This week in Washington: Infrastructure talks continue, Labor HHS Appropriations bill clears House Committee and is on the way to the floor.

House

Reps. Guthrie and Nunes Announce Panels as Part of Healthy Future Task Force
On July 19, Reps. Brett Guthrie (R-KY) and Devin Nunes (R-CA) announced the Healthy Future Task Force’s five health panels, which will focus on lowering health care costs, increasing access to therapies and medical devices, strengthening U.S. supply chains, increasing care choices and expanding providers available. The Healthy Future Task Force, which was announced by House Minority Leader Kevin McCarthy (R-CA) in June, will create legislative proposals and lay out the Republican health care agenda. Each of the panels will have one chair and two members, and the membership is listed below.

  • The Security Panel will be chaired by Rep. Richard Hudson (R-NC), with Reps. Jim Banks (R-IN) and Tom Cole (R-OK) as members.
  • The Affordability Panel will be chaired by Rep. Kevin Hern (R-OK), with Reps. Rick Allen (R-GA) and Victoria Spartz (R-IN) as members.
  • The Treatment Panel will be chaired by Rep. Brad Wenstrup (R-OH), with Reps. John Joyce (R-PA) and Bruce Westerman (R-AR) as members.
  • The Doctor/Patient Relationship Panel will be chaired by Rep. Larry Bucshon (R-IN), with Reps. Greg Murphy (R-NC) and Beth Van Duyne (R-TX) as members.
  • The Modernization Panel will be chaired by Rep. Mariannette Miller-Meeks (R-IA), with Reps. Morgan Griffith (R-VA) and Mike Kelly (R-PA) as members.

House Energy and Commerce Committee Advances Health Care Bills
On July 21, the House Energy and Commerce Committee held a markup of 24 bills. The following health care bills were approved by the committee and will go next to the House for a vote.

  • H.R. 4369, the “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act”
  • H.R. 654, the “Drug-Free Communities Pandemic Relief Act”
  • H.R. 2051, the “Methamphetamine Response Act of 2021”
  • H.R. 2379, the “State Opioid Response Grant Authorization Act of 2021”
  • H.R. 2364, the “Synthetic Opioid Danger Awareness Act”
  • H.R. 2355, the “Opioid Prescription Verification Act of 2021”
  • H.R. 4026, the “Social Determinants of Health Data Analysis Act of 2021”
  • H.R. 3743, the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”
  • H.R. 550, the “Immunization Infrastructure Modernization Act”
  • H.R. 1550, the “Promoting Resources to Expand Vaccination, Education, and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021”
  • H.R. 951, the “Maternal Vaccination Act”
  • H.R. 4387, the “Maternal Health Quality Improvement Act of 2021”
  • H.R. 3742, the “Vaccine Information for Nursing Facility Operators Act” or the “Vaccine INFO Act”
  • H.R. 2347, the “Strengthening the Vaccines for Children Act of 2021”
  • H.R. 3894, the “Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021” or the “CARING for Social Determinants Act of 2021”
  • H.R. 4406, the “Supporting Medicaid in the U.S. Territories Act”

The markup page can be found here.

New Congressional Social Determinants of Health Caucus Requests Input
On July 21, Reps. Cheri Bustos (D-IL), Tom Cole (R-OK), G.K. Butterfield (D-NC) and Markwayne Mullin (R-OK) launched the Congressional Social Determinants of Health Caucus. The caucus will highlight opportunities to address social determinants of health such as food, housing and transportation. The caucus requests feedback from stakeholders and members of Congress before Sept. 21.

Senate

Senators Leahy and Daines Request Update on Expanded FTC and DOJ Antitrust Authorities in the Health Insurance Market
On July 20, Sens. Patrick Leahy (D-VT) and Steve Daines (R-MT) wrote a letter to Attorney General Merrick Garland and Federal Trade Commission (FTC) Chair Lina Khan regarding the expansion of FTC and Department of Justice (DOJ) antitrust authorities over the health insurance industry. The Competitive Health Insurance Reform Act (CHIRA) of 2020, which recently went into effect, repeals the McCarran-Ferguson Act’s antitrust exemption for the health insurance industry. In the letter, the senators request additional information on how DOJ and FTC have exercised their expanded antitrust authorities. The letter can be found here.

Bipartisan Group of Sens. and Reps. Write to HHS Secretary and CMS Administrator Expressing Concern with OPO Rule Timeline
On July 20, a bipartisan group consisting of members of the Senate Finance Committee and the House Oversight and Reform Committee wrote to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, voicing their support of the CMS Organ Procurement Organizations (OPOs) Conditions for Coverage Final Rule. The letter requests that CMS consider ways to accelerate the Final Rule’s implementation. The letter was signed by Sens. Ron Wyden (D-OR), Chuck Grassley (R-IA), Todd Young (R-IN), Ben Cardin (D-MD), Joni Ernst (R-IA), Michael Bennet (D-CO) and Jerry Moran (R-KS) and Reps. Carolyn Maloney (D-NY), James Comer (R-KY), Raja Krishnamoorthi (D-IL), Michael Cloud (R-TX) and Katie Porter (D-CA). The letter can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

On Wednesday, July 14, 2021 Senators Chuck Schumer (D-NY), Cory Booker (D-NJ), and Ron Wyden (D-OR) released draft legislation titled the Cannabis Administration and Opportunity Act. Today, adult use of cannabis, which is classified as a Schedule 1 controlled substance under the Controlled Substances Act (CSA), is legal in 18 states, and the medical use of cannabis is legal in 37 states, though cannabis use remains illegal under federal law. The Cannabis Administration and Opportunity Act would expunge federal non-violent marijuana crimes to petition a court for resentencing, reinvest federal cannabis tax revenue into communities historically afflicted by the “War on Drugs,” and ultimately end the federal prohibition of cannabis, while allowing states to continue to determine their own cannabis laws. If implemented, regulatory responsibility of cannabis would be transferred from the U.S. Drug Enforcement Agency (DEA) to the Alcohol and Tobacco Tax and Trade Bureau (TTB), the Bureau of Alcohol Tobacco Firearms and Explosives (ATF). The bill includes several provisions for additional research to investigate the impact of legalization on public health, driving safety, and similar areas. Senators Schumer, Booker, and Wyden are currently seeking feedback from the public as the proposal is finalized, encouraging stakeholders to submit comments by September 1st, 2021.

The discussion draft has not yet been formally introduced on the Senate floor. Senators Schumer, Wyden, and Booker are taking comment from lawmakers and the general public, including advocates, the cannabis industry, public health experts, and the law enforcement community, until September 1.

Read more on the draft bill details on McGuireWoods Consulting’s website.

This week in Washington: Infrastructure, Executive Order on Anti-competitiveness, House Appropriations Committee Acts on Labor-HHS Appropriations Bill, Senate Budget Committee Democrats Agree on Budget Resolution.

House

House Energy and Commerce Health Subcommittee Holds Markup of 19 Bills
On July 15, the House Energy and Commerce Committee Subcommittee on Health held a markup of 19 bills. All of the bills were reported favorably to the full committee. The bills can be found below.

  • H. R. 4369, the “National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act”
  • H. R. 654, the “Drug-Free Communities Pandemic Relief Act”
  • H. R. 2051, the “Methamphetamine Response Act of 2021”
  • H. R. 2379, the “State Opioid Response Grant Authorization Act of 2021”
  • H. R. 2364, the “Synthetic Opioid Danger Awareness Act”
  • H. R. 2355, the “Opioid Prescription Verification Act of 2021”
  • H. R. 2503, the “Social Determinants Accelerator Act of 2021”
  • H. R. 4026, the “Social Determinants of Health Data Analysis Act of 2021”
  • H. R. 3743, the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”
  • H. R. 550, the “Immunization Infrastructure Modernization Act”
  • H. R. 1550, the “Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021”
  • H. R. 951, the “Maternal Vaccination Act”
  • H. R. 925, the “Data to Save Moms Act”
  • H. R. 4387, the “Maternal Health Quality Improvement Act of 2021”
  • H. R. 3742, the “Vaccine Information for Nursing Facility Operators Act” or the “Vaccine INFO Act”
  • H. R. 1978, the “Protecting Seniors Through Immunization Act”
  • H. R. 2347, the “Strengthening the Vaccines for Children Program Act”
  • H. R. 3894, the “Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021” or the “CARING for Social Determinants Act of 2021”
  • H. R. 4406, the “Supporting Medicaid in the U.S. Territories Act”

House Appropriations Committee Approves FY 2022 Funding Bill
On July 15, the House Appropriations Committee approved the fiscal year (FY) 2022 Labor, Health and Human Services, Education, and Related funding bill with a vote of 32-25. The bill would provide HHS with $119.8 billion, which is $22.9 billion above the 2021 amount but $129 million lower than President Biden’s May budget request. The bill would give the National Institutes of Health (NIH) $3 billion to create the Advanced Research Projects Agency for Health (ARPA-H), less than the $6.5 billion requested by President Biden. Two amendments were adopted by a voice vote. The bill text, before the adoption of the amendments, can be found here.

Rep. Doggett Introduces Bill to Provide Dental, Vision and Hearing Care in Medicare
On July 6, Rep. Lloyd Doggett (D-TX) introduced the Medicare Dental, Vision and Hearing Benefit Act, which would add dental, vision and hearing benefits to Medicare. The bill would treat dental, vision and hearing care the same as existing health care under Medicare, with no cost-sharing or preventative care, with no more than 20 percent copay for all other services. The bill has the support of 75 members of Congress. The press release for the bill can be found here.

Senate

Senate Budget Committee Democrats Agree on $3.5 Billion Budget Resolution
On July 12, the Senate Budget Committee Democrats agreed on a budget resolution that would add dental, hearing and vision benefits to Medicare. The resolution would cost $3.5 billion and would be paid for with tax changes. Senate Majority Leader Chuck Schumer (D-NY) stated the budget resolution includes priorities President Biden detailed in the American Jobs Plan and the American Families Plan.

Democratic Senators Introduce Bill That Would Direct CMS to Create a Federal Medicaid-Style Program
On July 12, Sens. Raphael Warnock (D-GA), Jon Ossoff (D-GA) and Tammy Baldwin (D-WI) introduced the Medicaid Saves Lives Act. The bill would direct the Centers for Medicare and Medicaid Services (CMS) to create a federal Medicaid-style program. The program, which would be administered by CMS, would be available to people in non-Medicaid expansion states that earn up to 138 percent of the federal poverty level. The bill text can be found here. A fact sheet on the bill can be found here.

Sen. Schumer Releases Draft Legislation to Decriminalize Cannabis
On July 14, Senate Majority Leader Chuck Schumer (D-NY), along with Sens. Ron Wyden (D-OR) and Corey Booker (D-NJ), released a draft of the Cannabis Administration and Opportunity Act. The bill would remove cannabis from the federal list of controlled substances, provide for the expungement of certain cannabis offenses and devote resources to communities that were harmed during the War on Drugs. The draft bill text can be found here. A summary of the draft bill can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

In late June, President Biden endorsed the Senate’s bipartisan infrastructure agreement and discussions will continue over the next month on what projects will be included in the final package. Georgia-based companies, organizations and public entities have an opportunity to proactively engage with members to promote Georgia interests within the legislation. Georgia’s Senators are uniquely positioned to deliver maximum impact, and can work to convey Georgia needs through infrastructure discussions, congressionally directed spending with the return of earmarks and additional COVID-19 relief dollars.

The political grounds continue to shift in Georgia with a Republican in the governor’s mansion, Republicans leading the House Delegation and Democratic representation in the Senate. With new districts being drawn and an upcoming battle at the polls for the governorship and the 2022 midterm elections, Georgia will remain a battleground state. Bipartisan representation is crucial to communicate Georgia’s top priorities to the House and Senate delegation, the Biden Administration and state officials.

Georgia natives Scott Binkley and Clayton Cox serve as vice presidents with McGuireWoods Consulting and have advised and managed campaigns across Georgia, worked as staff to Georgia elected officials, and maintain deep relationships in their home state. They offer clients a bipartisan perspective and reach. Binkley draws upon his background in Georgia politics, the Republican Governors Association and the Republican Lieutenant Governors Association to advise and deliver results for clients with interests in the state. As the former national finance director for the Democratic National Committee (DNC), Cox is a recent addition to MWC’s bipartisan federal team, bringing a unique understanding of the opportunities and challenges within Georgia politics. MWC’s bipartisan experience on Capitol Hill and in the executive branch provides clients with the knowledge and contacts needed to achieve positive results on both sides of the aisle and at both ends of Pennsylvania Avenue.


Scott BinkleyScott Binkley

Scott Binkley is a vice president on McGuireWoods Consulting’s national multistate strategies team, based in Washington, D.C. He focuses on the design and implementation of multistate and federal public affairs strategy for a large variety of clients. Binkley has managed and advised both federal and statewide campaigns across Georgia. He also served in various staff positons for  former House Policy Chairman, Tom Price. Binkley provides clients national strategies drawing on his time at the Republican Governors Association and as executive director of the Republican Lieutenant Governors Association. Binkley is from Alpharetta, Georgia and attended Georgia College.

Clayton CoxClayton Cox

Clayton Cox is a vice president on McGuireWoods Consulting’s federal public affairs team, based in Washington, D.C. With over a decade of experience at the highest levels of Democratic politics, he provides an incomparable set of contacts and perspectives to clients. Cox most recently oversaw the fundraising for the DNC during its most successful four-year cycle ever. He helped lead the Biden Victory Fund which raised a record breaking $1.6 billion for the presidential campaign. Cox also served as a senior advisor to Democratic Party Chairman Tom Perez in 2017, playing a major role in rebuilding the national party. Cox is a native of Marietta, Georgia and is a UGA alum.

This week in Washington: Senate in recess, conversations continue on infrastructure and administration’s health initiatives.

Bipartisan Bill to Alter Language on Substance Use Disorder Agencies and Programs
On June 29, Reps. David Trone (D-MD) and Lisa McClain (R-MI) introduced the Stopping Titles that Overtly Perpetuate (STOP) Stigma Act, which would change the name of several federal agencies and programs with the objective of decreasing stigma surrounding substance use disorder. The bill text can be found here. A summary of the bill can be found here.

Rep. Trone Introduces CARA 3.0 Act
On July 1, Rep. David Trone (D-MD) introduced the Comprehensive Addiction and Recovery Act (CARA) 3.0 Act. The bill aims to mitigate the impact of COVID-19 on the addiction epidemic by dedicating resources to prevention, education, research, treatment and recovery. The bill would build on the original CARA Acts of 2016 and the CARA 2.0 Act of 2018. The bill was cosponsored by Reps. Annie Kuster (D-NH), Brian Fitzpatrick (R-PA), Jaime Herrera Beutler (R-WA), Tim Ryan (D-OH), David McKinley (R-WV), Paul Tonko (D-NY) and Dave Joyce (R-OH). A Senate version of the bill was introduced in March. The bill text can be found here. A summary of the bill can be found here.

Rep. Suozzi Introduces Bill to Create a Long-Term Care Insurance Program
On July 1, Rep. Tom Suozzi (D-NY) introduced the Well-Being Insurance for Seniors to be at Home (WISH) Act, which would create a public-private partnership to provide long-term care insurance for older Americans who want to receive care at home instead of in a care facility. The bill would create a Long-Term Care Insurance Trust Fund and enable private insurance companies to offer affordable coverage plans for the initial years of potential disability. The proposed changes in the bill would be paid for by workers’ social insurance contributions equivalent to 0.3 percent of wages. The bill text can be found here. A summary of the bill can be found here.

Reps. Introduce Bill to Increase Mental and Behavioral Health Care Resources for the IHS
On July 1, Reps. Frank Pallone (D-NJ) and Raul Ruiz (D-CA) and Sens. Tina Smith (D-MN) and Kevin Cramer (R-ND) introduced the Native Behavioral Health Access Improvement Act. The bill would create a special behavioral health program within the Indian Health Services (IHS). The bill text can be found here, and a summary of the bill can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This week in Washington: Infrastructure deal struck, but it still has a long road ahead to passage; Senate Budget Committee discussed draft resolution with health initiatives included.

House

Cures 2.0 Draft Released
On June 22, Reps. Diana DeGette and Frank Upton (R-MI) released draft legislation that would create an Advanced Research Projects Agency for Health (ARPA-H) and authorize more than $6.5 billion to run the agency. The draft bill also aims to make innovative health care technologies more available, increase diversity in clinical trials, require the FDA to expand the collection of real-world evidence, provide training programs for caregivers, provide patients greater access to health information and increase access to telehealth services for patients under government-based health programs. A summary of the draft legislation can be found here.

House Appropriations Subcommittee Approves Bill to Increase FDA Funding
On June 25, the House Appropriations Committee Subcommittee on Agriculture, Rural Development, and the Food and Drug Administration (FDA) approved legislation that would allocate $3.47 billion in federal spending to the FDA in fiscal year 2022, a $257 million increase from 2021. The legislation would give the FDA’s drug center $2.1 billion, with a minimum of $8.5 million designated for surprise foreign inspection pilots. In addition, the Center for Biologics Evaluation and Research would receive $454 million, and the medical devices center would receive $652 million. The bill will be sent on to a full committee vote next week. A draft of the appropriations legislation can be found here.

House Panels Request Information about J&J and AstraZeneca’s Response to Emergent’s Response to Contaminated COVID-19 Vaccines
On June 22, House Oversight Chair Carolyn Maloney (D-NY) and House Coronavirus Crisis Chair Jim Clyburn (D-SC) wrote to the chief executives of AstraZeneca and Johnson & Johnson (J&J), asking them to explain their agreements with Emergent BioSolutions in an effort to better understand how the contractor contaminated millions of COVID-19 vaccines. In the letters, Reps. Maloney and Clyburn state that the Baltimore contract manufacturer Emergent was warned multiple times about manufacturing problems and insufficient controls at the facility but failed to act. Manufacturing of the J&J COVID-19 vaccine at the Emergent facility was halted by the FDA in April after ingredients from the AstraZeneca vaccine contaminated a batch of the J&J vaccine. Emergent had to destroy 85 million doses as a result. The committee chairs instructed J&J and AstraZeneca to respond to the letters by July 6. The letter to Dr. Pascal Soriot, AstraZeneca CEO, can be found here. The letter to Alex Gorsky, J&J CEO, can be found here.

Senate

Senate Budget Draft Resolution Would Add to Medicare
A Senate Democratic discussion budget outline would result in a roughly $6 trillion package of gross spending increases that on net would add $3 trillion to deficits over the next decade. That’s far more than the roughly $850 billion in bigger deficits over 10 years that President Biden had proposed. Among the health care proposals included in the budget are the inclusion of new Medicare dental and vision benefits and dropping Medicare’s eligibility age to 60. In addition, the health care spending would be offset by $617 billion obtained through Medicare drug price negotiation authority and other drug pricing savings. A budget resolution is a broad outline of spending and taxing priorities and is not a law. Authorizing committees would have to pass legislation to actually enact the new programs envisioned in the resolution.

Sen. Wyden Releases Principles for Drug Pricing Reform
On June 22, Senate Finance Committee Chair Ron Wyden (D-OR) released a document outlining a proposal to reduce prescription drug prices. The proposal includes provisions that would allow Medicare to negotiate with pharmaceutical companies and apply lower prices to private and public insurance programs. In the document, Sen. Wyden’s plan also includes measures to block a Trump-era ban on rebates and protect small biotechnology companies. Sen. Wyden’s Principles for Drug Pricing Reform document can be found here.

Better Care Better Jobs Act Introduced
On June 24, a group of Democratic senators introduced the Better Care Better Jobs Act, which would increase Medicaid funding for home and community-based services (HCBS) in line with President Biden’s vision laid out in the American Rescue Plan. The bill was introduced by Sens. Bob Casey (D-PA), Ron Wyden (D-OR), Chuck Schumer (D-NY), Patty Murray (D-WA), Tammy Duckworth (D-IL), Maggie Hassan (D-NH) and Sherrod Brown (D-OH). A House companion bill was introduced by Reps. Debbie Dingell (D-MI), Frank Pallone (D-NJ), Jan Schakowsky (D-IL) and Doris Matsui (D-CA). The bill can be found here.

Bipartisan VALID Act Introduced
On June 24, the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 was introduced in the Senate by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) and in the House by Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN). The bill, which was first introduced in 2020, would create a new framework for regulating diagnostic tests. The 2021 version of the bill would also remove pre-approval requirements during public health emergencies.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This week in Washington: Supreme Court dismisses challenge to the Affordable Care Act.

House

House Appropriations Committee Releases Fiscal Year 2022 Bill Schedule
On June 15, chair of the House Appropriations Committee Rep. Rosa DeLauro (D-CT) released the markup schedule for fiscal year (FY) 2022 spending bills. The Appropriations Committee plans to take up the Food and Drug Administration’s (FDA) appropriations next week and the Department of Health and Human Services’s (HHS) appropriations in July. The schedule can be found here.

Accountable Care in Rural America Act Reintroduced
On June 8, a group of bipartisan representatives reintroduced the Accountable Care in Rural America Act (H.R. 3746), which would amend Title XVIII of the Social Security Act with the objective of improving the benchmarking process for accountable care organizations (ACOs) by removing an organization’s beneficiaries from the calculation of a regional benchmark. The bill was sponsored by Reps. Jodey Arrington (R-TX), Suzan DelBene (D-WA), Mike Kelly (R-PA), Ami Bera (D-CA), Tom O’Halleran (D-AZ), Terri Sewell (D-AL), Neal Dunn (R-FL) and Lance Gooden (R-TX). Thirteen health stakeholders, including the American Hospital Association, wrote a letter in support of the bill. The letter can be found here.

House Republicans Send Becerra Letter Asking for Greater Investment in COVID-19 Therapies
On June 15, 23 House Republicans sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting further investment, research and development of COVID-19 therapies. Eleven of the 23 Republicans who signed the letter are members of the GOP Doctors Caucus.

Rep. Doggett Introduces Bill to Authorize CMS to Work With Localities to Expand Medicaid Coverage
On June 17, Rep. Lloyd Doggett (D-TX) introduced the Cover Outstanding Vulnerable Expansion-Eligible Residents (COVER) Now Act, which aims to give the Centers for Medicare and Medicaid Services (CMS) the authority to contract directly with counties, cities and other subdivisions to expand Medicaid eligibility with demonstration projects. The bill would give local governments 100 percent of federal funding for the first three years of expansion, with a reduction to 90 percent by the seventh year. The legislation would approve 100 demonstrations for local expansion, and currently has more than 40 Democratic cosponsors.

Rep. Manchin Asks President Biden to Nominate a Permanent FDA Commissioner
On June 17, Rep. Joe Manchin (D-WV) wrote a letter to President Biden urging him to nominate a permanent Food and Drug Administration (FDA) commissioner. In the letter, Rep. Manchin stated that the acting commissioner, Dr. Janet Woodcock, is not suited for the role, and cited as evidence the recent FDA decision to approve Aduhelm (aducanumab) to treat Alzheimer’s despite no members of the advisory panel voting in favor. The letter can be found here.

Senate

Bipartisan Manufacturing API, Drugs, and Excipients (MADE) in America Act Reintroduced
On June 16, Sens. Tim Scott (R-SC) and Jacky Rosen (D-NV) reintroduced the Manufacturing API, Drugs, and Excipients (MADE) in America Act, which aims to reduce the U.S. pharmaceutical supply chain’s dependence on China. The bill would create a new tax credit that would apply to manufacturers operating in certain “Opportunity Zones” and improve the Food and Drug Administration’s (FDA) reporting and monitoring efforts. Companion legislation was introduced in the House by Reps. Tom Rice (R-SC) and Darren Soto (D-FL).

Bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Introduced
On June 16, Sens. Michael Bennet (D-CO) and Todd Young (R-IN) introduced a revised version of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, which aims to incentivize the development of new antibiotics through a subscription-style reimbursement model for antimicrobial drugs. The bill was revised to include the Centers for Disease Control and Prevention’s (CDC) recommendations on drugs that target fungi and measures to ensure that the government’s investments are protected if pharmaceutical companies default on their contracts.

Republican Doctors Caucus Members Ask FDA to Research COVID-19 Immunity
On June 17, members of the GOP Doctors Caucus sent a letter to the Food and Drug Administration (FDA) urging the agency to improve vaccine research to better understand COVID-19 immunity achieved by vaccination or through natural infection. The letter also calls on the FDA to prioritize T-cell tests. Signatories to the letter were Sen. Roger Marshall (R-KS), Rep. Andy Harris (R-MD), Sen. Rand Paul (R-KY), Rep. Neal Dunn (R-FL), Rep. Ronny Jackson (R-TX) and Rep. Mariannette Miller-Meeks (R-IA), who are all doctors. The letter can be found here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

The Affordable Care Act (ACA) survived another challenge to its constitutionality today. In a 7-2 decision, the court threw out the challenge to the law, citing lack of standing by the plaintiffs. The plaintiffs, a group of Republican-controlled states and two Texas residents, argued that the entire ACA became unconstitutional when Congress eliminated the penalty for individuals who fail to obtain health insurance, known as the individual mandate. In Oct. 2020, a divided three-judge panel of the 5th U.S. Circuit Court of Appeals issued a ruling stating the individual mandate was unconstitutional because it can no longer be justified as a tax since Congress set the penalty at zero. However, the panel also remanded the case to the lower court to determine what portions of the ACA are or are not severable from the individual mandate. A coalition of Democratic attorneys general who had asked to intervene in the case then asked the U.S. Supreme Court to take up the case and not wait for the Texas court to rule on whether some or all of the ACA provisions are unconstitutional. Oral arguments were held just prior to the 2020 election.

The Ruling: What It Means  

Nothing will change for providers and consumers within the current structure of the Affordable Care Act. The ACA has expanded Medicaid, created the federal exchange and permitted states to develop exchanges to provide insurance that met standards in the ACA. The law also made changes in Medicare to assist in developing value-based healthcare and other changes to provide better quality care.

Today’s ruling does not prevent another novel legal challenge to its constitutionality. It also does not change the zero penalty for the individual mandate.

The Biden administration has undone some of the Trump administration’s policy changes that affected the ACA, while other policy changes have been challenged in court. With today’s Supreme Court ruling, the Biden Administration can move forward in its quest to gain coverage for more individuals, address healthcare costs and improve how the ACA operates.

Read more on healthcare policy on McGuireWoods Consulting’s website.

On June 8, 2021 the administration released a report detailing its findings from a 100-day review of vulnerabilities within the supply chains of four critical products:

  • semiconductors;
  • large capacity batteries;
  • critical minerals and materials; and
  • pharmaceuticals

The report is in response to President Biden’s Feb. 24, 2021 executive order calling for an assessment of the vulnerabilities within essential supply chains. The administration analyzed and provided recommendations on the supply chains within the report and also seeks to create a Supply Chain Disruptions Task Force to address supply chain challenges across the government. In addition, the report calls for the United States to begin the process of building comprehensive strategies for revitalizing six key industrial bases:

  • defense;
  • public health;
  • information and communication technology;
  • energy;
  • transportation; and
  • agriculture and food production

This whole-of-government approach intends to engage the private and public sector as well as government agencies to ensure essential supply chains are more resilient, in order to promote national security, economic security, and job creation.

The report analyzes the United States’ supply chain vulnerabilities and provides recommendations to improve U.S. economic resilience and independence. Across all four sectors, the general theme remains the same: the United States is currently heavily dependent upon foreign imports, which exposes the country to vulnerabilities and potential supply chain disruptions. The recommendations in this report seek to strengthen the United States’ domestic capacity to manufacture across these sectors to decrease net dependence upon foreign adversaries and countries. The administration seeks to employ the private and public sectors as well as agencies such as the DOD, DOS, DOE, DOI, and HHS to increase transparency and invest in sustainable improvements across these four key supply chains.

Read on for details on the risks and recommendations for each of the four critical products reviewed in the report.

This week in Washington: Discussions on infrastructure and prescription drug changes continue.

House Energy and Commerce Committee to Discuss Vaccine Legislation
On June 15, the House Energy and Commerce Subcommittee on Health will hold a hearing titled “Booster Shot: Enhancing Public Health Through Vaccine Legislation.” Bills to be discussed at the hearing are listed and linked below.

  • H.R. 550, the “Immunization Infrastructure Modernization Act”
  • H.R. 951, the “Maternal Vaccinations Act”
  • H.R. 979, the “Vaccine Fairness Act”
  • H.R. 1452, to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes
  • H.R. 1550, the “Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021”
  • H.R. 1978, the “Protecting Seniors Through Immunization Act of 2021”
  • H.R. 2170, the “Helping Adults Protect Immunity Act” or the “HAPI Act”
  • H.R. 2347, the “Strengthening the Vaccines for Children Program Act of 2021”
  • H.R. 3013, the “COVID Vaccine Transportation Access Act”
  • H.R. 3655, the “Vaccine Injury Compensation Modernization Act”
  • H.R. 3742, the “Vaccine Information for Nursing Facility Operators Act” or the “Vaccine INFO Act”
  • H.R. 3743, the “Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act”

Bipartisan Essential Drugs Stockpile Bill Reintroduced
On June 3, Reps. Buddy Carter (R-GA) and Lisa Blunt Rochester (D-DE) reintroduced the Essential Medicines Strategic Stockpile Act. The bill would pilot a program that allows states to partner with pharmaceutical companies to maintain a six-month supply of drugs.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.