The following LPG Weekly Health Care Watch provides a summary update of legislative and regulatory health care activities from May 25 – 31. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
On May 26, House Minority Leader Kevin McCarthy (D-CA), along with 20 GOP lawmakers and four constituents, filed a lawsuit in the U.S. District Court for the District of Columbia (D.C.) against Speaker Nancy Pelosi (D-CA). Leader McCarthy argues that the House’s new proxy voting system is unconstitutional because it dilutes members’ votes, and by extension, their ability to represent constituents.
The House and Senate will reconvene on June 1, although there are no votes expected in the House that week.
NON-CORONAVIRUS REGULATORY UPDATE
On May 26, the Centers for Medicare & Medicaid Services (CMS) announced that over 1,750 standalone Medicare Part D prescription drug plans and Medicare Advantage (MA) plans that offer prescription drug coverage have applied to participate in the voluntary Part D Senior Savings Model for the 2021 plan year. Under the program, participating plans will offer beneficiaries plan choices that provide broad access to multiple types of insulin at a maximum $35 copay for a 30-days’ supply in the deductible, initial coverage, and coverage gap phases of the Part D benefit. CMS estimates that beneficiaries who use insulin and enroll in a participating plan could see a 66% ($446) decrease in their out-of-pocket costs for insulin; however, CMS Administrator Seema Verma acknowledged that beneficiaries may experience a small increase in premiums (likely $1 or $2 more per month). Administrator Verma also indicated that if the program is successful, the Agency may extend it to other types of drugs.
On May 28, the Centers for Disease Control & Prevention (CDC) National Center for Health Statistics published survey data that describes health insurance coverage between January-June 2019. During this period, 30.7 million Americans of all ages (9.5%) were uninsured. Among covered individuals, 37.4% had public coverage and 62.1% were enrolled in private plans.
On May 28, the White House Office of Management & Budget (OMB) concluded its review of CMS’ Amendments to the Health & Human Services (HHS) Operated Risk Adjustment Data Validation under the Patient Protection and Affordable Care Act’s (ACA) HHS-operated Risk Adjustment Program proposed rule.
On May 28, the Food & Drug Administration (FDA) announced it has detected higher-than-acceptable levels of the potential carcinogen N-Nitrosodimethlyamine in the extended-release version of metformin, a drug used to treat type 2 diabetes. FDA has asked five companies to voluntarily recall the drug.
CORONAVIRUS UPDATE
White House Update
On May 27, it was reported that the Trump administration is working on a plan to shield patients from “surprise” medical bills and hopes to include the proposal in the next coronavirus aid package.
On May 28, President Donald Trump announced plans to extend the deployment of over 40,000 National Guard members working on the pandemic response effort through mid-August. Their deployment was previously set to expire on June 24.
On May 29, President Trump declared the U.S. will withdraw its membership from the World Health Organization (WHO) over his concern that the organization has demonstrated a bias towards China.
Legislative Update
On May 26, the Oversight & Reform Committee held a briefing with the U.S. Health & Human Services (HHS) Principal Deputy Inspector General Christi Grimm, who has been serving as the Acting Inspector General (IG) since January. The briefing centered on an April Office of Inspector General (OIG) report assessing hospitals’ preparedness for the pandemic. According to Chairwoman Carolyn Maloney (D-NY), President Trump personally criticized Grimm for the report “for no valid reason.” However, Ranking Member Jim Jordan (R-OH) argued the President’s criticism was not unfounded because OIG used a faulty methodology to conduct the report. Furthermore, Ranking Member Jordan claimed allegations that Grimm was fired because of the report are incorrect as she remains the Acting IG during Jason Weida’s pending Senate confirmation. Grimm focused her testimony on OIG’s strategic plan to conduct oversight of the federal government’s COVID-19 response and recovery efforts.
On May 27, the Ways & Means Committee held the House’s first virtual hearing, entitled the Disproportionate Impact of COVID-19 on Communities of Color. Chairman Richard Neal (D-MA) and Ranking Member Kevin Brady (R-TX) claimed the disproportion impact of COVID-19 on minorities highlights longstanding inequalities that must be addressed, such as access to care. According to Chairman Neal, less than 22% of U.S. counties are disproportionately black, yet they account for 52% of confirmed cases and 58% of deaths nationally. Witnesses included: Ibram Kendi, Founding Director, the Antiracist Research & Policy Center, American University; Raynald Samoa, MD, Endocrinologist, City of Hope; Thomas Dean Sequist, MD, Chief Quality & Safety Officer, Partners HealthCare, Professor of Medicine and Health Care Policy at Harvard Medical School, with joint appointments in the Division of General Medicine at Brigham and Women’s Hospital and the Department of Health Care Policy at Harvard Medical School; Alicia Fernandez, MD, Professor of Medicine at University of California San Francisco; James Hildreth, MD, President & Chief Executive Officer (CEO), Meharry Medical College; and Douglas Holtz-Eakin, President, the American Action Forum.
On May 27, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) introduced two bills to increase testing accessibility and capacity, especially in rural and underserved areas. The Diagnostic Testing for Public Health Labs Act would instruct the CDC to award grants to public health laboratories to purchase high-throughput diagnostic testing platforms and supplies. The Rapid Testing for Communities Act would direct the CDC to issue grants to providers that would support diagnostic testing outside of a lab setting; priority would be given to underserved areas.
On May 27, House Majority Whip Jim Clyburn (D-SC) introduced H.R. 7022, a bill to expedite the Federal Communications Commission’s timeline for distributing the $16 billion Rural Digital Opportunity Fund, which was included in the Coronavirus Aid, Relief, & Economic Security (CARES) Act to promote broadband access.
On May 28, the House voted 417-1 to pass H.R. 7010, the Paycheck Protection Program (PPP) Flexibility Act. The bill would grant small businesses that receive PPP aid 24 weeks to spend their loans (instead of eight) and lower the minimum amount that must be spent on payroll from 75% to 60%. Senate Majority Leader McConnell (R-KY) stated on May 21 that the chamber will consider legislation authored by Sens. Rubio (R-FL), Cardin (D-MD), Collins (R-ME) and Shaheen (D-NH) that would give businesses 16 weeks to spend the loan money while still qualifying for forgiveness, allow businesses to use loans to purchase personal protective equipment for employees, and to pay for other "adaptive investments" needed to reopen safely. It is likely that a PPP reform bill, in some form, will reach the President’s desk in the coming weeks.
On May 28, the Education & Labor Workforce Protections Subcommittee held a hearing entitled Examining the Federal Government’s Actions to Protect Workers from COVID-19. Subcommittee Chair Alma Adams (D-NC) argued the COVID-19 pandemic has triggered the worst worker safety crisis since the Occupational Safety & Health Administration (OHSHA) was created; however, she claimed the Agency’s presence has been “largely invisible.” She encouraged OSHA to issue mandatory guidance to protect employees that are unable to telework and face a heightened risk of COVID-19 exposure. Witnesses included: Loren Sweatt, Principal Deputy Assistant, Secretary, OHSHA, and John Howard, MD, Director, National Institute for Occupational Safety & Health.
On May 28, Sen. Tim Kaine (D-VA) announced that both he and his wife tested positive for COVID-19 antibodies after experiencing flu-like symptoms in March and April. On May 29, Sen. Bob Casey (D-PA) claimed he tested positive for antibodies as well.
On May 28, the Appropriations Military Construction, Veterans’ Affairs (VA) & Related Agencies Subcommittee held a hearingentitled VA – Response to COVID-19. Subcommittee Chair Debbie Wasserman Shultz (D-FL) raised concerns that the VA is still not providing all health care employees sufficient personal protective equipment (PPE), despite requests from Congress to do so. Further, she claimed that PPE shortages could be mitigated if the Trump administration leveraged the Defense Production Act to boost domestic manufacturing. In response to Chair Shultz’s question on why the VA continues to use hydroxychloroquine, Secretary Robert Wilkie claimed that the VA has reduced its use of the drug and is relying more on other treatments options, such as remdesivir and convalescent plasma. Witnesses included: Paul Lawrence, Under Secretary for Benefits, VA; Jennifer MacDonald, Chief Consultant to the Deputy Under Secretary for Health, VA; Jon Rychalski, Assistant Secretary for Management and Chief Financial Officer, VA; and Robert Wilkie, Secretary, VA.
On May 28, VA Committee Chairman Mark Takano (D-CA), along with Reps. Joaquín Castro (D-TX), Judy Chu (D-CA), and Karen Bass (D-CA), sent Secretary Wilkie a letter requesting more data on COVID-19 patients being treated by the VA. Specifically, the lawmakers are requesting daily updates on cases at VA hospitals based on age, race, ethnicity, gender, tribal affiliation, and native language.
Regulatory Update
On May 26, HHS sent a congressionally mandated report to the House and Senate Appropriations Committees that outlines how much states, territories, and D.C. have received from the $175 billion Provider Relief Fund. As of April 30, HHS had issued nearly $40 billion to providers. More information on Provider Relief Fund recipients Fund is available here.
On May 26, FDA issued guidance for industry that answers questions about the effects of the public health emergency on the Agency’s formal meetings and user fee applications. Notably, FDA indicates that some new and generic drug approvals may be delayed due to its increased workload. Potential drugs to treat or prevent COVID-19 will be given priority.
On May 27, National Institute of Allergy & Infectious Diseases (NIAID) Director Anthony Fauci claimed that hydroxychloroquine is not an effective treatment, according to current data: "The scientific data is really quite evident now about the lack of efficacy.”
On May 27, CMS released a fact sheet that outlines how state and local governments developing alternate care sites can receive payments through CMS programs (Medicare, Medicaid, and the Children’s Health Insurance Program) for acute inpatient and outpatient care furnished at the alternate site.
On May 27, FDA granted an Emergency Use Authorization (EUA) to Quest Diagnostics’ self-collection kit, which allows consumers to swab the front of their nostril and send the sample to a lab for testing. Quest is aiming to produce at least 500,000 kits by the end of June; priority will be given to health workers, states, and return-to-work testing programs.
On May 27, FDA created a SARS-CoV-2 reference panel to allow diagnostic test developers to independently validate the performance of their products before applying for an EUA. According to FDA’s Center for Devices & Radiological Health Director Jeffrey Shuren, the reference panel “will provide test developers with well-characterized reagents to compare the performance of different molecular diagnostic tests under the same conditions.”
On May 28, HHS awarded $15 million to rural tribal communities across 20 states to prepare, prevent, and respond to the pandemic.
On May 28, the U.S. Department of Labor reported that for the week ending on May 23, over 2.1 million Americans filed for unemployment. Since lockdown orders were first issued in mid-March, 40.8 million have filed for unemployment.
Other
On May 25, WHO suspended its clinical trials of hydroxychloroquine, citing safety concerns. The announcement follows the Lancet medical journal’s publication of a study linking hydroxychloroquine and chloroquine to increased risk of mortality and cardiovascular complications when used as a treatment for hospitalized patients.
On May 26, French health agencies advised against using hydroxychloroquine outside of clinical trials and suspended its use in clinical trials.
On May 26, Merck and IAVID announced a partnership to develop a potential COVID-19 vaccine. According to a press announcement, “both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approve.” The Biomedical Advanced Research & Development Authority (BARDA) has awarded the companies $38 million.
On May 27, the Kaiser Family Foundation (KFF) released a poll showing that 48% of Americans claim at least one member of their family has delayed or forgone some form of medical care during the pandemic; 11% claim the person’s condition worsened because of the missed care.
On May 27, Quest Diagnostics launched a suite of “Return to Work” services centered on large-scale workforce testing. Quest is expanding its testing capacity and hopes to be able to perform 150,000 molecular diagnostic tests a day by the end of June – nearly double its current capacity.
On May 28, GlaxoSmithKline (GSK) announced plans to produce one billion doses of a vaccine adjuvant that can reduce the amount of vaccine required per dose and create longer-lasting immunity against the virus. GSK has already agreed to use its adjuvant to help develop Sanofi’s vaccine candidate.
On May 29, Kaiser Permanente extended its COVID-19 cost waiver through December 31, 2020. The waiver, originally set to expire on May 31, allows members to receive inpatient and outpatient COVID-19 treatments at no cost.
On June 3, the Pandemic Response Accountability (PRAC) will hold a virtual public meeting entitled Stakeholder Perspectives on Oversight of the Federal COVID-19 Spending and Response. The Committee was created by the CARES Act to conduct oversight of $2.4 trillion in economic relief funds and is composed of 20 IGs. The forum is intended to provide stakeholders an opportunity to submit feedback on areas where PRAC should direct its focus to support transparency and accountability.
As of May 31, the U.S. had 1,770,384 confirmed COVID-19 cases resulting in 103,781 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities—Third Party Payments (CMS-3337-P); Proposed Rule; Received 6/6/2019
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/2019
Medicare Coverage of Innovative Technologies (CMS-3372-P); Received 7/30/2019
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482-P); Proposed Rule; Received 12/27/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/10/20
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare
CY2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Rates (CMS-1736); Proposed Rule; Received 4/21/20
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730); Proposed Rule: 5/6/2020
CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1734); Proposed Rule; 5/12/20
CY 2021 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1732); Proposed Rule; 5/14/20
HHS-FDA
Annual Summary Reporting Requirements Under the Right to Try Act; Proposed Rule; Received 3/31/20
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/20
HHS-OCR
Nondiscrimination in Health and Health Education Programs or Activities; Final Rule; 4/23/2020
HHS-SAMHSA
Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders; Final Rule; 3/16/20
REPORTS
Government Accountability Office (GAO)
On May 26, GAO published a “Science & Tech Spotlight” on COVID-19 Vaccine Development.
On May 29, GAO released a report entitled Defense Health Care: Additional Information and Monitoring Needed to Better Position the U.S Department of Defense (DOD) for Restructuring Medical Treatment Facilities. According to the report, DOD issued a plan in February to restructure its Medical Treatment Facilities, including decreasing capability at 43 of them and closing five. DOD conducted an analysis on care adequacy before implementing the plan; however, GAO claims its analysis was based on incomplete and inaccurate information. Therefore, GAO made six recommendations to ensure DOD’s plan does not inappropriately reduce care access.
UPCOMING HEARINGS
Senate
Senate Finance Committee
June 2, 2:20 p.m., 106 Dirksen Senate Office Building
COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process
Witnesses include: Judith A. McMeekin, Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA; Douglas Throckmorton, MD, Deputy Director for Regulatory Programs, Center for Drug Evaluation & Research, FDA; Mark Abdoo, Associate Commissioner for Global Policy & Strategy, FDA; Mary Denigan-Macauley, Director, Health Care, GAO; Martin VanTrieste, President & CEO,, CivicaRx; David Light, Founder and CEO, Valisure; and Harry M. Lever, MD, Medical Director, Hypertrophic Cardiomyopathy Clinic, Cleveland Clinic.
Veterans’ Affairs Committee
June 3, 3:00 p.m., 106 Senate Office Building
Details will be forthcoming.
HELP Committee
June 4, 10:00 a.m., 430 Dirksen Senate Office Building
COVID-19: Going Back to College SafelyWitnesses include: Mitchell Daniels, President, Purdue University; Christina Paxson President, Brown University; Logan Hampton, President, Lane College; and Georges Benjamin, MD, Executive Director, American Public Health Association.
House
Veterans’ Affairs Health Subcommittee
June 3, 2:00 p.m., Virtual
Mission Readiness: VA’s Preparedness for Natural Disasters During a Pandemic
Details will be forthcoming.
Energy & Commerce Oversight & Investigations Subcommittee
June 2, 11:30 a.m., Virtual
On the Front Lines: How Governors are Battling the COVID-19 Pandemic
Witnesses include: Colorado Gov. Jared Polis (D); Michigan Gov. Gretchen Whitmer (D); and Arkansan Gov. Asa Hutchinson (R).
Appropriations Labor, HHS, Education & Related Services Subcommittee
June 4, 11:00 a.m., 1324 Longworth House Office Building
CDC Director Robert Redfield will testify.
OTHER HEALTH POLICY NEWS
On May 26, it was reported that UnitedHealthcare applied to return to Washington state’s individual marketplace after leaving in 2016. The insurer applied to return to Maryland’s exchange earlier this month.
On May 28, FDA approved Eli Lilly & Co.'s Tauvid, the first drug to detect tau neurofibrillary tangles in the brain – a known characteristic of Alzheimer's disease. While Tauvid is not a treatment, it can help diagnose Alzheimer's.
On May 28, the Oklahoma Health Care Authority confirmed that it will suspend Gov. Kevin Stitt’s (R) plan to expand Oklahoma’s Medicaid program under CMS’ Health Adult Opportunity demonstration due to rising costs caused by the coronavirus pandemic. The plan was originally set to take effect as soon as July 1. However, voters will still consider a Medicaid expansion ballot measure on June 30.