The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 19 - April 24. 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 April 22, Senate Republican’s unveiled their infrastructure counterproposal to Biden’s $2.5 trillion proposal. The Republican $568 billion package includes:
$299 billion for roads and bridges;
$61 billion for public transit systems;
$20 billion for rail;
$35 billion for drinking water and wastewater,
$13 billion for safety;
$17 billion for ports and inland waterways,
$44 billion for airports;
$65 billion for broadband infrastructure; and
$14 billion for water storage.
Many Democrats immediately rejected the package as being far too small.
House
On April 21, the New Democrat Coalition sent a letter to President Biden outlining health policies for Biden to prioritize in his American Families Plan, including:
Stabilizing Affordable Care Act (ACA) marketplaces and reduce premiums with a national reinsurance program as proposed in the State Health Care Premium Reduction Act;
Capping families’ health costs with permanent expansions of the premium tax credit and other enhancements in the American Rescue Plan aimed at reducing deductibles and other out-of-pocket expenses;
Simplifying enrollment for an estimated four million people by encouraging states to auto enroll uninsured individuals who qualify for $0 premium health plans and for five million people who qualify for Medicaid or CHIP;
Incentivizing states that have not expanded Medicaid to increase coverage to newly eligible individuals with a 100% federal match, building on the base rate increase for expansion states under the American Rescue Plan;
Embracing and fostering existing value-based models which were permanently authorized under the ACA and have demonstrated the ability to simultaneously improve quality and reduce costs;
Exploring other innovations, to increase choice and competition and close coverage gaps;
Improving coverage and cost transparency for patient care, and streamlining the prior authorization process;
Addressing provider shortages, especially in rural, economically distressed, and underrepresented minority communities, and embracing expanded telehealth and home care under the CARES Act and the American Rescue Plan;
Modernizing and expanding supplemental benefits and exploring innovative payment mechanisms aimed at eliminating the financial and health burdens that barriers such as poor transportation and internet access have on underserved, elderly, and rural populations and our health care system writ large; and
Expanding health care savings and spending vehicles for workers and families.
A press release on the health priorities is available here.
On April 21, key House Republicans reintroduced drug pricing legislation entitled the Lower Costs, More Cures Act (H.R. 19). This bill is intended to serve as an alternative to the House Democrats’ bill (H.R. 3, described below) which would set pharmaceutical reimbursements at levels paid by other countries, penalize manufacturers who increase prices above inflation, and reform the Medicare Part D benefit. Additionally, Energy & Commerce Ranking Member Cathy McMorris Rodgers (R-WA), Education and Labor Ranking Member Virginia Foxx (R-NC), and Ways & Means Ranking Member Kevin Brady (R-TX) sent a “Dear Colleague” Letter in favor of H.R. 19 over H.R. 3.
On April 22, Energy & Commerce Chair Frank Pallone (D-NJ), Ways & Means Chair Richard Neal (D-MA), and Education & Labor Chair Bobby Scott (D-VA) reintroduced H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, which would: allow the Health & Human Services (HHS) Secretary to set prescription drug prices in Medicare based on prices in foreign countries and make those negotiated prices available to commercial health insurance plans, reform the Part D benefit, require drug manufacturers to pay a rebate back to the federal government if they increase prices faster than inflation, and use the savings to increase funding to the National Institutes of Health (NIH) and Food & Drug Administration (FDA) to support research and development of new breakthrough treatments and cures, as well as make investments in combating the opioid crisis. In 2019, the Congressional Budget Office (CBO) estimated that the foreign reference pricing in the bill would save the federal government about $456 billion over 10 years.
On April 22, 29 Democrats urged President Biden to advance comprehensive coverage and affordability provisions, including by making the expanded advance premium tax credits (APTCs) from the American Rescue Plan permanent.
Senate
On April 22, the Health, Education, Labor, & Pension (HELP) Committee held a hearing entitled Protecting U.S. Biomedical Research: Efforts to Prevent Undue Foreign Influence. Witnesses included: Michael Lauer, MD, Deputy Director for Extramural Research, NIH; Lisa Aguirre, Acting Director, Office of National Security, HHS; Gary Cantrell, Deputy Inspector General for Investigations, HHS Office of Inspector General (OIG); Candice Wright, Acting Director, Science, Technology Assessment, and Analytics; Government Accountability Office (GAO).
On April 19, Sens. Warren (D-MA) and Chuck Grassley (R-IA) requested an update on institutional health care claim transactions and asked the Accredited Standards Committee to finalize recommendations that Medicare include device identifiers on its claims forms.
On April 21, Sens. Debbie Stabenow (D-MI), Sherrod Brown (D-OH), and Tammy Baldwin (D-WI) reintroduced the Medicare at 50 Act to give people between the ages of 50 and 64 years old the option of buying into the Medicare program.
On April 22, the Finance Committee advanced the nomination of Andrea Palm for Deputy Health Secretary in a 20-8 vote. Committee deadlocked the nomination of Chiquita Brooks-LaSure for the Centers for Medicare & Medicaid Services (CMS) Administrator in a 14-14, party line vote, due to the Administration’s decision to revoke a 10-year extension of Texas’s Medicaid waiver last week. Sen. John Cornyn (R-TX) placed a hold on Brooks-LaSure's nomination from advancing to a floor vote for the same reason.
On April 22, Sen. Jeff Merkley (D-OR) and Rep. Peter Welch (D-VT) introduced the End Price Gouging for Medications Act, which seeks to establish reference pricing for prescription drugs using prices in Australia, Canada, Germany, Italy, Japan, the Netherlands, Spain, and the U.K. A summary of the legislation is available here.
On April 22, Sens. Elizabeth Warren (D-MA) and Marco Rubio (R-FL) introduced the U.S. Pharmaceutical Supply Chain Review Act, which would require a government study examining the impact of foreign direct investment in the U.S. drug industry. A summary of the legislation is available here.
NON-CORONAVIRUS REGULATORY UPDATE
On April 19, the FDA posted a summary of the second user fee negotiation meeting between the FDA and external stakeholder. Topics discussed during the meeting, included: increasing engagement with insurers, utilization of real-world evidence, investing in digital health, diversity in clinical trials, and medical device safety surveillance. FDA and industry disagreed over if the agency met its deficiency letter commitments under the last round of user fees and what constitutes an appropriate amount of device user fees.
On April 19, the Office for Civil Rights (OCR), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Administration for Children and Families (ACF) at HHS partnered with the National Center on Substance Abuse and Child Welfare to produce a new video series, “Civil Rights Protections for Individuals in Recovery from an Opioid Use Disorder.” The series informs audiences about the application of federal disability rights laws to child welfare programs and activities, discusses protections that apply to some individuals in recovery from an opioid use disorder, provides an overview of medication-assisted treatment (MAT), and addresses common misconceptions about MAT as a treatment approach.
On April 19, HHS Secretary Xavier Becerra announced commitments from national organizations to support Latino outreach and enrollment efforts during the current Special Enrollment Period to share information with Latino consumers and use social media to encourage them to enroll in health plans through HealthCare.gov.
On April 20, CMS’ Center for Medicare & Medicaid Innovation (CMMI) Administrator Elizabeth Fowler announced that CMMI will focus on enacting fewer and more targeted models to promote value-based care.
On April 21, CMS announced $80 million in grants to Navigators in Federal Marketplaces for the 2022 plan year for outreach and education efforts.
On April 21, HHS released the 2021 Marketplace Open Enrollment report which summarizes health plan selections made on the individual Marketplaces during the 2021 Open Enrollment Period (OEP). The report found that over 12 million consumers nationally selected a Marketplace plan during the 2021 OEP, a 5% increase from the 2020 OEP.
On April 21, CMS released data from the Market Saturation and Utilization Data Tool to monitor market saturation to help prevent potential fraud, waste, and abuse.
On April 22, the White House Office of Management & Budget (OMB) received a proposed rule from CMS entitled CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751).
On April 23, OMB concluded review on a notice from Substance Abuse and Mental Health Services Administration (SAMHSA) entitled Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder.
On April 22, Centers for Disease Control and Prevention (CDC) Respiratory Disease Chief Nancy Messonnier was reassigned from the CDC COVID-19 Vaccine Task Force to CDC Director Rochelle Walensky’s Incident Management Response Team.
On April 23, CMS released a case study in effective advisory board collaboration from the Accountable Health Communities Model that illustrates strong community partnerships to address social needs.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On April 19, the NIH announced $155 million for a Phase III clinical trial to test seven prescription and over-the-counter medications already approved by FDA for other conditions for people to self-administer to treat mild-to-moderate COVID-19 symptoms and patients who are not hospitalized.
On April 19, HHS announced $150 million in funding for community-based health care providers to help boost their COVID-19 response for underserved communities and vulnerable populations.
On April 21, HHS Secretary Becerra extended the Public Health Emergency (PHE) for an additional 90 days, until July 20.
On April 21, a CDC study published in the New England Journal of Medicine found that the Pfizer and Moderna COVID-19 vaccines do not pose any serious risk during pregnancy.
On April 21, CDC released a report finding that vaccinations of skilled nursing facilities residents and health care personnel is essential to reduce the risk for symptomatic COVID-19.
On April 21, the NIH launched a Phase II/III trial to evaluate SAB-185, a polyclonal antibody therapeutic developed by SAB Biotherapeutics, to target COVID-19 for mild or moderate non-hospitalized COVID-19 cases.
On April 22, the FDA released a report on the Baltimore Emergent BioSolutions manufacturing plant that ruined 15 million Johnson & Johnson (J&J) vaccine doses. The report found that the facility had multiple procedural failures, including unsanitary conditions and inadequate cleaning procedures.
On April 23, CDC and FDA lifted the pause of J&J’s COVID-19 vaccine, but included new warning statements about potential blood clots included in FDA’s health care provider and patient fact sheets. The CDC Advisory Committee on Immunization Practices recommended the continued use of J&J’s COVID-19 vaccine, following reports of a rare and severe type of blood clot. The Committee considered a recommendation for women under 50 of the potential risk of clotting and low platelet levels but ultimately did not vote on the specific recommendation.
On April 23, HHS launched a new initiative as part of the We Can Do This campaign to connect Americans with facts and information on vaccines from doctors, scientists, and health professionals through social media and TV.
HHS will hold a virtual COVID-19 Health Equity Task Force meeting on April 30 to consider interim recommendations specific to mental and behavioral health across the life course.
White House
On April 19, all 50 states, plus Washington, D.C. and Puerto Rico, have made individuals over the age of 16 eligible for COVID-19 vaccines, successfully meeting the deadline set by President Biden.
On April 21, the Administration unveiled a paid leave tax credit to offset the cost for employers with fewer than 500 employees to provide full pay for any time their employees need to get a COVID-19 vaccination or recover from that vaccination.
On April 21, the U.S. met President Biden’s goal of administering 200 million COVID-19 vaccine shots in his first 100 days in office.
Other
On April 19, Abbott Laboratories announced its COVID-19 rapid test BinaxNOW will be available over the counter at major pharmaceutical chains, including Walgreens, CVS, and Walmart.
On April 19, Emergent BioSolutions temporarily shut down operations at the plant at the request of the FDA as the agency continues its inspection of the facility, following 15 million doses of the J&J COVID-19 vaccine that were ruined at the plant. J&J said that it is working with the FDA and Emergent to address the findings of the inspection.
On April 19, J&J resumed the rollout of its vaccine in Europe and its COVID-19 vaccine clinical trials, following the European Medicines Agency's (EMA) review of the J&J COVID-19 vaccine. The company is also establishing a vaccine supply network with ten manufacturing sites to produce its COVID-19 vaccine.
On April 20, the EMA safety committee concluded that the risk of blood clots associated with the J&J COVID-19 vaccine should be listed as a "very rare" side effects and that the benefits of the shot still outweigh the risks.
On April 20, a study released in Cell Reports Medicine found that the B117 variant from the U.K. is 45% more transmissible than the original COVID-19 variant, but the Pfizer COVID-19 vaccine protected elderly populations against infections caused by the variant.
On April 20, the World Health Organization released a report finding that there were more new COVID-19 cases reported globally last week than in any seven-day period since the beginning of the pandemic.
On April 21, J&J published data in the New England Journal of Medicine supporting that its COVID-19 vaccine protected against symptomatic and asymptomatic infection and prevented hospitalization and death in all participants 28 days after vaccination.
On April 23, Moderna predicted that regulators could approve its COVID-19 booster dose targeting the original COVID-19 strain and the South African variant by late summer.
As of April 24, more than 138 million people have received the first dose of COVID-19 vaccines (more than 93 million have received both doses) and more 290 million doses have been distributed, according to the CDC COVID Data Tracker. As of April 18, more than half of all American adults have now gotten at least one vaccine dose.
As of April 24, the U.S. had 32,042,857 confirmed COVID-19 cases resulting in 571,910 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
FY 2022 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, and the Long-Term Care Hospital Prospective Payment System (CMS-1752); Proposed Rule; Received 2/16/21
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
Comprehensive Care for Joint Replacement Model Three-Year Extension and Modifications to Episode Definition and Pricing (CMS-5529); Final Rule; Received 3/19/21
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Final Rule, Received 3/24/21
COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414); Interim Final Rule; 3/29/21
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; 3/30/21
REPORTS
HHS Office of Inspector General (OIG)
On April 20, OIG released a report entitled Medicare Advantage Compliance Audit of Diagnosis Codes That Humana, Inc., (Contract H1036) Submitted to CMS. The report found that a Humana MA plan in FL did not submit some diagnosis codes to CMS for use in the risk adjustment program in accordance with Federal requirements. Some HCCs were not validated and resulted in overpayments and there were an additional 15 HCCs for which the medical records supported diagnosis codes that Humana should have submitted to CMS but did not. OIG estimated that Humana received at least $197.7 million in net overpayments for 2015, due to Humana's policies and procedures to prevent, detect, and correct noncompliance with CMS' program requirements – as mandated by Federal regulations – not always being effective. OIG recommended that Humana refund $197.7 million of net overpayments and enhance its policies. Humana disagreed with the findings and recommendations. A summary of the report is available here.
On April 21, OIG released a report entitled Colorado's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 18 of 30 Providers Reviewed. The report found that Colorado's monitoring process did not always ensure provider compliance with State requirements related to criminal background checks. Colorado did not retain criminal background check records for child care center individuals who required background checks and instead relied on the child care centers to retain these documents and did not require child care providers and associated individuals to receive training on background check requirements. OIG recommended that Colorado conduct all required criminal background checks; ensure that child care providers and associated individuals requiring a background check receive training on background check requirements; and ensure that all required background checks are completed and retain these records until the background check expires. Colorado concurred with all of the recommendations and described corrective actions that it had taken or planned to take. A summary of the report is available here.
On April 23, OIG released a report entitled OIG’s Partnership with the Office of the New York State Comptroller: Improper Medicaid Payments for Individuals Receiving Hospice Services Covered by Medicare. The report found that the New York State Comptroller identified approximately $50 million in actual and potential Medicaid overpayments, cost-saving opportunities, and questionable payments for services provided to dually eligible individuals receiving Medicare-covered hospice care. The State Comptroller concluded that the actual and potential overpayments it identified were made because the Department of Health has not established sufficient controls to ensure Medicaid payments are appropriate for dually eligible individuals receiving Medicare-covered hospice care. The State Comptroller recommended that DOH review the actual and potential overpayments identified in the audit report and ensure proper recoveries are made.
Government Accountability Office (GAO)
On April 19, GAO released a report entitled COVID-19: HHS Should Clarify Agency Roles for Emergency Return of U.S. Citizens during a Pandemic. The report found that HHS experienced coordination and safety issues that put repatriates, HHS personnel, and nearby communities at risk while coordinating the return of about 1,100 U.S. citizens from abroad and quarantining them domestically to prevent the spread of COVID-19. HHS component agencies did not follow plans or guidance delineating their roles and responsibilities for repatriating individuals during a pandemic, leading to issues, including: lack of clarity as to which agency was in charge when the first repatriation flight from Wuhan, China, arrived at the quarantine facility; coordination issues among HHS component agencies resulted in component agencies operating independently of each other; HHS' delay in issuing its federal quarantine order; and HHS personnel's inconsistent use of personal protective equipment (PPE), and HHS officials' disagreement on which agency was responsible for managing infection prevention and control. An HHS official also directed personnel to remove their PPE as it created “bad optics,” according to an HHS report that examined the repatriation effort. OIG recommended that HHS revise or develop and test repatriation response plans to clarify agency roles. A summary of the report is available here.
On April 23, GAO released a report entitled Medicaid: Information on the Use of Electronic Asset Verification to Determine Eligibility for Selected Beneficiaries. The report found that in the 42 states and the District of Columbia that use the Supplemental Security Income (SSI) asset limit, the Social Security Administration is the entity that verifies applicants' assets. GAO found that eight states that may set their own asset limits, the state's Medicaid program must verify Medicaid eligibility for SSI recipients using an electronic asset verification system. A summary of the report is available here.
HEARINGS
House
Ways & Means Health Subcommittee
The Long Haul: Forging a Path through the Lingering Effects of COVID-19
April 28, 11:00pm, Webex
Ways & Means Health Subcommittee
Hearing on Charting the Path Forward for Telehealth
April 28, 2:00pm, Webex
Senate
HELP Committee
April 28, 10:00 a.m. 430 Dirksen Senate Office Building
Subcommittee on Military Construction, Veterans Affairs, and Related Agencies
VA Telehealth Program: Leveraging Recent Investments to Build Future Capacity
April 28, 3:00 p.m. Dirksen Senate Office Building SD-138
OTHER HEALTH POLICY NEWS
On April 19, an opioid related trial of J&J, Teva, Allergan and Endo International versus several California counties began. The counties allege that the companies downplayed the risks of addiction to push painkiller sales and that the marketing tactics used by the companies contributed to the opioid epidemic.
On April 19, Kaiser Family Foundation released a report entitled Relatively Few Drugs Account for a Large Share of Medicare Prescription Drug Spending. The report found that a relatively small number and share of drugs accounted for a disproportionate share of Medicare Part B and Part D prescription drug spending in 2019. The 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition (7% of all Part D covered drugs) accounted for 60% of net total Part D spending. The top 50 drugs covered under Medicare Part B (8.5% of all Part B covered drugs) accounted for 80% of total Part B drug spending.
On April 20, HHS asked the U.S. District Court for the Southern District of Indiana to dismiss Lilly’s lawsuit claiming that HHS acted unlawfully when it confirmed that manufacturers must continue supplying discounted products to contract pharmacies through the 340B Drug Discount Program.
On April 21, a study released in the American Journal of Health-System Pharmacy found that overall drug spending in the U.S. in 2020 was a total of $535.3 billion, a 5% increase from 2019. Clinics face increases of 7% to 9% and hospitals face increases of 3% to 5% in drug spending, in 2020.
On April 21, the Commonwealth Fund released a report entitled How Agents Influence Medicare Beneficiaries’ Plan Choices. The report found that Medicare brokers play an important role for beneficiaries, but the existing approach affects information about coverage options and may not optimally serve beneficiaries’ needs by limiting their choice.
On April 22, the National Health Law Program and Tennessee Justice Center filed a lawsuit against HHS over TennCare, the state’s Medicaid block grant waiver that caps federal Medicaid funding for the state.
On April 20, the American Hospital Association and other hospital advocacy groups urged HHS to deem drug manufacturers refusing to provide discounts to 340B hospitals that are dispensing those drugs through community pharmacies illegal and impose civil penalties on noncomplying manufacturers.