programs have sufficient supplies to treat patients suffering from opioid use disorder,” the agency said. In addition, DEA will approve increases in imports of certain Schedule III and IV controlled substances that are used to treat patients on ventilators.
HHS Office of Inspector General (OIG)
April 3—OIG issued a policy statement to exercise enforcement discretion not to impose administrative sanctions under the Anti-Kickback Statute for certain remuneration related to COVID-19 that is covered by the blanket waivers CMS issued last week for the Stark Law, subject to certain conditions. The policy statement applies as of April 3 and terminates when the Stark blanket waivers terminate. OIG said the policy statement, which applies to remuneration that is covered by section II.B.(1)-(11) of the blanket waivers, is intended to avoid the need for parties to undertake a separate legal review under the AKS.
Other Developments
April 6—In a series of letters, the American Hospital Association asked HHS and CMS to waive interest or substantially reduce the interest rate on accelerated/advanced payments; to take additional steps to temporarily ease certain requirements, including fully implementing waivers of the EMTALA, delaying Medicare cost report audits, ensuring teaching hospitals that increase bed capacity for COVID-19 aren’t penalized in their indirect medical education payments, and confirming HIPAA protection through the declared health emergency; take additional steps to allow hospitals and health systems to expand telehealth, including allowing hospital outpatient departments to bill for outpatient psychiatry programs and outpatient therapy services provided via telehealth, allowing additional practitioners such as licensed respiratory therapists, physical therapists, occupational therapists, and speech language pathologists to provide services via telehealth, and allowing home health and hospice services to be provided via telehealth where clinically appropriate; and to extend the 20% add-on payment to the diagnosis-related group rate for Medicare beneficiaries with COVID-19 that was included in the CARES Act for inpatient hospitals to long term care hospitals.
April 4—The Department of Justice (DOJ) cleared the way for five major medical distributors—McKesson Corp., Owens & Minor Inc., Cardinal Health Inc., Medline Industries Inc., and Henry Schein Inc.—to collaborate in expediting and increasing manufacturing, sourcing, and distribution of personal-protective equipment (PPE) and coronavirus-treatment-related medication. The distributors submitted a business review letter to DOJ pursuant to the expedited temporary review provision recently announced by the Antitrust Division and the Federal Trade Commission. In a March 24 Joint Statement, the agencies pledged to review requests to collaborate on COVID-19-related projects within seven calendar days of receiving all necessary information. DOJ approved the distributors’ request five days later indicating it wouldn’t challenge the collaboration to source and distribute PPE and medications. In its April 4 letter to the companies, DOJ noted that the distributors’ collaboration is at the direction of the federal government to help resolve supply challenges stemming from the pandemic. The distributors are already involved in a public-private partnership, Project Airbridge, with the federal government under the direction of the Federal Emergency Management Agency and HHS to quickly source and airlift PPE and distribute medications.