This Week in Washington: Debt-ceiling agreement passes, House Energy and Commerce Committee reports out legislation on site-neutral Medicare payments for certain drugs

Congress

House

House Energy and Commerce Committee Holds Markup on 19 Bills

On May 24, the House Energy and Commerce Committee marked up 19 bills. The healthcare bills that were considered include:

  • H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023

This legislation, a package of bipartisan bills, would implement various provisions to increase prescription drug price transparency and lower drug costs. This package includes a provision that would expand Medicare site-neutral payments for certain drugs administered in off-campus hospital outpatient departments. It would expand various Centers for Medicare and Medicaid Services (CMS) price transparency rules, bar spread pricing payment arrangements for Medicaid plans, strengthen oversight over pharmacy benefit managers (PBMs), mandate reporting of health-related entity ownership information, and extend various health programs including the Special Diabetes Program and Graduate Medical Education programs.

Additionally, it would eliminate planned Disproportionate Share Hospital (DSH) Payment Reduction cuts for fiscal years (FYs) 2024-2025.

  • H.R. 1418, Animal Drug User Fee Amendments of 2023

This legislation would reauthorize ADUFA and AGDUFA for fiscal years (FYs) 2024 to 2028. It would also establish new transparency requirements for the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM), allow for amendments to the “major species” definition and codify reporting dates for CVM antimicrobial development and stewardship.

  • H.R. 2544, Securing the U.S. Organ Procurement and Transplantation Network Act

This legislation would allow for additional flexibilities within the Organ Procurement and Transplantation Network (OPTN) by amending Section 372 of the Public Health Service Act.

  • H.R. 2666, Medicaid VBPs for Patients (MVP) Act

This legislation would permit pharmaceutical manufacturers and states to enter into value-based payment arrangements to offer an alternative means to cover high-cost, one-time cell and gene therapies in the Medicaid program. It would allow for multiple reporting of the drug’s best price and average manufacturer and sales price.

  • H.R. 3284, Providers and Payers COMPLETE Act

This legislation would require the Department of Health and Human Services (HHS) to consider the implications its annual hospital and provider inpatient and outpatient care payment rules have on the horizontal and vertical consolidation of providers and payers in the healthcare system.

  • H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program

This legislation would implement reporting requirements for hospitals participating in the 340B program, and would require hospitals to report total 340B savings.

In addition, the committee considered seven bills related to broadband issues and five related to energy issues.

For more information, click here.

Senate

Debt Ceiling Deal Passes House and Senate

The debt ceiling agreement announced Memorial Day weekend was passed by the House and Senate in time to avoid the June 5 date when the government would default. The agreement suspends the U.S. borrowing limit until Jan. 1, 2025. The legislation addresses discretionary spending—not mandatory spending programs like Medicare, Medicaid and Social Security. Discretionary spending while important is a smaller part of the federal budget. 

Caps Nondefense Spending: The deal caps nondefense spending in fiscal year (FY) 2024 and increases it by 1 percent in 2025. The House Republican fact sheet says that nondefense discretionary spending would be limited to (FY) 2022 levels and topline federal spending would be limited to 1 percent annual growth for the next six years. 

The breakdown of nondefense discretionary spending for (FY) 2024 is thought to be capped at about $700 billion of which $121 billion would be for veterans’ healthcare and $583 billion would be for other areas. 

Work Requirements: Medicaid will not be subject to work requirements, but the agreement calls for broadening work requirements for certain adults receiving benefits from the Supplemental Nutrition Assistance Program (SNAP) formerly known as food stamps. The agreement increases the upper age limit to 55 in phases. The deal, however, would expand exemptions for veterans, people who are homeless and former foster youth. All changes would end in 2030. The agreement also tightens current work requirements in the Temporary Assistance for Needy Families (TANF) program. It appears that this will be achieved by primarily adjusting the work participation rate credits that states can receive for reducing their caseloads.

COVID-19 Funds: The agreement rescinds unobligated COVID-19 funds, which are estimated to be about $28 billion from more than 120 accounts—including the National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC). However, $5 billion in funding to accelerate the development of COVID-19 vaccines and treatments, and vaccines for the uninsured is retained.

Last, the agreement also increases funds for healthcare fraud and abuse control by providing new budget authority for fiscal years 2024 and 2025. The administration had requested additional funding for fraud and abuse efforts in its budget, which are divided between the Department of Health and Human Services (HHS) and the Department of Justice (DOJ).

Administrative PAY-GO: Under the compromise package, federal agencies would be subject to an administrative version of PAY-GO rules through 2024. This is part of the “enforcement” effort to control spending.

Before finalizing a rule that would increase direct spending by more than $1 billion over 10 years or $100 million in any single year, federal agencies would have to submit a plan that reduces direct spending by an equal or greater amount. For agency actions mandated by law, agencies would have to identify a least costly implementation option for executive rulemakings. If a rule were to be finalized and hit the spending thresholds set up by the administrative PAY-GO structure, the bill would require the agency to send a written opinion from the general counsel of the agency explaining that the rule is legally required, along with a projection of the amount of direct spending under the least costly implementation option reasonably identifiable by the agency that meets the requirements under the statute. That opinion would go to the Director of the Office of Management and Budget (OMB). The OMB Director would be able to waive the requirements if an agency action is deemed necessary for the delivery of essential services of effective program delivery.

Senators Seek to Add Fentanyl Provision to National Defense Authorization Act

On May 16, Sens. Kaine (D-VA) and Ernst (R-IA) introduced the Disrupt Fentanyl Trafficking Act of 2023. The bill would declare fentanyl trafficking a national security threat and would direct the Pentagon to develop fentanyl-specific counter-drug strategies with Mexican defense officials. Additionally, it would require the U.S. Secretary of Defense to increase cooperation with the Mexican military and address coordination efforts between military and law enforcement agencies. Reps. Bice (R-OK) and Carbajal (D-CA) introduced a companion bill in the House.

The senators also announced their intention to introduce the bill as an amendment to the fiscal year (FY) 2023 National Defense Authorization Act (NDAA). The NDAA authorizes funding levels for the U.S. Department of Defense and specifies the department’s annual budget and expenditures. The Senate Armed Services Committee will hold a closed session to mark up the bill next month.

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

This Week in Washington: President and Speaker McCarthy to meet on debt limit with 10 days to go, House Energy and Commerce Subcommittee on Health marks up 17 bills, House Appropriations Committee begins moving appropriation bills

Congress

House

House Energy and Commerce Health Subcommittee Holds Markup on 17 Bills

On May 17, the House Energy and Commerce Committee Subcommittee on Health marked up 17 healthcare-related bills and voted to move seven bills forward. They include:

  • H.R. 1418, the Animal Drug User Fee Amendments of 2023

This legislation would reauthorize ADUFA and AGDUFA for fiscal years 2024 to 2028. Reauthorization of these programs would include the negotiated agreement on performance goals and procedures between the FDA and industry for the upcoming five-year period. This would be the fifth iteration of ADUFA and the fourth iteration of AGDUFA.

  • H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act

This legislation would amend Section 372 of the Public Health Service Act to allow for additional flexibilities within the Organ Procurement and Transplantation Network (OPTN).

Note: A companion bill was introduced in the Senate on May 17 by Senate Finance Committee Chairman Ron Wyden (D-OR) and Sens. Grassley (R-IA), Cardin (D-MD), Young (R-IN) and Cassidy (R-LA) and referred to the Senate Health, Education, Labor and Pensions Committee.

  • H.R. 3281, the Transparent PRICE Act

This legislation would require hospitals to make their standard charges public through machine-readable files as well as payer specific negotiated charges, including for cash-paying patients, for 300 shoppable services. Additionally, the legislation would require health insurance companies to make personalized pricing information available to enrollees and post machine-readable files containing in-network negotiated rates, historical prescription drug prices and out-of-network allowed amounts. Finally, the bill would increase penalties for noncompliance with existing rules and implement policies to improve the quality of data reported by hospitals and insurers to provide actionable information for patients and employers.

  • H.R. 2666, the Medicaid VBPs for Patients (MVP) Act

This legislation would codify Medicaid rules that permit the use of varying best price points under value-based purchasing arrangements such as gene therapies.

  • H.R. 3285, the Fairness for Patient Medications Act

This legislation would establish deductible and cost-sharing limitations on highly rebated drugs. Specifically, cost-sharing would be capped at the price paid by the insurer for the drug in the previous year to ensure patients are never paying more than the cost of the drug.

  • H.R. 3284, Providers and Payers COMPETE Act

This legislation would require the U.S. Department of Health and Human Services (HHS), during each of its annual hospital and other provider payment rules like those for inpatient and outpatient care, to consider the implications that its proposals may have on further consolidating the healthcare system by studying both horizontal and vertical consolidation among both providers and payers.

  • H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program

This legislation would establish reporting requirements for hospitals participating in the 340B program. Specifically, participating hospitals would be required to report total 340B savings and other key metrics to the Health Resources and Services Administration on an annual basis.

  • H.R. 2559, the Strengthening Community Care Act of 2023

This legislation would extend funding for the Community Health Center Fund and National Health Service Corps.

  • H.R. 2547, the Special Diabetes Program for Indians Reauthorization Act of 2023

This legislation would extend funding for the Special Diabetes for Indians program.

  • H.R. 2550, the Special Diabetes Program Reauthorization Act of 2023

This legislation would extend funding for the Special Diabetes Program.

  • H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023

This legislation would require pass-through pricing and prohibit spread-pricing for payment arrangements with pharmacy benefit managers under Medicaid.

  • H.R. 2665, the Supporting Safety Net Hospitals Act

This legislation would eliminate the disproportionate share hospital payment reductions under the Medicaid program for fiscal years 2024 and 2025.

  • H.R. 2679, the PBM Accountability Act

This legislation would require pharmacy benefit managers (PBMs) regularly to furnish employers with detailed data on prescription drug spending, including the cost of drugs, total out-of-pocket spending, formulary placement rationale and aggregate rebate information. Additionally, the Comptroller General of the United States would be required to submit a report to Congress on pharmacy networks of group health plans, health insurance issuers and entities providing pharmacy management services under such group health plans or group or individual health insurance coverage.

  • H.R. 3248, Diagnostic Lab Testing Transparency Act

This legislation would require diagnostic laboratories to disclose three data points for clinical diagnostic laboratory tests included on the list of shoppable services specified by the Centers for Medicare and Medicaid Services: the discounted cash price of each test, the de-identified minimum rate for each test and the de-identified maximum rate for each test.

  • H.R. 3262, Ownership Transparency

This legislation would require hospitals, freestanding emergency centers, ambulatory surgical centers, physician practices with more than 25 physicians, physician practices owned by hospitals, insurance companies and other entities to report to the Department of Health and Human Services (HHS) upon changes in ownership. HHS would be required to use this data to submit annual reports on trends in healthcare consolidation.

  • H.R. 3282, The Promoting Transparency and Healthy Competition in Medicare Act

This legislation would increase transparency into the effects of vertical integration in healthcare by requiring Medicare Advantage Organizations and Part D plan sponsors to report data with respect to how these companies interact with healthcare providers that they share common ownership with—like physician groups, pharmacy benefit managers (PBMs) and pharmacies—compared to those that they do not.

  • 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 of a provider to submit to the Centers for Medicare & Medicaid Services an attestation with respect to each such department

This legislation would require that each department of a provider include a unique identification number on claims for services, and require hospitals with an outpatient department of a provider to submit to the Centers for Medicare and Medicaid Services an attestation with respect to each outpatient department.

For more information, click here.

House Appropriations Subcommittee Advances FDA Funding Bill

On May 18, the House Appropriations Committee’s Agriculture, Rural Development, and Food and Drug Administration (FDA) Subcommittee convened to mark up the fiscal year (FY) 2024 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill. The bill, also referred to as the FDA Funding Bill, was forwarded by the subcommittee with no amendment. House Democrats strongly oppose the bill, stating that it would override important FDA decisions and negatively impact public health. In addition, House Republicans omitted from the bill a longstanding policy rider that for years has blocked FDA from using appropriations funding to finalize a rule that would require pharmaceutical prescribing information to be shared electronically, rather than in paper format. The bill would:

  • Provide the FDA with $6.6 billion in funding in FY 2024;
  • Reverse the FDA decision to allow mifepristone to be dispensed by certified pharmacies;
  • Prevent the FDA from banning flavored cigars and menthol cigarettes;
  • Prevent the FDA from imposing nicotine limits on cigarettes; and
  • Delay any plans to impose population-wide sodium reduction targets;

For more information, click here.

Congressional Rare Disease Caucus Urges FDA to Create Rare Disease Task Force

On May 12, the Congressional Rare Disease Caucus urged the Food and Drug Administration (FDA) to improve reliability and consistency of the agency’s rare disease therapy review process. Caucus cochairs Klobuchar (D-MN), Wicker (R-MS), Bilirakis (R-FL) and Matsui (D-CA) led a group of 25 senators and representatives in sending a letter to FDA Commissioner Robert Califf, in which they asked the commissioner to establish a task force to review and address shortcomings in FDA rare disease policies and guidance. The members are requesting that the task force release a public report by December 2024 that would:

  • Explain how FDA advisory committees have addressed rare disease applications;
  • Identify inconsistent processes and policies;
  • Review how the accelerated approval pathway is used for rare disease therapies;
  • Clarify how real-world evidence can be used in regulatory approvals;
  • Include tracking metrics on rare disease policy implementation issues; and
  • Highlight FDA statutory changes and new authority.

For more information, click here.

Telemental Health Services Act Reintroduced

On May 16, Reps. Matsui (D-CA) and Johnson (R-OH) reintroduced the Telemental Health Services Act. The bill would remove a Medicare provision that requires beneficiaries who receive treatment for mental or behavioral health concerns via telehealth to see a doctor in-person within six months of receiving their virtual treatment.

For more information, click here.

Black Maternal Health Momnibus Act of 2023 Reintroduced

On May 15, Reps. Underwood (D-IL) and Adams (D-NC) reintroduced the Black Maternal Health Momnibus Act of 2023. The bill would increase investments to address social determinants of health and provide funding for community-based organizations. It would also diversify and expand the perinatal health workforce, broaden access to maternal mental health care, increase funding for veteran maternal healthcare services, improve maternal health crisis data collection processes and more.

For more information, click here.

Senate

Debt-Ceiling Talks Hit a Pause

On May 16, President Biden met with House Speaker Kevin McCarthy (R-CA), Senate Majority Leader Chuck Schumer (D-NY) and House Minority Leader Hakeem Jeffries (D-NY) to discuss the debt-ceiling.

Despite the ongoing gridlock, Tuesday’s meeting signaled a shift from Democratic leaders, as they acknowledged that the only way forward is through negotiations. However, negotiations while the President has been out of the country hit a snag with each side saying the other wanted a package that was unrealistic. The President and Speaker McCarthy will meet today with ten days to go until the debt limit and Treasury’s exhaustive measures will run out. Democrats are urging the President to use an untried measure involving the Fourteenth Amendment. In the House, democrats are also seeking the use of a discharge petition, but that would require some republicans also signing on.

Senate HELP Ranking Member Seeks Feedback on Dually-Eligible Beneficiary Draft Legislation

On May 18, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) announced that he is seeking feedback on draft legislation that would impact dually-eligible Medicare and Medicaid beneficiaries. The draft legislation would, among other things:

  • Direct states to choose an integrated care model to provide comprehensive care for full-benefit dual beneficiaries;
  • Require integrated plans that enroll dually-eligible beneficiaries to regularly update provider directories and collect quality measures data;
  • Require the Department of Health and Human Services (HHS) to review the processes states use to determine whether someone is a full-benefit or partial-benefit dual beneficiary;
  • Require HHS to identify legislative changes needed to align billing codes for Medicare, Medicaid and state integrated-dual beneficiary programs;
  • Direct the Centers for Medicare and Medicaid Services (CMS) to issue guidance for brokers on how to enroll dual beneficiaries;
  • Require states to make the Program of All-Inclusive Care for the Elderly (PACE) available to all Medicare beneficiaries under the age of 55; and
  • Direct CMS to review the hospital star rating program.

NIH Clinical Trial Diversity Act Introduced

On May 18, Sens. Menendez (D-NJ) and Collins (R-ME) introduced the NIH Clinical Trial Diversity Act. The bill would require the National Institutes of Health (NIH) to ensure the availability of less burdensome clinical trial follow-ups, to increase participation of underrepresented populations and to develop clear recruitment and retention objectives with clinical trial sponsors. The bill would also require the NIH to launch a public awareness campaign to highlight research opportunities across federal agencies.

A companion bill was introduced in the House by Reps. Kelly (D-IL) and Fitzpatrick (R-PA).

For more information, click here.

Sen. Sanders Develops Package on Healthcare Workforce

Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced a new package that would over five years provide $130 billion for community health centers and $60 billion in funding to grow the healthcare workforce. Within that $60 billion, the package would set aside $15 billion for graduate medical education programs with an emphasis on primary care. Overall the $200 billion package is the chairman’s response to the months-long discussion the committee members have had about how to address healthcare workforce shortages and concerns about community health centers in the wake of the pandemic. 

Medicare for All Act Reintroduced

On May 17, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) led 14 senators in introducing the Medicare for All Act. The bill would establish a Medicare-for-all health insurance program that would be implemented over a four-year period. The Medicare eligibility age would be reduced to 55 in the first year, and Medicare Part A, B and D deductibles would be eliminated. By the fourth year, all Americans, including children, would be entitled to Medicare benefits and comprehensive healthcare services.

A companion bill cosponsored by more than 110 members was introduced in the House by Reps. Jayapal (D-WA) and Dingell (D-MI).

For more information, click here.

Facilitating Access to Innovative Diagnostics Act Reintroduced

On May 16, Sens. Blackburn (R-TN) and Baldwin (D-WI) reintroduced the Facilitating Access to Innovative Diagnostics Act. The bill would improve patient access to diagnostic radiopharmaceuticals and technologies used to detect diseases such as cancer and Alzheimer’s. It would also revise payment policies for imaging diagnostics that use innovative technologies and promote further research and development opportunities. The bill is supported by a large number of prostate cancer, Alzheimer’s and Parkinson’s stakeholder groups.

For more information, click here.

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

This Week in Washington: Debt Ceiling Continues to Loom Over the Capitol; DEA Extends COVID-19 Controlled Medications Prescribing Telehealth Flexibilities


Congress

House

House Ways and Means Health Subcommittee Holds Hearing on Therapy Access and Medical Innovation

On May 10, the House Ways and Means Health Subcommittee held a hearing to examine policies that inhibit medical innovation and patient’s access to therapies. Witnesses included:

  • Tony Gonzales, National Early-Stage Advisor at the Alzheimer’s Association
  • Ted Okon, Executive Director of Community Oncology Alliance
  • Darius Lakdawalla, Professor of Pharmaceutical Economics and Public Policy at the USC Leonard D. Schaeffer Center for Health Policy and Economics
  • Joshua Makower, MD, Director of the Stanford Byers Center for Biodesign at Stanford University
  • Aaron S. Kesselheim, MD, JD, MPH, Professor of Medicine at Harvard Medical School

During the hearing, Republican subcommittee members raised concerns about oversight of the Center for Medicare and Medicaid Innovation (CMMI). The Center creates payment and service delivery models that seek to save money within the Medicare program has been controversial since its inception. Subcommittee members pointed out that few of the payment models have been incorporated into Medicare. CMMI recently released three payment models the goal of which would be to lower drug prices. One would pay a lower amount for drugs that are approved through the Food and Drug Administration’s accelerated pathway. Republican subcommittee members argued at the hearing that such an approach would devalue drugs that use the accelerated pathway.

For more information, click here.

Senate

Senate HELP Committee Advances PBM and Generic Drug Bills

On May 11, the Senate Health, Education, Labor, and Pensions (HELP) Committee concluded the markup of legislation concerning drug prices and pharmacy benefit managers (PBMs). Originally, the markup was to occur early in the month, but a compromise developed by the Chair and the ranking member fell apart and the markup was delayed. The following bills were considered:

  • 1067, the Ensuring Timely Access to Generics Act of 2023
    • This bill would allow the Food and Drug Administration (FDA) to deny citizen petitions that are submitted to intentionally prevent generic drug approval. It would also allow the FDA to deny citizen petitions that do not raise valid scientific of regulatory issues. The committee voted 21-0 in favor of the bill as amended.
    • 1114, the Expanding Access to Low-Cost Generics Act of 2023
    • This bill would seek to put an end to an anti-competitive drug practice known as “parking.” “Parking” refers to a practice in which a brand-name drug manufacturer agrees to not sue a generic drug manufacturer in exchange for the delayed release of the generic drug manufacturer’s product to the market. During this time, no other generic drug manufacturer may bring a drug to the market for a period of 180 days. The committee voted 20-1 in favor of the bill as amended.
    • 1214, the Retaining Access and Restoring Exclusivity (RARE) Act
    • This bill would specify that a seven-year orphan drug market exclusivity period for rare disease drugs outlined in the Food, Drug and Cosmetic (FD&C) Act, bans only the approval of other drugs with the same approved use or indication, not drugs that seek to treat the same disease or condition. The committee voted 21-0 in favor of the bill as amended.
    • 1339, the Pharmacy Benefit Manager Reform Act.
    • This bill would restrict ban pharmacy benefit manager (PBM) spread pricing, require all rebates to be passed to insurance plans, and strengthen annual PBM reporting requirements. The committee voted 18-3 in favor of the bill as amended.

It is unclear when the full Senate will take up this legislation, but it is expected to be soon.

For more information, click here.

Senate Finance Committee Holds Hearing on Pharmaceutical Manufacturers and International Tax Policy

On May 11, the Senate Finance Committee held a hearing on pharmaceutical manufacturers and U.S. International Tax Policy. Witnesses included:

  • Brad W. Setser, Senior Fellow at the Council on Foreign Relations
  • Diane M. Ring, Professor of Law and Distinguished Scholar at the Boston College Law School
  • William Morris, Global Tax Policy Leader at PwC
  • Daniel Bunn, President and CEO of the Tax Foundation

Committee members discussed tax practices used by U.S pharmaceutical companies to lower their tax bill. Committee Chair Ron Wyden (D-OR) criticized pharmaceutical companies for moving their profits overseas, in an effort to obtain tax breaks, and denounced them for also placing their intellectual property in other countries. He also criticized a 2017 Republican tax law that cut taxes for some U.S pharmaceutical companies by more than 40 percent.

The Chair also announced the release of new findings from an ongoing investigation into drug company tax practices. The Senate Finance Committee majority staff have been investigating the tax practices of pharmaceutical companies since 2021. The findings of their work demonstrate that U.S pharmaceutical companies report more than 75 percent of their taxable income as offshore income. Additionally, the findings show that pharmaceutical companies are making use of profit shifting structures to circumvent certain taxes.

The findings of the Chairman’s report are available here.

The committee’s hearing on U.S. international tax policy is available here.

Senate HELP Committee Holds Hearing on Insulin Product Prices

On May 10, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the pricing of insulin and other diabetes medication. Witnesses included:

  • David Ricks, Chair and Chief Executive Office at Eli Lilly and Company
  • Lars Fruergaard Jørgensen, President and Chief Executive Officer at Novo Nordisk
  • Paul Hudson, Chief Executive Officer at Sanofi
  • David Joyner, Executive Vice President and President of Pharmacy Services at CVS Health
  • Adam Kautzner, President at Express Scripts
  • Heather Cianfrocco, Chief Executive Officer at OptumRx

Committee members questioned witnesses on the prices they charge for diabetes medications and discussed how complicated pricing is hurting patients. Chairman Bernie Sanders (I-VT) criticized witnesses for increasing the price of insulin products despite making record profits and stated that the high price of insulin was contributing to the deaths of thousands of Americans who cannot afford it. Several committee members pressed witnesses on the role of pharmacy benefit managers (PBMs) and criticized PBMs for placing higher list prices on insulin products to generate more rebates that are not being passed along to patients.

For more information, click here.

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

This Week in Washington: Debt Limit fight continues; Disagreements arise during Senate HELP Committee mark-up of PBM and Generic Drug Competition Bills

Congress

House

Debt Limit Fight Continues Amidst Approaching Default Deadline

Despite warnings by Secretary of the Treasury Janet Yellen that the U.S. could default on its federal debt as early as June 1, no debt limit bill has been agreed upon by Congress. On May 1, Secretary Yellen sent a letter to House Speaker Kevin McCarthy (R-CA), urging Congress to suspend or increase the debt limit as soon as possible. In response, Speaker McCarthy issued his own response, stating that House Republicans had done their job by passing the Limit, Save, Grow Act of 2023, H.R. 2811, by a vote of 217-215. McCarthy criticized the Senate and President Biden for not acting promptly in the wake up the bill’s passage. The bill is not expected to pass in the Democrat-controlled Senate. The leaders of the House and Senate are expected to meet with the President on May 9. In addition, House Democrats are exploring the possibility of a discharge petition, which would be a long shot.

Expanding Care in the Home Act Introduced

On April 26, Reps. Dingell (D-MI) and Smith (R-NE) introduced H.R. 2853, the Expanding Care in the Home Act. The bill specifically would:

  • Authorize certain Medicare beneficiaries who are not eligible for Medicaid to receive 12 hours of at-home personal care services per week from a personal care worker;
  • Increase access and broaden reimbursement for in-home dialysis treatment, advanced diagnostic imaging, lab testing and infusion services; and
  • Allow doctors to receive monthly payments for Primary Care Qualified Evaluation and Management Services (PQEM) as an alternative to fee-for-service reimbursements.

For more information, click here.

MADE in America Act Reintroduced

On April 26, Rep. Miller (R-WV), joined by 15 other members, reintroduced the Manufacturing API, Drugs, and Excipients (MADE) in America Act. The bill seeks to decrease the U.S. pharmaceutical supply chain’s dependency on China and would encourage manufacturing of drugs and pharmaceutical supplies such as active pharmaceutical ingredients (APIs) and personal protection equipment (PPE).

For more information, click here.

Association Health Plans Act Introduced

On April 25, Reps. Walberg (R-MI), Foxx (R-NC), Allen (R-GA), Burgess (R-TX), Crenshaw (R-TX) and Good (R-VA) introduced the Association Health Plans Act. The bill would expand healthcare plan options and costs for small businesses by allowing them to offer association health plans (AHPs). This legislation or variations of it have been introduced in past Congresses.

For more information, click here.

Senate

Senate HELP Committee PBM and Generic Drug Competition Bills Markup Falls Apart

On May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee met to mark up a total of four bipartisan bills.

Ensuring Timely Access to Generics Act: Introduced by Sens. Bennet (D-CO), Shaheen (D-NH) and Collins (R-ME), this bill would help increase generic drug competition by strengthening oversight of the Food and Drug Administration’s (FDA) citizen petition process. The bill would grant the FDA permission to reject citizen petitions if the agency determines that the petition has been submitted to intentionally delay the approval of an application.

Expanding Access to Low-Cost Generics Act: Introduced by Sens. Smith (D-MN) and Braun (R-IN), this bill would address an anti-competitive drug practice known as “parking.” “Parking” refers to a practice in which a brand-name drug manufacturer agrees to not sue a generic drug manufacturer in exchange for the delayed release of their generic drug to the market. During this time, no other drug manufacturer may bring their own generic version of the drug to the market until 180 days have passed. This bill would allow a generic drug manufacturer to receive the 180-day market exclusivity if the first generic drug manufacturer does not make their drug available within 75 days.

Retaining Access and Restoring Exclusivity (RARE) Act: Introduced by Sens. Baldwin (D-WI) and Cassidy (R-LA), this bill would specify that the seven-year orphan drug market exclusivity period outlined in the Food, Drug and Cosmetic (FD&C) Act bans only the approval of other drugs with the same approved use or indication, not drugs that seek to treat the same disease or condition.

Pharmacy Benefit Manager Reform Act: Introduced by Sens. Sanders (I-VT), Cassidy (R-LA), Murray (D-WA) and Marshall (R-KS), this bill would seek to ban a practice utilized by pharmacy benefit managers (PBMs) known as “spread pricing,” a technique whereby PBMs charge health insurance plans more for a drug than the amount they reimburse to pharmacies for dispensing it. The bill would require that all rebates negotiated with drug manufacturers and all fees collected by PBMs are passed through to applicable health insurance plans.

Although Committee Chairman Sanders (I-VT) and Ranking Member Cassidy (R-LA) had announced that they had come to an agreement to mark up the bills and to advance certain measures, the markup did not go as planned. Sen. Cassidy accused Sen. Sanders of reneging on the agreement when Sen. Sanders announced that he would allow a number of bipartisan amendments to the RARE Act to move forward. Sen. Cassidy criticized Sen. Sanders for failing to share FDA technical assistance and Congressional Budget Office (CBO) cost estimates for the amendments in question. The committee decided to go into recess, and Sens. Sanders and Cassidy agreed to reschedule the markup for May 11.

For more information, click here.

Cutting Medicare Prescription Drug Prices in Half Act Introduced

On May 4, Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) and Sen. Klobuchar (D-MN) introduced the Cutting Medicare Prescription Drug Prices in Half Act. The bill seeks to cut the Medicare price of prescription drugs by half by requiring Medicare to pay no more for prescription drugs than the U.S. Department of Veterans Affairs (VA). The bill would also require drug manufacturers to make their medicines available to Medicare at the same prices paid by the VA or the Federal Supply Schedule, whichever is lowest.

For more information, click here.

PASTEUR Act Reintroduced

On April 27, Sens. Young (R-IN) and Bennet (D-CO) reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. The bill would encourage the appropriate use of antibiotics, increase domestic availability of antibiotics and support the development of antibiotics that target drug-resistant infections. The bill would specifically:

  • Establish a subscription payment model for antibiotic drug developers, whereby developers would be offered an upfront payment in exchange for access to their antibiotics. This payment amount would range anywhere from $750 million to $3 billion. This subscription model is intended to encourage antimicrobial drug development, particularly drugs that target so-called “superbugs” such as Candida auris and Clostridioides difficile. Developers are currently paid through contracts based on the total volume of their drugs. Subscription-based contracts would be valid for a period of five years or up to the point of an antimicrobial drug’s patent life;
  • Enhance existing frameworks of the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network, the Emerging Infections Program and other programs focused on analyzing and reporting antibiotic usage and resistance data;
  • Establish a Committee on Critical Need Antimicrobials, which would be tasked with developing and implementing guidance on how to treat infections of concern. The committee would be made up of federal agency representatives, doctors, patients and outside experts; and
  • Offer small subscription contracts to smaller antimicrobial drug developers.

A companion bill was introduced in the House by Reps. Peters (D-CA), Ferguson (R-GA), Levin (D-CA) and LaTurner (R-KS).

For more information, click here.

Workforce Legislation Introduced

In the Senate several bills were introduced related to workforce and direct care. The Resident Physician Shortage Reduction Act was introduced on April 27 by Sens. Menendez (D-NJ), Boozman (R-AR), Schumer (D-NY) and Collins (R-MN). The bill would eliminate the cap on Medicare-funded graduate medical education (GME) positions and would increase the number of GME positions by 14,000 over the next seven years. Hospitals in rural areas and those serving Health Professional Areas (HPSAs) would be prioritized. Hospitals in states with new medical schools and those currently training over their caps would also be granted priority.

For more information, click here.

In addition, the Supporting Our Direct Care Workforce and Family Caregivers Act was introduced, led by Senator Casey (D-PA). The legislation would:

  • Direct the Department of Health and Human Services (HHS) to award grants to states and eligible entities to be used for the recruitment, training and promotion of direct care workers and family caregivers. The grants would also go towards caregiver education and training support. Grants would be administered through the Administration on Community Living (ACL); and
  • Direct the ACL to establish a center that would be tasked with offering technical assistance to grant awardees and direct care workforce development entities. The center would be responsible for establishing direct care career development, advancement strategy, apprenticeship, specialization, certification and on-the-job training programs. Additionally, the center would be tasked with identifying workforce shortages and evaluating the effectiveness of grants.

For more information, click here.

Senate Finance Committee Discusses Ghost Networks

On May 3, Sen. Wyden (D-OR) held a hearing to discuss the findings of a secret shopper study conducted by the committee majority staff. Staff reviewed directories from 12 different plans in a total of six states, calling 10 systematically selected providers from each plan, for a total of 120 calls. Of the total 120 provider listings contacted by phone, 33 percent were inaccurate, nonworking numbers or unreturned calls. Staff could only make appointments 18 percent of the time.

The Chair’s statement on the findings is available here.

The Chair’s hearing on ghost networks is available here.

Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act Introduced

On April 24, 23 Sens. Klobuchar (D-MN) and Welch (D-VT) led 23 senators in introducing the Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act. The bill would grant the Department of Health and Human Services (HHS) enhanced authority to negotiate Medicare Part D drug prices and would allow new drugs and biologics approved by the Food and Drug Administration (FDA) to be eligible for price negotiation for a period of five years. The bill would also increase the number of drugs that HHS can negotiate after 2026 and allow Medicare Part B drugs to be negotiated two years earlier than allowed under current law.

For more information, click here.

GAO Appoints Six New MACPAC Board Members and Vice Chair

On May 1, the Government Accountability Office (GAO) announced the appointment of six new members to the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC). They are as follows:

  • Timothy Hill, MPA, Vice President for Client Engagement at the American Institute for Research (AIR);
  • Carolyn Ingram, MBA, Executive Vice President of Molina Healthcare, Inc.;
  • Patti Killingsworth, Senior Vice President of Long Term Services and Supports (LTSS) Strategy at CareBridge;
  • John B. McCarthy, MPA, Founding Partner at Speire Healthcare Strategies;
  • Adrienne McFadden, MD, JD, Chief Medical Officer of Medicaid at Elevance Health; and
  • Jami Snyder, MA, President and Chief Executive Officer at JSN Strategies LLC.

The GAO also announced that Robert Duncan will serve as MACPAC’s new Vice Chair. Duncan serves as Executive Vice President and Chief Operating Officer of Connecticut Children’s Speciality Care Center, and previously served as Executive Vice President of Children’s Wisconsin and the President of Children’s Service Society.

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

This Week in Washington: House Republicans release debt ceiling plan, Speaker McCarthy moves forward with proposal that includes Medicaid work requirements

Congress

House

Debt Ceiling Text Released

On April 19, Speaker Kevin McCarthy (R-CA) unveiled the bill text of his proposal for raising the debt ceiling, cutting federal spending and negating some of President Biden’s priorities and initiatives. 

The Speaker plans to bring the bill to the House floor for a vote this week even though it is unclear that even with the Republican caucus there are enough votes to pass the proposal. Republicans have 222 votes, and 218 are needed to pass.

The proposal is estimated to save over $4.5 trillion and includes a proposal to require Medicaid work requirements.

Conservative members want deeper cuts and stricter language on work requirements for food stamps, while moderates are concerned about spending cuts that are dead on arrival in the Senate. Some are concerned about cuts to energy tax credits and would oppose stricter language about food stamps.

For more information, click here.

Pharmacy Benefits Manager Accountability Act Introduced

On April 20, Reps. Kuster (D-NH), Carter (R-GA), Eshoo (D-CA) and Guthrie (R-KY) introduced the “Pharmacy Benefits Manager Accountability Act.” The bill would raise reporting requirements for pharmacy benefits managers (PBMs) in an effort to increase transparency in the drug supply chain. The bill will specifically:

  • Require PBMs to submit an annual report to employers, health insurers and prescription drug sponsors starting Jan. 1, 2025, detailing which prescription drugs were dispensed by the PBM during the reporting period and outlining each drug’s wholesale acquisition and out-of-pocket costs. The report would also require PBMs to reveal how much they received in drug rebates, fees and alternative discounts, and how much health plan sponsors spent on prescription drugs during the reporting period;
  • Require health insurers offering group health insurance coverage or entities providing pharmacy benefits management services to report the practices of pharmacy networks to the Comptroller General of the United States; and
  • Strengthen the enforcement powers of the Secretary of the Department of Health and Human Services, the Secretary of the Department of Labor and the Secretary of the Department of the Treasury to ensure that violators are held accountable.

For more information, click here.

Doctors of Community Act Introduced

On April 11, Reps. Pallone (D-NJ), Vasquez (D-NM) and Ruiz (D-CA) introduced the Doctors of Community (DOC) Act. The bill would authorize the Teaching Health Center Graduate Medical Education (THCGME) program to support and fund primary care medical and dental residents. It would increase funding from $277 million in fiscal year (FY) 2024 to $582 million in FY 2033 and would increase the number of residency slots available each year. The THCGME program is a Health Resources and Services Administration (HRSA) program that seeks to support the training of medical professionals preparing to work in rural and underserved communities.

For more information, click here.

Senate

INSULIN Act of 2023 Introduced

On April 21, Sens. Shaheen (D-NH) and Collins (R-ME) introduced the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023. The bill will foster competition among the insulin product market, broaden patient access and extend patient protections. The bill specifically:

  • Limits out-of-pocket costs for patients with diabetes by requiring group and individual market health insurers to waive any deductible and limit cost-sharing to no more than $35 or 25 percent of the list price of at least one insulin of each type and dosage form;
  • Prohibits pharmacy benefit managers (PBMs) from placing utilization management tools on products with capped out-of-pocket costs;
  • Requires PBMs to pass along to plan sponsors 100 percent of insulin rebates and discounts received from manufacturers;
  • Creates a new expedited Food and Drug Administration (FDA) approval pathway for biologic drugs;
  • Strengthens oversight over the FDA’s citizen petition process;
  • Allows Medicare Part D plans to place biosimilar drugs on formulary immediately upon their introduction to the market; and
  • Requires the Secretary of the Department of Health and Human Services (HHS), Administrator of the Centers for Medicare and Medicaid Services (CMS) and the Commissioner of the FDA to submit a report to Congress identifying variables delaying or restricting competition among the biosimilar insulin market.

For more information, click here.

Drug-Price Transparency for Consumers Act Reintroduced

On April 20, Sens. Durbin (D-IL) and Grassley (R-IA) reintroduced the Drug-Price Transparency for Consumers (DTC) Act. The bill seeks to strengthen prescription drug transparency by requiring prescription drug and biological product advertisements to disclose the list price of the drug or product being marketed.

Senate Finance Committee Releases Legislative Framework to Address PBMs

On April 20, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a legislative framework that the committee will use to develop policy solutions to modernize federal prescription drug programs and address the role of pharmacy benefits managers (PBMs). The bipartisan framework outlines the four challenges committee members have identified within the prescription drug supply chain and explains what steps the committee will take to address and resolve them.

For more information, click here.

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

This Week in Washington: CMS Releases Annual Payment Rules for Skilled Nursing Facilities, Hospice and Other Segments of Medicare


Congress

House and Senate on Recess

House

House Energy and Commerce Chair Questions SAMHSA on COVID-19 Spending and Action on Mental Illness

On April 5, House Energy and Commerce Chairman Cathy McMorris Rodgers (R-WA), joined by Reps. Guthrie (R-KY) and Griffith (R-VA), sent a letter to the Substance Abuse and Mental Health Services Administration (SAMHSA) Administrator Dr. Miriam Delphin-Rittmon. The letter asked for information concerning: 

  • SAMHSA’s supplemental COVID-19 funds and how they were used;
  • A 2021 outage of the 9-8-8 suicide hotline; and
  • The new Office of Recovery and how it will support mental illness treatment efforts.

For more information, click here.

Senate

Senate Committee Chairmen Urge HHS to Allow Continued Medicare Coverage of COVID-19 At-Home Tests

On April 4, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Special Committee on Aging Chairman Bob Casey (D-PA) led 16 senators in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, urging HHS to continue allowing Medicare to cover the costs of rapid, at-home COVID-19 tests following the COVID-19 public health emergency (PHE) unwinding on May 11. The senators are concerned about the impact the loss of Medicare coverage for COVID-19 at-home tests would have on vulnerable populations such as seniors and people with disabilities.

The other senators who signed the letter include Democratic senators Blumenthal (CT), Warren (MA), Merkley (OR), Duckworth (IL), Reed (RI), Stabenow (MI), Whitehouse (RI), Cardin (MD), Menendez (NJ), Brown (OH), Smith (MN), Kaine (VA), Kelly (AZ) and Warner (VA). Sens. Sinema (I-AZ) and King (I-ME) also signed.

For more information, click here.

Drug Price Transparency in Medicaid Act of 2023 Introduced

On April 4, Sens. Marshall (R-KS) and Welch (D-VT) introduced the Drug Price Transparency in Medicaid Act of 2023. The bill would prohibit pharmacy benefit managers (PBMs) from using spread pricing. Spread pricing refers to a technique used by PBMs whereby PBMs charge Medicaid more than they pay pharmacies for a particular drug. The bill would also require Medicaid payments made to PBMs to go directly through pharmacies, and would require pharmacies participating in state Medicaid programs to report National Average Drug Acquisition Costs (NADAC), to ensure prescription drug price transparency. A companion bill was introduced by Reps. Carter (R-GA) and Gonzalez (D-TX) in the House.

For more information, click here.

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

This Week in Washington: FDA Approves Narcan OTC Nasal Spray, Senate Finance Committee Investigates Pharmacy Benefit Manager Practices


Congress

House and Senate on Recess

House

VALID Act Re-introduced

On March 29, Reps. DeGette (D-CO) and Bucshon (R-IN) reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. The bill would give the Food and Drug Administration (FDA) explicit authority to regulate certain laboratory-developed tests (LDT). The FDA has sought to regulate LDTs that are currently overseen by the Centers for Medicare and Medicaid Services (CMS).

In the last days of the Obama administration, the FDA published a guidance to use a risk-based approach to oversee LDTs. The guidance was rejected by the Trump administration. The then-FDA Commissioner Scott Gottlieb said he believed that Congress needed to legislate. Current FDA Commissioner Robert Califf has said he would consider rule-making but has also said he would prefer Congress provide explicit authority to regulate these tests.

For more information, click here.

House Energy and Commerce Committee Chair Presses FDA on Gain-of-Function Research

On March 27, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Reps. Guthrie (R-KY) and Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf requesting that the FDA provide specifics regarding any gain-of-function experiments conducted during coronavirus research experiments. The Energy and Commerce Committee is investigating whether the FDA is adequately monitoring and overseeing FDA-funded research that has the potential of creating biosafety and biosecurity risks.

For more information, click here.

Senate

Reentry Act Introduced

On March 30, Sens. Baldwin (D-WI) and Braun (R-IN) introduced the Reentry Act. The bipartisan legislation would expand access to healthcare and mental health services for Medicaid-eligible individuals who are within 30 days of being released from prison or jail. The bill would also make it easier for states to provide substance-use disorder treatment services and provide previously incarcerated individuals a smoother transition back into their communities.

For more information, click here.

Senate Finance Committee Examines PBMs

On March 30, the Senate Finance Committee held a hearing on pharmacy benefit managers (PBMs). The committee is interested in learning more about what impacts PBM tactics are having on the prescription drug supply chain, particularly on prescription drug pricing. Witnesses included:

  • Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law and Director of the Center For Innovation at the University of California Hastings College of Law
  • Karen Van Nuys, Ph.D., Executive Director of the Value of Life Sciences Innovation Leonard D. Schaeffer Center at the University of Southern California Center for Health Policy and Economics
  • Lawton Robert Burns, Ph.D., James Joo-Jin Kim Professor of Health Care Management and Co-Director of the Roy and Diana Vagelos Program in Life Sciences and Management at the University of Pennsylvania Wharton School
  • Matthew Gibbs, Pharm.D., President of Capital Rx
  • Jonathan E. Levitt, Founding Partner of Frier Levitt Attorneys at Law

For more information, click here.

Senate Finance Committee Holds Hearing on Oral Health Disparities

On March 29, the Senate Finance Committee held a hearing on identifying and addressing oral health disparities. Witnesses included:

  • Warren A. Brill, DMD, MS (HYG), FAAPD, FACD, FICD, Owner of Eastpoint Pediatric Dental Associates
  • Jonathan P. Forte, MHA, FACHE, President and CEO of RiverStone Health
  • Cherae M. Farmer-Dixon, DDS, MSPH, FACD, FICD, Dean and Professor of Meharry Medical College, School of Dentistry
  • Marko Vujicic, Ph.D., Chief Economist and Vice President of the American Dental Association Health Policy Institute

For more information, click here.

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

This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees



Congress

House

House Energy and Commerce Committee Marks-up Health Legislation

On March 23, the House Energy and Commerce Committee met to markup 19 bills, including 5 healthcare-related bills. They were:

  • R. 501, Block, Report, and Suspend Suspicious Shipments Act

This bill would require drug manufacturers, distributors, and other Drug Enforcement Agency (DEA) registrants, to report and decline suspicious orders of all controlled substances. It would also require the DEA to specify what indicators give rise to suspicious orders, and how these orders could be diverted if filled.

  • R. 498, 9-8-8 Lifeline Cybersecurity Responsibility Act

This bill would require the Department of Health and Human Services (HHS) to maintain internal coordination to protect the 9-8-8 lifeline from cybersecurity threats. It would also require the 9-8-8 network administrator to immediately report potential cybersecurity threats to the Substance Abuse and Mental Health Services Administration (SAMSHA), and would require the Comptroller General to conduct a study on 9-8-8 lifeline cybersecurity flaws and risks.

  • R. 485, Protecting Health Care for All Patient Act of 2023

This bill would prohibit all federal health care programs and federally-funded state health care programs from considering quality-adjusted life years (QALYs) or other similar measures that discount the value of life based on disability, when calculating thresholds for health care coverage, reimbursements, and incentive programs.

  • R. 467, Halt All Lethal Trafficking of Fentanyl Act

This bill would place fentanyl-related substances (FTS) on the Controlled Substances Act Schedule I list permanently. It would also make the registration process to research Schedule I substances simpler.

  • R. 801, Securing the Border for Public Health Act of 2023

This bill would amend the Public Health Services Act and expand Title 42 authority. It would allow the Secretary of Health and Human Services (HHS), following a consultation with the U.S. Attorney General, to prohibit the entry of persons and imports related to certain controlled substances from certain countries, into the United States.

For more information, click here.

Health Care Affordability Act Reintroduced

On March 22, Rep. Underwood (D-IL) reintroduced the Health Care Affordability Act. The bill would lower the cost of health care premiums by expanding the availability of health care premium tax credits. Provisions of the bill expanding health care premium tax credits were included in the Inflation Reduction Act (IRA) but are set to expire in 2025. This legislation would make the expansions permanent.

For more information, click here.

House Energy and Commerce Committee and Oversight and Accountability Committee Chairmen Request Info on CMS Ransomware Attack

On March 20, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and House Oversight and Accountability Committee Chairman James Comer (R-KY) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, requesting information on the ransomware attack that CMS subcontractor Healthcare Management Solutions, LLC. suffered on Oct. 8, 2022. CMS determined that the ransomware attack likely resulted in the breaching of sensitive Medicare beneficiary data. Both committees are requesting that CMS submit any documents and communications related to the attack, to facilitate their respective investigations of the incident.

For more information, click here.

Drug Price Transparency in Medicaid Act of 2023 Introduced

On March 17, Reps. Carter (R-GA), Gonzalez (D-TX), Stefanik (R-NY), Ross (D-NC), Allen (R-GA), and Auchincloss (D-MA) introduced the Drug Price Transparency in Medicaid Act of 2023. The bipartisan legislation would improve transparency of prescription drug prices and would prohibit pharmacy benefit managers (PBMs) from using spread pricing in Medicaid programs. The bill would also establish an oversight and accountability program, which would monitor PBMs for predatory prescription drug pricing tactics.

For more information, click here.

Senate

Senate Homeland Security and Governmental Affairs Committee Holds Hearing on Drug Shortage Risks

On March 22, the Senate Homeland Security and Governmental Affairs Committee held a hearing to discuss the health and national security risks of drug shortages. Witnesses included:

  • Andrew Shuman, M.D., Associate Professor of Otolaryngology-Head and Neck Surgery and Chief of the Clinical Ethics Service Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School
  • Vimala Raghavendran, Vice President of Informatics Product Development at U.S. Pharmacopeia
  • Erin Fox, Pharm.D., Associate Chief Pharmacy Officer of Shared Services and Adjunct Professor at the University of Utah College of Pharmacy
  • John C. Goodman, Ph.D., President of the Goodman Institute for Public Policy Research

For more information, click here.

Senate Finance Committee Holds Hearing on President’s FY 2024 Health and Human Services Budget

On March 22, the Senate Finance Committee held a hearing on the President’s Fiscal Year (FY) 2024 budget for the Department of Health and Human Services (HHS). Witnesses included:

  • The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS)

For more information, click here.

Senate HELP Committee Holds Hearing on Moderna’s COVID-19 Vaccine Price Quadrupling

On March 22, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the quadrupling of the Moderna COVID-19 price. Witnesses included:

  • Stéphane Bancel, MBA, MEng, MSc, Chief Executive Officer and Director of Moderna, Inc.
  • Christopher J. Morten, Ph.D., J.D, Associate Clinical Professor of Law at Columbia Law School
  • Ameet Sarpatwari, Ph.D., J.D, Assistant Professor of Medicine at Harvard Medical School
  • Craig Garthwaite, Ph.D., MPP, Herman Smith Research Professor in Hospital and Health Services Management at Northwestern University Kellogg School of Management

For more information, click here.

Senate Appropriations Committee Labor, Health and Human Services, Education and Related Agencies Subcommittee Holds Hearing on President’s FY 2024 Health and Human Services Budget

On March 22, the Senate Appropriations Committee held a hearing on the President’s Fiscal Year (FY) 2024 budget for the Department of Health and Human Services (HHS). Witnesses included:

  • The Honorable Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS)

For more information, click here.

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

This Week in Washington: CMS releases first list of Inflation Rebate Program drugs, initial guidance on Medicare Drug Negotiation Program


Congress

House

Chiropractic Medicare Coverage Modernization Act Reintroduced

On March 14, Reps. Steube (R-FL), Higgins (D-NY), Alford (R-MO) and Larson (D-CT) reintroduced the Chiropractic Medicare Coverage Modernization Act. The legislation would expand Medicare coverage to include chiropractic services, and would ensure that Medicare patients have access to chiropractic care as an alternative to using prescription drugs for pain management. Sens. Blumenthal (D-CT) and Cramer (R-ND) introduced a companion bill in the Senate.

For more information, click here.

Senate

Rural Health Legislation Announced

On March 16, Sens. Blackburn (R-TN) and Warner (D-VA) reintroduced the Save Rural Hospitals Act. The legislation would reduce hospital closures in rural areas by establishing a minimum Medicare Area Wage Index of 0.85. The wage index is used to calculate the overall Medicare payment hospitals receive based on the average labor costs in the area in which the hospital is located.

Sen. Blackburn and Sen. Hickenlooper (D-CO) intend to introduce the Rural Health Innovation Act. The legislation would:

  • Create two 5-year grant programs administered by the Health Resources and Services Administration (HRSA) Community-Based Division;
  • Ensure that the first grant program go toward establishing Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), aimed at addressing a community’s urgent care and triage needs. Grants awarded by the program would be limited to $500,000 for existing facilities and $750,000 for startup facilities; and
  • Ensure that the second grant program go toward expanding existing rural health departments. Grants awarded by the program would be limited to $500,000. Grants would only be awarded to communities that are rural and are located at least 30 minutes away from the nearest emergency department. Communities that have lost a hospital in the past seven years will be given priority.

Additionally, Sen. Blackburn and Sen. Durbin (D-IL) intend to introduce the Rural America Health Corps Act. The legislation would:

  • Create a new loan repayment program titled “NHSC Rural Provider Loan Repayment Program”;
  • Ensure practitioners would be eligible for flexible loan repayments, based on the severity of healthcare staff shortages in the area;
  • Waive associated income tax liability for the loan repayment program; and
  • Allow nurse practitioners and physician assistants to participate in the loan repayment program.

For more information, click here.

Maximizing Opioid Recovery Emergency (MORE) Savings Act Introduced

On March 15, Special Committee on Aging Chairman Bob Casey (D-PA) introduced the Maximizing Opioid Recovery Emergency (MORE) Saving Act. The goals of the legislation are to lower the cost of treatment for opioid use disorder (OUD) and eliminate the cost of treatment and recovery services for privately insured individuals, as well as those enrolled in a new Medicare pilot program. It would also increase federal funding for Medicaid treatment programs and establish a pilot program in 15 states, which would allow individuals to seek Medicare OUD services at no cost for the next five years. Rep. Dean (D-PA) will be introducing a companion bill in the House.

For more information, click here.

Senate Finance and Veterans’ Affairs Committee Chairmen Send Letter to CMS Regarding IRA Medicare Part B Coinsurance

On March 13, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Veterans’ Affairs Committee Chairman Jon Tester (D-MT) led 20 senators in sending a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, asking CMS to announce which Medicare Part B medications would be subject to the Inflation Reduction Act’s (IRA) Medicare Part B and D inflation rebate provision. The senators also asked CMS to announce what the coinsurance percentage and amount would be for each applicable Part B drug.

This request came just as CMS released on March 15 a list of the first 27 drugs that fall under the rebate provision.

The other senators who signed the letter include Democratic senators Bennet (CO), Klobuchar (MN), Brown (OH), Gillibrand (NY), Casey (PA), Cortez Masto (NV), Cardin (MD), Kaine (VA), Blumenthal (CT), Manchin (WV), Warnock (GA), Merkley (OR), Baldwin (WI), Warner (VA), Carper (DE), Welch (VT), Whitehouse (RI), Kelly (AZ), Murray (WA) and Murphy (CT).

For more information, click here.

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

This Week in Washington: President releases FY2024 Budget



Congress

House

Prescription Information Modernization Act of 2023 Introduced

On March 9, Reps. Harshbarger (R-TN) and Sherrill (D-NJ) introduced the Prescription Information Modernization Act of 2023. The bipartisan bill would give healthcare professionals the option to choose whether to receive digital or printed versions of prescription information from manufacturers. Current policy restricts healthcare professionals from obtaining prescription information digitally. The bill will allow the Food and Drug Administration (FDA) to move forward with a proposed rule that will grant drug manufacturers permission to transmit prescription information electronically.

For more information, click here.

EFFECTIVE Act Introduced

On March 3, Reps. Trone (D-MD) and Meuser (R-PA) introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act. The bipartisan bill would grant the Food and Drug Administration (FDA) authority to deny new drug applications for opioids if they do not offer material safety advantages over approved opioids already on the market. Sens. Manchin (D-WV) and Braun (R-IN) introduced a companion bill in the Senate.

For more information, click here.

Senate

Senators Send Letter Concerning Healthcare Pricing Transparency

On March 6, Sens. Hassan (D-NH) and Braun (R-IN) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, expressing their concerns over the amount of transparency in healthcare pricing. The senators are concerned health insurance companies are evading CMS’ July 2022 Transparency in Coverage rule. That rule requires health insurance companies to publish their in- and out-of-network rates for healthcare plans. The letter urges CMS to update the rule and increase its enforcement of health plan pricing transparency and compliance.

For more information, click here.

Access to Prescription Digital Therapeutics Act of 2023 Introduced

On March 8, Sens. Shaheen (D-NH) and Capito (R-WV) introduced the Access to Prescription Digital Therapeutics Act of 2023. The bipartisan bill would expand Medicare coverage to include Prescription Digital Therapeutics (PDTs). PDTs are software-based disease treatments that can be used to treat a variety of illnesses, such as mental health and substance abuse disorders. Reps. Hern (R-OK) and Thompson (D-CA) introduced a companion bill in the House.

For more information, click here.

Modernizing Opioid Treatment Access Act Introduced

On March 6, Sens. Markey (D-MA) and Paul (R-KY) introduced the Modernizing Opioid Treatment Access Act. The legislation would help patients access medication treatment for Opioid Use Disorder (OUD), by updating outdated rules, allowing board-certified physicians to prescribe methadone and granting U.S. pharmacies permission to dispense methadone. It would also require the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) to submit an annual report that provides the names of patients who were prescribed methadone, as well as those of the providers and state physicians who are registered to prescribe methadone. Reps. Norcross (D-NJ) and Bacon (R-NE) introduced a companion bill in the Senate.

Cosponsors of the Senate bill include Sens. Sanders (I-VT), Braun (R-IN), Booker (D-NJ) and Hassan (D-NH). Cosponsors of the House bill include Reps. Kuster (D-NH), Trone (D-MD), Fitzpatrick (R-PA), Tonko (D-NY), Pettersen (D-CO) and Kim (D-NJ).

For more information, click here.

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