The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 28 – July 5. 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
Senate
On June 29, the Wall Street Journal published an op-ed by Finance Committee Chairman Chuck Grassley (R-IA) entitled America Needs Leadership on Prescription Prices. He outlined three reasons why drug legislation has not moved this Congress: “a bipartisan lack of political courage, an unwillingness to compromise, and a powerful lobby with deep pockets.” Furthermore, he accused Democrats of leaving the negotiating table prematurely and suggested “too many Republicans are sitting on their hands.” Ranking Member Ron Wyden (D-OR) countered that “Democrats have not walked away from the table on drug pricing – Republicans never showed up in the first place.”
On June 30, Chairman Grassley – along with Sens. Mike Braun (R-IN), Joni Ernst (R-IA), Mike Enzi (R-WY), John Kennedy (R-LA), and Kelly Loeffler (R-GA) – introduced the Health Care Price Transparency Act. The measure would effectively codify two price transparency regulations issued by the Trump administration in November 2019, included in the CY2020 Outpatient Prospective Payment System Final Rule and the Transparency in Coverage Proposed Rule. Specifically, the bill would require hospitals to disclose “standard charges” and negotiated rates. Likewise, insurers would have to provide real-time cost-sharing information to consumers and publicly post negotiated rates for in-network providers and allowed amounts paid for out-of-network providers.
Subsequently on July 2, Chairman Grassley re-introduced the Prescription Drug Pricing Reduction Act of 2020 (S.2543), which originally passed out of the committee on a bipartisan 19-9 vote, including all committee Democrats. The updated version is structurally unchanged, but includes minor updates, from the earlier version. Notably, however, the re-introduced legislation does not include any Democrat co-sponsors. The bill is co-sponsored by nine Republicans, including Sens. Rob Portman (R-OH), Bill Cassidy (R-LA), Steve Daines (R-MT), Joni Ernst (R-IA), Susan Collins (R-ME), Martha McSally (R-AZ), Mike Braun (R-ID), Cindy Hyde-Smith (R-MS) and Lisa Murkowski (R-AK). Chairman Grassley urged the Senate to include his drug pricing bill in its next COVID-19 relief package.
The Senate stands in recess until July 20.
House
On June 29, the House voted 234-179 to pass H.R. 1425, the State Health Care Premium Reduction Act. The measure seeks to expand upon the Affordable Care Act (ACA) by: loosening eligibility for premium subsidies; increasing the Medicaid federal match from 90% to 100% for non-expansion states; incentivizing states to launch their own marketplaces; eliminating the Trump administration’s expansion of non-ACA compliant plans; restoring funding for enrollment outreach and navigators; and requiring states to cover postpartum Medicaid coverage for a full year. These provisions would be offset by the international reference pricing mechanism included in the House-passed drug pricing reform legislation (H.R. 3), which is estimated to save around $580 billion. The measure is seen primarily as a messaging bill and is unlikely to be taken up by the Senate. A fact sheet is available here.
On June 30, the Energy & Commerce Health Subcommittee held a virtual legislative hearing entitled High Anxiety and Stress: Legislation to Improve Mental Health During Crisis. According to Subcommittee Chair Anna Eshoo (D-CA), mental health is a neglected part of the health care system, with less than 40% of people with a mental health illness receiving any treatment. She attributed this to the high cost of care, insufficient insurance coverage, poor provider reimbursement, and an outdated system that depends too heavily on prisons, jails, and shelters. She claimed there is “clear bipartisan demand” to address mental health care. Chair Eshoo and Full Committee Chairman Frank Pallone (D-NJ) both emphasized the need to move mental health legislation. Former Rep. Patrick Kennedy (D-RI) testified that many health insurers do not comply with the “Federal Parity Law” he authored in 2008 that requires health insurers to treat mental health the same as physical health care. Witnesses included: Former Rep. Kennedy, Founder, The Kennedy Forum; Arthur Evans, CEO, American Psychological Association; Jeffrey Geller, MD, President, American Psychiatric Association, Professor of Psychiatry, University of Massachusetts Medical School; and Arriana Gross, National Youth Advisory Board Member, Sandy Hook Promise Students Against Violence Everywhere Promise Club. Legislation considered is noted below and summarized here.
H.R. 5201, the Telemental Health Expansion Act of 2019, a bill to provide Medicare coverage of certain mental health telehealth services;
H.R. 2874, the Behavioral Health Coverage Transparency Act, a bill to strengthen parity mental health and substance use disorder benefits;
H.R. 7080 the Stopping the Mental Health Pandemic Act, a bill to direct the Secretary of the U.S. Department of Health & Human Services (HHS) to award grants to address behavioral health needs caused by the public health emergency;
H.R. 7316, a bill to create the “Emergency Mental Health and Substance Use Training and Technical Assistance Center;”
H.R. 4861, the Effective Suicide Screening and Assessment in the Emergency Department Act of 2019, a bill to establish a program to improve the identification, assessment, and treatment of patients in the emergency department who are at risk of suicide;
H.R. 7293, a bill to establish and implement a school-based student suicide awareness and prevention training policy;
H.R. 7159, a bill to amend the Community Mental Health Service Block Grant to authorize a “set-aside” for crisis care services;
H.R. 6645, a bill to direct the HHS Secretary to conduct or support research on the mental health consequences of the pandemic;
H.R 5855, the Bipartisan Solution to Cyclical Violence Act of 2020, a bill to establish a grant program supporting trauma center violence intervention and violence prevention programs;
H.R. 5619, the Suicide Prevention Act, a bill to authorize a pilot program to expand and intensify surveillance of self-harm in partnership with state and local public health departments;
H.R. 5469, the Pursuing Equity in Mental Health Act of 2019, a bill to address mental health issues for youth, particularly youth of color;
H.R. 4585, the Campaign to Prevent Suicide Act, a bill to require the Centers for Disease Control & Prevention (CDC) Director to conduct a national suicide prevention media campaign;
H.R. 4564, the Suicide Prevention Lifeline Improvement Act of 2019, a bill to ensure the provision of high-quality service through the Suicide Prevention Lifeline;
H.R. 4428, the Greater Mental Health Access Act, a bill to ensure the provision of high-quality service through the Suicide Prevention Lifeline;
H.R. 3539, the Behavioral Health Intervention Guidelines Act of 2019, a bill to require the Substance Abuse & Mental Health Services Administration (SAMHSA) to develop best practices for the establishment and use of behavioral intervention teams at schools;
H.R. 2519, the Improving Mental Health Access from the Emergency Department Act of 2019, a bill to award grants to implement innovative approaches to securing prompt access to appropriate follow-on care for individuals who experience an acute mental health episode and present for care in an emergency department;
H.R. 1646, the Helping Emergency Responders Overcome (HERO) Act of 2019, a bill to establish a series of programs relating to the behavioral health of public-safety officers;
H.R. 1109, the Mental Health Services for Students Act of 2019, a bill to revise and extend projects relating to children and to provide access to school-based comprehensive mental health programs;
H.R. 945, the Mental Health Access Improvement Act of 2019, a bill to provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare Part B; and
H.R. 884, the Medicare Mental Health Access Act, a bill to expand the definition of "physician," for purposes of the Medicare program, to include a clinical psychologist.
On July 1, the House voted 223-188 to pass Democrats’ $1.5 trillion infrastructure package (H.R. 2), which is projected to cost just shy of $450 billion over a decade. The bill, considered “dead on arrival” in the Senate, includes $100 billion to expand broadband in underserved communities and $30 billion to modernize the health care infrastructure. A section-by-section summary is available here.
On July 1, Energy & Commerce Chairman Pallone sent letters to 10 provider and lab companies, as well as one trade association, requesting information about their process for setting prices for diagnostic and serological tests. According to a preliminary investigation conducted by his Committee, some providers are charging up to $6,000 for one diagnostic test – well above the $100 paid by Medicare. Chairman Pallone suggested the companies have not been in full compliance with the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief & Economic Security (CARES) Act, which created certain rules around testing to promote access.
The House is not expected to hold its next votes until July 20.
NON-CORONAVIRUS REGULATORY UPDATE
On June 30, the U.S. Department of Justice (DOJ) accused Glenmark Pharmaceuticals of conspiring to fix prices for pravastatin and other generic drugs between May 2013 and December 2015. Glenmark is the fifth company DOJ has charged over the past 13 months for antitrust violations among generic manufacturers. The offense charged carries a statutory maximum penalty of $100 million.
On June 30, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma notified staff of personnel changes. Lee Fleisher will be the Agency’s new Chief Medical Officer and Director of the Center for Clinical Standards & Quality (CCSQ) – a position formerly held by Kate Goodrich. Fleisher was previously chair of the University of Pennsylvania Medical School’s Department of Anesthesiology & Critical Care. Additionally, Michelle Schreiber was promoted to the CCSQ Deputy Director for Quality & Value. Formerly, she was the Director of CCSQ’s Quality Measurement & Value-Based Incentives Group. Lastly, Karen Tritz will be the Director of CCSQ’s Survey & Operations Group, a newly created role. Previously, Tritz was the Director of CCSQ’s Quality Safety & Oversight Group.
On June 30, OMB released HHS’ Spring 2020 regulatory agenda, which provides a brief explanation of pending regulations and the date when they might take effect.
On July 2, OMB completed its review of a CMS proposed rule entitled CY2021 Changes to the End-Stage Renal Disease Prospective Payment System and Quality Incentive Program.
CORONAVIRUS UPDATE
White House Update
On June 29, HHS Assistant Secretary for Public Affairs Michael Caputo announced that HHS intends to extend the Public Health Emergency declaration before it expires on July 25; the extension would prolong the designation for 90 days.
On June 30, the Coronavirus Task Force called for widespread use of face masks to reopen the country.
On July 1, Testing Czar Brett Giroir acknowledged that the nation’s testing capacity is strained because of the rise in new cases in certain areas of the country: “It is absolutely correct that some labs across the country are reaching or near capacity… Recent data from several states indicate rising infections and now an uptick in hospitalizations and death, even as other states and the great majority of counties are maintaining a low infection burden."
Legislative Update
On June 29, Energy & Commerce Chairman Pallone and Oversight & Investigations Subcommittee Chair Diana DeGette (D-CO) sent HHS a letter expressing concern that the Trump administration has “sidelined” the CDC in the nation’s response to the pandemic. The lawmakers requested that HHS Secretary Alex Azar respond to a series of questions regarding CDC’s involvement by July 15.
On June 29, Speaker Nancy Pelosi (D-CA) extended the House’s proxy voting rules through mid-August.
On June 29, Senate Finance Chairman Grassley and Energy & Commerce Ranking Member Greg Walden (R-OR) requested that the HHS Office of Inspector General (OIG) initiate an investigation into whether five states – California, Michigan, New Jersey, New York and Pennsylvania – violated federal guidance by encouraging nursing home facilities to accept patients who tested positive for COVID-19.
On June 30, Majority Leader Mitch McConnell (R-KY) confirmed the Senate is maintaining its plan to consider another relief package when it returns from its July 4 recess, noting that this timeline sets lawmakers up nicely to assess the economy and determine whether or not additional assistance is needed for health care providers. He indicated the package would include liability protections and be focused on helping children, jobs, and health care. Leader McConnell also predicted the upper chamber will leave for its scheduled August recess (which is scheduled to begin on August 10).
On June 30, Minority Leader Chuck Schumer (D-NY) and HELP Ranking Member Patty Murray (D-WA) introducedSenate Democrats’ new pandemic relief package that would include $430 billion for child care, K-12 schools, and higher education. A fact sheet is available here.
On June 30, the Senate HELP Committee held a hearing entitled COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School. Chair Lamar Alexander (R-TN) argued it is imperative that students return to school in the fall, citing the detrimental effects on learning, mental health, social development, food security, and even physical safety for students who are unable to attend in-person classes. Ranking Member Murray reiterated the need for the Administration to produce a vaccine blueprint, claiming that vaccinating the public “isn’t just about doing things fast, it’s about doing them right.” National Institute of Allergy & Infectious Diseases (NIAID) Director Anthony Fauci testified that he would not be surprised if the number of new cases reached 100,000 per day, given the recent uptick in infections in certain states that "puts the entire country at risk." Testing Czar Giroir called for detailed testing plans for education systems in order to reopen safely, including pooled surveillance testing. Witnesses included: Anthony Fauci, MD, Director, NIAID; Admiral Brett Giroir, MD, Assistant Secretary for Health, HHS, Stephen Hahn, MD, Commissioner, Food & Drug Administration (FDA); and Robert Redfield, MD, Director, CDC.
On June 30, the Senate Foreign Relations Committee held a hearing entitled COVID-19 and U.S. International Pandemic Preparedness, Prevention, and Response: Additional Perspectives. Chairman Jim Risch (R-ID) argued Congress must pass legislation now to prepare for future pandemics. Ranking Member Bob Menendez (D-NJ) maintained that, now more than ever, there is a need for the U.S. to actively lead the international community’s response to the virus, which he considered to be a “common threat” to all nations. He claimed his bill, the COVID–19 International Response and Recovery Act, would help advance this goal. Witnesses included: Mark Dybul, MD, Co-Director of the Center for Global Health Practice and Impact, Professor, Department of Medicine, Georgetown University Medical Center; Ashish K. Jha, MD, Director, Harvard Global Health Institute; Jimmy Kolker, Former Assistant Secretary for Global Affairs, HHS; and Jeremy Konydyk, Senior Policy Fellow, Center for Global Development.
On July 1, the Senate Veterans’ Affairs Committee held a hearing entitled Recruitment, Retention, and Building a Resilient Veterans Health Care Workforce. Chairman Jerry Moran (R-KS) drew attention to 27 job vacancies at the Veterans Health Administration (VHA), which the OIG has labeled “critical shortages.” He also raised concerns about the VHA’s recruitment capabilities, noting the difficulty in hiring providers due to a slow, bureaucratic hiring process and pay restrictions. Ranking Member Jon Tester (D-MT) commended the VHA’s ability to rapidly hire employees during the pandemic and called for adopting the expedited hiring procedure permanently. Witnesses included: Steven L. Lieberman, MD, Acting Principal Deputy Under Secretary for Health, VHA; Jessica Bonjorni, Chief, Human Capital Management, VHA; and Victoria Brahm, Director, Veterans Integrated Service Network, VHA.
On July 1, the Senate Indian Affairs Committee held a hearing entitled Evaluating the Response and Mitigation to the COVID-19 Pandemic in Native Communities. Chairman John Hoeven (R-ND) noted that at least five Native American tribes have higher cases per capita of COVID-19 than any other group or region in the nation. He also cited a CDC study that shows Native Americans are more likely to suffer severe illness due to COVID-19, as compared to their white counterparts. Ranking Member Tom Udall (D-NM) highlighted the inconsistent access to federal programs and benefits that Native communities receive. He expressed concerns with how the U.S. Department of the Treasury has distributed CARES Act funding to Tribal communities. Witnesses included: Michael Weahkee, Rear Admiral, Director, Indian Health Service; Robert Fenton, Jr., Regional Administrator, Region 9, Federal Emergency Management Agency; Scott Davis, Executive Director, North Dakota Indian Affairs Commission; and Lisa Elgin, Secretary, National Indian Health Board.
On July 1, the House sent legislation to extend the Paycheck Protection Program (PPP) deadline to the President’s desk. Under the bill, small businesses would be able to apply for loans until August 8 (the previous deadline was June 30).
On July 1, nine Senate Democrats sent a letter to Secretary Azar requesting that HHS take steps to prohibit issuing aid from the Provider Relief Fund to private equity owners and to require Fund recipients to provide documentation on how the aid has been spent.
On July 2, the Senate Appropriations Labor-HHS-Education & Related Agencies Subcommittee held a hearingentitled Review of Operation Warp Speed: Researching, Manufacturing, and Distributing a Safe and Effective Coronavirus Vaccine. Chairman Roy Blunt (R-MO) maintained that while developing a vaccine is the federal government’s first priority, a fair and equitable vaccine distribution plan should be a close second. CDC Director Redfield testified that his Agency is the most qualified government body to lead the distribution effort. Furthermore, National Institutes of Health (NIH) Director Francis Collins suggested “big thinkers,” such as a National Academy of Medicine panel, should outline principals for vaccine allocation. Both Chairman Blunt and Ranking Member Murray agreed that the vaccine development timeline should not compromise safety. Director Collins confirmed safety and efficacy standards will not be reduced in order to develop the vaccine on an expedited schedule. Biomedical Advanced Research & Development Authority (BARDA) Acting Director Gary Disbrow agreed, claiming that the only risks associated with Operation Warp Speed are financial. Several Democrats pressed Director Disbrow on recently disclosed BARDA contracts with drug manufacturers that weaken the government’s ability to influence the price of future vaccines. In addition, Chairman Blunt questioned whether vaccine producers have an obligation to sell their product in “a reasonable way” in exchange for the federal government absorbing some of drug companies’ risk. Director Disbrow responded that goal of BARDA’s contracts are to “negotiate the best price for the U.S. government.” Witnesses included: Francis Collins, MD, Director, NIH; Robert Redfield, MD, Director, CDC; and Gary Disbrow, Acting Director, BARDA.
On July 2, the House Oversight & Reform Committee’s Select Coronavirus Crisis Subcommittee held a hearingentitled The Administration’s Efforts to Procure, Stockpile, and Distribute Critical Supplies. Chairman James Clyburn (D-SC) highlighted previous and continuing shortages of critical personal protective equipment across the nation. Chairman Clyburn encouraged the Trump administration to develop clear guidance for procuring supplies. Ranking Member Steve Scalise (R-LA) expressed optimism about improved knowledge about COVID-19 and noted that, even with recent spikes, no state has reached its hospital capacity. Testing Czar Giroir announced the deployment of surge testing to COVID-19 hotspots around the nation, along with expansions in testing capabilities. Witnesses included: John Polowcyk, Rear Admiral, Director, Supply Chain Stabilization Task Force, U.S. Department of Defense (DOD); Brett Giroir, MD, Admiral, Assistant Secretary for Health, HHS; and Kevin Fahey, Assistant Secretary of Defense for Acquisition, DOD.
On June 2, the Senate confirmed General Gustave Perna to serve as the Chief Operating Officer of Operation Warp Speed. General Perna was tapped by President Donald Trump for the position in May.
Regulatory Update
On June 28, Secretary Azar warned that the “window is closing” for the U.S. to contain the virus, calling the rate of spread a “very, very serious situation.”
On June 29, HHS announced it has secured over 500,000 treatment courses of remdesivir, representing 100% of Gilead’s projected production for July and 90% for both August and September. The Department will maintain its existing distribution framework, in which it allocates the drug to state and territorial health departments based on COVID-19 hospital burden and then the health departments divide it among hospitals. Gilead noted that after September, “once supplies are less constrained”, HHS will no longer manage allocation.
On June 30, FDA issued final guidance detailing its standards for approving a vaccine to prevent COVID-19, noting that any vaccine should be a least 50% more effective than a placebo. The Agency said it may issue an emergency use authorization for a vaccine, but that it preferred for the candidate to undergo the clinical standards associated with the traditional approval framework.
On June 2, the U.S. Department of Labor (DOL) reported that 4.8 million jobs were added in June and that the unemployment rate dropped to 11.1%, down from 13.3% in May. DOL also reported that over 1.4 million Americans filed for unemployment benefits during the week ending on June 27; nearly 49 million have field for unemployment since lockdown orders were issued in mid-March.
COVID-19 information released by CMS is posted here; specific waivers are available here.
Other
On June 29, Gilead disclosed prices for remdesivir after donating an initial supply of 120,000 treatment courses to the Strategic National Stockpile in May. The company will charge U.S. hospitals $520 for each dose for standard patients with commercial health insurance (amounting to $3,120 for a short-term treatment course and $5,720 for a long-term course). For patients on U.S. government-sponsored insurance and for those in other countries with national health care systems, it will charge $390 per dose ($2,340 for a short-term treatment and $4,290 for a long-term course). According to Gilead, the price for U.S. commercial insurance will be higher “because of the way the U.S. system is set up and the discounts that government healthcare programs expect.” Nevertheless, House Ways & Means Health Subcommittee Chair Lloyd Doggett maintained the price is still too high, labeling it “an outrageous price for a very modest drug.”
On June 30, intellectual property advocacy group Knowledge Ecology International (KEI) released language from seven contracts BARDA and DOD signed with private companies to conduct COVID-19 research. KEI reports that the contracts weaken the federal government’s authority granted under the Bayh-Dole Act to control the patents on drugs that were developed with federal funding (i.e., “march-in rights”). HHS commented that the BARDA contracts “are focused on product development” and that when purchasing the drugs, “one of the considerations in the price is any federal funding that was provided to develop the product.”
On June 30, presumptive Democratic presidential nominee Joe Biden released a comprehensive, federally-driven plan to combat the current pandemic and prepare for future public health threats. Biden calls for spending “whatever it takes” to mitigate spread and recover from the pandemic. Among other things, his plan would make testing widely available and free for patients, mandate masks in public, create a “Pandemic Testing Board,” expand use of telehealth, establish a national contact tracing workforce, appoint a “Supply Commander,” leverage the Defense Production Act to increase production of needed supplies, and expand paid leave and unemployment benefits.
On July 1, Pfizer and BioNTech announced preliminary positive data from its ongoing clinical trials of their vaccine candidate BNT162b1, one of four mRNA constructs the companies are studying in Phase I/II trails. The companies will choose a lead vaccine candidate based on further clinical results.
As of July 5, the U.S. had 2,852,807 confirmed COVID-19 cases resulting in 129,718 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
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
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
CY2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1734); Proposed Rule; 5/12/20
Request for Information; Electronic Prescribing for Controlled Substances (CMS-3394); Notice; Received 6/22/20
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
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c); Guidance for Industry; Notice; Received 5/26/20
HHS-OS
Health & Human Services Grants Regulation; Final Rule; Received 5/26/20
COVID-19 Hoarding Prevention Under the Defense Production Act; Interim Final Rule; 6/23/20
REPORTS
Congressional Budget Office (CBO)
On June 30, CBO released a cost estimate of H.R. 2, the Moving Forward Act.
HHS OIG
On June 25, OIG published a report entitled Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020. According to the report, the ACA requires OIG to study the extent to which formularies used by Part D plans include drugs commonly used by full benefit dual eligible individuals (“duals”). OIG found that the rate of Part D plan formularies’ inclusion of the 195 drugs most commonly used by duals is high, with some variation. On average, Part D plan formularies include 97% of these drugs, and 75% of the drugs are included by all Part D plan formularies. These findings are consistent with OIG’s previous reports on Part D formularies. OIG notes that, due to some variation in the inclusion and utilization management of these drugs, some duals may need to make additional efforts to access the drugs they take, such as appealing coverage decisions.
UPCOMING HEARINGS
Senate
House
Appropriations Agriculture, Rural Development, FDA & Related Agencies Subcommittee
July 6, 6 p.m., 2118 Rayburn House Office Building
Appropriations Labor-HHS-Education Subcommittee
July 7, 5:00 p.m., 2118 Rayburn House Office Building
Energy & Commerce Committee
July 8, 11 a.m., Virtual
Addressing the Urgent Needs of Tribal Communities
Details will be forthcoming.
Appropriations Military Construction, Veteran Affairs & Related Agencies Subcommittee
July 8, 8:00 p.m., 2118 Rayburn House Office Building
Homeland Security Committee
July 8, 12:00 p.m., Virtual
Examining the National Response to the Worsening Coronavirus Pandemic
Witness include: J. B. Pritzker, Governor, Illinois; Jason Shelton, Mayor, City of Tupelo, Mississippi; and Umair Shah, MD, Executive Director and Local Health Authority, Harris County Public Health, Texas.
Financial Services Committee Task Force on Artificial Intelligence (AI)
July 8, 12:00 p.m., Virtual
Details will be forthcoming.
Budget Committee
July 8, 1:00 p.m., Virtual
Fueling American Innovation and Recovery: The Federal Role in Research and Development
Witnesses include: Sudip Parikh, CEO, American Association for the Advancement of Science; Paul Romer, Professor, New York University; and Deborah Wince-Smith, President & CEO, Council on Competitiveness.
OTHER HEALTH POLICY NEWS
On June 28, Patients for Affordable Drugs published a report concluding that, between January 20 and June 20, drug companies increased the price of 245 drugs – on par with the same period over the past two years. More than 75% of such drugs were directly related to COVID-19: 61 were drugs being using the treat COVID-19, 30 were undergoing trials to combat it, and 118 were used to manage chronic conditions. The average price increase was 23.8%.
On June 29, the White House Office of National Drug Control released an analysis pointing to a 11.4% year-over-year increase in drug overdose deaths between January and April 2020.
On June 29, the Supreme Court ruled 5-4 in June Medical Services v. Russo to strike down a Louisiana law that required all abortion providers to have admitting privileges at a local hospital, effectively forcing all but one of the state’s providers to close and posing an “undue burden” on patients seeking abortions. Chief Justice John Roberts cast the deciding vote but did not join the majority’s reasoning.
On June 30, the Campaign for a Sustainable Rx Pricing released a survey showing that 83% of Americans believe drug price increases should be suspended during the pandemic and nearly 75% agree biennial summer price increases should be canceled.
On June 30, voters in Oklahoma narrowly approved a ballot measure that will expand Medicaid eligibility to residents at or below 138% of the federal poverty level. At least 200,000 Oklahoman adults will be newly eligible. The measure, which passed with 50.5% support, requires the state to expand eligibility by July 1, 2021. The vote will make it more difficult for Gov. Kevin Stitt’s (R) to implement his plan to receive federal funds for the state’s expansion population in the form of a block grant under CMS’ Healthy Adult Opportunity program.
On June 30, the Pharmaceutical Research & Manufacturers of America (PhRMA) filed a complaint against Minnesota health officials for a new law that seeks to provide low-cost insulin to patients rationing the product. Specifically, the law would allow residents running low on their supply of insulin and cannot otherwise afford to buy more to immediately purchase a 30-day supply from a pharmacy for $35. PhRMA argues the law, scheduled to take effect July 1, 2020, violates a provision of the Constitution that precludes the government from taking manufacturers’ private property for public use without just compensation.