This Week in Washington: House appropriations talks continue, Senate vote to advance mini omnibus fails; Lower Costs, More Transparency Act pulled from House consideration; House Budget Committee marks up budget resolution

Congress

House

Appropriations Talks Continue As Shutdown Nears

Both the House and Senate return Tuesday to consider appropriations. In the Senate, they are prepping a Continuing Resolution (CR) to go to sometime in December. Both Republicans and Democrats are involved in crafting it. However, because Sen. Rand Paul (R-KY) objects to the inclusion of funding for Ukraine, the Senate cannot speed up consideration of the legislation. Thus, the Senate legislation is unlikely to be sent to the House until the end of the week or Saturday at the earliest.

In the House, Speaker McCarthy has been discussing a CR only through early or mid-November. He has been told by several Republicans that if he gets a bill done with Democrats, they will trigger consideration of his removal.

The House leaders have lined up 4 appropriations bills to be considered this week – Defense, Ag, State-Foreign Ops and Homeland Security. However, there is a complicated rule to allow this to happen. Leadership is now trying to determine if they have enough votes for the rule. If the rule fails, they cannot move forward. On Saturday, McCarthy floated to his caucus a 30 day CR or a 45 day CR. He may try to attach a CR to the border security bill and possibly include a debt commission, after the four appropriations bills are considered. By then the Senate may be wrapping up their CR.

Lower Costs, More Transparency Act Pulled from House Consideration

On Sept. 18, the House was expected to hold a floor vote on the Lower Costs, More Transparency Act but the bill was unexpectedly pulled from consideration. The bill is a large healthcare package that includes provisions to increase hospital and other provider price transparency, implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager (PBM) spread pricing and extend funding for health programs.

House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) has announced that she remains committed to getting the bill passed by year’s end.

House Budget Committee Marks Up Budget Resolution for FYs 2024-2033

On Sept. 20, the House Budget Committee reported out of committee the Concurrent Resolution on the Budget for fiscal years (FYs) 2024-2033. The budget resolution outlines House Republican spending priorities over the next 10 years. It seeks to balance the budget and reduce the deficit by a projected $16.3 trillion by 2033, resulting in an estimated $130 billion budget surplus in FY 2033. It would:

  • Cap FY 2024 discretionary spending at $1.47 trillion and limit spending growth at 1 percent per year;
  • Cut total discretionary spending by $4.6 trillion by FY 2033;
  • Cut mandatory spending by $8.7 by FY 2033;
  • Lower interest payments on the national debt by $3 trillion;
  • Repeal Inflation Reduction Act and Green New Deal provisions; and
  • Create a bipartisan commission to recommend changes and oversee the solvency of Social Security and Medicare.

In addition, the resolution contains several policy statements, including one that urges Congress to enact legislation implementing Medicaid work requirements and decreasing the share of federal funds supporting state healthcare services. It is doubtful that the budget resolution will be considered by the full House.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter to CDC and USDA Regarding Federal Select Agent Program

On Sept. 15, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and Subcommittee on Health Chairman Brett Guthrie (R-KY) sent a letter to Centers for Disease Control and Prevention Director Mandy Cohen and Department of Agriculture Secretary Tom Vilsack requesting information on the federal select agent program (FSAP).

The FSAP oversees the possession, use and transfer of potentially dangerous biological agents and toxins. The chairmen are interested in the program because the committee is investigating the safety and security of federal high-containment laboratories.

For more information, click here.

Vote Planned for SUPPORT Act Reauthorization and Maternal Health Legislation

The House plans to vote this week on legislation to reauthorize the SUPPORT Act, and vote on maternal health legislation that was reported out of the Senate Health Education Labor and Pensions (HELP) Committee on Sept. 21.

The Preventing Maternal Deaths Reauthorization Act of 2023 reauthorizes the Center for Disease Control and Prevention’s support for state-based mortality review committees through fiscal year 2028. The legislation also includes a new provision directing CDC, in consultation with the Health Resources and Services Administration, to disseminate best practices on maternal mortality prevention to hospitals, state-based professional societies and perinatal quality collaboratives. 

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act would advance the requirement that state Medicaid plans provide medication-assisted treatment and continued support for Naloxone for first responders. 

Senate

Senate Vote to Move Forward “Mini Omnibus” Fails

On Sept. 20, the Senate failed to move forward a package of three appropriations bills known as a “mini omnibus” that combines the Agriculture-FDA, Military Construction-VA and Transportation-HUD appropriations bills. Republican senators continue holding out on supporting the bill, notably Sen. Rand Paul (R-KY) who announced that he will not support any bill that includes military aid to Ukraine.

Senate HELP Committee Marks Up Bipartisan Primary Care and Health Workforce Act

On Sept. 21, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up and moved out of committee the Bipartisan Primary Care and Health Workforce Act. The legislation, which was introduced by Chairman Bernie Sanders (I-VT) and Sen. Marshall (R-KS), aims to address primary care challenges and health workforce shortages and would reauthorize community health and medical education programs. It would:

  • Reauthorize $5.8 billion per year in funding for the Community Health Center Fund through fiscal year (FY) 2026;
  • Reauthorize $1.5 billion in funding for the Teaching Health Center Graduate Medical Education Program through FY 2028;
  • Reauthorize $950 million per year in funding for the National Health Service Corps through FY 2026;
  • Provide $1.2 billion in grants to community colleges and universities to increase nursing program enrollment;
  • Provide $300 million to primary care doctor residency programs and invest in dental training and workforce programs; and
  • Implement provisions aimed at prohibiting anticompetitive practices by hospitals and insurance companies, including banning certain facility fees.

Ranking Member Bill Cassidy (R-LA) opposed the legislation, announcing that it is rushed and fails to specify how funding increases will be paid for. During the mark up, he submitted 67 amendments but withdrew the majority of them, citing a lack of support.

The Ranking Member and a number of HELP committee senators are concerned about cost offsets included in the bill that would draw funds from the Prevention and Public Health Fund. The Chairman has announced that he was continuing to look for other funding sources, including drawing funds from bills related to pharmacy benefit managers (PBMs) and generic drug access. He is also in discussions with the Chair of the Senate Finance Committee, Sen. Ron Wyden (D-OR), concerning potential pay for mechanisms. 

In addition, the committee reported out of committee bills related to maternity and pediatric healthcare programs.

For more information, click here.

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

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to vote on large healthcare package on transparency

Congress

House

House Delays Vote on Defense Spending Bill

On Sept. 13, House Republicans delayed a procedural vote on the defense appropriations bill after House Freedom Caucus members stated they would not vote for the bill due to a lack of spending cuts outlined in other appropriations bills. In the meantime, the Main Street Republican Caucus and the House Freedom Caucus negotiated to develop a plan to have a Continuing Resolution through Oct. 31, with an eight percent across-the-board reduction in spending except for the Department of Defense and the Department of Veterans Affairs. It is unclear that there are enough votes in the House to pass such a measure.

House to Vote on Lower Costs, More Transparency Act

The House is expected to vote on the Lower Costs, More Transparency Act, a large healthcare package seeking to increase healthcare pricing transparency. The legislation contains provisions that would implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager (PBM) spread pricing, extend funding for health programs and require hospitals and other providers to publish the prices they charge for services.

The package includes:

H.R. 3561, PATIENT Act of 2023
This legislation would expand hospital price transparency requirements, extend funding for the Community Health Center Fund and other programs, and implement site-neutral payments for drugs administered by physicians in off-campus hospital outpatient departments.

H.R. 4839, Hospital and ASC Price Transparency Act of 2023
This legislation would require hospitals to publicly disclose the standard charges for all items and services for at least 300 shoppable services.

H.R. 3248, Diagnostic Lab Testing Transparency Act
This legislation would strengthen price transparency of clinical diagnostic laboratory tests under the Medicare program and require providers to disclose the discounted cash price and insurer- negotiated minimum and maximum rates of tests.

H.R. 4882, Clinical Laboratory Price Transparency Act of 2023
This legislation would require providers to publicly disclose the cash and insurer-negotiated rates for clinical diagnostic laboratory tests offered by a lab included on the list of shoppable services by the Centers for Medicare and Medicaid Services (CMS).

H.R. 4828, Imaging Services Price Transparency Act of 2023
This legislation would require providers to disclose the cash price and insurer-negotiated rates for certain imaging services.

H.R. 4905, Health Insurance Price Transparency Act of 2023
This legislation would require health insurers to share cost-sharing and pricing information with patients.

H.R. 4507, Transparency in Coverage Act of 2023
This legislation would require insurers to share pricing information for healthcare services and require PBMs to share cost information with plan sponsors.

H.R. 2697, Pharmacy Benefit Manager Accountability Act
This legislation would require PBMs to disclose information regarding the rebates, fees and alternative discounts they receive from prescription drugs. It would also require PBMs to disclose drug wholesale acquisition costs and enrollee total out-of-pocket spending.

H.R. 4822, Health Care Price Transparency Act
This legislation would require PBMs to share net price data, aggregate rebate information, out-of-pocket spending and acquisition costs for all drug classes upon request by an employer.

H.R. 3282, Promoting Transparency and Health Competition in Medicare Act
This legislation would require public reporting of data from healthcare entities who share common ownership interests within the Medicare program, specifically insurers who own pharmacies, PBMs and healthcare providers.

H.R. 4883, Medicare Common Ownership Transparency Act of 2023
This legislation would require Medicare Advantage (MA) organizations to disclose common ownership of pharmacies, PBMs and providers to the Department of Health and Human Services (HHS).

H.R. 3284, Providers and Payers COMPETE Act
This legislation would require the HHS Secretary to submit an annual report to Congress detailing the impact Medicare regulations have on healthcare payer and provider consolidation.

H.R. 3839, Increasing Transparency in Generic Drug Applications Act
This legislation would improve the Food and Drug Administration’s (FDA) review process of generic drugs and allow the FDA to inform drug sponsors about differences between their application and the reference product.

H.R. 1613, Drug Price Transparency in Medicaid Act
This legislation would prohibit PBMs from using spread pricing within the Medicaid program.

H.R. 3237, to amend title XVIII of the Social Security Act to require each off-campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department to submit to the Centers for Medicare and Medicaid services an attestation with respect to each such department.
This legislation would require off-campus outpatient departments to use a unique health identifier when billing for services.

H.R. 3417, FAIR Act
This legislation would require off-campus outpatient departments to bill for services provided using a unique health identifier.

H.R. 4509, Transparency in Billing Act
This legislation would require group health plans to only pay claims submitted by hospitals that have implemented accurate billing practices, policies and procedures.

H.R. 2559, Strengthening Community Care Act of 2023
This legislation would extend funding for the Community Health Center Fund, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

H.R. 2550, Special Diabetes Program Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program through calendar year (CY) 2025.

H.R. 2547, Special Diabetes Program for Indians Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program for Indians through CY2025.

H.R. 2665, Supporting Safety Net Hospitals Act
This legislation would delay cuts to the Medicaid Disproportionate Share Hospital (DSH) payment for fiscal years (FYs) 2024-2025.

H.R. 4527, Health Data Access, Transparency, and Affordability (DATA) Act
This legislation would improve transparency of the health insurance market and ensure that plan fiduciaries can access cost and quality of care information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would clarify and strengthen employer-sponsored health plan disclosure requirements.

For more information, click here.

House Committee Chairmen Send Letter to HHS Reiterating Request for COVID-19 Origin Information

On Sept. 14, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and Subcommittee on Health Chairman Brett Guthrie (R-KY) sent a letter to the Secretary of the Department of Health and Human Services (HHS) Xavier Becerra, requesting that officials comply with the committee’s requests for COVID-19 origins information.

The chairmen are urging HHS to send requested COVID-19 origin documents and communications by Sept. 21 and stated that they will consider the use of subpoenas if they do not receive them in time. House Committee on Oversight and Accountability Chairman James Comer (R-KY) and Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH) also signed the letter.

For more information, click here.

Rep. Stewart Resigns from Congress

On Sept. 15, Rep. Stewart (R-UT) resigned from Congress. He represented Utah’s 2nd congressional district and was a member of the House Appropriations Committee and the House Permanent Select Committee on Intelligence. There will be a two-month gap before a special election is held to elect his successor on Nov. 21. His resignation comes at a critical time in Congress, with the GOP holding a slim nine vote majority in the House of Representatives.

Senate

Senate Vote on “Mini Omnibus” of Three Appropriations Bills May Be Delayed

On Sept. 12, the Senate voted 85-12 to begin debate on the Agriculture-FDA, Military Construction-VA, and Transportation-HUD appropriations bills. The Senate was expected to vote on the mini omnibus this week, however, one senator is objecting because he wants a freestanding Military Construction bill. This is providing time for the House Republicans to continue their negotiations.

Majority Leader Leads Senate Forum on AI

On Sept. 13, Senate Majority Leader Chuck Schumer (D-NY) led the Senate AI Insight Forum. The forum was attended by tech industry leaders and more than 60 senators and staff, and aimed to spur discussion on artificial intelligence (AI) and on the manner in which Congress should draft legislation to regulate the development and use of AI technologies. It was the first of a series of AI-focused forums that the Majority Leader had called for in his AI framework released in June.

For more information, click here.

Senate HELP Committee Chairman Unveils Bipartisan Primary Care and Health Workforce Act

On Sept. 14, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a draft of the Bipartisan Primary Care and Health Workforce Act and announced that he and Sen. Marshall (R-KS) had reached an agreement on the bill. The legislation would address primary care challenges and health workforce shortages and would reauthorize community health and medical education programs. It would:

  • Reauthorize $5.8 billion per year in funding for the Community Health Center Fund through fiscal year (FY) 2026;
  • Reauthorize $1.5 billion in funding for the Teaching Health Center Graduate Medical Education Program through FY 2028;
  • Reauthorize $950 million per year in funding for the National Health Service Corps through FY 2026;
  • Provide $1.2 billion in grants to community colleges and universities to increase nursing program enrollment;
  • Provide $300 million to primary care doctor residency programs and invest in dental training and workforce programs; and
  • Implement provisions aimed at prohibiting anticompetitive practices by hospitals and insurance companies, including banning certain facility fees.

The Senate HELP Committee will mark up the legislation on Sept. 21. Ranking Member Bill Cassidy (R-LA) announced that he opposes the bill, arguing that it lacks full Hyde amendment protections related to abortion and fails to specify how funding increases will be paid.

For more information on the bill, click here.

Sen. Romney Announces Plan to Retire

On Sept. 13, Sen. Romney (R-UT) announced that he will not run for reelection and will retire after his current term ends on Jan. 3, 2025.

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

This Week in Washington: House to unveil sweeping health bill

Congress

House

Appropriations Process Remains Top Priority

With the fiscal year set to expire on Sept. 30, time is running out for Congress to pass appropriations bills to fund the government through the new fiscal year. The House is expected to move appropriations bills for the Department of Defense, Department of Homeland Security and Department of Agriculture-Food and Drug Administration. The Senate is expected to move appropriations bills for the Department of Agriculture, Military Construction, and Veterans’ Affairs, the Department of Transportation and the Department of Housing and Urban Development. It is not yet known whether a continuing resolution will be passed to avert a government shutdown.

House Republicans Release Healthcare Package Draft

On Sept. 6, Republicans on the House Energy and Commerce, Ways and Means, and Education and Workforce committees released a draft of the Lower Cost, More Transparency Act. The legislation is a major healthcare package composed of bills advanced by the committees relating to price transparency, pharmacy benefit managers (PBMs), Medicare site-neutral payments and healthcare program funding. The proposal could change after consideration by the full GOP caucus. The package includes:

H.R. 3561, PATIENT Act of 2023
This legislation would expand hospital price transparency requirements, extend funding for the Community Health Center Fund and other programs, and implement site-neutral payments for drugs administered by physicians in off-campus hospital outpatient departments.

H.R. 4839, Hospital and ASC Price Transparency Act of 2023
This legislation would require hospitals to publicly disclose the standard charges for all items and services for at least 300 shoppable services.

H.R. 3248, Diagnostic Lab Testing Transparency Act
This legislation would strengthen price transparency of clinical diagnostic laboratory tests under the Medicare program and require providers to disclose the discounted cash price and insurer- negotiated minimum and maximum rates of tests.

H.R. 4882, Clinical Laboratory Price Transparency Act of 2023
This legislation would require providers to publicly disclose the cash and insurer-negotiated rates for clinical diagnostic laboratory tests offered by a lab included on the list of shoppable services by the Centers for Medicare and Medicaid Services (CMS).

H.R. 4828, Imaging Services Price Transparency Act of 2023
This legislation would require providers to disclose the cash price and insurer-negotiated rates for certain imaging services.

H.R. 4905, Health Insurance Price Transparency Act of 2023
This legislation would require health insurers to share cost-sharing and pricing information with patients.

H.R. 4507, Transparency in Coverage Act of 2023
This legislation would require insurers to share pricing information for healthcare services and require PBMs to share cost information with plan sponsors.

H.R. 2697, Pharmacy Benefit Manager Accountability Act
This legislation would require PBMs to disclose information regarding the rebates, fees and alternative discounts they receive from prescription drugs. It would also require PBMs to disclose drug wholesale acquisition costs and enrollee total out-of-pocket spending.

H.R. 4822, Health Care Price Transparency Act
This legislation would require PBMs to share net price data, aggregate rebate information, out-of-pocket spending and acquisition costs for all drug classes upon request by an employer.

H.R. 3282, Promoting Transparency and Health Competition in Medicare Act
This legislation would require public reporting of data from healthcare entities who share common ownership interests within the Medicare program, specifically insurers who own pharmacies, PBMs and healthcare providers.

H.R. 4883, Medicare Common Ownership Transparency Act of 2023
This legislation would require Medicare Advantage (MA) organizations to disclose common ownership of pharmacies, PBMs and providers to the Department of Health and Human Services (HHS).

H.R. 3284, Providers and Payers COMPETE Act
This legislation would require the HHS Secretary to submit an annual report to Congress detailing the impact Medicare regulations have on healthcare payer and provider consolidation.

H.R. 3839, Increasing Transparency in Generic Drug Applications Act
This legislation would improve the Food and Drug Administration’s (FDA) review process of generic drugs and allow the FDA to inform drug sponsors about differences between their application and the reference product.

H.R. 1613, Drug Price Transparency in Medicaid Act
This legislation would prohibit PBMs from using spread pricing within the Medicaid program.

H.R. 3237, to amend title XVIII of the Social Security Act to require each off-campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department to submit to the Centers for Medicare and Medicaid services an attestation with respect to each such department.
This legislation would require off-campus outpatient departments to use a unique health identifier when billing for services.

H.R. 3417, FAIR Act
This legislation would require off-campus outpatient departments to bill for services provided using a unique health identifier.

H.R. 4509, Transparency in Billing Act
This legislation would require group health plans to only pay claims submitted by hospitals that have implemented accurate billing practices, policies and procedures.

H.R. 2559, Strengthening Community Care Act of 2023
This legislation would extend funding for the Community Health Center Fund, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

H.R. 2550, Special Diabetes Program Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program through calendar year (CY) 2025.

H.R. 2547, Special Diabetes Program for Indians Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program for Indians through CY2025.

H.R. 2665, Supporting Safety Net Hospitals Act
This legislation would delay cuts to the Medicaid Disproportionate Share Hospital (DSH) payment for fiscal years (FYs) 2024-2025.

H.R. 4527, Health Data Access, Transparency, and Affordability (DATA) Act
This legislation would improve transparency of the health insurance market and ensure that plan fiduciaries can access cost and quality of care information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would clarify and strengthen employer-sponsored health plan disclosure requirements.

For more information, click here.

House Ways and Means Committee Chair Requests Information on Rural Health Disparities

On Sept. 7, House Ways and Means Committee Chairman Jason Smith (R-MO) sent a letter to stakeholders requesting their input on how to address the challenges facing patients living in rural and underserved areas when accessing healthcare services.

The Chairman noted that the committee is particularly interested in payment disparities that exist between geographic areas, payments for identical care provided in different sites of service and the long-term financial health of healthcare providers and facilities. The committee is also interested in innovative care models that could improve patient outcomes and incentives aimed at revitalizing the healthcare workforce.

Public comments will be accepted until Oct. 5. For more information, click here.

Senate

Senate HELP Committee Ranking Member Releases White Paper on AI

On Sept. 6, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper on artificial intelligence (AI) and its projected risks and benefits to society. The white paper focuses on AI’s potential role within the healthcare space and examines how AI could strengthen pharmaceutical research and development, disease detection and treatment, health data privacy and healthcare workload. The paper also examines AI’s potential impact on education and job security.

The Ranking Member is requesting that stakeholders submit feedback on the outlined topics by Sept. 22.

For more information, click here.

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

This Week in Washington: HHS announces lowest national uninsured rate, CDC recommends RSV antibody for infants, CMS releases rules on inpatient and long-term care hospitals and skilled nursing facilities

Congress

House

The House has recessed for its August district work period.

House Energy and Commerce Chairmen Send Letter Concerning Gain-of-Function Research

On Aug. 1, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent a letter to the Government Accountability Office (GAO) requesting that it gather information on the risks and benefits of gain-of-function research involving pathogens with pandemic potential. The members are also requesting information on how gain-of-function research is being defined and used across federal agencies.

For more information, click here.

One Hundred and One Representatives Send Letter Concerning Medicare Physician Payment Reform

On July 28, Rep. Bera (D-CA) led a group of 101 representatives in sending a letter to House Speaker Kevin McCarthy (R-CA) and House Minority Leader Hakeem Jeffries (D-NY) urging the leadership to work with them to create reform of Medicare physician payments to stabilize the system and pay for health outcomes.

In their letter, the members argue that the Medicare Access and CHIP Reauthorization Act (MACRA) Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) have logistical challenges for providers resulting in lower uptake of these models. The members point to incentive payments in APMs that are temporary and underutilized and state that thresholds to qualify for APM payment adjustments are steep.

For more information, click here.

Senate

The Senate has recessed for its August state work period.

Senate Finance Committee Chairman Sends Letter Concerning ADHD Drug Shortages

On Aug. 3, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to attention deficit hyperactivity disorder (ADHD) drug manufacturers urging them to either increase their production of ADHD medications or relinquish their remaining amphetamine product quota allotment to allow other manufacturers to produce more than their production limit. The Chairman is also asking manufacturers to report voluntary and required production information to the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) to help track the ongoing shortage of ADHD medications.

The letter is the Chairman’s response to a joint statement issued by FDA Commissioner Robert Califf and DEA Administrator Anne Milgram, which stated ADHD drug manufacturers produced just 70 percent of their allotted amphetamine product quota in 2022. The DEA and FDA acknowledged that production rates remain under permitted limits thus far in 2023.

For more information on the Chairman’s letter, click here.

For more information on the joint statement, click here.

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

This Week in Washington: Senate Finance Committee reports out Modernizing and Ensuring PBM Accountability Act; House Ways and Means Committee reports out healthcare bills; Senate Appropriations Committee reports out FY 2024 Labor-HHS funding bill; Congress leaves for August recess

Congress

House

House Ways and Means Committee Marks Up Two Healthcare Bills

On July 26, the House Ways and Means Committee reported out two healthcare bills on a party line vote. The bills are:

H.R. 4822, the Health Care Price Transparency Act of 2023
This legislation would implement additional site-neutral payment cuts and regulatory measures on off-campus hospital outpatient departments. It would also impose Medicare sequester cuts on hospitals, codify hospital price transparency regulations, require healthcare plans to limit beneficiary cost-sharing for a month’s supply of a drug covered under Medicare Part D, and establish an electronic prior authorization system for Medicare Advantage plans.

H.R. 3284, the Providers and Payers COMPETE Act
This legislation would require the Secretary of Health and Human Services (HHS) to submit an annual report to Congress outlining the effects of Medicare payment rules on provider and payer consolidation. The report would also detail the effects of payer and provider consolidation with respect to Centers for Medicare and Medicaid (CMS) Innovation Center models.

During the markup, the committee rejected four amendments. Among them was an amendment offered by Rep. Pascrell (D-NJ) that would have required the disclosure of hospitals and nursing homes owned by private equity entities.

For more information, click here.

House Energy and Commerce Committee Chairman Issues Drug Shortage Discussion Draft

On July 28, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) released a discussion draft concerning drug shortages. The discussion draft outlines proposals that the committee developed from stakeholder feedback from a request for information (RFI) the Chair and Senate Finance Committee Ranking Member Mike Crapo (R-ID) issued on drug shortages in June.

Among the policy proposals are provisions that would:

  • Exempt certain specified drugs from increases in rebates under the Medicaid program;
  • Implement a cap on total rebates for certain generic drugs;
  • Exempt generic, sterile injection drugs from the 340B Drug Discount Program;
  • Direct the Government Accountability Office (GAO) to study the number of generic drugs that are subject to 340B penny pricing;
  • Direct the Health Resources and Services Administration (HRSA) to issue guidance on preventing drug diversions during shortages;
  • Reduce inflation rebate amounts for certain shortage drugs subject to rebate waivers under the Medicare program;
  • Direct the Department of Health and Human Services (HHS) to study Medicare coding policies for generic sterile injectables and other Part B drugs facing shortages;
  • Strengthen reporting requirements for Group Purchasing Organizations; and
  • Require the Food and Drug Administration (FDA) to issue noncompliance letters relating to drug volume reporting.

The committee is seeking public comment on the draft discussion and will accept comments until Aug. 25, 2023.

For more information, click here.

Senate

Senate Finance Committee Marks Up Modernizing and Ensuring PBM Accountability Act

On July 26, on a 26 to 1 vote, the Senate Finance Committee reported out of committee the Modernizing and Ensuring PBM Accountability (MEPA) Act. The legislation would update federal prescription drug programs and implement provisions aimed at reforming pharmacy benefit manager (PBM) practices. It would:

  • Prohibit PBMs and their affiliates from deriving income or renumeration for Medicare Part D covered drugs based on a manufacturer’s price for the drug;
  • Require PBMs to define and apply drug and drug pricing terms in contracts with Part D plan sponsors in a transparent and consistent manner;
  • Strengthen PBM reporting requirements and expand the amount of information that PBMs provide to Part D plan sponsors and the Secretary of Health and Human Services (HHS);
  • Allow Part D plan sponsors to audit their PBM for compliance with contract requirements;
  • Require the HHS Secretary to implement standard Part D measures to assess network pharmacy performance;
  • Ban PBM spread pricing in the Medicaid program; and
  • Require retail community pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) survey.

For more information, click here.

Senate Appropriations Committee Marks Up FY 2024 Labor-HHS Funding Bill

On July 27, the Senate Appropriations Committee reported out of committee the fiscal year (FY) 2024 Labor, Health and Human Services (HHS) and Education appropriations bill. The legislation would authorize $224.4 billion in total discretionary funding, of which $117 billion would go to the Department of Health and Human Services (HHS). In addition, it included $2 billion in supplemental funding. The bill would:

  • Authorize $47.8 billion in funding for the National Institutes of Health (NIH);
  • Authorize $5 billion in funding for opioid and substance use disorder treatment and prevention programs;
  • Authorize $1.5 billion in funding for the NIH Advanced Research Projects Agency for Health (ARPA-H);
  • Authorize $3.67 billion in funding for the Administration for Strategic Preparedness and Response (ASPR);
  • Retain funding for the Teen Pregnancy Prevention Program;
  • Increase funding for the Ending the HIV Epidemic Initiative;
  • Increase funding for childcare and mental health programs; and
  • Award $2 billion in additional emergency funding to HHS.

For more information, click here.

Senate HELP Committee Chairman Cancels Two Days of Mark Ups

On July 26 and 27, the Senate Health, Education, Labor and Pensions (HELP) Committee was scheduled to mark up legislation relating to primary care, health workforce development, and job and apprenticeship programs. However, both markups were canceled by committee Chairman Bernie Sanders (I-VT). Ranking Member Bill Cassidy (R-LA) raised concerns about the postponements.

The bills that were scheduled to be marked up include:

Primary Care and Health Workforce Expansion Act
This legislation would authorize $86.5 billion in funding for various health workforce development programs, including the National Health Service Corps and the Primary Care Training and Enhancement Program. It would also implement new prior authorization requirements, prohibit hospitals from charging facility fees when patients receive care from off-site physicians and place a cap on hospital and physician fees.

National Apprenticeship Act of 2023
This legislation would support the creation and expansion of registered, youth and pre-apprenticeship programs. It would also grant the Department of Labor Office of Apprenticeship (OA) additional statutory authority to support state apprenticeship programs and agencies.

Youth Apprenticeship Advancement Act
This legislation would support the expansion of youth apprenticeship opportunities available to high school students and would authorize an investment of $500 million in youth apprenticeship programs over the next five years.

JOBS Act of 2023
This legislation would expand Pell Grant eligibility to students who are enrolled in short-term job training programs that result in their obtaining industry-recognized credentials and certificates.

Gateway to Careers Act of 2023
This legislation would create a grant program aimed at strengthening job training. The grant program would support workforce partnerships established among community colleges, industry stakeholders and other community organizations.

For more information on the primary care legislation markup, click here.

For more information on the job and apprenticeship program legislation markup, click here.

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

This Week in Washington: House Energy and Commerce Committee marks up 15 healthcare bills; Senate HELP Committee to hold mark up on primary care bill; CMS concerned over procedural Medicaid coverage terminations

Congress

House

House Energy and Commerce Committee Marks Up 15 Healthcare Bills

On July 19, the House Energy and Commerce Committee reported out of committee 15 healthcare bills. The bills are:

  • H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023

This legislation would expand COVID-19 telehealth flexibilities issued by the Departments of Health and Human Services (HHS), Labor and the Treasury, and allow employers to offer stand-alone coverage of telehealth-only services to employees.

  • H.R. 3226, Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023

This legislation would reauthorization the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act for fiscal years (FYs) 2024 to 2028. It would direct the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) to strengthen efforts to reduce preterm births and infant mortality and would authorize a new study to analyze the financial costs of premature births on society.

  • H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023

This legislation would reauthorize federal support of state efforts to address disparities that exist in maternal health outcomes. It would require the CDC to work with HRSA to inform hospitals and healthcare providers of maternal mortality prevention strategies.

  • H.R. 3843, Action for Dental Health Act of 2023

This legislation would reauthorize Section 340G of the Public Health Service Act to address dental workforce needs.

  • H.R. 3884, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023

This legislation would reauthorize Section 1106 of the Public Health Service Act for FYs 2024 to 2028 to continue research and treatment services.

  • H.R. 3821, Firefighter Cancer Registry Reauthorization Act of 2023

This legislation would reauthorize funding for FYs 2024 to 2028, for a voluntary CDC registry used to report firefighter cancer incidents.

  • H.R. 3391, Gabriella Miller Kids First Research Act 2.0

This legislation would reauthorize funding through FY 2028 for the National Institutes of Health (NIH) Gabriella Miller Kids First Pediatric Research Program. It would also enhance the coordination of federal pediatric cancer research efforts and require HHS to report on federally funded pediatric cancer research programs and initiatives.

  • H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act

This legislation would reauthorize federal programs supporting public health security and all-hazards response, the Biomedical Advanced Research and Development Authority (BARDA), the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the Strategic National Stockpile (SNS). It would also contain provisions aimed at streamlining emergency response authorities and medical countermeasure research and enhancing transparency across federal agencies.

  • H.R. 4420, Preparedness and Response Reauthorization Act

This legislation would reauthorize CDC programs that support the distribution of medical countermeasures and the control of biological agents and mosquito-borne diseases. It would also strengthen epidemiological monitoring.

  • H.R. 4529, Public Health Guidance Transparency and Accountability Act of 2023

This legislation would require the CDC to implement public participation requirements prior to finalizing and implementing guidance. It would also clarify that CDC guidance is nonbinding.

  • H.R. 4381, Public Health Emergency Congressional Review Act

This legislation would establish a congressional review process for a public health emergency (PHE) and would allow Congress to consider and vote on terminating a PHE six months after it was declared.

  • H.R. 3813, CDC Leadership Accountability Act of 2023

This legislation would require any director of the CDC appointed by the president on or after June 1, 2023, to be confirmed by the Senate.

  • H.R. 3836, Medicaid Primary Care Improvement Act

This legislation would clarify that current Medicaid law does not prohibit state Medicaid programs from using direct primary care to provide services to Medicaid beneficiaries. It would also require the Centers for Medicare and Medicaid Services (CMS) to report to Congress on existing Medicaid primary care contracting arrangements.

  • H.R. 4531, Support for Patients and Communities Reauthorization Act

This legislation would reauthorize portions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. It would reauthorize public health programs related to substance use disorder prevention, treatment and recovery and the permanent extension of Medicaid’s required coverage of medication-assisted treatments.

  • H.R. 3887, Children’s Hospital GME Support Reauthorization Act

This legislation would reauthorize payments to children’s hospitals that have Graduate Medical Education programs for FYs 2024 to 2028. It would also prohibit payments to children’s hospitals that furnish specified procedures or drugs for minors.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter to FDA over Foreign Drug Manufacturing Inspections

On July 18, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chairman Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf concerning FDA-led foreign drug manufacturing inspections. The FDA recently decided to allow the import of drugs from India and China to alleviate the ongoing U.S. critical drug shortage. The members are concerned that this decision may lead to drug products entering the U.S. that are in violation of FDA safety regulations.

For more information, click here.

Senate

Senate HELP Committee Marks Up Pandemic and All-Hazards Preparedness and Response Act

On July 20, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up and voted in favor of authorizing the Pandemic and All-Hazards Preparedness and Response (PAHPARA) Act. The legislation would improve U.S. biosecurity capabilities and pandemic preparedness and response capabilities among state and federal healthcare agencies. The legislation would:

  • Improve planning and coordination efforts among federal agencies during public health emergencies, natural disasters and biological, chemical and nuclear threats;
  • Reauthorize the Hospital Preparedness Program;
  • Update the National Health Security Strategy, the Annual Threat-Based Review for the Strategic National Stockpile (SNS), the Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP);
  • Encourage the Biomedical Advanced Research and Development Authority (BARDA) to support innovate medical countermeasures and identify virus families with significant pandemic potential; and
  • Direct the Government Accountability Office (GAO) to study the economic impact and health outcomes of COVID-19 response strategies.

During the markup, the committee adopted two amendments offered by Sens. Budd (R-NC), Hassan (D-NH) and Hickenlooper (D-CO) that seek to strengthen the SNS and establish an emerging pathogen preparedness program at the Food and Drug Administration (FDA).

For more information, click here.

Senate HELP Committee Chairman Introduces Primary Care Bill

On July 19, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sander (I-VT) introduced the Primary Care and Health Workforce Expansion Act. The legislation would:

  • Authorize $86.5 billion in funding for the Community Health Center Fund, the National Health Service Corps, the Children’s Hospital Graduate Medical Education Program, the Teaching Health Center Graduate Medical Education Program, the Primary Care Training and Enhancement Program and other education and loan repayment programs through fiscal year (FY) 2028;
  • Require insurance plans to use electronic prior authorization forms;
  • Prohibit insurance plans from imposing duplicate prior authorization requirements on patients who switch their health plans while receiving treatment;
  • Prohibit hospitals from charging facility fees when patients receive care from off-site physicians;
  • Prohibit hospitals and physicians from billing separately for a given service; and
  • Cap hospital and physician fees to equal no more than the median amount that health plans and issuers pay for the service in a physician’s office.

The legislation is the Chairman’s response to a bill introduced last week by HELP Committee Ranking Member Bill Cassidy (R-LA) that also seeks to reauthorize various primary care and medical education programs. The Chairman and Ranking Member have been unable to agree on funding levels and negotiations have stalled between their staff. A markup of the Chairman’s bill has been scheduled for July 26.

For more information, click here.

Senate Finance Committee to Consider PBM Legislation on July 26

The Senate Finance Committee will hold a markup on July 26 to consider legislation to reform pharmacy benefit managers (PBM). The legislation builds upon the bipartisan framework released in April and a subsequent draft released by Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID).

For more information, click here.

Seventeen Senators Send Letter Concerning HIPAA Privacy Regulations

On July 18, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Appropriations Committee Chairman Patty Murray (D-WA) led a group of 17 senators and 28 members of the House of Representatives in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra. The letter urges HHS to add additional provisions to a proposed rule that HHS issued in April that seeks to strengthen federal privacy requirements under the Health Insurance Portability and Accountability (HIPAA) Act. The members are urging HHS to:

  • Require law enforcement agencies to obtain a warrant before requiring doctors, pharmacists and healthcare providers to pass along patient health information (PHI);
  • Prohibit PHI from being shared among law enforcement agencies unless it is needed to further an investigation specified in a warrant application; and
  • Inform patients when their PHI is shared with law enforcement agencies.

For more information, click here.

SUPPORT for Patients and Communities Reauthorization Act of 2023 Introduced

On July 20, Senate Health, Education, Labor and Pensions (HELP) Ranking Member Bill Cassidy (R-LA) introduced the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Reauthorization Act of 2023. The legislation would reauthorize programs that support mental illness and substance use-disorder prevention, treatment and recovery services. It would also:

  • Reauthorize programs that support first responder training, child and youth mental health, pregnant and postpartum women, and work-reentry;
  • Increase access to treatment for patients with treatment-resistance depression;
  • Direct the Food and Drug Administration (FDA) to carry out a review of at-home drug disposal standards and systems;
  • Require the Department of Labor (DOL) to report on the 25-year implementation of mental health parity laws;
  • Direct the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) to issue a special registration process for practitioners who prescribe controlled substances via telehealth; and
  • Provide guidance to states on how to treat children with serious emotional disturbance and individuals with serious mental illness.

In addition, on July 19 the House Energy and Commerce Committee reported its version H.R. 4531, the Support for Patients and Communities Reauthorization Act out of committee.

For more information, click here.

PBM Oversight Act of 2023 Introduced

On July 20, Sens. Carper (D-DE) and Grassley (R-IA) introduced the PBM Oversight Act of 2023. The legislation would increase oversight over the practices pharmacy benefit managers (PBMs) use to determine which medications are included on drug formularies and would require the Government Accountability Office (GAO) to conduct a study on the practices and report their findings to Congress. It would also require the GAO to study the practices that pharmacy and therapeutic committees use when developing drug formularies under Medicare Part D.

For more information, click here.

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

This Week in Washington: Appropriation bills move forward but remain incomplete; House Energy and Commerce Committee markup includes 17 healthcare bills; Senate Finance Committee schedules PBM markup

Congress

House

House Appropriators Continue Work on Funding Bills

On July 14, the House Appropriations Committee Subcommittee on Labor, Health and Human Services, and Education subcommittee held a markup of the FY 2024 Labor, Health and Human Services and Education appropriations bill and moved it out of the subcommittee.

The proposed House Republican funding levels for the Labor-HHS bill are below the spending caps agreed to in the debt-ceiling agreement.

The proposed bill would:

  • Authorize $147 billion in overall funding to labor and health programs, a 29 percent reduction from FY 2023 funding levels;
  • Cap funding for the Department of Health and Human Services (HHS) at $103.3 billion, $14 billion less than in FY 2023;
  • Reduce funding for the Centers for Disease Control and Prevention (CDC) by $1.6 billion;
  • Reduce funding for the National Institutes of Health (NIH) by $3.8 billion; and
  • Eliminate funding for various healthcare programs, including the Agency for Healthcare Research and Quality and the CDC Center for Forecasting and Outbreak Analytics.

For more information, click here.

House Energy and Commerce Health Subcommittee Marks Up 17 Healthcare Bills

On July 13, the House Energy and Commerce Subcommittee on Health marked up and voted out of committee 17 healthcare bills. The bills that were considered include:

H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023
This legislation would expand COVID-19 telehealth flexibilities issued by the Departments of Health and Human Services (HHS), Labor, and the Treasury, and allow employers to offer stand-alone coverage of telehealth-only services to employees.

H.R. 3226, Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023
This legislation would reauthorization the Prematurity Research Expansion and Education for Mother who deliver Infants Early (PREEMIE) Act for fiscal years (FYs) 2024 to 2028. It would direct the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) to strengthen efforts to reduce preterm births and infant mortality and would authorize a new study to analyze the financial costs of premature births on society.

H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023
This legislation would reauthorize federal support of state efforts to address disparities that exist in maternal health outcomes. It would require the CDC to work with HRSA to inform hospitals and healthcare providers of maternal mortality prevention strategies.

H.R. 3843, Action for Dental Health Act of 2023
This legislation would reauthorize Section 340G of the Public Health Service Act to address dental workforce needs.

H.R. 3884, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023
This legislation would reauthorize Section 1106 of the Public Health Service Act for FYs 2024 to 2028 to continue research and treatment services.

H.R. 3821, Firefighter Cancer Registry Reauthorization Act of 2023
This legislation would reauthorize funding for FYs 2024 to 2028, for a voluntary CDC registry used to report firefighter cancer incidents.

H.R. 2365, National Plan to End Parkinson’s Act
This legislation would direct the HHS Secretary to coordinate and improve federal prevention, treatment and cure strategies for Parkinson’s disease. It would also require HHS to form an advisory council to assess current national Parkinson’s disease recommendations and strategies.

H.R. 3391, Gabriella Miller Kids First Research Act 2.0
This legislation would reauthorize funding through FY 2028 for the National Institutes of Health (NIH) Gabriella Miller Kids First Pediatric Research Program. It would also enhance the coordination of federal pediatric cancer research efforts and require HHS to report on federally funded pediatric cancer research programs and initiatives.

H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act
This legislation would reauthorize federal programs supporting public health security and all-hazards response, the Biomedical Advanced Research and Development Authority (BARDA), the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and the Strategic National Stockpile (SNS). It would also contain provisions aimed at streamlining emergency response authorities and medical countermeasure research and enhancing transparency across federal agencies.

H.R. 4420, Preparedness and Response Reauthorization Act
This legislation would reauthorize CDC programs that support the distribution of medical countermeasures and the control of biological agents and mosquito-borne diseases. It would also strengthen epidemiological monitoring.

H.R. 4529, Public Health Guidance Transparency and Accountability Act of 2023
This legislation would require the CDC to implement public participation requirements prior to finalizing and implementing guidance. It would also clarify that CDC guidance is nonbinding.

H.R. 4381, Public Health Emergency Congressional Review Act
This legislation would establish a congressional review process for a public health emergency (PHE) and would allow Congress to consider and vote on terminating a PHE six months after it was declared.

H.R. 3813, CDC Leadership Accountability Act of 2023
This legislation would require any director of the CDC appointed by the president on or after June 1, 2023, to be confirmed by the Senate.

H.R. 3836, Medicaid Primary Care Improvement Act
This legislation would clarify that current Medicaid law does not prohibit state Medicaid programs from using direct primary care to provide services to Medicaid beneficiaries. It would also require the Centers for Medicare and Medicaid Services (CMS) to report to Congress on existing Medicaid primary care contracting arrangements.

H.R. 4531, Support for Patients and Communities Reauthorization Act
This legislation would reauthorize portions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. It would reauthorize public health programs related to substance use disorder prevention, treatment and recovery and the permanent extension of Medicaid’s required coverage of medication-assisted treatments.

H.R. 4056, Ensuring Medicaid Continuity for Foster Care Act
This legislation would lift Medicaid’s institutions for mental diseases (IMD) exclusion pertaining to qualified residential treatment programs (QRTPs) for foster youth. It would limit the lifting of the IMD Exclusion to QRTPs that are in compliance with existing QRTP guardrails outlined in the Family First Prevention Services Act of 2018.

H.R. 3887, Children’s Hospital GME Support Reauthorization Act
This legislation would reauthorize payments to children’s hospitals that have Graduate Medical Education programs for FYs 2024 to 2028. It would also prohibit payments to children’s hospitals that furnish specified procedures or drugs for minors.

For more information, click here.

House Education and Workforce Committee Marks Up Four Healthcare Bills

On July 11, the House Education and Workforce Committee marked up and voted out of committee four healthcare bills. The bills that were considered include:

H.R. 4509, Transparency in Billing Act
This legislation would prohibit group health plans from paying a hospital for providing services at an off-campus location unless they provide a separate health identifier. It would also authorize the Department of Health and Human Services (HHS) to charge hospitals for noncompliance. Hospitals with more than 30 beds would be charged up to $5500 per day and hospitals with less than 30 beds would be charged up to $300 per day.

H.R. 4507, Transparency in Coverage Act
This legislation would codify the October 2020 Centers for Medicare and Medicaid Services (CMS) Transparency in Coverage Final Rule, which would require health plans to publicly disclose price and cost-sharing information to consumers. In addition, it would require pharmacy benefit managers (PBMs) to disclose spending and compensation data to their plan administrator.

H.R. 4527, Health DATA Act
This legislation would allow health plan fiduciaries to access and review de-identified cost and quality information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would strengthen requirements for pharmacy benefit managers (PBMs) and third-party administrators and require them to disclose fees and compensation data to plan sponsors.

For more information, click here.

House Energy and Commerce Committee Chairman Announces Plans to Circulate Drug Shortage Discussion Draft

On July 12, House Energy and Commerce Chairman Cathy McMorris Rodgers (R-WA) announced that the committee will circulate a drug shortage discussion draft following the completion of a recent request for information (RFI) that the chairman led alongside Senate Finance Committee Ranking Member Mike Crapo (R-ID).

For more information, click here.

Senate

Senate Majority Leader Outlines Work Priorities in Dear Colleague Letter

On July 9, Senate Majority Leader Chuck Schumer (D-NY) sent out a Dear Colleague letter outlining his plan for the July congressional work period. The leader is urging his colleagues to work on a bipartisan basis and advance legislation relating to an array of policy areas, among them health bills that seek to address the ongoing fentanyl crisis and the cost of insulin and prescription drugs. The leader is also encouraging the Senate to build upon his previously released artificial intelligence (AI) framework and to continue confirming judicial nominees.

For more information, click here.

Senate Continues Work on Appropriations Bills

The Senate Appropriations Committee is continuing its work on appropriations for fiscal year 2024, including commerce, science, financial services, the legislative branch and general government. Before going on recess, the Senate Appropriations Committee passed two bills: the FY 2024 Agriculture-FDA and the Military Construction and Veterans Affairs funding bills. Senate appropriators are setting funding levels close to spending caps that were agreed to in the debt-ceiling agreement. This is in contrast to House appropriators who are setting funding levels below those agreed upon.

Senate HELP Committee Ranking Member Unveils Legislation

On July 13, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) introduced the Community Health Care Reauthorization Act. The bill would increase funding for the Community Health Center Fund (CHCF) to $4.2 billion and increase funding for the National Health Service Corps to $350 million over the next two years. It would also increase funding for the Teaching Health Center Graduate Medical Education (THCGME) program to $275 million over the next six years.

In addition, the ranking member noted that his decision to introduce the bill came after negotiations regarding the reauthorization of community health center funding between his office and committee Chairman Bernie Sanders (I-VT) stalled. The chairman and ranking member are in disagreement over the total amount of funding that should be allocated.

For more information, click here.

Senate Finance Committee Continues Work on PBMs

On July 12, the Senate Finance Committee unveiled a draft bill that would increase pharmacy benefit manager (PBM) disclosure requirements. The committee has been developing legislation since April, when committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a bipartisan framework outlining legislative solutions.

In addition, the chair and ranking member announced that they will mark up PBM and federal prescription drug program proposals on July 26.

For more information on the draft PBM bill, click here.

For more information on the upcoming markup, click here.

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

This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare coverage pathway for breakthrough devices

Congress

House

House Appropriators Approved Six Funding Bills

As Congress left town for their Fourth of July break, the House Committee on Appropriations approved six appropriation bills for FY 2024. That includes Energy-Water, Defense, Military Construction-VA, Legislative Branch, Agriculture-FDA and Homeland Security. The current fiscal year ends on Sept. 30, and Congress plans to be in recess for all of August.

Two Hundred Thirty-Three Representatives Send Letter Concerning Prior Authorization

On June 21, Rep. DelBene (D-WA) led a group of 230 representatives in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. The letter was also signed by 61 senators. It urges CMS to speed up the prior authorization process for Medicare Advantage (MA) plans and calls on CMS to implement provisions from the Improving Seniors’ Timely Access to Care Act. The provisions seek to:

  • Establish real-time prior authorization for routine matters;
  • Increase detailed transparency metrics; and
  • Implement a 24-hour deadline for MA plans to respond to prior authorization requests for urgent care.

For more information, click here.

Senate

Senate Majority Leader Releases Policy Response to AI

On June 22, Senate Majority Leader Chuck Schumer (D-NY) released a policy outline concerning artificial intelligence (AI) titled the SAFE Innovation Framework for AI. The Majority Leader is concerned about the rise of unregulated AI technologies and has urged since April for the Senate to begin creating a regulatory framework to protect U.S. consumers and national security from them. The SAFE Innovation Framework is five principles from which legislation or regulations can be developed. The principles are:

  • Protect U.S. national security from AI threats and strengthen economic security for workers who may lose their jobs to AI technologies;
  • Support efforts to protect intellectual property, tamp down on misinformation and bias, and address copyright concerns and liability;
  • Curtail harmful AI technologies, ensure that AI systems align with democratic values and promote AI societal benefits;
  • Determine what data and information the federal government and the American public should know about AI developer content and systems; and
  • Strengthen US-led AI innovation and promote security, transparency and accountability.

In addition, the Majority Leader announced that he will convene multiple AI insight forums later this year where AI experts will be asked to provide information on topics such as risk management, intellectual property, liability, privacy and national security concerns.

For more information, click here.

Senate Appropriations Committee Marks Up Agriculture-FDA Funding Bill

On June 22, the Senate Appropriations Committee met to agree on the top-line numbers for budget functions from which the appropriations bills will be derived. This is setting up a fight with the House because of significant differences in the two bodies’ top-line numbers overall. 

Also on June 22, the Senate Appropriations Committee reported out of committee the fiscal year (FY) 2024 funding bill for Agriculture, Food and Drug Administration, and Rural Development. The Senate bill is about $1 billion more than the House version. However, the House bill relies on clawing back $8 billion in unspent pandemic-era funds, a move that is likely dead on arrival in the Senate.

The Senate bill would allocate $3.55 billion in base funding to the FDA in FY 2024, a $20 million net increase compared to FY 2023. Total FDA funding with user fee revenues included is $6.63 billion. The $20 million increase will go toward funding cosmetics oversight, food safety, device and drug shortages, neuroscience research and ALS research programs.

For more information, click here.

CONNECT for Health Act Reintroduced

On June 15, Sens. Schatz (D-HI), Wicker (R-MS), Cardin (D-MD), Thune (R-SD), Warner (D-VA) and Hyde-Smith (R-MS) reintroduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act. The legislation would:

  • Permanently remove telehealth service geographic restrictions;
  • Expand telehealth service originating sites to include patient homes and other sites;
  • Remove in-person visit requirements for telemental health services;
  • Allow health centers and rural health centers to provide telehealth services permanently;
  • Allow telehealth service restrictions to be waived during a public health emergency; and
  • Require more data to be collected on telehealth usage, quality of care and improvement options.

A companion bill was introduced in the House by Reps. Thompson (D-CA), Matsui (D-CA), Schweikert (R-AZ) and Johnson (R-OH).

For more information, click here.

Medical Supply Chain Resiliency Act

On June 22, Sens. Carper (D-DE) and Tillis (R-NC) introduced the Medical Supply Chain Resiliency Act. The legislation seeks to strengthen U.S. economic resilience and combat medical device, treatments and equipment shortages. It would authorize the president to engage in trade negotiations with “trusted trading partner” countries to increase access to medical goods and supplies for patients in the U.S. and overseas.

For more information, click here.

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

This Week in Washington: FDA funding bill passes House Appropriations Committee, MedPAC and MacPAC release June 2023 report to Congress, RSC budget blueprint brings back premium support concept for Medicare

Congress

House

RSC Releases FY2024 Budget Blueprint

On June 14, the Republican Study Committee (RSC) released its proposed budget plan for fiscal year (FY) 2024. The plan proposes to raise the age at which retirees can claim full Social Security benefits from 67 to 69, for individuals who turn 62 in 2033. It also calls for the adoption of a premium support concept for Medicare. The premium support concept is an approach to reforming Medicare that seeks to reduce growth in Medicare spending by increasing competition among health plans and providing a stronger incentive for beneficiaries to be cost conscious and incentivize beneficiaries to choose private health plans. These plans would run alongside traditional Medicare. Premium support was championed by Rep. Paul Ryan (R-WI) when he was in Republican leadership and by former President Trump. It was widely criticized by Democrats.

In addition, the plan would:

  • Cut total spending by $16.3 trillion over the next 10 years;
  • Increase defense spending to $969 billion by FY 2033;
  • Decrease nondefense spending to $522 billion in FY 2024 and increase it to $553 billion by FY 2033;
  • Implement $5.1 trillion in tax cuts over the next 10 years; and
  • Eliminate funding for the Community Development Block Grant, National Endowment for the Arts and Corporation for Public Broadcasting programs.

For more information, click here.

House Appropriations Committee Marks Up FDA Funding Bill

On June 14, the House Appropriations Committee marked up and reported out of committee the fiscal year (FY) 2024 funding bill for the Food and Drug Administration (FDA). The bill would allocate $6.6 billion to the FDA in FY 2024, approximately $7.2 billion less than what the president had requested in his budget. Committee members were divided over riders and provisions that are included in the bill.

One provision would narrow prescribing requirements for the abortion pill mifepristone and prohibit the pill from being mailed to patients. Another would prevent the Department of Health and Human Services (HHS) from banning menthol cigarettes and prohibit the department from limiting the nicotine content of cigarettes. During the markup, Democratic committee members introduced two amendments to the bill but both failed.

For more information, click here.

House Energy and Commerce Committee Chairman and Senate Finance Committee Ranking Member Request Information on Drug Shortages

On June 12, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Finance Committee Ranking Member Mike Crapo (R-ID) issued a request for information (RFI) on the rise of drug shortages throughout the country.

The RFI is directed at prescription drug supply chain stakeholders. The RFI contains a series of questions that the Chair and Ranking Member would like answered to understand why the shortages are occurring and what can be done to resolve them. Both the House Energy and Commerce and Senate Finance Committees have been working on legislation related to strengthening drug supply chains and increasing patient access to prescription drugs. Responses for the RFI are due by July 7, 2023.

For more information, click here.

Senate

Patients Before Middlemen Act Introduced

On June 14, Senate Finance Committee Chairman Ron Wyden (D-OR), Ranking Member Mike Crapo (R-ID) and Sens. Menendez (D-NJ), Blackburn (R-TN), Tester (D-MT) and Marshall (R-KS) introduced the Patients Before Middlemen (PBM) Act. The legislation would:

  • Prohibit pharmacy benefit managers (PBMs) from receiving compensation based on the price of a prescription drug when entering into a contract with a Medicare Part D plan. PBM service fees will not be linked to the price of a drug, discounts, rebates or other fees; and
  • Implement an enforcement measure that would require PBMs to pay the Secretary any amount that exceeds the designated service fees.

In April, the Chair and Ranking Member of the Senate Finance Committee released a legislative framework to address PBMs and issues with the prescription drug supply chain. It seeks to reduce prescription drug costs for patients and taxpayers by modernizing and reforming federal prescription drug programs. In 2021, the Senate Finance Committee released a report that concluded insulin manufacturers were raising prices to maintain formulary placements with PBMs.

For more information, click here.

No Free TRIPS Act Introduced

On June 15, Sens. Blackburn (R-TN), Lummis (R-WY) and Tuberville (R-AL) introduced the No Free Trade-Related Aspects of Intellectual Property (TRIPS) Act. The legislation would prohibit the president from negotiating or affirming any suspension, modification or withdrawal to the World Trade Organization (WTO) TRIPS agreement without the authorization of Congress. It seeks to protect the intellectual property (IP) of U.S. biopharmaceutical manufacturers and encourages American innovation and domestic investment.

For more information, click here.

Senate HELP Committee Chairman Releases Report on Prescription Drug Prices

On June 12, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a majority staff report that examines the cost of certain prescription drugs that were developed with support of federal government agencies such as the Department of Health and Human Services (HHS), the Department of Defense (DoD) and the Department of Veterans’ Affairs (VA).

The report highlights the market prices for prescription drugs in the U.S. and other countries and analyzes why the prices for the same drugs are higher in the U.S. than overseas. It also calls on a “reasonable pricing clause” to be implemented for all biomedical products developed with support of the federal government.

For more information, click here.

MedPAC Releases Report to Congress and Announces Leadership Change

On June 15, the Medicare Payment Advisory Committee (MedPAC) released its June 2023 report to Congress. Some of the recommendations in the report are:

  • Congress should require the U.S. Department of Health and Human Services (HHS) secretary to cap the Medicare payment rate for Part B drugs and biologics that are approved under the accelerated approval program, under certain circumstances;
  • Congress should give the HHS secretary the authority to establish a single average sales price-based payment rate for drugs and biologics with similar health effects;
  • Congress should require the secretary to reduce add-on payments for costly Part B drugs and biologics paid based on average sales prices to minimize the relationship between average sales prices and add-on payments, and eliminate add-on payments for Part B drugs and biologics paid based on wholesale acquisition cost;
  • Congress should repeal the existing Medicare wage index statutes, including current exceptions, and require the secretary to phase in new Medicare wage index systems for hospitals and other types of providers, based on provider type and metropolitan or rural areas, while smoothing wage index; and
  • Congress should align fee-for-service payment rates across ambulatory settings. MedPAC cited recent growth in hospital acquisition of physician practices as a specific reason for the recommendation.

In addition, MedPAC announced that Executive Director James E. Mathews, Ph.D., will be departing the commission at the end of August. Dr. Mathews has been leading the commission since November 2017. MedPAC Chairman Michael Chernew, Ph.D., announced that he will be replaced by Paul Masi. Masi is the current unit chief of the health systems and Medicare cost estimates unit at the Congressional Budget Office (CBO) and has 15 years of health policy experience. He previously served as MedPAC’s Assistant Director from 2017 to 2019.

For more information concerning the June report, click here.

MacPAC Releases June 2023 Report to Congress

On June 15, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MacPAC) released its June 2023 report to Congress. MacPAC focused on federal medical assistance percentage (FMAP) and the metric set each year by the federal government that inversely dictates the maximum state governments can direct to fund DSH funding. The commission made four recommendations, some of which detach total DSH funding from changes in FMAP and streamline the process that the Centers for Medicare and Medicaid Services (CMS) follows to finalize annual DSH allotments. Other recommendations relate to integrating care for dually eligible beneficiaries, improving access to Medicaid coverage for adults leaving incarceration, and identifying Medicaid home and community-based (HCBS) services.

For more information, click here.

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

This Week in Washington: Fallout from debt ceiling holds up House floor action; SCOTUS rules to allow patients to sue nursing homes

Congress

House

House Speaker Faces Backlash Over Debt Ceiling Agreement

Led by members of the conservative House Freedom Caucus, a group of 11 Republicans broke with their party on a routine procedural vote and paralyzed the House floor, tossing the week’s schedule into disarray. It is the first procedural vote to fail since 2002.

The members said the recently passed debt ceiling agreement, both in substance and in process, violated the promises McCarthy made to conservatives during the speakership vote in January.

The unhappy members have prevented votes on four GOP bills scheduled to be considered by the House. The House adjourned for the week with no path forward outlined.

However, the longer-term implications of this opposition are significant. The speaker and the House leadership will need to unite the Republican caucus in order to move crucial legislation like funding the government.

House Ways and Means Committee Marks Up Nine Bills

On June 7, the House Ways and Means Committee marked up nine bills. The healthcare bills that were considered include:

H.R. 3799, Custom Health Option and Individual Care Expense Arrangement (CHOICE) Act This legislation would codify a 2019 rule that allows employers to provide tax-advantaged funds when reimbursing employees for buying their own health insurance on the individual market.

H.R. 3798, Small Business Flexibility Act

This legislation would require the U.S. Treasury to notify businesses of various flexible healthcare coverage options available to them, including custom health option and individual care expense (CHOICE) arrangements, qualified small employer health reimbursement arrangements and the small business healthcare tax credit.

H.R. 3800, Chronic Disease Flexible Coverage Act

This legislation would codify chronic disease management flexibilities and allow beneficiaries with high-deductible health plans in connection with health savings accounts to access 14 preventative care services related to chronic disease management. Beneficiaries would be able to access these services at no cost and before their minimum deductible is reached.

H.R. 1843, Telehealth Expansion Act of 2023

This legislation would amend the Internal Revenue Code of 1986 and permanently extend the exemption for telehealth services from certain high-deductible health plan rules. It would allow beneficiaries with high-deductible health plans to access telehealth services before they hit their minimum deductible.

H.R. 3797, Paperwork Burden Reduction Act

This legislation would allow employers to access 1095-B and 1095-C forms online and would end the requirement that both forms be mailed to employees. These forms are used to verify employee health insurance coverage.

H.R. 3801, Employer Reporting Improvement Act

This legislation would make changes to the Affordable Care Act (ACA) annual health insurance coverage data reporting requirement. It would grant employers more flexibility when providing personal information for employees, spouses and children to the Internal Revenue Services (IRS) and would extend the appeal window for incorrectly submitting information to the IRS to a minimum of 90 days. It would also implement a six-year statute of limitations on the IRS’s ability to assess penalties on small businesses.

In addition, the committee considered three bills related to identity theft and Social Security protections.

For more information, click here.

SCREENS Act Introduced

On June 7, Reps. Fitzpatrick (R-PA) and Morelle (D-NY) introduced the Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act. The legislation would reauthorize the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) through 2028 and would help make cancer screening services more accessible. Sens. Baldwin (D-WI) and Collins (R-ME) introduced a companion bill in the Senate.

For more information, click here.

Senate

Senate Finance Committee Holds Hearing on Healthcare Ownership and Consolidation

On June 8, the Senate Finance Committee held a hearing on corporate healthcare ownership and consolidation. Witnesses included:

  • Zack Cooper, Ph.D., Associate Professor of Public Health and Economics at Yale University
  • Shawn Martin, Executive Vice President and Chief Executive Officer of the American Academy of Family Physicians
  • Karen Maddox, M.D., MPH, Associate Professor of Medicine at Washington University
  • Chris Thomas, FACHE, President and Chief Executive Officer of Community Hospital
  • Caroline Pearson, Executive Director of Peterson Center on Healthcare

For more information, click here.

Wyden and Pallone Urge CMS to Prevent More Coverage Losses Under Medicaid Redeterminations

Senate Finance Committee Chair Ron Wyden (D-OR) and ranking House Energy and Commerce Committee member Frank Pallone (D-NJ) wrote the Centers for Medicare and Medicaid Services (CMS) to urge the agency to use all the tools Congress has provided to prevent more coverage losses in states where early reports show thousands of Medicaid beneficiaries have lost coverage for procedural reasons. The members also requested that CMS immediately release the redetermination data that states must report that the agency has yet to produce.

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