The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 20 – 27. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
Senate
On July 20, the Senate confirmed Russell Vought as the director of the Office of Management & Budget (OMB) in a 51-45 party-line vote. Vought has served as the Acting Director for more than one year.
House
On July 24, the House voted 224-189 to pass its first Fiscal Year (FY) 2021 minibus, H.R. 7608, which packages the State-Foreign Operations, Agriculture-Rural Development, Interior-Environment, and Military Construction-Veterans Affairs (VA) spending bills. A division-by-division summary is available here. The measure is projected to cost nearly $260 billion over ten years.
The House is expected to consider its second FY2021 appropriation minibus the week of July 27. The package, H.R. 7617, combines seven spending bills, including Labor-Health & Human Services (HHS)-Education, Defense, Commerce-Justice-Science, Energy-Water Development, Financial Services, Homeland Security, and Transportation-Housing & Urban Development. A division-by-division summary is available here.
House members have been advised to not make plans during the first week of August, when the Senate is in session, in the event it needs to consider the next pandemic relief package.
NON-CORONAVIRUS REGULATORY UPDATE
On July 19, the Centers for Medicare & Medicaid Services (CMS) will resume auditing health care providers' Medicare fee-for-service claims on August 3. CMS suspended medical reviews in March due to the pandemic.
On July 20, the Center for Medicare & Medicaid Innovation awarded $126 million to eight participants of the Integrated Care for Kids Model, a seven-year demonstration to improve child health outcomes, reduce avoidable out of home placement and inpatient stays, and create sustainable alternative payment models to support provider accountability for cost and quality outcomes.
On July 20, the Food & Drug Administration (FDA) extended the enforcement discretion policy for certain human cell, tissue, cellular and tissue-based products (HCT/Ps). This extension gives manufacturers an additional six months to determine if they need to submit an investigational new drug or marketing application.
On July 21, the Department of Justice (DOJ) charged two Chinese men with hacking into the computer systems of companies to steal intellectual property and other valuable business information over the course of 10 years. The impacted organizations include pharmaceutical companies, some of which are developing COVID-19 vaccines and treatments.
On July 21, OMB received a CMS final rule entitled Modernizing and Clarifying the Physician Self-Referral Regulations and a final rule from HHS Office of Inspector General (OIG) entitled Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement.
On July 22, HHS and the American Society of Nephrology announced the six winners of the $3 million KidneyX: Redesign Dialysis Phase 2 competition. Each recipient will receive $500,000. The competition was created to encourage the development of innovation technologies to replicate normal kidney functions or improve dialysis access.
On July 23, the FDA published a proposed rule entitled Annual Summary Reporting Requirements Under the Right to Try Act. This rule would require drug companies to annually report patient requests to use experimental medicines under the “Right to Try” pathway. Comments are due by September 22, 2020.
On July 23, the DOJ charged Taro Pharmaceuticals with a two-count felony for conspiring to fix prices for generic drugs between 2013 and 2015. The DOJ and Taro reached a $205.7 million settlement to drop the charges and Taro Pharmaceuticals admitted that its sales due to these actions were in excess of $500 million. Taro Pharmaceuticals will also pay restitution and $213.3 million in civil damages tied to health care program claims.
On July 23, FDA held its first meeting to discuss the Reauthorization of the Prescription Drug User Fee Act for FY2023 through FY2027.
On July 23, FDA recommended that all health care providers discuss naloxone when prescribing opioids or medicines to treat opioid use disorder. An FAQ is available here.
White House
On July 24, President Donald Trump signed three Executive Orders (EOs) to lower drug prices, none of which are immediately enforceable and would likely require a lengthy rulemaking process that is unlikely conclude prior to the November election:
The Lowering Prices for Patients by Eliminating Kickbacks to Middlemen EO eliminates rebates between drug manufacturers and pharmacy benefit managers to ensure patients benefit directly from manufacturer discounts at the point of sale.
The Increasing Drug Importation to Lower Prices for American Patients EO allows states to import certain drugs from abroad, authorizes the re-importation of insulin, and creates a pathway for personal importation.
The Access to Affordable Life-Saving Medications EO requires Federally Qualified Health Centers (FQHCs) to pass 340B discounts for insulin and epinephrine to certain low-income patients.
A fourth EO’s language was not released, but according to President Trump, seeks to ensure that the U.S. pays the lowest price available among developed countries for Medicare Part B drugs (known as the “favored nations” policy). This EO would be triggered on August 24, unless Congress passes sufficient drug pricing legislation or if the pharmaceutical industry presents an alternative option that is passed by Congress.
CORONAVIRUS UPDATE
Legislative
On July 20, Appropriations Committee Ranking Member Patrick Leahy (D-VT), Defense Subcommittee Vice Chairman Dick Durbin (D-IL), HELP Ranking Member Patty Murray (D-WA), and Homeland Security Ranking Member Jon Tester (D-MT) requested that President Trump utilize unspent funds and resources allocated in previous COVID-19 relief packages to increase production of Personal Protective Equipment (PPE) and testing capacity.
On July 21, the House Energy & Commerce Oversight & Investigations Subcommittee held a hearing entitled Pathway to a Vaccine: Efforts to Develop a Safe, Effective, and Accessible COVID-19 Vaccine. Committee leadership expressed concern that the safety and efficacy of a potential vaccine may be compromised in order to develop a vaccine quickly. They also emphasized the need for a vaccine to be widely available at little or no cost to Americans and called for a plan to scale up manufacturing of vaccines and associated supplies. Representatives from drug companies with developing vaccines testified that they would depend on the U.S. government to allocate and distribute their products. Additionally, they did not believe FDA’s standards for approval would compromise safety and efficacy, noting that a vaccine would be a global product and must meet the clinical standards set by countries around the world. Witnesses from Merck and Moderna pledged they would sell their vaccines at cost. Similarly, Janssen promised to sell its vaccine on a “not-for-profit” basis and Pfizer indicated its vaccine would be priced responsibly. Witnesses included: 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; and John Young, Chief Business Officer, Pfizer.
On July 21, the Senate Special Committee on Aging held a hearing entitled The COVID-19 Pandemic and Seniors: A Look at Racial Health Disparities. Chairwoman Susan Collins (R-ME) highlighted disparities in COVID-19 cases among racial and ethnic minorities. Ranking Member Bob Casey (D-PA) emphasized the importance of health equity for older people of color and outlined measures to be included in the next pandemic relief package that assists nursing homes and elderly Americans. Witnesses included: Dominic Mack, Professor of Family Medicine, Director, Morehouse School of Medicine's National Center for Primary Care; Rodney Jones, Chief Executive Officer (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.
On July 21, Rep. Joe Kennedy (D-MA) released a resolution calling for universal behavioral health care and to address the systemic inequities of the current system. This week, Rep. Kennedy proposed:
The Virtual Community Support Act, to provide training and development to increase the workforce, enable providers and peers to move their services virtually, and help identify and coordinate care for those who need access to multiple services, through Substance Abuse & Mental Health Services Administration;
The Crisis Counseling Act, to automatically approve requests by any state, territory, and tribe for a Crisis Counseling and Training Program after it had been granted a Stafford Act declaration, through Federal Emergency Management Agency (FEMA); and
The Behavioral Health Coordination and Communication Act, to create an Interagency Coordinator to oversee all federal behavioral health efforts, mandate reports and proposals to identify systemic gaps, and study the potential incorporation of mental health and substance use disorder screenings as a vital sign
On July 21, 34 Senators, led by Sen. Cory Booker (D-NJ), requested that President Trump reverse his decision to withdraw from the World Health Organization. Furthermore, Sens. Leahy and Chris Coons (D-DE) introduced legislation to ban the use of Congressionally appropriated funds to terminate the U.S.’ membership from the organization.
On July 22, Energy & Commerce Committee Chairman Frank Pallone (D-NJ), Health Subcommittee Chair Anna Eshoo (D-CA), Oversight & Investigations Subcommittee Chair Diana DeGette (D-CO), and Consumer Protection & Commerce Subcommittee Chair Jan Schakowsky (D-IL) asked the Federal Trade Commission and the FDA to provide information on fraudulent antibody tests. Specifically, the lawmakers requested that the agencies describe how prevalent antibody testing scams are, what current market monitoring systems are in place, and how investigations are launched and conducted.
On July 22, the House Homeland Security Committee held a hearing entitled Examining the National Response to the Worsening Coronavirus Pandemic: Part II. FEMA Administrator Peter Gaynor testified that many states report having equipment stockpiles that could last 60 or 90 days or more; however, he warned that the U.S. does not have enough PPE to keep up with increased demand, due to the reliance on other countries for the equipment. Administrator Gaynor was the sole witness.
On July 22, Sens. Bob Menendez (D-NJ) and Ben Cardin (D-MD) introduced The COVID-19 Health Disparities Action Act, a bill to address the disproportionate impact of COVID-19 on communities of color. Specifically, it would direct HHS to develop an action plan, make targeted grants, and implement public awareness campaigns to mitigate the disease’s impact on vulnerable populations.
On July 23, the House Ways & Means Trade Subcommittee held a hearing entitled Trade, Manufacturing, and Critical Supply Chains: Lessons from COVID-19. Trade Subcommittee Chair Earl Blumenauer (D-OR) underscored the lack of transparency into U.S. supply chains and the decline of U.S. manufacturing capacity. Trade Subcommittee Ranking Member Vern Buchanan (R-FL) advocated for tax cuts and incentives to improve the U.S. supply chain in order to accomplish greater medical independence. Witnesses included: Erica Fuchs, Professor of Engineering and Public Policy, Carnegie Mellon University; Prashant Yadav, Senior Fellow, Center for Global Development; Roxanne Brown, International Vice President at Large, United Steelworkers; Kim Glas, President and CEO, National Council of Textile Organizations; and Thomas Duesterberg, Senior Fellow, Hudson Institute.
On July 23, 24 House Democrats expressed their concern to HHS Secretary Alex Azar regarding the transparency and oversight of Operation Warp Speed (OWS). The representatives had specific concerns with how candidates are selected to participate in OWS and how vaccines and therapeutics will be priced and distributed to the public.
On July 24, Senate Homeland Security & Governmental Affairs Committee held a hearing entitled The Role of the Strategic National Stockpile (SNS) in Pandemic Response. Committee Chairman Ron Johnson (R-WI) called for an update and redesign of the structure and management of the SNS. Committee Ranking Member Gary Peters (D-MI) called for an improvement in communication between the federal government and the states and in domestic manufacturing of critical drugs and medical supplies. Witnesses included: Julie Gerberding, MD, former Director, Centers for Disease Control & Prevention (CDC); Daniel Gerstein, Senior Policy Researcher, RAND Corporation; W. Gregory Burel, Former Director, SNS, HHS; and Andrew Phelps, Director, Oregon Office of Emergency Management, on behalf of the National Emergency Management Association.
The Senate GOP plans to introduce its pandemic relief proposal the week of July 27, with hopes of clearing the package before the chamber’s August recess. The legislation, anticipated to cost at least $1 trillion, is expected to include:
$25 billion for testing;
$105 billion for schools;
liability protections (draft available here);
targeted direct payments to individuals;
tax credit for vaccine research and development;
flat unemployment payment for two months;
$90 billion for the Paycheck Protection Program for certain small businesses; and
expanded flexibility for states and local governments to spend previously appropriated federal aid.
Some GOP lawmakers have suggested there may be multiple iterations of the GOP bill and that the enhanced unemployment benefits (expiring on July 31) could be extended as a stand-alone measure.
White House
On July 22, the Deborah Brix of the Coronavirus Task Force privately warned 11 cities of their increased positive COVID-19 cases and encouraged state and local leaders to take aggressive steps to mitigate their outbreaks. The 11 identified cities included Baltimore, Cleveland, Columbus, Indianapolis, Las Vegas, Miami, Minneapolis, Nashville, New Orleans, Pittsburgh, and St. Louis.
Regulatory
On July 20, the HHS Office for Civil Rights released guidelines entitled Civil Rights Protections Prohibiting Race, Color and National Origin Discrimination During COVID‐19: Application of Title VI of the Civil Rights Act of 1964. The guidelines outline Title VI compliance requirements for federally funded health care providers to prevent discrimination based on race, color, and national origin during the pandemic. A summary is available here.
On July 20, HHS released its new COVID-19 data system entitled HHS Protect, replacing CDC’s platform for publicly reporting COVID-19 hospital data. According to Secretary Azar, the new approach will be more transparent and capture a wider range of health information. It will collect data from about 4,500 hospitals daily and will use the same predictive models as the CDC platform. Some of the data will be made publicly available. Some hospitals are facing issues transitioning to this new system.
On July 21, HHS unveiled the National COVID-19 Testing Implementation Forum, a group of industry stakeholders that will advise federal officials on how to improve the nation’s testing capacity.
On July 21, the Trump administration filed a legal brief under Chicago v. Azar, defending its decision to not create a special enrollment period (SEP) for the federal marketplace during the pandemic. The brief argues this decision is not unlawful and that reopening Healthcare.gov would attract sicker patients and increase insurance premiums. The city of Chicago maintains that the Administration was compelled to issue an SEP in response to the “exceptional circumstances” consumers faced during the pandemic.
On July 22, OWS reserved 100 million doses of the Pfizer-BioNTech investigational vaccine for $1.95 billion. Following FDA approval or an Emergency Use Authorization, the doses will be made available to Americans at no cost; however, providers could still charge for administration. The deal also specifies that OWS can acquire up to 500 million additional doses at a later date. This marks the largest contract OWS has negotiated to date.
On July 22, CMS announced $5 billion from the Provider Relief Fund will be devoted to nursing homes to combat COVID-19 transmission. Nursing homes will now be required to test all staff every week in states with at least a 5% COVID-19 positivity rate; CMS will provide 15,000 testing devices over the next few months to support this mandate. Additionally, CMS and the CDC will provide online educational resources to nursing homes and the White House and CMS will update states weekly on facilities with a notable increase in cases.
On July 22, the National Institutes of Health (NIH) selected 27 tests to enter the first phase of its $1.5 billion Rapid Acceleration of Diagnostics program, which was created to encourage innovation for point-of-care diagnostic tests. Over 600 tests developers have applied to the program.
On July 23, Secretary Azar extended the Public Health Emergency (PHE) declaration for another 90 days; it will now expire in late October.
On July 23, the CDC released updated school guidelines entitled Preparing K-12 School Administrators for a Safe Return to School in Fall 2020. The guidance outlines how administrators should plan for reopening schools in the fall and includes suggestions on how to accommodate the unique needs of each school.
On July 23, CMS released a report entitled Early 2020 Effectuated Enrollment Snapshot for the Affordable Care Act (ACA) Exchanges. The report shows that enrollment remains steady and the number of consumers who paid for coverage in February 2020 increased compared to February 2019, from 10.6 million to 10.7 million people. There was also a decline in average total monthly premium, from $594.17 in February 2019 to $576.16 in February 2020.
On July 23, DoJ announced it will not prevent companies currently working on a COVID-19 treatment from sharing information regarding manufacturing facilities and the production of monoclonal antibody treatments. This announcement follows a letter from Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GSK, requesting that potential collaboration to not be deemed in violation of ani-trust laws.
Other
On July 20, Synairgen announced positive Phase I trial results showing that its investigational nebulizer reduced risk of developing “severe” COVID-19 by 79% in a randomized controlled trial of 101 patients. The results have not been peer-reviewed and the full study has been released.
On July 20, AstraZeneca and Oxford University published Phase I clinical trial data on their vaccine candidate in the Lancet. The trial concluded the vaccine is safe and triggers a strong immune response. Phase II/III trials have begun, which will examine the vaccine’s effectiveness. AstraZeneca has agreed to provide the U.S. 300 million doses of the vaccine this fall.
On July 20, CanSino Biologics published Phase II trial results of its vaccine candidate in the Lancet. The vaccine provoked a strong immune response in a 500-person trial. Phase III trials are underway.
On July 20, Pfizer and BioNTech announced that their prospective mRNA-based vaccine generated high levels of antibodies in a Phase I/II trial, which took place in Germany. The preliminary clinical results support data from a previous U.S. trial.
On July 21, the American Economic Liberties Project and Public Citizen urged Ways & Means Committee Chairman Richard Neal (D-MA) to extend the surprise billing ban from COVID-19 related services to all health care services.
On July 21, the Kaiser Family Foundation (KFF) released a report entitled Rising Cases in Long-term Care Facilities are Cause for Concern. KFF found that over a 14 day period ending July 10, cases in long-term care cases in “hotspot” states increased more than four times the rate as long-term care cases in non-hotspot states, even with strict safety protocols. KFF predicted that ongoing staff limitations, PPE shortages, and community spread may be contributing to the continued spread of cases in long-term care facilities.
On July 21, AdvaMed released a registry that shows how many COVID-19 tests are being manufactured and shipped nationwide by 13 commercial diagnostics manufacturers. The registry will provide weekly updates on the number of molecular, antigen, and antibody tests shipped in the U.S on both a state and national level.
On July 21, scientists from 16 state departments of health and the CDC COVID-19 Response Team published a JAMA article concluding that that certain areas in the U.S. had six to 24 times more COVID-19 infections than were originally estimated from March 23 to May 12, 2020. Sites examined in the study include: San Francisco Bay area, California; Connecticut; south Florida; Louisiana; Minneapolis-St Paul-St Cloud metro area, Minnesota; Missouri; New York City metro area, New York; Philadelphia metro area, Pennsylvania; Utah; and western Washington State.
On July 21, the National Academies of Sciences, Engineering & Medicine announced it will form a committee to recommend how to equitably distribute potential vaccines, per requests from the NIH and CDC. The committee will consider criteria such as population health disparities, health risk level, occupation, and geographic distribution of active virus spread. The committee held its first meeting July 24.
On July 21, KFF released a report entitled An Early Look at 2021 Premium Changes on ACA Exchanges and the Impact of COVID-19 on Rates. The report concludes that many rate changes for FY2021 appear to be moderate, ranging from a 12.0% decrease to a 31.8% increase, with more than half of premiums in the sample falling between a 2.0% decrease and 6.0% increase. KFF noted that because many insurers have not yet incorporated a rate impact from the pandemic, it is too early to know how marketplace premiums will change next year.
On July 21, the National Community Pharmacists Association outlined their requests for executive action on drug pricing, including eliminating retroactive pharmacy direct and indirect remuneration fees, ensuring timely reimbursements, increased claim transparency, eliminating pharmacy liability and implementation costs associated with the rebate rule, ensuring proper agency oversight, including small business protections, and allowing pharmacies to choose trading partners.
On July 22, the American Hospital Association (AHA), American Medical Association (AMA), and American Nurses Association urged Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schumer (D-NY) to allocate an additional $100 billion in the next pandemic relief package for front line health care providers and personnel.
On July 23, a study funded by the hospitals and research institutes participating in “Coalition Covid-19 Brazil” and published in the New England Journal of Medicine concluded that hydroxychloroquine did not improve hospitalized patients with mild-to-moderate COVID-19.
As of July 27, the U.S. had 4,233,927 confirmed COVID-19 cases resulting in 146,934 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 (Health Resources & Services Administration)
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Notice; Received 7/9/20
REPORTS
HHS OIG
On July 21, OIG released a report entitled HRSA's Monitoring Did Not Always Ensure Health Centers' Compliance With Federal Requirements for HRSA's Access Increases In Mental Health and Substance Abuse Services Supplemental Grant Funding. The audit found that HRSA followed its policies and procedures for awarding Access Increases in mental health and substance abuse services grants but did not always follow its policies and procedures when monitoring health centers’ progress for ongoing funding and for funding for health information technology and training. The report also found that the agency was not consistent with responding timely to requests to carry over grant funds. OIG recommends better assessing health centers progress and increasing follow up, reviewing budget period progress reports to identify health centers that did not properly report their progress, and improving the agency’s response time for carry over requests. HRSA partially agreed with the findings and recommendations presented in the report. A summary is available here.
On July 22, OIG posted an update to the annual Health Care Fraud and Abuse Control program report, which was originally released in June 2020.
On July 22, OIG published a report entitled CMS Could Have Saved $192 Million by Targeting Home Health Claims for Review With Visits Slightly Above the Threshold That Triggers a Higher Medicare Payment. OIG found that Medicare improperly paid some home health agencies (HHAs), amounting to an estimated $191.8 million in overpayments in 2017. Overpayments occurred because the Medicare Administrative Contractors (MACs) did not analyze claim data or perform risk assessments of claims with visits slightly above the Low Utilization Payment Adjustment (LUPA) threshold of four visits. OIG recommends recovering overpayments from claims included in the audit, requiring MACs to target and review claims about the LUPA threshold, and instructing MACs to educate HHAs on proper home health service billing. CMS agreed with the recommendations. A summary of this report is available here.
Congressional Budget Office (CBO)
On July 22, CBO released a cost estimate of H.R.7608, the minibus that packages the Sate-Foreign Operation, Agriculture-Rural Development, Interior-Environment, and Military Construction-VA spending bills for FY2021.
UPCOMING HEARINGS
Senate
Finance Committee
July 28, 10:15 a.m., 215 Dirksen Senate Office Building
Part 1: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic
Witnesses include: Thomas Overacker, Cargo and Conveyance Security, Office of Field Operations, Customs & Border Protection; Steve Francis, Assistant Director, Homeland Security Investigations, Global Trade Investigations Division, Director, National Intellectual Property Rights Coordination Center, U.S. Immigration, Customs & Enforcement; and Soraya Correa, Chief Procurement Officer, Department of Homeland Security.
Veterans’ Affairs Committee
July 29, 3:00 p.m., Dirksen Senate Office Building SD-G50
VA Telehealth During and Beyond COVID-19: Challenges and Opportunities in Rural America
Details will be forthcoming.
Finance Committee
July 30, 9:30 a.m., 215 Dirksen Senate Office Building
Part 2: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic
Witnesses include: Cathy Denning, Group Senior Vice President, Sourcing Operations, Analytics and Center of Excellence; Rob Wiehe, Senior Vice President, Chief Supply Chain and Logistics Officer UC Health; and Charles Johnson, President, International Safety Equipment Association.
House
Energy & Commerce Health Subcommittee
July 29, 10 a.m., Virtual Hearing
Improving Access to Care: Legislation to Reauthorize Key Public Health Programs
Witnesses include: Robert Boyd, President, School-Based Health Alliance; Linda Goler Blount, President and CEO, Black Women’s Health Imperative; Nancy Goodman, Founder and Executive Director, Kids v. Cancer; Aaron Seth Kesselheim, MD, Professor of Medicine, Harvard Medical School; Brian Lindberg, Chief Legal Officer and General Counsel, National Bone Marrow Donor Program; and Travis Tygart, CEO, U.S. Anti-Doping Agency
Coronavirus Crisis Select Subcommittee
July 31, 9:00 a.m., Virtual Hearing
The Urgent Need For A National Plan To Contain The Coronavirus
Witnesses include: Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, NIH; Robert Redfield, MD, Director, CDC; Brett Giroir, Assistant Secretary of Health, HHS
OTHER HEALTH POLICY NEWS
On July 20, a coalition of 23 Democratic state attorneys general sued HHS over the finalized rule Protecting Civil Rights in Health Care, Restoring the Rule of Law, and Relieving Americans of Billions in Excessive Costs. The rule pertains to a provision of the that bans federally funded health programs and facilities from discriminating against patients based on race, color, national origin, sex, disability, or age. The lawsuit alleges that the new rule allows providers and insurers to discriminate against certain vulnerable and protected populations, specifically transgender and nonbinary patients.
On July 20, 279 national and state groups called on HHS to terminate Medicaid work requirements and allow the extension of postpartum coverage beyond the current 60-day cutoff in order to mitigate racial health disparities.
On July 21, Presumptive Democratic nominee Joe Biden released an economic recovery plan entitled The Biden Plan for Mobilizing American Talent and Heart to Create a 21st Century Caregiving and Education Workforce. The plan aims to expand access to care for older Americans and those with disabilities by providing $450 billion in funding for home or community care and expanding access to care by:
Increasing Medicaid funding to states and giving states the choice to convert current home and community-based care services waivers into new state plan options with an enhanced federal match to eliminate the current waitlist for home and community services under Medicaid;
Expanding home and community-based alternatives to institutional care by encouraging states to provide alternative care models that provide long-term services;
Providing direct grant funding, as well as adding community health worker services as an optional benefit for states under Medicaid to add 150,000 community health workers to the workforce; and
Improving health care infrastructure by training 35,000 workers to address the opioid epidemic and substance use disorders, providing additional funding to build the nation’s nurse workforce, investing in veteran employment, increasing funding to the Indian Health Service, and creating a Public Health Jobs Corps.
On July 21, AMA’s Opioid Task Force published a report entitled Opioid Task Force 2020 Progress Report: Physicians’ progress toward ending the nation’s drug overdose and death epidemic. The report concludes that prescription drug overdoses are declining, but overdoses related to other kinds of opioids, stimulants, heroin, and cocaine are increasing.
On July 24, the AHA and Association of American Medical Colleges announced that they are seeking a rehearing of a July 17 ruling by the U.S. Court of Appeal for D.C. that upheld the Trump administration’s “site-neutral” hospital payment policy.