The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 13 – 19.  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

  • The Senate will return from its recess on July 20.  The Senate is expected to be in session for three weeks before breaking for its August recess.

House

  • On July 13, the Appropriations Committee passed the Labor, Health & Human Services (HHS), Education, & Related Agencies Fiscal Year (FY) 2021 spending bill, on a 30-22 party-line vote. The bill would appropriate $96.4 billion to HHS, a $1.5 billion increase from the FY2020 enacted level. Annual appropriations for HHS would include:

    • $42 billion for the National Institutes of Health (NIH), a $500 million increase;

    • $8 billion for the Centers for Disease Control & Prevention (CDC), a $232 million increase;

    • $6 billion for the Substance Abuse & Mental Health Services Administration (SAMHSA), a $96 million increase;

    • $7.2 billion for the Health Resources & Services Administration (HRSA), a $157 million increase;

    • $2.8 billion for the Public Health & Social Services Emergency Fund (“Provider Relief Fund”), a $90 million increase; and

    • $4 billion for Centers for Medicare & Medicaid Services (CMS) administrative expenses, a $315 million increase.

  • Notably, the bill would direct CMS to use $100 million in carryover funds from the Affordable Care Act (ACA) user fees to support outreach and education during the ACA open enrollment period. In addition, the measure would appropriate $24.4 billion in pandemic emergency relief, including $4.5 billion to the Biomedical Advanced Research & Development Authority (BARDA) and $5 billion to establish a permanent public health emergency fund. Committee Republicans, including Labor-HHS-Education Subcommittee Ranking Member Tom Cole (R-OK), voiced concerns with the appropriations of emergency spending as ways to circumvent spending caps and advocated instead for the funding to be included in a separate supplemental bill. By voice vote, the Committee adopted Rep. Mark Pocan’s (D-WI) amendment to direct HHS to create guidelines for employer-sponsored health plans to submit annual public compliance reports related to coverage of mental and behavioral health services. A summary of the spending bill is available here.

  • On July 15, the Energy & Commerce Committee advanced 17 health bills, summarized here, to the House floor. Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR) outlined the agenda and emphasized the bipartisan spirit of the bills.

    • H.R. 2477, the Beneficiary Enrollment Notification & Eligibility Simplification (BENES) Act of 2019, improves beneficiary outreach and education, reduces gaps in coverage, and simplifies the Part B enrollment process;

    • H.R. 3935, the Protecting Patients Transportation to Care Act makes non-emergency medical transportation on the list of mandatory Medicaid benefits and requires state Medicaid programs to have in place a utilization management process for the benefit;

    • H.R. 5201, the Telemental Health Expansion Act of 2019, removes Medicare’s “originating site” rule and geographic restrictions for mental health services delivered via telehealth;

    • H.R. 5534, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019, permanently removes the 36-month limit for Medicare coverage of immunosuppressive drugs following a kidney transplant;

    • H.R. 7539, the Strengthening Behavioral Parity Act, improves and strengthens enforcement of existing mental health parity laws by prohibiting health plans from imposing benefit limitations, increase transparency, and requires follow up for non-compliant health plans;

    • H.R. 1646, the Helping Emergency Responders Overcome (HERO) Act of 2019, creates systems and mental and behavioral health programs to support public safety officers;

    • H.R. 2117, the Food Allergy Safety, Treatment, Education & Research (FASTER) Act of 2019, requires the CDC to collect and present data on the prevalence of food allergies to Congress and allow the Food and Drug Administration (FDA) to expand ingredients on major allergen lists;

    • H.R. 2271, the Scarlett's Sunshine on Sudden Unexpected Death Act, requires the CDC to update the Sudden Unexplained Infant Death Investigation Reporting Form, improve comprehensive death scene investigations requirements, and authorizes HRSA to create educational programs and support services for sudden unexplained infant death and sudden unexplained death in children;

    • H.R. 2468, the School-Based Allergies and Asthma Management Program Act, adds preference to states that have additional access to certain health care professionals and programs for grants;

    • H.R. 4564, the Suicide Prevention Lifeline Improvement Act of 2019, increases funding for the National Suicide Prevention Lifeline program to $50 million per year from FY2020 to FY2022 and creates a pilot program to improve technology for suicide prevention and reporting;

    • H.R. 4585, the Campaign to Prevent Suicide Act, creates a national suicide prevention media campaign;

    • H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, updates the Orphan Drug Act with additional requirements for drug manufacturers seeking orphan drug designations and directs the FDA to take into consideration the sales of all drugs made by the manufacturer under the same orphan drug designation;

    • H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, amends the 21st Century Cures Act to direct the FDA to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs) and appropriates $80 million for NCEs per year from FY 2021 through FY 2025;

    • H.R. 5619, the Suicide Prevention Act, establishes two grant programs to prevent self-harm and suicide under the CDC and SAMHSA;

    • H.R. 5663, the Safeguarding Therapeutics Act, extends FDA’s administrative destruction authority to medical devices;

    • H.R. 5668, the Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act of 2020, gives additional authority to FDA to require modifications of outdated labeling for generic drugs; and

    • H.R. 7574, the Strengthening America's Strategic National Stockpile (SNS) Act of 2020, improves the financial security, supply chain, and transparency of the SNS. This bill also creates a pilot program for state stockpiles and increases appropriations for the SNS from $610 million to $705 million for FY2020 through FY 2023.

  • On July 15, the Appropriations Committee sent its final FY2021 spending bill to the floor. Early next week, the House is scheduled to consider its first four-bill minibus: H.R. 7608, the State, Foreign Operations, Agriculture, Rural Development, Interior, Environment, Military Construction, and Veterans Affairs Appropriations Act of 2021. A division-by-division summary is available here.

  • The House is expected to hold votes the weeks of July 20 and 27 before breaking for its August recess.  Recess could be delayed, however, if a pandemic relief bill is not passed prior to that date.

NON-CORONAVIRUS ADMINISTRATION UPDATE

Regulatory

  • On July 13, SAMHSA issued a final rule entitled Confidentiality of Substance Use Disorder (SUD) Patient Records. The rule allows for patients to consent to sharing their SUD records with a broader group of providers, rather than with specific individuals, and authorizes disclosures between SUD treatment providers during natural or major disasters. The final rule notes that additional changes will be made to comply with the Coronavirus Aid, Relief & Economic Security (CARES) Act, which directs 42 CFR Part 2 to be more closely aligned with Health Insurance Portability & Accountability Act (HIPAA) standards. The CARES Act provisions would take effect March 27, 2021. A fact sheet is available here.

  • On July 14 and 15, FDA convened a virtual large advisory committee for the first time since February. The Oncologic Drugs Advisory Committee considered GlaxoSmithKline’s multiple myeloma drug and the Cardiovascular & Renal Drugs Advisory Committee considered Mallinckrodt’s drug to treat hepatorenal syndrome Type 1.

  • On July 14, the Department of Justice (DOJ) filed a legal brief with the Supreme Court requesting that Medicaid work requirements be reinstated in Arkansas and New Hampshire. DOJ argues the U.S. Court of Appeals for D.C.’s previous ruling that Arkansas’ requirements are “arbitrary and capricious” should be overturned and “threatens to impede innovations that may make states’ Medicaid programs more effective and sustainable.”

  • On July 15, CDC released preliminary data showing 70,980 overdose deaths last year, surpassing a record high of 70,699 deaths in 2017. This amounts to a 4.6% increase from 2018, when the overdose rate declined for the first year in three decades. Fentanyl and other synthetic opioids are driving overdose deaths, though there is also an uptick in cocaine and methamphetamine deaths.

  • On July 17, HHS published date corrections to a final rule entitled 21st Century Cures Act: Interoperability, Information Blocking, and the Office of the National Coordinator (ONC) Health Information Technology (IT) Certification Program. This includes a change in date from November 2, 2020 to June 30, 2020 for health IT developer contract restrictions for communications certification requirements. The correction also includes a change in date from November 2, 2020 to June 30, 2020 for testing requirements for electronic prescribing.

  • On July 17, CMS published date corrections to a proposed rule entitled Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy. This correction changes the final date for comments to be considered from August 24, 2020 to August 31, 2020.

  • On July 17, the U.S. Court of Appeals for D.C. ruled that HHS has the authority to implement “site-neutral” hospital payments. The ruling dismissed the American Hospital Association’s (AHA’s) argument that CMS violated Congressional intent in cutting Medicare's rates to outpatient clinics.

CORONAVIRUS UPDATE  

Legislative

  • On July 12, Speaker Nancy Pelosi (D-CA) maintained the next COVID-19 package must include enhanced unemployment benefits, which are scheduled to expire at the end of July. However, Senate Majority Leader Mitch McConnell (R-KY) has assured GOP Senators that the enhanced benefits will not be included in the next package. This provision will be a major sticking point to any deal.  We would not be surprised to see a gradual phasing out of the higher benefit level or a transition to back to work bonus payments.

  • On July 13, Senate Democrats, led by HELP Ranking Member Patty Murray (D-WA), released a white paper urging Congress to include $25 billion in the next COVID-19 package to research, manufacture, purchase, and distribute vaccines. The proposal includes recommendations for the federal government to make the vaccine available at no cost to Americans, be developed with rigorous clinical standards, be manufactured at scale, mitigate supply shortages, ensure equitable distribution, prepare for and implement widespread administration, and monitor post-market surveillance. In response, HELP Chairman Lamar Alexander (D-TN) called for a bipartisan effort to accelerate the development and distribution of vaccines.

  • On July 13, top Energy & Commerce Committee Chairman Frank Pallone (D-NJ), Health Subcommittee Chair Anna Eshoo (D-CA), and Oversight & Investigations Chair Diana DeGette (D-CO) questioned FDA Commissioner Stephen Hahn whether standards for COVID-19 tests are too low. The lawmakers asked Commissioner Hahn to provide information on FDA’s oversight of post-market reliability of diagnostic and antibody tests, issues that have arisen while reviewing Emergency Use Authorizations (EUA) applications, and adverse event reports associated with tests by July 27.

  • On July 13, Senate Majority Leader McConnell (R-KY) called for lawsuit protections for "everyone related to the coronavirus" covering the period from December 2019 to December 2024 to be included in the next COVID-19 package. He also predicted the next pandemic relief package will be released within the next three weeks. It was later reported that the Senate GOP is aiming to unveil their package next week. The proposal is expected to cost around $1 trillion.

  • On July 13, Majority Leader Steny Hoyer (D-MD) suggested the House might be in session for the first week of August to negotiate a pandemic relief package. Furthermore, on July 14, Speaker Nancy Pelosi (D-CA) indicated she would be willing to forgo the House's August recess to negotiate another relief package. Sticking points are anticipated to include: funding levels for state and local governments, liability protections, extending enhanced unemployment benefits, making school funding contingent upon holding in-person classes, oversight mechanisms, and a payroll tax cut – which President Trump has suggested must be included. On July 17, the Trump administration announced they would push for 10% of the package to be set aside for nonpublic schools and education freedom scholarships.

  • On July 14, the House Oversight & Reform Economic & Consumer Policy Subcommittee held a briefing entitled Guardrails to Ensure a Safe and Effective COVID-19 Vaccine. Subcommittee Chairman Raja Krishnamoorthi (D-IL) highlighted two guardrails of vaccine development that the FDA has not officially committed to: successful phase III clinical trials and consideration of Vaccine and Related Biological Products Advisory Committee (VRBPAC) advice for transparency, public accountability and scientific insight to the approval process. Committee Chairwoman Carolyn Maloney (D-NY) urged the importance of following FDA protocols to create a safe and effective COVID-19 vaccine. Committee Ranking Member James Comer (R-KY) commended the safety measures in place for Operation Warp Speed and asserted that a COVID-19 vaccine would be made to Americans at no or low cost. He also mentioned the CDC ranking system that will be necessary for distributing the vaccine. Committee Democrats, including Subcommittee Chairman Krishnamoorthi, advocated that the FDA should be required to consult with the VRBPAC for every COVID-19 vaccine it reviews. Witnesses included: Bruce Gellin, MD, President, Global Immunization, Sabin Vaccine Institute, Former-Director, National Vaccine Program, HHS; Jesse Goodman, MD, Director, Center on Medical Product Access, Safety and Stewardship, Georgetown University, Former-Chief Scientist, FDA; Ruth Karron, MD, Director, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Former-Chair, VRBPAC; Jason Schwartz, Assistant Professor of Health Policy, Yale School of Public Health; and Jay Bhattacharya, MD, Professor of Medicine, Stanford University.

  • On July 14, the Homeland Security Oversight, Management & Accountability Subcommittee and  Emergency Preparedness, Response & Recovery Subcommittee held a joint hearing entitled Reviewing Federal and State Pandemic Supply Preparedness and Response. Oversight, Management & Accountability Subcommittee Chairwoman Xochitl Torres Small (D-NM), Emergency Preparedness, Response, & Recovery Subcommittee Chairman Donald Payne Jr. (D-NJ), and Homeland Security Chairman Bennie G. Thompson (D-MS) commented on states competing for personal protective equipment (PPE) and how some areas faced shortages. Oversight, Management & Accountability Subcommittee Ranking Member Dan Crenshaw (R-TX) called to strengthen the U.S.’s medical supply chain domestically and highlighted U.S. companies that converted to producing PPE. Witnesses included: Craig Fugate, Former Administrator, FEMA, Senior Advisor, Blue Dot Strategies; Chris Currie, Director, Homeland Security and Justice team, U.S. Government Accountability Office; and Mark Ghilarducci, Director, Office of Emergency Services, Governor’s Office, California.

  • On July 14, Sens. Elizabeth Warren (D-MA), Chris Van Hollen (D-MD), and Catherine Cortez Masto (D-NV) requested that Federal Reserve Chairman Jerome Powell and Treasury Department Secretary Steve Mnuchin provide direct financial assistance to state and local governments to stabilize the economy.

  • On July 14, Democrats on the Coronavirus Crisis Select Subcommittee – including Reps. Carolyn B. Maloney (D-NY), Nydia M. Velázquez (D-NY), Bill Foster (D-IL), Jamie Raskin (D-MD), and. Andy Kim (D-NJ) – asked HHS, the Department of Defense, the Department of Homeland Security, and the Department of Veterans Affairs (VA) for an explanation of COVID-19 related contracts that were awarded to politically connected or inexperienced companies. The letter also requested biweekly updates on the projected supply and demand for PPE and testing supplies beginning on July 20, 2020.

  • On July 14, Sen. Elizabeth Warren (D-MA) and Rep. Ayanna Pressley (D-MA) requested that HHS provide information on racial health disparities, as required by the ACA. The letter also requests information on the plans and actions HHS has made to address racial health disparities exacerbated by COVID-19.

  • On July 16, Senate Democrats unveiled the Economic Justice Act, which would provide $350 billion funding for communities of color including $135 billion in immediate funding for childcare, mental health, primary care, jobs, and small businesses, as well as $215 billion for infrastructure and Medicaid expansion over the next five years. Funding would partially come from unspent money from the CARES Act. A summary of the proposal is available here.

  • On July 16, Sen. Rick Scott (R-FL) suggested the Treasury Department should trace and publicly report how the $1 trillion for state and local governments from the CARES Act was distributed, before Congress approves additional funding. Sen. Scott raised transparency concerns and questioned if the Department plans to make COVID-19 spending information available and accessible to taxpayers.

  • On July 16, Sen. Bob Casey (D-PA) proposed S. 4108, the Coronavirus Medicaid Response Act. This bill would automatically link the Medicaid Federal Medical Assistance Percentage (FMAP) to state unemployment levels, allowing that federal aid to change based on a state’s economic situation. A summary is available here.

  • On July 16, Senate Finance Ranking Member Ron Wyden (D-OR) asked the White House Office of Management and Budget (OMB) to increase transparency measures surrounding CARES Act funding by creating a comprehensive public database of funds distributed to health care providers.

Regulatory

  • On July 13, the FDA granted “Fast Track” status to two mRNA-based experimental COVID-19 vaccines created by Pfizer and BioNTech. On July 10, BioNTech’s chief executive officer projected the vaccine candidate is expected to be ready to seek regulatory approval by the end of 2020 and several hundred million doses could be produced before the approval.

  • On July 13, 3M and researchers at MIT received $500,000 in funding from NIH’s Rapid Acceleration of Diagnostics Tech program for the development of a rapid point-of-care (POC) coronavirus antigen test.

  • On July 13, the FDA published a proposed rule entitled Authorization of Emergency Use of Certain Medical Devices during COVID-19. This rule reissues the EUAs for certain medical devices related to COVID-19.

  • On July 13, the FDA revoked the EUA given to Chembio Diagnostic Systems for their COVID-19 antibodies test.

  • On July 14, HHS published new guidelines on reporting COVID-19 data, requesting hospitals to send COVID-19 data to HHS, not the CDC, to streamline data collection and inform federal level decisions. Congressional Democrats and public health experts, including the Infectious Diseases Society of America, suggested the change will reduce transparency and create potential for the data to become politicized.

  • On July 14, HHS announced it will deploy rapid POC diagnostic tests to nursing homes in “hotspots” for nursing home residents and staff, and potentially visitors. Distribution of diagnostic test instruments and tests will begin next week. HHS will distribute BD Veritor systems and Quidel Sofia and Sofia 2 systems for antigen testing.

  • On July 14, the FDA published an update on the COVID-19 drug development programs in the Coronavirus Treatment Acceleration Program (CTAP), including a breakdown of what types of treatments are being studied. To date, the Agency has reviewed over 230 trials of potential COVID-19 therapies and granted EUAs to two drugs, Gilead’s remdesivir and a sedative produced by Fresenius for patients on ventilators (Propoven 2%).

  • On July 15, CMS Administrator Seema Verma published a Health Affairs blog on telehealth. Verma writes that CMS recognizes the increased use of telehealth services as an alternative for in person services during the pandemic and is reviewing which temporary changes should be made permanent. CMS plans to assess the clinical safety of telehealth, Medicare payment rates for telehealth services, and how to monitor fraud and abuse.

  • On July 17, HHS announced it will begin distributing an additional $10 billion from the Provider Relief Fund to hospitals located in COVID-19 “hotspots” starting next week.

  • On July 17, CMS released an update to the Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19). This report provided updated guidelines for testing nursing home residents and patients and an update on applying the Skilled Nursing Facility (SNF) benefit period waiver.

  • On July 18, the FDA granted an EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

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

Other

  • On July 10, America’s Health Insurance Plans (AHIP) and Blue Cross Blue Shield Association sent a letter to House and Senate leadership to support a series of policies in the next pandemic relief package. The letter recommends policies to ensure health care affordability for employers and patients; ensure access to widespread testing for COVID-19 with federal funding; support patient access to a safe, effective and affordable vaccines; strengthen support for MA and Part D beneficiaries; bolster support for State Medicaid programs seniors and people with disabilities; and delay the implementation of the Medicaid Fiscal Accountability Regulation and the interoperability rule.

  • On July 10, Gilead released data on their COVID-19 antiviral remdesivir. The company found that remdesivir was associated with an improvement in clinical recovery and a 62% reduction in mortality, compared with the standard of care.

  • On July 13, the American Clinical Laboratory Association released a statement that labs are receiving more tests than they are able to process and urged providers to prioritize testing for those most in need. Furthermore, Quest Diagnostics said that due to high demand from hotspot areas, its average turnaround time for non-priority COVID-19 diagnostic testing is now at least seven days, up from four to five days at the end of June.

  • On July 13, the National Center for Coverage Innovation at FamiliesUSA issued a report entitled The COVID-19 Pandemic and Resulting Economic Crash Have Caused the Greatest Health Insurance Losses in American History. The report found that an estimated 5.4 million workers who lost their jobs or left the labor force due to COVID-19 became uninsured between February to May, an increase 39% larger than any annual increase ever recorded. Nearly half of all newly uninsured live in California, Texas, Florida, New York, and North Carolina. The report urged federal lawmakers to take action to protect comprehensive health insurance in the next COVID-19 bill. A summary of the report is available here.

  • On July 14, Moderna published positive results from a Phase I clinical trial of its experimental vaccine (mRNA-1273) in the New England Journal of Medicine, showing a provoked immune response (i.e., a notable increase in neutralizing antibodies) without major side effects in all 45 of its healthy volunteers. Moderna plans to enroll 30,000 people in a Phase III trial on July 27. So far, Moderna has received over $500 million from the federal government for its vaccine and has conducted its clinical trials in partnership with the National Institute of Allergy and Infectious Diseases (NIAID).

  • On July 14, FAIR Health published a brief entitled Key Characteristics of COVID-19 Patients: Profiles Based on Analysis of Private Health Care Claims. The brief found that the median charge in commercial plans for a hospitalization for COVID-19 ranged from $34,662 to $45,683, with variation depending on age group.

  • On July 15, Kaiser Family Foundation (KFF) released a study entitled COVID-19 Test Prices and Payment Policy. The report showed that large hospitals charge between $20 to $850 for a single, out-of-network COVID-19 diagnostic test. In comparison, Medicare pays for $51 or $100, depending on the type of test. According to KFF, the median price was $127 and roughly half were priced between $100-$199. Furthermore, prices for antibody tests range between $36 to $300, with 82% of posted prices below $150. Though the Families First Coronavirus Response Act (FFCRA) and CARES Act had the goal of eliminating cost barriers for COVID-19 testing for patients, KFF concludes that cost may still be a hurdle for patients accessing care during COVID-19 regardless of their insurance coverage.

  • On July 15, the Urban Institute published an analysis estimating that 10.1 million adults will lose their employer-sponsored insurance because of the pandemic during the last three quarters of 2020. According to the analysis, the largest cohort of this population, roughly 35%, will become uninsured, while 32% will switch to another source of employer coverage through a family member, 28% will enroll in Medicaid, and six percent will turn to the ACA marketplace. Furthermore, about 55% of the people estimated to become uninsured are eligible for, but do not use, subsidized coverage through Medicaid or the marketplace.

  • On July 15, Gavi, an international vaccine alliance, announced that 75 countries, including France, Germany, Italy and the Netherlands, signed onto the public-private partnership to jointly purchase COVID-19 vaccines.

  • On July 15, the Committee for a Responsible Federal Budget published a report finding a difference in economic output due to COVID-19 to be $750 billion over the next six months, or $2 trillion over two years.

  • On July 16, more than 100 U.S. scientists and ethicists voiced support in a letter sent to the NIH of human challenge studies, accelerating the vaccine development process by intentionally infecting people with the COVID-19.

  • On July 16, a study published by international scientists in The Lancet found that COVID-19 contact tracing cannot reduce transmission when testing results are delayed by several days.

  • On July 16, AARP launched a national ad campaign and sent letters to Congress to send more supplies to nursing homes and require greater transparency.

  • On July 16, the Rockefeller Foundation published a report entitled the National COVID-19 Testing & Tracing Action Plan. The plan calls for at least 25 million fast and affordable diagnostic tests per week to identify asymptomatic Americans, reducing the turnaround time for diagnostic tests to 48 hours, and improved communication and contact tracing. The report also calls for an additional $75 billion for testing in the next stimulus bill and for the Defense Production Act to be invoked to oversee the production and distribution of diagnostic tests. 

  • On July 17, a new study found that dexamethasone, a low cost steroid, can help reduce the risk of death for seriously ill COVID-19 patients. However, researchers concluded there is a lack of clear benefit and possibility of harm for using dexamethasone for COVID-19 patients not receiving oxygen.

  • As of July 17, the U.S. had 3,626,500 confirmed COVID-19 cases resulting in 138,979 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

  • 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

  • FY 2021 Inpatient Psychiatric Facilities Prospective Payment System Rate Updates (CMS-1731); Final Rule; Received 7/6/20 FY 2021

  • FY2021 Skilled Nursing Facility (SNFs) Prospective Payment System Rate and Value-Based Purchasing Program Updates (CMS-1737); Final Rule; Received 7/9/20

  • Hospice Wage Index, Payment Rate Update (CMS-1733); Final Rule; Received 7/9/20

  • FY 2021 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update (CMS-1729); Final Rule; Received 7/10/20

  • Basic Health Program; Federal Funding Methodology for Program Year 2021 (CMS-2432-PN); Final Rule; Received 7/10/20

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 6/19/20

  • Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff; Notice; Received 7/8/20

  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Guidance for Industry; Availability; Notice; Received 7/8/20

HHS-HRSA

  • National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Notice; Received 7/9/20

REPORTS     

HHS Office of Inspector General (OIG)

  • On July 13, OIG released an audit entitled Texas Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities. According to OIG, Texas did not ensure that all beneficiary deaths were reported and reviewed; that all complaints not closed within 10 days were tracked; and that all allegations of abuse, neglect, and exploitation were entered into the Human Services Enterprise Administration Reporting and Tracking (HEART) system. OIG provides three recommendations to the state: ensure that procedures are followed to detect unreported deaths; implement a system to ensure that it can track complaints not closed within 10 days; and implement procedures to ensure that investigations of abuse, neglect, and exploitation are entered in the HEART system. Texas agreed to the findings and recommendations of the audit and described actions that it has taken or plans to take to address them. A summary of the audit is available here.

  • On July 14, OIG released a report entitled Medicaid Data Can be Used to Identify Instances of Potential Child Abuse or Neglect. OIG determined Medicaid claims data can be used to identify incidents of potential child abuse or neglect and identified that almost all children in the sample were potential victims. OIG recommends that CMS should require states to report potential abuses, under their mandatory reporting laws and consider strengthening oversight over such cases. In comments on the OIG draft report, CMS agreed to strengthening oversight but did not agree with extending mandatory reporting. A summary of the audit is available here.

  • On July 15, OIG issued a report entitled Hospitals Overbilled Medicare $1 Billion by Incorrectly Assigning Severe Malnutrition Diagnosis Codes to Inpatient Hospital Claims. The report found that hospitals incorrectly billed Medicare for severe malnutrition diagnosis codes in 86.5% of reviewed claims, resulting in estimated $1 billion in hospital overpayments for FYs 2016 and 2017. OIG recommends CMS collect incorrectly billed hospital claims included in the study and review claims not included in the sample. OIG also recommends working with hospitals to ensure correct billing practices when using severe malnutrition diagnosis codes. A summary of the report is available here.

  • On July 16, OIG issued an audit report entitled CMS Did Not Administer and Manage Strategic Communications Services Contracts in Accordance With Federal Requirements. OIG determined CMS did not administer and manage contracts audited between June 2017 through April 2019 in accordance with federal requirements. Specifically, CMS violated requirements by allowing subcontractors to perform governmental functions and administering strategic communications services contracts as personal services contracts. OIG also found that CMS did not properly manage contract deliverables and approve the use of a subcontractor, did not maintain complete working files for the contracts, and paid some questionable costs. OIG recommends HHS and CMS improve contract management and review whether any HHS or CMS contracts are not in current compliance with federal requirements. HHS agreed to follow OIG’s recommendations but CMS did not agree with the report's findings and did not comment on the presented recommendations. A summary of the report is available here. In response to the report, some Congressional Democrats have suggested Administrator Verma should be removed from her post. 

Government Accountability Office (GAO)

  • On July 14, GAO released a report entitled COVID-19: FEMA's Role in the Response and Related Challenges. The report identified potential challenges FEMA faces in responding to the pandemic and areas to improve in based on previous reports, including: coordinating and communicating with states and localities on advance contracts; managing supplies distribution, acquisition, and the adequacy of the SNS; addressing staffing shortages and other workforce challenges; consistently completing after-action reports; and coordinating and planning interagency preparedness efforts. A summary of the report is available here.

  • On July 14, GAO released a report entitled Medicaid: Primer on Financing Arrangements. This report details different ways states can finance the nonfederal share of state's Medicaid expenditures and shift share of the cost to local governments, providers, and the federal government. States use general funds, including intra-agency funds; state provider taxes; intergovernmental transfers from local governments; and certified public expenditures. A summary of the report is available here.

  • On July 17, GAO released a report entitled VA Health Care: Actions Needed to Improve Oversight of Graduate Medical Education Reimbursement. This report found that Veterans Health Administration (VHA) policy, guidance, training, and the tools distributed for disbursement agreement oversight were inefficient, unclear, and did not reflect the distinct purposes officials described. GAO also concluded that identified overlapping mechanisms cause inefficiencies and put unnecessary burden on VA medical facility staff. GAO recommended better defining policies, reducing overlapping mechanisms, and improving the oversight mechanisms training. VHA agreed with the recommendations. A summary of the report is available here.

UPCOMING HEARINGS

Senate 

  • Note of note.

House

  • Oversight and Reform Government Operations Subcommittee

July 20, 1:30 p.m., 2154 Rayburn House Office Building

Federal IT Modernization: How the Coronavirus Exposed Outdated Systems

Witnesses include: Steve O'Keeffe, Founder, MeriTalk; Matthew Cornelius, Executive Director, Alliance for Digital Innovation; Hana Schank, Director of Strategy, Public Interest Technology, New America; Gordon Bitko, Senior Vice President of Policy, Information Technology Industry Council

  • Energy & Commerce Oversight Subcommittee

July 21, 10:00 a.m., Virtual

Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine

Witnesses include: Mene Pangalos, MD, Executive Vice President, BioPharmaceuticals R&D AstraZeneca; Macaya Douoguih, MD, Head of Clinical Development and Medical Affairs, Janssen Vaccines, Johnson & Johnson; Julie Gerberding, MD, Executive Vice President and Chief Patient Officer, Merck; Stephen Hoge, President, Moderna; John Young, Chief Business Officer, Pfizer

  • Special Committee on Aging

July 21, 9:30 a.m., Senate Dirksen Office Building 562

The COVID-19 Pandemic and Seniors: A Look at Racial Health Disparities

Witnesses include: Dominic Mack, Professor of Family Medicine, Director, Morehouse School of Medicine's National Center For Primary Care; Rodney Jones, CEO, East Liberty Health Center; Eugene Woods, President, CEO, Atrium Health; Mercedes Carnethon, Professor of Epidemiology, Vice Chair, Northwestern University's Department of Preventive Medicine

  • Education & Labor Early Childhood, Elementary & Secondary Education Subcommittee

July 23, 10:15 a.m., 2175 Rayburn House Office Building

Hearing to Examine the Reopening of Schools

CDC Director Robert Redfield was invited to testify.

  • Ways and Means Trade Subcommittee

July 23, 2:00 p.m.

Trade, Manufacturing, and Critical Supply Chains: Lessons from COVID-19

Details will be forthcoming.

OTHER HEALTH POLICY NEWS

  • On July 13, the Supreme Court published its October schedule. Notably, the Court will not hear Texas v. California (the major suit challenging the constitutionality of the entire ACA) in October. However, on October 6, the Court will hear arguments for Rutledge v. Pharmaceutical Care Management Association, which questions whether states can regulate pharmacy benefit managers.

  • On July 13, Presumptive Democratic nominee Joe Biden expressed openness to eliminating the Senate filibuster, assuming Democrats gain majority of the upper chamber in November.

  • On July 14, the Center for American Progress (CAP) released a report entitled Administrative Actions to Reverse Sabotage and Lower Costs in the ACA Marketplaces. The report outlines policy options to undo measures enacted by the Trump administration that have “undermined” the ACA, as well lower premiums and improve the functioning of the nongroup market. Among other things, CAP proposes to reallocate funds to administer and publicize HealthCare.gov; restore funds for outreach and enrollment support; broaden the enrollment period; issue a special enrollment period in early 2021; and reverse the Trump administration’s expansion of  short-term, limited-duration plans (STLD). The report also outlines actions for the next administration to make ACA marketplaces accessible and user-friendly, including upgrading HealthCare.gov; adopting a standardized benefit plan; requiring plans on the federal marketplace to incorporate payment and delivery reforms; making participating in MA contingent upon participation in the marketplaces; and encouraging states with their own marketplace to implement reinsurance programs.

  • On July 14, the American Action Network launched an ad campaign in support of H.R. 19, the Lower Costs, More Cures Act of 2019, House Republicans’ counter proposal to Democrat’s H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act. The ads are airing in 16 GOP districts, highlighting their lawmakers’ support of the bill. 

  • On July 15, UnitedHealth reported $6.64 billion in earnings and a 3% increase in total revenue (amounting to $62.14 billion) during the second quarter. Regarding Medical Loss Ratio (MLR), United spent 70 cents in claims for every dollar in premiums, down from to 83 cents last year.

  • On July 17, in a 2-1 ruling, the U.S. Court of Appeals for the D.C. Circuit upheld a Trump administration rule that expanded how long consumers could enroll in STLD plans, which are exempt from certain ACA rules. Specifically, Judge Thomas Griffith concluded that the rule is consistent with the ACA’s goal to increase coverage "by expanding coverage to the uninsured, including those in the Medicaid coverage gap, at the expense of higher unsubsidized premiums for comprehensive insurance." In contrast, Judge Judith Rogers dissented that the rule undermines the ACA’s “interlocking reforms” and provoked “the same problems in the health insurance market that the ACA was designed to solve.” The Association for Community Affiliated Health Plans indicated it will appeal the ruling to the full D.C. appellate court.

  • On July 17, BioPRIA and Monash University’s Chemical Engineering Department published results of a new test that can determine COVID-19 in about 20 minutes.

  • July 18, Ways and Means Committee Member and civil rights leader John Lewis (D-GA) passed away.