POLICY BRIEFINGS


Diaz-Balart, McAdams, Paul Test Positive for COVID-19, Others Self-Quarantine


Several lawmakers have announced that they have tested positive for the coronavirus, while several others have made the decision to self-quarantine after coming into contact with someone who had tested positive. Testing positive are Rep. Mario Diaz-Balart (R-Fla.), Rep. Ben McAdams (D-Utah), and Sen. Rand Paul, MD (R-KY). Those in self-quarantine include Reps. Don Beyer (D-Va.), Anthony Brindisi (D-N.Y.), Julia Brownley (D-Calif.), Matt Cartwright (D-Pa.), Tom Cole (R-Okla.), Jason Crow (D-Colo.), Joe Cunningham (D-S.C.), Sharice Davids (D-Kan.), Drew Ferguson (R-Ga.), Vicente Gonzalez (D-Texas), Kendra Horn (D-Okla.), Andy Kim (D-N.J.), Ben Ray Lujan (D-N.M.), Gwen Moore (D-Wis.), Stephanie Murphy (D-Fla.), David Price (D-N.C.), Kathleen Rice (D-N.Y.), Steve Scalise (R-La.), Adam Schiff (D-Calif.), David Schweikert (R-Ariz.), Ann Wagner (R-Mo.), as well as Sens. Cory Gardner (R-Colo.), Mike Lee (R-Utah), Mitt Romney (R-Utah), and Rick Scott (R-Fla.).


Dems Request Details from WH on COVID Related Shortages


House Oversight Committee Democrats are requesting a briefing from the U.S. Department of Health and Human Services (HHS) on the Department’s plans to meet shortages of ventilators, hospital beds, and personal protective equipment (PPE) for health care workers. The lawmakers ask for details on how equipment and medical gear will be distributed, how the Defense Production Act (DPA) will be used to increase production, and what role the Federal Emergency Management Agency will play in distribution. The panel has also asked for a copy of the administration’s plan for addressing the shortfall of coronavirus diagnostic tests. House Education and Labor Committee Chairman Bobby Scott (D-Va.) is urging the White House to appoint a designated official to coordinate the distribution of PPE and other equipment to health care workers across the country. His letter argues that coordination will be necessary to address nationwide shortages and direct supplies to the highest priority areas as they become available.


Senate Democrats Push For COVID Coverage Expansion


A group of Senate Democrats are urging health insurance companies to cover all services – not just the limited official diagnostic – for patients with a presumptive COVID-19 diagnosis. The letter, led by Sen. Maggie Hassan (D-N.H.), was sent to the CEOs of Aetna, Cigna, the Blue Cross Blue Shield Association, Humana, Kaiser Permanente, United Health, and America’s Health Insurance Plans. The lawmakers ask for a commitment to cover diagnostic services and therapeutic care, even in the absence of an authorized COVID-19 diagnostic test due to the current limited capacity to providing testing to all who need it.


Supreme Court Postpones March Session


The U.S. Supreme Court has postponed a two-week argument session that was scheduled to begin this week as a result of the COVID-19 outbreak. The court was set to hear arguments in 11 cases, and is examining options for rescheduling those cases given the developing circumstances. The court’s next two-week sitting is planned to start April, and includes consideration of the Trump administration’s expansion of employer exemptions from the Affordable Care Act (ACA) requirement to offer free birth control through health care plans. While the Supreme Court’s nine-month term typically concludes in late June, it could be extended if necessary.


CMS Approves First 1135 Waivers, Extends Quality Pay Program Deadlines


The Centers for Medicare and Medicaid Services (CMS) has approved the first state requests for 1135 Medicaid waivers in response to the COVID-19 national emergency. The Florida waiver will permit the state to waive prior authorization requirements, streamline provider enrollment processes, allow care to be provided in alternative settings when there is an evacuation to an unlicensed facility, suspend certain nursing home screening requirements, and extend deadlines for appeals and state fair hearing requests. The Washington waiver includes similar changes. CMS expects more states to submit 1135 requests in line with the waivers already granted, and is working to expeditiously review and approve the requests. Additional Section 1135 approval letters will be posted here as they are issued.

CMS also announced that it will extend deadlines for doctors and clinicians who participate in Medicare quality reporting programs. The deadline for submitting data for the Quality Payment Program will be extended from March 31 to April 30. The agency will not count data from the first half of calendar year 2020 when evaluating the care provided by ambulatory surgical centers, hospital inpatient and outpatient programs, purchasing programs, and other participants.


FDA Suspends Domestic Inspections


The Food and Drug Administration (FDA) announced that it is suspending domestic routine surveillance facility inspections as it works to mitigate the coronavirus outbreak. For-cause inspection assignments will be evaluated and will proceed if mission-critical. The agency will also continue its work in responding to natural disasters and other public health emergencies involving FDA-regulated products.


COVID-19 Likely to Impact Clinical Trials


A new survey indicates that COVID-19 will significantly impact nearly one-third of clinical trial sites and their ability to recruit patients for new trials or keep patients enrolled in existing studies. Thirty-nine percent of the 170 U.S. clinical trial sites surveyed between March 12-13 responded that they believe patients will be much less or somewhat less likely to enroll in new clinical research trials, while 25 percent of sites expect patients currently enrolled in a trial will be much less or somewhat less willing to continue their participation. Non-academic hospital sites were more likely to face challenges in recruiting new patients, while academic institutions reported more barriers to retaining currently enrolled patients. The FDA has issued a new guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic.



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