The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 28 - October 4. 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

House

  • On September 30, Oversight & Reform Committee Chairwoman Carolyn Maloney (D-NY) released staff reports detailing the Committee’s investigation of prescription drug prices. The reports detail Celgene and Bristol Myers Squibb raising the price of Revlimid, a critical drug to treat multiple myeloma and other forms of cancer and Teva raising the price of Copaxone, a drug used to treat multiple sclerosis. On October 1, the Committee released staff reports describing actions of Amgen, raising the price of the rheumatoid arthritis biologic Enbrel and the kidney failure drug Sensipar; Novartis, raising the price of cancer drug Gleevec; and Mallinckrodt, raising the price of Acthar gel. The reports call for allowing Medicare to negotiate drug prices with manufacturers.

  • On September 30, the House Oversight & Reform Committee held a hearing entitled Unsustainable Drug Prices: Testimony from the CEOs (Part I). The committee’s Democratic members broadly criticized the drug company CEOs over prescription drug prices, calling the price increases unjustified by research costs and that the companies are taking advantage of the Medicare program. The CEOs affirmed that the high prices are due to the costs of research and development. Witnesses included: Mark Alles, Former CEO, Celgene Corporation; Giovanni Caforio, MD, CEO, Bristol Myers Squibb; and Kare Schultz, CEO, Teva Pharmaceuticals.

  • On October 1, the House Oversight & Reform Committee held a hearing entitled Unsustainable Drug Prices: Testimony from the CEOs (Part 2). Chairwoman Maloney highlighted how drug companies have delayed generic competition to keep prices and profits high and further emphasized the need to allow the federal government to negotiate directly with drug companies, in order to save an estimated $456 billion. Witnesses included: Robert Bradway, CEO, Amgen, Inc.; Mark Trudeau, CEO, Mallinckrodt Pharmaceuticals; and Thomas Kendris, U.S. Country President, Novartis AG. 

  • On October 1, the House passed:

    • H.R. 4764 the TRANSPLANT Act of 2019, to reauthorize the Stem Cell Therapeutic and Research Act of 2005; and

    • H.R. 2519 the Improving Mental Health Access from the Emergency Department Act of 2020, to Authorize Substance Abuse and Mental Health Services Administration (SAMHSA) to award grants to qualifying emergency departments for the purpose of supporting mental health services and support follow up services to those with mental health episodes.

  • The House will remain in session until a relief package is passed, with lawmakers remaining “on call” for a return to Washington.

Senate

  • On September 29, Senate Minority Leader Chuck Schumer (D-NY) took rare procedural steps to force a vote on S. 4653 A bill to protect the healthcare of hundreds of millions of people of the United States and prevent efforts of the Department of Justice to advocate courts to strike down the Patient Protection and Affordable Care Act. The bill would prevent the Department of Justice (DOJ) from supporting litigation scheduled for November 10 to strike down the Affordable Care Act (ACA). On September 30, Majority Leader Mitch McConnell (R-KY) scheduled a vote on S. 4675,  the Protect Act, that would prohibit insurance companies from excluding coverage of treatments for a pre-existing condition but all Senate Democrats and Sens. Ted Cruz (R-TX), Rand Paul (R-KY), and Mike Lee (R-UT) voted against the bill 44-50. On October 1, the Senate voted on S. 4653 and even with six Republican senators in support, with a 51-43 vote, the chamber was unable to advance the bill to the House. 

  • On September 30, the Senate passed 84-10 H.R. 8337, a continuing resolution (CR), to extend government spending until December 11. Notably, the estimated $1.6 trillion bill would delay repayment requirements for the Medicare Accelerated and Advance Payment programs emergency loans from The Coronavirus Aid, Relief, and Economic Security Act for one year and give providers 29 months to repay the full amount. The bill would gradually phase in these repayments and reduce the interest on unpaid amounts. The bill also freezes the 2021 Medicare Part B monthly premium at the 2020 amount, plus 25% of the difference between the 2020 amount and the preliminary monthly actuarial rate for 2021. Both House and Senate leaders indicated that they would like to negotiate spending for the rest of fiscal year (FY) 2021 by mid-December. On October 1, President Trump signed the CR into law.  

  • On October 3, Senate Majority Leader Mitch McConnell announced that the full Senate will not return until October 19, two weeks later than planned, after three GOP senators tested positive for the coronavirus: Sens. Thom Tillis (R-NC), Mike Lee (R-UT), and Ron Johnson (R-WI).  Senator McConnell also indicated that the Senate would still move ahead with Judge Amy Coney Barrett’s Supreme Court nomination, with the Senate Judiciary Committee set to begin confirmation hearings on October 12.  With multiple people in the administration and the Senate testing positive for COVID-19, Senate Democrats are calling for a delay in the confirmation hearings. 

NON-CORONAVIRUS REGULATORY UPDATE

  • On September 28, the Centers for Medicare & Medicaid Services (CMS) announced the Confidential Dry Run Reports containing FY 2018 and FY 2019 performance scores for the Skilled Nursing Facility (SNF) Healthcare-Associated Infections Requiring Hospitalizations measure in the Certification and Survey Provider Enhanced Reports. These reports allow SNFs familiarize themselves with this measure and to inform them of their performance in comparison to their peers. The public comment period closes October 14, 2020. 

  • On September 28, the Office of Management and Budget (OMB) received a final rule from CMS entitled Contract Year 2022 Policy and Technical Changes to the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190).

  • On September 30, the Centers for Disease Control and Prevention (CDC) released data finding that 14.5% of working adults ages were uninsured in 2019, an increase from 13.3% in 2018, with the lack of affordable coverage being the top reason for being uninsured. 

  • On September 30, CMS released a report entitled Medicaid and Children's Health Insurance Program (CHIP) Enrollment Trends Snapshot through June 2020. This report found that overall enrollment in Medicaid and CHIP sharply increased with the COVID-19 Public Health Emergency (PHE), with over 4 million new enrollments between February and June 2020, increasing 6% from pre-PHE enrollment. A summary of the report is available here.

  • On October 1, DOJ announced that the National Health Care Fraud and Opioid Takedown brought charges against 345 defendants responsible for more than $6 billion in fraud losses, including more than $4.5 billion connected to telemedicine, more than $845 million connected to substance abuse treatment facilities, and more than $806 million connected to other health care fraud and illegal opioid distribution schemes. 

  • On October 1, CMS issued a Comparative Billing Report on Part B claims for Therapeutic Injections and Infusions. 

  • On October 1, CMS posted the list of successful hospices for FY 2021 Hospice Quality Reporting Program. 

  • On October 2, CMS released initial data from the Accountable Health Communities Model from the first 750,000 completed screenings, including one in three beneficiaries reporting at least one core health-related social need. 

  • On October 2, CMS released the updated Radiation Oncology Model FAQ document addressing stakeholder questions. 

CORONAVIRUS UPDATE  

Legislative

  • On September 30, the House Energy & Commerce Oversight and Investigations subcommittee held a hearing entitled Pathway to a Vaccine: Ensuring a Safe and Effective Vaccine People Will Trust. Energy & Commerce Chairman Frank Pallone (D-NJ) called for the panel to propose guardrails to help develop and administer a COVID-19 vaccine, without political interference or misinformation. Witnesses include: Helene Gayle, MD, Co-Chair, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, National Academies of Sciences, Engineering, and Medicine; Ashish Jha, MD, Dean, School of Public Health, Brown University; Ali  Khan, MD, Dean, College of Public Health, University of Nebraska Medical Center; Mark McClellan, MD, Founding Director, Duke-Margolis Center for Health Policy, Duke University; and Paul Offit, MD Director, Vaccine Education Center, Children’s Hospital of Philadelphia. 

  • On October 1, 30 Senate Democrats called for HHS OIG to investigate whether administration political appointees interfered with the COVID-19 response and minimized COVID-19 related risks and reports. 

  • On October 1, the House passed H.R. 7496, the COVID PREPARE Act of 2020, to require federal agencies to submit to Congress plans for responding to any resurgence of COVID-19;

  • On October 1, Reps. Bill Pascrell (D-NJ), Katie Porter (D-CA), and Rosa DeLauro (D-CT) asked Health and Human Services (HHS) Secretary Alex Azar about the interest-free loans provided to private-equity owned health care companies. This letter is a follow up to a previous request asking about Provider Relief Funds, Medicare Accelerated and Advanced Payments Program funding, and other loans going towards private-equity owned hospitals during COVID-19.  

  • On October 2, Reps. Suzan DelBene (D-WA), Mikie Sherrill (D-NJ), and Terri Sewell (D-AL) introduced a bill entitled Strictly Pay for Efficient and Expedited Delivery of Your COVID-19 Tests Act, that would adjust lab reimbursement rates, depending on the turnaround for COVID-19 test results. The proposed legislation would grant a 25% add-on payment for results returned within 24 hours and results that take longer than 72 hours would receive no reimbursement.

  • On October 2, the Select Subcommittee on the Coronavirus Crisis held a hearing entitled Hybrid Hearing With HHS Secretary Alex Azar.  Directly before the hearing, the Select Subcommittee released a staff analysis detailing 47 instances of political interference in the Administration’s response to COVID-19 between February and September 2020. HHS Secretary Azar said that he is ordering a review of the $300 million public service ad campaign aimed at boosting COVID-19 and vaccine confidence. Witnesses included: Alex Azar, Secretary, HHS. 

  • House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin restarted relief package discussions this week, following the House Democrats revised $2.2 trillion COVID relief package proposed last week, including funding for airlines, schools, unemployment benefits, stimulus checks, and additional funding for states. Secretary Mnuchin proposed a $1.62 trillion price tag. A summary of the House package is available here. On October 1, 23 House Democrats called for House leaders to compromise with Republicans over this package. On October 1, the House passed 214-207, mostly along party lines, a revised version of H.R. 8406 the Heroes Act, with $2.2 trillion of relief funding, but Speaker Pelosi and Secretary Mnuchin are continuing to speak about a compromise.  On October 3, President Trump tweeted, “OUR GREAT USA WANTS & NEEDS STIMULUS. WORK TOGETHER AND GET IT DONE!”  

Regulatory

  • On September 28, Operation Warp Speed released the program’s organizational chart from July 30, detailing extensive involvement by the military in COVID-19 vaccine development and distribution. 

  • On September 28, HHS announced a $22.2 million contract with Pfizer to supply COVID-19 drugs to the Strategic National Stockpile and prepare for future emergencies.

  • On September 28, the FDA granted Emergency Use Authorization (EUA) to Hologic for the company’s Panther Fusion® SARS-CoV-2 assay for testing asymptomatic individuals.

  • On September 29, the FDA put a partial clinical hold on Inovio Pharmaceuticals Inc's Phase III COVID-19 vaccine clinical trial, seeking additional information on the delivery device used to inject genetic material into cells. With this delay, the earliest the trial could begin enrolling participants is November. 

  • On September 30, CMS announced an update to COVID-19 testing guidelines for nursing homes, adjusting how the agency measures community spread. Instead of requiring nursing homes to test staff at a frequency of once monthly if the facility’s county positivity rate is less than 5%, counties with 20 or fewer tests over 14 days will follow the monthly testing protocol. 

  • On September 30, the FDA updated the COVID-19 reference panel comparative data, allowing for a more precise comparison of the analytical performance of different molecular in vitro diagnostic assays for COVID-19. 

  • On September 30, the FDA Commissioner Stephen Hahn highlighted the agency’s Center for Devices and Radiological Health’s response to the pandemic in a report entitled A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response

  • On September 30, the National Institutes of Health awarded $234 million to 32 institutions to improve COVID-19 testing for underserved and vulnerable populations, as part of the Rapid Acceleration of Diagnostics initiative. The program aims to understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce these disparities in COVID-19 testing. 

  • On October 1, Health Resources and Services Administration (HRSA) announced $20 billion in new Phase 3 Provider Relief Funding. Providers that have already received Provider Relief Fund payments may apply for additional funding that considers financial losses and changes in operating expenses caused by COVID-19. Providers can begin applying for funds October 5, 2020.

  • On October 1, HHS announced that hospitals can purchase remdesivir, the antiviral drug authorized to treat hospitalized COVID-19 patients, directly from Gilead, instead of going through states and HHS. HHS announced that the drug is no longer a scarce resource, so the agency does not need to oversee the allocation and distribution of the drug. 

  • On October 1, HHS and The Rockefeller Foundation agreed to identify and share effective approaches for using rapid point-of-care antigen tests to screen for COVID-19 in communities, especially K-12 schools. 

  • The National Vaccine Advisory Committee will hold a virtual meeting October 16. 

  • COVID-19 information released by CMS is posted here; specific waivers are available here.

White House

  • On September 28, President Trump announced the distribution of 100 million Abbott BinaxNOWTM rapid coronavirus tests to states through the end of the year and urged governors to use tests to further reopen states and reopening K-12 schools. 6.5 million tests will be delivered this week. States will be responsible for distributing and administering the tests. 

  • On October 2, President Trump and first lady Melania Trump tested positive for COVID-19.  The White House announced that President Trump was taken to Walter Reed Medical Center later in the day “as a precautionary measure” where he will remain for a “few days.”  President Trump received Regeneron’s experimental antibody cocktail treatment, as well as remdesivir, the steroid dexamethasone, and several nutritional supplements to treat the disease.  On October 4, the President’s doctor announced that he could be discharged as early as October 5.  Additionally, a number of President Trump’s staff and advisors also tested positive including his campaign manager Bill Stepien, advisor Hope Hicks, informal advisers Kellyanne Conway and Chris Christie, and RNC Chairwoman Ronna McDaniel.       

Other

  • On September 29, the World Health Organization announced plans to distribute 120 million SD Biosensor and Abbott rapid COVID-19 antigen diagnostic tests to lower and middle-income countries, through the Access to COVID-19 Tools Accelerator. 

  • On September 29, seven former FDA commissioners published an op-ed that raised concern over the administration potentially undermining the credibility of a COVID-19 vaccine and the FDA. The commissioners warned that a lack of public confidence in a vaccine and the agency could lead to people not wanting to take a COVID-19 vaccine, out of concern of the vaccine's safety and effectiveness. 

  • On September 29, Moderna published results from the Phase I COVID-19 vaccine clinical trial for the company’s two-dose vaccine candidate, mRNA-1273. The results support that the vaccine can generate antibodies in older and elderly adults at levels comparable to younger adults. 

  • On September 29, Regeneron announced the Phase I/II/III clinical trial of the company’s investigational COVID-19 antibody cocktail, REGN-COV2, reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19.  As indicated above, President Trump received the highest dose of the antibody cocktail as part of his treatment for COVID-19.

  • On September 29, the American Health Care Association and the National Center for Assisted Living urged governors to make long-term care facility staff and residents among the first to receive a COVID-19 vaccine, in order to mitigate the risk and prevent further deaths. 

  • On September 30, Moderna’s Chief Executive Stéphane Bancel announced that the company’s COVID-19 vaccine candidate would not have enough safety data to seek an EUA for frontline medical workers and at-risk individuals until November 25, not expecting the vaccine to be widely distributed until next spring.

  • On September 30, ONE, a global NGO to end extreme poverty and preventable disease by 2030, scored the U.S. and many other countries and drug companies as impeding equitable access to a future COVID-19 vaccine, due to lack of participation in COVAX and the COVID-19 Tools Accelerator. 

  • As of October 4, the U.S. had 7,392,285 confirmed COVID-19 cases resulting in 209,563 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); Received 6/6/19

  • International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/19

  • 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

  • Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20

  • Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20

  • Revisions to Medicare Part A Enrollments (CMS-4194)l Proposed Rule; Received 9/9/20

  • Transparency in Coverage (CMS-9915); Final Rule; Received 9/11/20

  • Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20

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 5/28/2020

HHS-OCR

  • HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement; Proposed Rule; Received 7/31/20

HHS-OIG

  • Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement; Final Rule; Received 7/21/20

REPORTS     

HHS Office of Inspector General (OIG)

  • On September 29, OIG released a report entitled North Carolina Made Capitation Payments to Managed Care Entities After Beneficiaries' Deaths. The report found that North Carolina made unallowable capitation payments to certain managed care entities on behalf of deceased beneficiaries, resulting in $2.9 million in unallowable payments to certain managed care entities. OIG recommends that North Carolina refund the unallowable payments, improve the accuracy of eligibility system date of death information, and better manage applying Medicaid Management Information System edits as necessary to identify all deceased beneficiaries. A summary of the report is available here.

  • On September 29, OIG released a report entitled FDA's Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis. The report found that the FDA struggled to measure the effectiveness of the Risk Evaluation and Mitigation Strategies (REMS) for transmucosal immediate-release fentanyl drugs and for extended-release/long-acting opioids in mitigating the misuse of opioids. OIG found that FDA found data in the assessments suggesting that the manufacturers were not meeting all their goals and also found the data for some of the REMS goals to be inadequate. A summary of the report is available here.

  • On September 29, the DOJ OIG released a report entitled Audit of the Drug Enforcement Administration’s Prescription Drug Take Back Activities. The report found that since the inception of the Take Back Days in 2010, the Drug Enforcement Administration (DEA) has facilitated 18 events resulting in over 12 million pounds of unwanted and potentially dangerous pharmaceuticals, at a cost of almost $74 million. DOJ OIG found deficiencies in the DEA’s practices in accounting for collected drugs, significantly increasing the risk of lost, stolen, or misused drugs during testing. The report outlines 10 recommendations to assist the DEA in improving its management and oversight of Take Back Day collection, custody, and disposal of prescription drugs. 

  • On October 1, OIG released a report entitled the National Snapshot of State Agency Approaches to Child Care During the COVID-19 Pandemic. The report found that state agencies adopted various approaches to ensure access to safe child care, as well as to protect the providers rendering that care in their Child Care and Development Fund programs during COVID-19. The report found challenges including communication with stakeholders, difficulties with fingerprinting for prospective child care employees' background checks, insufficient funding for providers, health and safety considerations on the part of child care staff members, and the lack of and inability to secure personal protective equipment and cleaning supplies. A summary of the report is available here.

  • On October 1, OIG released a report entitled Youth For Tomorrow - New Life Center, Inc., an Administration for Children and Families Grantee, Did Not Comply With All Applicable Federal Policies and Requirements. The report found that Youth For Tomorrow (YFT) did not meet some requirements for the care and release of children in its custody and claimed unallowable and potentially unallowable expenditures. OIG recommends that YFT strengthen existing procedures to ensure that it meets all requirements for the care and release of children and refund unallowable expenditures found in the report. A summary of the report is available here.

  • On October 2, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Alta Bates Summit Medical Center. The Alta Bates Summit Medical Center did not fully comply with Medicare billing requirements, resulting in overpayments of $16.3 million. OIG recommended that the hospital refund overpayments to the Medicare contractor and strengthen controls to ensure full compliance with Medicare requirements. A summary of the report is available here

  • On October 2, OIG released a report entitled Risk Assessment of Food and Drug Administration's Purchase Card Program. The report found that the FDA generally designed and implemented controls and strategies to mitigate the potential risks of illegal, improper, or erroneous purchases in its purchase card program. OIG assessed the FDA purchase card program as low risk. A summary of the report is available here

Government Accountability Office (GAO)

  • On October 1, GAO released a report entitled Prescription Drug Monitoring Programs: Views on Usefulness and Challenges of Programs.  The report finds that the physicians interviewed generally found prescription drug monitoring programs (PDMPs) to be useful in preventing drug misuse and potentially dangerous drug prescribing, including identifying potential doctor shopping and avoiding potentially dangerous drug prescribing. GAO found that the lack of integration of PDMP information into electronic health records (EHR) systems is a challenge for most effectively using PDMPs for patient care. State and federal agencies are taking steps to improve PDMP integration with EHR systems. A summary of the report is available here

Congressional Budget Office (CBO)

  • On September 29, the CBO released a report entitled Federal Subsidies for Health Insurance Coverage for People Under 65: 2020 to 2030.This report projects that net federal health insurance subsidies in 2021 for insured people are $920 billion and by 2030, that annual amount is projected to reach $1.4 trillion. CBO found that between 238 million and 241 million people are projected to have health insurance, mostly from employment-based plans and between 31 million and 32 million people are projected to be uninsured. The report also finds that due to the coronavirus pandemic, projections show about 1 million more people uninsured in 2021. A summary of the report is available here.   

  • On September 30, the CBO released a report entitled Who Went Without Health Insurance in 2019, and Why? The report describes the characteristics of the 12% of people under 65 that were uninsured in 2019. CBO found that about ⅔ of uninsured people were eligible for some form of subsidized coverage and that uninsured people have substantially less access to care and financial protection than insured people, though they receive some types of health care and are often not required to pay the full billed charges for that care. CBO finds that many uninsured people do not enroll in insurance because of cost and others may not know that they are eligible for subsidized coverage or may be deterred by the complexity of enrolling. The report also finds that most uninsured people went without coverage for at least one year. A summary of the report is available here.

  • On October 1, the CBO released a report entitled Policies to Achieve Near-Universal Health Insurance Coverage. The report looked at proposals to provide automatic, universal coverage, even for those who did not enroll in a plan on their own. Proposals spanned partially subsidizing default coverage that operates in tandem with current sources of coverage; partially subsidized default coverage through a large public program that replaces Medicaid, CHIP, and nongroup market and retains employment-based coverage; premium subsidies for all people and default coverage through a fully subsidized plan; and a single-payer system. A summary of the report is available here

 UPCOMING HEARINGS

Senate

  • None of note.

House

  • None of note.

 OTHER HEALTH POLICY NEWS

  • On September 28, the Kaiser Family Foundation (KFF) released an issue brief entitled Affordability in the ACA Marketplace Under a Proposal Like Joe Biden's Health Plan. The report estimates that Biden’s proposed plan to expand subsidies for Marketplace and employer coverage would result in the cost of ACA Marketplace coverage decreasing for nearly all current Marketplace enrollees, including those who are currently priced out of the market. 

  • On September 28, the National Association of Insurance Commissioners released a report entitled the 2019 Accident and Health Policy Experience Report. The report found that short-term health plans paid for few members' medical claims in 2019. 

  • On September 28, California Gov. Gavin Newsom passed into law S.B. 852 the California Affordable Drug Manufacturing Act of 2020. This bill will allow the California Health and Human Services Agency to produce and distribute generic drugs to reduce drug prices. The bill also prioritizes manufacturing or distributing drugs for chronic and high-cost conditions, specifically mentioning insulin.

  • On September 29, a study published in Annals of Internal Medicine found that between 1997 and 2018, the FDA approved opioids looking at short or intermediate duration trials, in narrowly defined pain populations, without examining certain important safety outcomes.  

  • On September 28, Community Health Choice and Maine Community Health Options petitioned the U.S. Court of Appeals for the Federal Circuit to revisit the August 14 decision for the insurers to not receive the unpaid Cost-Sharing Reduction (CSR) payments subsidies. The original panel ruled that the federal government owes the insurers damages from the elimination of Cost-Sharing Reduction (CSR) payments in ACA exchanges in 2017, however the insurers would not receive the unpaid CSR payments subsidies because they already recovered the costs by raising premiums to attain bigger tax credits – a practice known as “silver loading.”

  • On September 30, the Bipartisan Policy Center released a report entitled Tracking FY2019 Federal Funding to Combat the Opioid Crisis.  The report found that total federal opioid funding was $7.6 billion in FY2019, an increase from $7.4 billion in FY2018, with three-quarters of the funding going towards treatment, recovery, and prevention efforts. The Center recommended that Congress boost funding for the SAMHSA’s substance abuse prevention and treatment block grant, focus on harm reduction by removing funding restrictions for syringes, and make COVID-19 PHE telehealth expansion permanent. 

  • On September 30, Democratic nominee Joe Biden and President Trump participated in the first presidential debate. The debate included Biden criticizing the Trump-supported lawsuit to overturn the ACA and Trump accusing Biden of not addressing prescription drug costs as Vice President and as a Senator. 

  • On September 30, the 3rd Circuit U.S. Court of Appeals ruled that Abbvie and Besins Healthcare will not have to pay the Federal Trade Commission $448 million for monopolizing the market for AndroGel and sent the case back to a lower court to determine whether patent litigation settlement for the licensing deal between AbbVie and Teva over Tricorthe amounted to a “pay-for-delay” agreement in violation of antitrust law. 

  • On October 1, some private health insurers, including UnitedHealthcare and Anthem, began no longer waiving the cost of copays, coinsurance, and deductibles for telehealth services. Other commercial insurers, including CVS Health and BlueCross BlueShield Tennessee, extended their telehealth cost waiving until the end of this year. 

  • On October 1, the Urban Institute released a brief entitled Progress in Children's Coverage Continued to Stall Out in 2018. The report found that children’s uninsurance rose and CHIP/Medicaid program participation fell in 2018, relative to 2016 levels, with more than 2 million children uninsured who were likely eligible for coverage through the programs. The Urban Institute identified that half of all Medicaid/CHIP-eligible but uninsured children in 2017–18 lived in Arizona, California, Florida, Georgia, New York, Pennsylvania, and Texas.

  • On October 1, KFF released a report entitled Eliminating the ACA: What Could It Mean for Medicaid Expansion? The report finds that overturning the ACA would eliminate a Medicaid coverage pathway and federal Medicaid financing for millions of people, leading to loss of coverage, and other gains in access, utilization, affordability and in addressing disparities could be lost. 

  • On October 1, AstraZeneca and Sanofi began limiting 340B discounts to hospitals using community pharmacies to dispense medicines. AstraZeneca discontinued the discounts universally and Sanofi discontinued the discounts for pharmacies that do not release claims data for low-income patients. These cuts come after HRSA sent a letter to Eli Lilly, criticizing the attempt to limit the discounts and warned of litigation. 

  • On October 1, Nebraska expanded Medicaid, after the state ballot initiative in 2018 and a two-year transition period. State officials expect expanded enrollment will reach 90,000. 

  • On October 1, Science Magazine and the American Association for the Advancement of Science released a report entitled FDA’s own documents reveal agency’s lax, slow, and secretive oversight of clinical research. The report found that the FDA rarely levels sanctions to enforce laws meant to safeguard volunteers for clinical trials during the Obama administration and even less frequently during the Trump Administration. Science also found that there was infrequent follow-up on trial issues, a lack of transparency for clinical trial results, and slow disqualifications for researchers who violate rules of human subjects research. 

  • On October 1, a study published in JAMA Network entitled Association of Medicaid Expansion Under the ACA With Use of Long-term Care found that ACA-funded Medicaid expansion was associated with an increase in any long-term care use among newly eligible low-income, middle-aged adults. The researchers suggest that the population covered by the Medicaid expansion may have had unmet long-term care needs before expansion.

  • On October 2, U.S. District Court of Northern Texas Judge Reed O’Connor ruled that LP Management Services’ self-insured plan complied with federal employer laws and were similar to association health plans. This rules against the Labor Department’s claims that the plan needed to comply with ACA-exchange requirements. 

  • On October 2, the National Academies of Sciences, Engineering, and Medicine released a final report entitled Framework for Equitable Allocation of COVID-19 Vaccine. The report recommends a four-phased equitable allocation framework that the HHS and state, tribal, local, and territorial authorities should adopt in the development of national and local guidelines for COVID-19 vaccine allocation.