Earmarks are continuing to make a return to Congress after a moratorium lasting a decade. Following the House’s announcement that the committee will accept Member requests for Community Project Funding in appropriations bills for the upcoming fiscal year (FY2022), the Senate followed suit. On April 26, 2021, the chair of the Senate Committee on Appropriations announced an intention to restore the use of congressionally directed spending items in appropriations bills for the upcoming fiscal year (FY2022). Such congressionally directed spending items will be subject to the Senate rules and restrictions governing earmarks.

Senate earmark disclosure rules apply to any congressional earmark included in either the text of the bill or the committee report accompanying the bill, as well as the conference report and joint explanatory statement. The disclosure requirements apply to items in authorizing legislation, appropriations legislation, and tax measures. Furthermore, they apply not only to measures reported by committees but also to unreported measures, amendments, House bills, and conference reports.

Read more on the Senate earmark disclosure rule, requirements for Senators submitting earmark requests and requirements for committees.

This week in Washington: CMS Administrator confirmed, President releases budget.

Brooks-LaSure Confirmed as CMS Administrator
On May 25, the Senate voted 55-44 to confirm Chiquita Brooks-LaSure as the Centers for Medicare and Medicaid Services (CMS) administrator. Brooks-LaSure’s nomination process had been delayed after Sen. John Cornyn (R-TX) expressed his opposition to CMS’s decision last month to revoke a 10-year extension of a Texas 1115 Medicaid waiver. Brooks-LaSure will be the first Black woman to lead CMS, and previously worked at CMS under the Obama administration.

Senate HELP Committee Advances Bipartisan Bills
On May 25, the Senate Health, Education, Labor and Pensions (HELP) Committee voted unanimously to pass six health bills out of committee. The bills are listed below.

  • S. 1675, Maternal Health Quality Improvement Act
  • S. 1491, Rural Maternal and Obstetric Modernization of Services Act
  • S. 1662, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act
  • S. 1301, Promoting Physical Activity for Americans Act
  • S. 610, Dr. Lorna Breen Health Care Provider Protection Act
  • S. 1658, Providing Urgent Maternal Protections for Nursing Mothers Act

Senate Republicans Propose Alternative Infrastructure Plan
On May 27, Sens. Shelley Moore Capito (R-WV), Pat Toomey (R-PA), Roy Blunt (R-MO) and John Barrasso (R-WY) proposed a $928 billion infrastructure plan as an alternative to President Biden’s $1.7 trillion American Jobs Plan. The Republican plan does not include funds for caregiving infrastructure investments, as Republican senators have stated they want a plan that solely addresses physical infrastructure.

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

In This Issue: Biden administration releases FY22 budget proposal, Senate follows House with return of earmarks, Department of Education higher education regulatory agenda, Title IX rule hearing, state legislatures update and McGuireWoods welcomes Farnaz Thompson.

Biden Administration Releases FY22 Budget Proposal

On Friday, May 28, 2021, President Biden released his FY2022 budget. The President’s budget includes two plans the President has already put forward—the American Jobs Plan and the American Families Plan—and outlines a package of discretionary proposals to help restore core functions of government and reinvest in the foundations of the nation’s strength.

The American Jobs Plan

The budget begins with the American Jobs Plan—an investment in America that would create millions of jobs, rebuild the nation’s infrastructure, and position the United States to out-compete China. The American Jobs Plan would invest in such projects as rebuilding roads, bridges, ports, airports, and transit systems. It would also invest in delivering clean water systems, the electric grid and affordable, highspeed internet. The plan would build, preserve, and retrofit more than two million homes and commercial buildings as well as modernize schools and childcare facilities. The plan would call on upgrade to veteran’s hospitals and federal buildings. It would raise wages and benefits for essential home care workers. In addition, resources would be used for research and development (R&D), manufacturing, and training.

The American Families Plan

Along with the American Jobs Plan, the budget also includes the American Families Plan—an investment to help families cover the basic expenses, lower health insurance premiums, and continue the reductions in child poverty in the American Rescue Plan Act of 2021. The American Families Plan would include such things as adding at least four years of free education and providing direct support to families to ensure that low- and middle-income families spend no more than seven percent of their income on childcare.

Reinvesting in the Foundations of the Nation’s Strength

The budget also looks to reinvest in core functions of government and the foundations of the nation’s strength. The budget includes targeted discretionary investments across a range of key areas—from improving America’s public health infrastructure and improving education, to tackling the climate crisis and fostering economic growth and security, to restoring America’s global standing and confronting 21st Century security challenges.

Overall, the budget would restore non-defense discretionary funding to 3.3 percent of Gross Domestic Product, roughly equal to the historical average over the last 30 years, while providing funding for national defense as well as for other instruments of national power—including diplomacy, development, and economic statecraft—that enhance the effectiveness of national defense spending and promote national security.

Below are the key foundational investments in education:

TRIO and GEAR UP: $1.097 billion for Federal TRIO programs, an increase of $7 million above the 2020 enacted level. Additionally, $368 million for GEAR UP, an increase of $3 million above the 2020 enacted level.

Makes Historic Investments in High-Poverty Schools. The budget proposes $36.5 billion investment in Title I grants, a $20 billion increase from the 2021 enacted level.

Expands Access to Affordable Early Child Care and Learning. The budget includes $7.4 billion for the Child Care and Development Block Grant, an increase of $1.5 billion from the 2021 enacted level, to expand access to quality, affordable childcare for families, as well as an $11.9 billion investment in Head Start, a $1.2 billion increase.

Boosts Support for Children with Disabilities. The budget includes $16 billion, a $2.7 billion increase from the 2021 enacted level, for Individuals with Disabilities Education Act (IDEA) grants. The budget also provides $732 million for early intervention services for infants and toddlers with disabilities or delays. The $250 million increase for early intervention services would be paired with reforms to expand access to these services for underserved children, including children of color and children from low-income families.

Prioritizes the Physical and Mental Well-Being of Students. The budget provides $1 billion in addition to the resources in the American Rescue Plan, to increase the number of counselors, nurses, and mental health professionals in schools. In addition, the budget provides $443 million for full-service community schools.

Increases Pell Grants and Expands Institutional and Student Supports. The budget provides discretionary funding to increase the maximum Pell Grant by $400. This increase, together with the $1,475 Pell Grant increase in the American Families Plan, represents a significant first step to deliver on the President’s goal to double the grant. The budget also increases discretionary funding, and provides funding first proposed under the American Families Plan, to expand institutional and student supports at community colleges, HBCUs, TCUs, and MSIs. The administration also looks forward to working with the Congress on changes to the Higher Education Act of 1965 that ease the burden of student debt, including through improvements to the Income Driven Repayment and Public Service Loan Forgiveness programs.

Other Education Related Items

Increases Rural Outreach and Connectivity. The budget provides $32 million for a renewed and expanded initiative, StrikeForce, to help people in high poverty rural communities tap into federal resources. The budget also provides an increase of $65 million from the 2021 enacted level for the Rural e-Connectivity Program “Reconnect” for rural broadband. The budget also includes $318 million for regional commissions, which provide economic development assistance in distressed, rural communities through infrastructure investments, workforce development, and other activities.

Read more on education policy in McGuireWoods Consulting’s Education Policy Update.

This week in Washington: Talks continue on infrastructure, Senate committees moving forward on health legislation, President’s budget due the end of the week.

House

Following Hearing, Democratic Committee Chairs Ask for FTC Investigation into AbbVie’s Pricing Practices
On May 18, Rep. Carolyn Maloney, chair of the Committee on Oversight and Reform, and Rep. Jerrold Nadler, chair of the Judiciary Committee, wrote to ask Federal Trade Commission (FTC) Acting Chair Kelly Slaughter to investigate if AbbVie broke antitrust laws with its patent strategy. The letter, which can be found here, stated that the committee’s review of nonpublic documents indicates that AbbVie has delayed biosimilar competition for far longer than warranted by its own evaluations of its patent portfolio strength, which anticipated biosimilar entry no later than 2017. The representatives’ request for a formal inquiry was made on the same day that the AbbVie CEO testified before Congress about the company’s pricing practices for drugs Humira and Imbruvica. Testimony from the May 18 hearing can be found here. In addition, the House Oversight Committee released a Drug Pricing Investigation report into AbbVie’s pricing practices for Humira and Imbruvica on May 18. The report can be found here.

House Passes Orphan Drug Exclusivity Loophole Bill
On May 19, the House passed the Fairness in Orphan Drug Exclusivity Act (H.R. 1629) by an overwhelming vote of 402-23. The bill would amend the cost recovery pathway under the Orphan Drug Act to require pharmaceutical companies seeking orphan drug designations to demonstrate they do not expect to recoup development costs.

Senate

Executive Session to Discuss Legislation
On May 25, the Senate Health, Education, Labor and Pensions Committee will hold an executive session titled “S. __, Maternal Health Quality Improvement Act; S. 1491; S.__, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act; S. 1301; S. 610; and S. 1658.” The bills to be discussed at this meeting are listed below.

  • S. __, Maternal Health Quality Improvement Act
  • S. 1491, Rural Maternal and Obstetric Modernization of Services Act
  • S. 1662, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act
  • S. 1301, Promoting Physical Activity for Americans Act
  • S. 610, Dr. Lorna Breen Health Care Provider Protection Act
  • S. 1658, Providing Urgent Maternal Protections for Nursing Mothers Act

Procedural Vote for Brooks-LaSure Nomination Set
On May 24, the Senate will vote on whether to invoke cloture on Chiquita Brooks-LaSure’s confirmation to be the next administrator for the Centers for Medicare and Medicaid Services (CMS). Senate Majority Leader Chuck Schumer (D-NY) filed cloture on May 20. A successful cloture vote would limit floor debate on the confirmation, and both the cloture and final vote require simple majorities.

Bipartisan Health Savings Bill Reintroduced
On May 20, Sens. Mike Crapo (R-ID), Ben Cardin (D-MD), Angus King (I-ME) and Kevin Cramer (R-ND) reintroduced the Preventive Health Savings Act (S. 1685), which would direct the congressional budget to include the cost savings of preventive health care. The bill would also allow certain committee chairs to request an analysis of preventive measures extending beyond the 10-year window. The bill text can be found here.

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

This week in Washington: HHS and CMS nominations move forward.

House

Representatives Ask HHS Secretary Becerra to Extend Deadline to Spend COVID-19 Provider Relief Funds
In a May 11 letter, 77 representatives sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra stating their concern that existing program requirements limit providers from making full use of COVID-19 relief. They asked Becerra to extend the deadline to spend provider relief funds and expedite distribution of the remaining COVID-19 relief. The letter can be found here.

Bipartisan Bill to Protect 340B Eligibility for Hospitals Introduced
On May 13, Reps. Doris Matsui (D-CA), Chris Stewart (R-UT), Cindy Axne (D-IA), David McKinley (R-WV), Abigail Spanberger (D-VA) and Dusty Johnson (R-SD) introduced a bill to protect hospitals from losing eligibility for the 340B drug pricing program during the COVID-19 public health emergency. A press release from Matsui’s office can be found here.

Bipartisan Bill to Curb Youth Vaping Reintroduced
On May 13, Reps. David Trone (D-MD), Raja Krishnamoorthi (D-IL) and Chris Steward (R-UT) reintroduced the Accurate Reporting of Smoking Variants Act. The bill would require the National Coordinator for Health Information Technology to ensure that electronic health records (EHRs) allow doctors to record vaping and e-cigarette use, understand the long-term impacts of these products and develop strategies to curb vaping among young people. The bill text can be found here.

13 Health Care Bills Passed the House This Week
This past week, the House passed 13 health care bills. The bills are listed and linked below.

  • H.R. 433, the Family Support Services for Addiction Act
  • H.R. 1475, the Pursuing Equity in Mental Health Act
  • H.R. 586, the Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act
  • H.R. 721, the Mental Health Services for Students Act
  • H.R. 1260, the Bipartisan Solution to Cyclical Violence Act
  • H.R. 1205, Improving Mental Health Access from the Emergency Department Act
  • H.R. 1324, the Effective Suicide Screening and Assessment in the Emergency Department Act
  • H.R. 1480, the Helping Emergency Responders Overcome (HERO) Act
  • H.R. 2862, the Campaign to Prevent Suicide Act
  • H.R. 2981, the Suicide Prevention Lifeline Improvement Act
  • H.R. 2955, the Suicide Prevention Act
  • H.R. 768, the Block, Report, and Suspend Suspicious Shipments Act
  • H.R. 2877, Behavioral Intervention Guidelines Act

A joint statement from Energy and Commerce Committee Chair Frank Pallone (D-NJ) and Health Subcommittee Chair Anna Eshoo (D-CA) about the above bills can be found here.

Senate

Brooks-LaSure’s Nomination for CMS Administrator Advances Out of Finance Committee
On May 12, the Senate voted 51 to 48 to advance the nomination of Chiquita Brooks-LaSure for administrator of the Centers for Medicare and Medicaid Services (CMS) after majority leader Chuck Schumer (D-NY) made a motion to discharge her nomination from the Finance Committee. Republican Sens. Susan Collins (R-ME) and Jerry Moran (R-KS) joined Democrats in supporting the motion. Next, Sen. Schumer will need to file cloture to limit floor debate on the confirmation. If the Senate passes cloture, Brooks-LaSure’s nomination will go before the full Senate for a final vote. A simple majority is needed to confirm both the cloture and the nomination.

Andrea Palm Confirmed as HHS Deputy Secretary
On May 11, the Senate voted 61-37 to confirm Andrea Palm as deputy secretary of Health and Human Services (HHS). Palm previously served as Wisconsin’s top health official.

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

This week in Washington: Biden Administration expresses support for WTO TRIPS Waiver.

House

House Energy and Commerce Hearing to Discuss HHS 2022 Budget Request
The House Energy and Commerce Subcommittee on Health will hold a hearing on May 12 with the Department of Health and Human Services (HHS) Secretary Xavier Becerra to discuss the HHS 2022 discretionary budget request. Representatives will likely use the hearing to ask Becerra about the Biden administration’s plans to cut prescription drug costs and expand coverage. More information about the hearing can be found here.

House Energy and Commerce Committee Republicans Ask Blinken to Declassify Documents Related to Chinese Military Research
On May 6, House Energy and Commerce Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-KY) and Morgan Griffith (R-VA) sent a letter to Secretary of State Antony Blinken requesting a release of unclassified and declassified documents related to a statement in a Jan. 15 fact sheet. The fact sheet, which can be found here, references Chinese military research taking place at the Wuhan Institute of Virology (WIV). The WIV has been a focus of U.S. government concerns regarding possible links to the COVID-19 virus origin. In the letter, the representatives argue that declassifying and releasing these documents will help inform a complete investigation into the origins of the COVID-19 pandemic. The letter requests a response from Secretary Blinken by May 20. The complete letter can be found here.

Senate

Sen. Cornyn Continues Hold on Brooks-LaSure’s CMS Administrator Nomination
Sen. John Cornyn (R-TX) has not lifted his hold on a floor vote for Chiquita Brooks-LaSure’s nomination for Centers for Medicare and Medicaid Services (CMS) administrator. Sen. Cornyn placed a hold on Brooks-LaSure’s nomination in response to the Biden administration’s April 16 decision to reverse an extension of Texas’s 1115 Medicaid waiver that was passed by the Trump administration. Brooks-LaSure’s nomination cannot move forward until the hold is lifted.

MACPAC Announces New Appointments
On May 3, the Government Accountability Office (GAO) announced five new appointments and two reappointments to the Medicaid and CHIP Payment and Access Commission (MACPAC). Current MACPAC Chair Melanie Bella will serve a second term. Commissioner Kisha Davis was named vice chair of MACPAC, and her term will end in 2023. Commissioner Katherine Weno was reappointed for a term that ends in 2023. New appointees to MACPAC include Heidi Allen, an associate professor at Columbia University School of Social Work; Robert Duncan, executive vice president of Children’s Wisconsin and president of Children’s Community Health Plan and Children’s Service Society of Wisconsin; Laura Herrera Scott, vice president of clinical strategy and product at Anthem; and Verlon Johnson, senior vice president of corporate strategy at CNSI.

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

Clayton Cox, former national finance director for the Democratic National Committee (DNC), will join McGuireWoods Consulting’s federal public affairs team as a vice president in May. Well known in the Democratic party for his pivotal roles in the last three presidential campaigns, Cox brings unparalleled insight into the priorities of President Biden’s Administration, as well as both branches of Congress.

In addition to helping lead the fundraising plan for the Biden Victory Fund, notably the most successful fundraising effort in DNC and presidential history, Cox developed the fundraising launch plan for Vice Presidential nominee Senator Kamala Harris and served as the fundraising lead for Members for Biden, a fundraising effort of current and former Members of Congress for the campaign.

Prior to that, Cox led the Southeast regional fundraising campaign for Secretary Hillary Clinton’s presidential campaign in 2016 and served as a regional finance assistant for President Barack Obama’s 2012 presidential campaign and inauguration.

“Clayton’s decade-long run in Democratic politics at the highest levels provides clients with unique insight and strategic guidance regarding policies of the Biden Administration and the Democratically controlled Congress,” said McGuireWoods Consulting’s president and former South Carolina Gov. Jim Hodges. “We are excited to have him on board.”

McGuireWoods Consulting’s Chairman Mark Bowles echoed Gov. Hodges: “Our firm attracts top-notch talent, and Clayton is a terrific addition to our team. We look forward to his arrival.”

During his tenure at the Democratic National Committee, Cox planned and executed major fundraising events with leading principals, including President Barack Obama, then Vice President Joe Biden, Secretary Hillary Clinton and the 2020 Democratic presidential field, among others. He also developed and orchestrated the fundraising campaign for Tom Perez’s successful race for Chair of the Democratic National Committee in 2017.

“The Democratic party saw record-breaking fundraising numbers during Clayton’s time with the DNC, and his relationships as a result of these successes only enhance the ways in which McGuireWoods Consulting offers value to its clients,” said Paul Reagan, senior vice president and director of McGuireWoods Consulting’s federal public affairs team. “Clayton will be a remarkable asset to our already strong team.”

Cox is a graduate of The University of Georgia and holds a master’s degree in political management from The George Washington University.

This week in Washington: President Biden Announces American Families Plan Vision in Speech to Joint Session of Congress.

House

House Education and Labor Committee to Hold Hearing to Discuss Drug Pricing Bill
On May 5, the House Education and Labor Committee’s Subcommittee on Health, Employment, Labor, and Pensions will hold a hearing to discuss the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3). The bill, which was first introduced in 2019, would allow the federal government to negotiate the cost of prescription drugs and cap seniors’ out-of-pocket costs for prescription drugs, among other things. The House passed the Lower Drug Costs Now Act with bipartisan support in 2020. However, the Senate did not take up the legislation.

House Energy and Commerce to Hold Hearing on Drug Pricing Legislation
The House Energy and Commerce Committee’s Subcommittee on Health will hold a hearing on May 4, at 11:30 a.m., titled “Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs” to discuss drug pricing legislation. Eight bills will be discussed at the hearing, and can be found listed below:

  • H.R. 3, the “Elijah E. Cummings Lower Drug Costs Now Act”
  • H.R. 19, the “Lower Costs, More Cures Act of 2021”
  • H.R. 153, the “Protecting Consumer Access to Generic Drugs Act of 2021”
  • H.R. 2815, the “Bolstering Innovative Options to Save Immediately on Medicines Act” or the “BIOSIM Act”
  • H.R. 2831, the “Prompt Approval of Safe Generic Drugs Act”
  • H.R. 2843, the “Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021” or the “STOP GAMES Act”
  • H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes
  • H.R. 2853, the “Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021” or the “BLOCKING Act”

Senate

Senate Finance Chair Ron Wyden to Move on Drug Pricing
Although President Biden stressed his commitment to addressing drug pricing in his April 28 address to Congress, drug pricing reform was not included in the American Families Plan. In response to this, Senate Finance Chair Ron Wyden (D-OR) stated he will start drafting drug pricing reform legislation.

Senators Thune and Carper Reintroduce Bill on Chronic Disease Management
On April 28, Sens. Tom Carper (D-DE) and John Thune (R-SD) reintroduced legislation to ensure that high-deductible health plans (HDHP) linked to health savings accounts (HSA) can cover services to manage chronic disease prior to a beneficiary’s reaching their plan deductible. The legislation was previously introduced in 2020, and the text can be found here.

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

This week in Washington: Andrea Palm’s nomination for HHS Deputy Secretary Advances out of Senate Finance Committee, Chiquita Brooks-LaSure’s nomination deadlocked.

House

House Republicans Introduce Drug Pricing Legislation

On April 21, Reps. Cathy McMorris Rodgers (R-WA), Kevin Brady (R-TX) and Virginia Foxx (R-NC) introduced the Lower Costs, More Cures Act (H.R. 19), which aims to reform drug pricing. In a letter, the representatives called on their Republican colleagues to support their legislation and oppose House Speaker Nancy Pelosi’s Elijah Cummings Lower Drug Costs Now Act (H.R. 3). The letter states that H.R 3 would make the U.S. more reliant on China and lead to fewer cures. The Lower Costs, More Cures Act would provide out-of-pocket cap and insulin cost cap for seniors in the Medicare Part D program, increase drug price transparency and reduce cancer treatment costs for Medicare beneficiaries, among other measures. The letter can be found here. The text of the Lower Costs, More Cures Act of 2021 can be found here.

House Passes Bill to Extend Schedule 1 Classification for Fentanyl-Related Substances

On April 21, the House passed a bipartisan bill to authorize a five-month extension on emergency scheduling of fentanyl-related substances, which classifies the analogues as Schedule 1 drugs. In 2018, the Drug Enforcement Administration (DEA) temporarily scheduled fentanyl-related substances as Schedule 1 substances. Classifying fentanyl-related substances as Schedule 1 designates them as illicit drugs with high potential for abuse and no potential medical use. The scheduling was set to expire on May 6, 2021. If the House bill is enacted, the Schedule 1 designation for fentanyl-related substances will expire on Oct. 22, 2021.

House Energy and Commerce Democrats Reintroduce Prescription Drug Pricing Bill

On April 22, Reps. Frank Pallone (D-NJ), Richard Neal (D-MA) and Bobby Scott (D-VA) reintroduced the Elijah Cummings Lower Drug Costs Now Act (H.R. 3). The bill would allow the federal government to negotiate the cost of prescription drugs and cap seniors’ out-of-pocket costs for prescription drugs, among other things. The House passed H.R. 3 with bipartisan support in 2020. The House Energy and Commerce Committee will hold a hearing on the bill May 4. The White House is reluctant to include drug pricing in the infrastructure package as it might not have the Senate votes to pass.

Senate

Senate Finance Committee Deadlocked on Advancing Nomination of Brooks-LaSure for CMS Administrator

On April 22, the Senate Finance Committee voted 14-14 along party lines to advance the nomination of Chiquita Brooks-LaSure for Centers for Medicare and Medicaid Services (CMS) administrator. The vote came after committee Republicans criticized the Biden administration’s decision to revoke Texas’s 10-year extension of an 1115 Medicaid waiver. The waiver, which had allowed Texas to use federal funding to increase its uncompensated care pool, was revoked on April 16. Earlier this week, Sen. John Cornyn (R-TX) asked that the Senate Finance Committee vote be delayed to give him time to meet with the White House chief of staff to discuss the Texas 1115 Medicaid waiver revocation, but the vote was not postponed. Sen. Cornyn put a hold on Brooks-LaSure’s floor vote confirmation on April 21. The hold, which is a request to temporarily block a vote from coming to the floor, can be either approved or denied by the majority leader. The Senate Finance Committee advanced the nomination of Andrea Palm for deputy secretary of the Department of Health and Human Services (HHS) out of the committee. The tie vote for Brooks-LaSure’s nomination requires Senate Majority Leader Chuck Schumer (D-NY) to file a discharge petition to bring the nomination before the full Senate.

Senate Democrats Introduce Bill to Expand Medicare to Individuals From 50-64

On April 21, Democratic Sens. Debbie Stabenow (D-MI), Sherrod Brown (D-OH) and Tammy Baldwin (D-WI) introduced the Medicare at 50 Act, which would allow adults from ages 50-64 to buy in to Medicare. The legislation comes as some Democrats express support for congressional action to strengthen public health programs in the next legislative package, rather than putting all savings into the Affordable Care Act (ACA). President Biden campaigned on providing Medicare for people age 60 and up. The Medicare at 50 Act is cosponsored by Sens. Jeff Merkley (D-OR), Tina Smith (D-MN), Jack Reed (D-RI), Ben Cardin (D-MD), Chris Van Hollen (D-MD), Gary Peters (D-MI), Tammy Duckworth (D-IL), Richard Blumenthal (D-CT), Jeanne Shaheen (D-NH), Amy Klobuchar (D-MN), Dick Durbin (D-IL), Kirsten Gillibrand (D-NY), Ed Markey (D-MA) and Bob Casey (D-PA). The Medicare at 50 Act was previously introduced in 2019.

Democratic Senators Introduce Bill to Let Employers Buy in to New Medicare Part E

On April 15, Sens. Chris Murphy (D-CO), Jeff Merkley (D-OR) and Dianne Feinstein (D-CA) introduced the Choose Medicare Act that would create a new Medicare Part E that would be available to individuals on the Affordable Care Act (ACA) exchanges. The bill would provide the Department of Health and Human Services (HHS) with $2 billion to develop a Medicare E plan that would cover all 10 essential health benefits required under the ACA and items and services covered by Medicare. The bill would also extend the ACA’s tax credits and cost-sharing subsidies, cap Medicare out-of-pocket costs and allow Medicare to negotiate drug prices. The legislation was cosponsored by Sens. Richard Blumenthal (D-CT), Brian Schatz (D-HI), Tammy Baldwin (D-WI), Tina Smith (D-MN), Jeanne Shaheen (D-NH), Tammy Duckworth (D-IL), Chris Van Hollen (D-MD), Richard Durbin (D-IL) and Jack Reed (D-RI). 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: President sends budget request to Congress.

House

House Passes Bill to Extend Medicare Sequester Moratorium

On April 13, the House of Representatives voted 384-38 to pass a bill that would eliminate the 2 percent cut to all Medicare payments, known as sequestration, until the end of 2021. In addition, the legislation would make several changes to the rural health clinic provisions included in the Consolidated Appropriations Act of 2021. The bill would increase FY 2030 sequester cuts to pay for the change. The bill was passed by the Senate last month, and President Biden is expected to sign it into law.

House Passes Eight Health Care Bills

This week, the House of Representatives passed the following eight bills:

  • H.R. 172, the “United States Anti-Doping Agency Reauthorization Act of 2021,” was introduced by Reps. Mike Thompson (D-CA), Bill Johnson (R-OH) and Diana DeGette (D-CO). The bill would extend and increase the authorization level for the U.S. Anti-Doping Agency (USADA) through fiscal year 2030, empower the agency to encourage a positive sporting environment for young athletes by providing educational materials on sportsmanship, character building and healthy performance, and would improve anti-doping efforts in the United States by encouraging federal agencies to coordinate and share information with USADA to prevent the use of performance-enhancing drugs and methods. The bill passed on the House floor by a vote of 381-37.
  • S. 578, the “Food Allergy Safety, Treatment, Education, and Research Act of 2021” or the “FASTER Act of 2021,” was introduced by Sen. Tim Scott (R-SC). The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to include sesame as a major allergen. The bill would also require the Department of Health and Human Services (HHS) to report specific recommendations and strategies to reduce risks related to food allergies, including recommendations for the development of a regulatory process to add additional foods or ingredients to the list of major food allergens. The bill passed on the House floor by a vote of 415-11.
  • H.R. 189, the “John Lewis NIMHD Research Endowment Revitalization Act,” was introduced by Reps. Nanette Diaz Barragan (D-CA), Earl “Buddy” Carter (R-GA) and Van Taylor (R-TX). The bill authorizes the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence. The bill passed on the House floor by voice vote.
  • H.R. 941, the “Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021” or the “TRANSPLANT Act of 2021,” was introduced by Reps. Doris Matsui (D-CA), Gus Bilirakis (R-FL) and Chellie Pingree (D-ME). The bill would reauthorize the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory to facilitate lifesaving bone marrow and umbilical cord blood donations to help patients suffering from blood cancers, disorders and diseases. The bill would also require HHS to review the state of science related to adult stem cells and birthing tissues for the purpose of potentially including in the program, and would require the National Institutes of Health, in consultation with other agencies, to further the field of regenerative medicine and commission a report by the Comptroller General on the state of the regenerative medicine workforce. The bill passed on the House floor by a vote of 415-2.
  • S. 164, the “Advancing Education on Biosimilars Act of 2021,” was introduced by Sens. Margaret Wood Hassan (D-NH) and Bill Cassidy (R-LA). The legislation would help provide patients and health care providers with greater information about biologics and biosimilars by requiring the Food and Drug Administration (FDA) to establish a public website with educational materials, including what products are interchangeable, as well as how to report any adverse events. The bill would also support the development of continuing education programs for health care providers about biologics. The bill passed on the House floor by a vote of 412-8.
  • S. 415, the “Ensuring Innovation Act,” was introduced by Sens. Bill Cassidy (R-LA), Tina Smith (D-MN) and Roger Marshall (R-KS). The legislation clarifies that five-year new chemical entity eligibility is only available for drugs containing no active component that has previously been approved in the United States. This would help reduce drug costs and improve access to more affordable generic drugs by ensuring that market exclusivity, which can delay generic drugs from entering the market, is only made available to truly innovative products. The bill passed on the House floor by voice vote.
  • H.R. 1002, the “Debarment Enforcement of Bad Actor Registrants Act of 2021” or the “DEBAR Act of 2021,” was introduced by Rep. Bob Latta (R-OH). The bill would amend the Controlled Substances Act to allow the attorney general to prohibit any registrant from manufacturing, distributing or dispensing a controlled substance or a List I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration, or has a history of prior suspension or revocations. The bill passed on the House floor by a vote of 411-5.
  • H.R. 1899, the “Ensuring Compliance Against Drug Diversion Act,” was introduced by Rep. Morgan Griffith (R-VA). The bill terminates the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice, or surrenders registration. A registrant who ceases legal existence or discontinues business is required to notify the Drug Enforcement Administration (DEA). Registrants must receive written consent from DEA in order to assign or transfer a registration, and they are also required to return certain documentation if a registrant’s work is discontinued. The bill passed on the House floor by a vote of 412-5.

Two of the bills, the Advancing Education on Biosimilars Act and the Ensuring Innovation Act, previously passed the Senate and are on their way to President Biden’s desk.

House Members Divided on Fentanyl Analogue Scheduling

In an April 14 Energy and Commerce Committee Subcommittee on Health hearing, several House Republicans expressed support for legislation that would extend or make permanent the Schedule 1 classification for fentanyl-related substances. On the other hand, some Democrats expressed support for a bill that would use harm-reduction strategies to address the fentanyl crisis.

In 2018, the Trump administration temporarily scheduled fentanyl-related substances as Schedule 1, which means that these substances are classified as illicit drugs with high potential for abuse and no potential medical use. Congress extended this classification in 2020 but it is set to expire on May 6. If the deadline is not extended past May 6, the Drug Enforcement Agency (DEA) will schedule individual fentanyl analogues once they are discovered, as was done prior to the Schedule 1 designation. Stakeholders express concern that allowing the Schedule 1 designation to end would make it more complicated to prosecute individuals for fentanyl distribution.

For more information on the hearing, click here.

Rep. Kevin Brady to Retire

On April 13, Rep. Kevin Brady (R-TX), ranking member and former chair of the House Ways and Means Committee, stated that he would not be running for reelection in 2022. He is currently serving his 13th term.

Senate

Senate Finance Hearing to Consider Nominees for CMS Administrator and HHS Deputy Secretary

On April 15, the Senate Finance Committee held a hearing to consider the nominations of Andrea Joan Palm to be deputy secretary of Health and Human Services (HHS) and Chiquita Brooks-LaSure to be administrator of the Centers for Medicare and Medicaid Services (CMS). Member questions centered on waivers, telehealth, equity, border policy, behavioral health and drug pricing.

Bipartisan Bill Would Require Cost-Free Breast Cancer Diagnostic Tests

On April 13, the Access to Breast Cancer Diagnosis Act of 2021 was reintroduced by Sens. Jeanne Shaheen (D-NH) and Roy Blunt (R-MO). The bill would require group health plans and individual insurers to cover diagnostic breast cancer tests that may be needed following an additional screening. The legislation was previously introduced in the last Congress. Under current law, plans are required to provide breast cancer screenings at no cost. Approximately 10 percent of breast cancer screenings require follow-up testing, which can include mammograms, ultrasounds and MRIs and can cost patients hundreds or thousands of dollars and result in delayed treatment.

Senators Ask HHS Secretary Becerra to Enforce Hospital Price Transparency Rule

On April 13, Senate Energy and Commerce Committee members, including Chair Frank Pallone (D-NJ), ranking member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Health Subcommittee ranking member Brett Guthrie (R-KY) wrote a letter to Health and Human Services (HHS) asking Secretary Xavier Becerra to ensure that hospitals are complying with the Hospital Price Transparency Rule.

The Hospital Price Transparency Rule, which went into effect Jan. 1, 2021, requires hospitals to make public the list of standard charges for items and services in a consumer-friendly format. The charges that need to be made public include gross charges, discount cash price, payer-specific negotiated charges and de-identified minimum and maximum negotiated charges for all items and services. HHS can issue warnings, request an action plan and issue penalties for hospitals found to be noncompliant with the rule.

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