Health Policy Report – May 31, 2023

Texas Oncology Hosts Rep. Beth Van Duyne

Earlier this month, Texas Oncology hosted Congresswoman Beth Van Duyne (R-TX) for a site visit at its Bedford practice. As a member of the House Committee on Ways and Means, Congresswoman Van Duyne helps shape policy related to Medicare payments.

During the site visit, Congresswoman Van Duyne met with Practice President Dr. Steven Paulson, Dr. Vasu Moparty, Practice Director Dr. Anna Schlatter, and Executive Director Stacie Harris to discuss issues of top priority to the community oncology community. The discussion centered around site of service payment disparities, Texas Oncology’s participation in the Oncology Care Model, the value of medically integrated dispensing, and precision medicine.

Congresswoman Van Duyne visited the infusion suite, the breast cancer center, and the radiation suite, meeting with staff along the way and learning about Texas Oncology’s model of care.

To read more, CLICK HERE.

The Network Applauds Texas Lawmakers for Passing Legislation to Prohibit White Bagging Mandates

On May 17, the Texas state Senate unanimously passed legislation that prohibits white bagging mandates. Specifically, HB 1647 will prohibit pharmacy benefit managers (PBM) or insurers from requiring patients with life-threatening conditions to receive their clinician-administered drugs from a PBM mail-order specialty pharmacy. The bill has now reached the Governor’s desk for signature and the Network encourages state leaders to implement it without delay.

In a press release, the Network praised HB 1647 for addressing white bagging, which continues to be one of the most serious barriers to cancer care in the community setting. By forcing community oncologists to use an insurer or pharmacy benefit manager’s (PBM) preferred pharmacy, white bagging threatens to delay patients’ access to the highly specific tailored drug regimens they need. Preventing white bagging will increase patient choice, improve safety, and streamline cancer patients’ access to timely care.

Dr. Debra Patt wrote an op-ed in support of the legislation that was published on May 14 in the Austin American-Statesman. “Given that there will be an estimated 139,100 new cancer diagnoses in Texas this year, this issue can’t wait,” Dr. Patt wrote.

For more detail on HB 1647, CLICK HERE.

To read the Network’s press release about the bill, CLICK HERE.

To read Dr. Patt’s op-ed in the Austin American-Statesman CLICK HERE and in Becker’s Hospital Review HERE.

Urge your Representative to Sign Bipartisan Letter to FDA on Oncology Drug Shortages

Congressional concern over nationwide drug shortages continues to grow. Following recent hearings on the root causes of drug shortages in the Senate Homeland Security and Governmental Affairs Committee (HSGAC) and the Energy and Commerce Subcommittee on Oversight and Investigations, Reps. Ami Bera, MD (D-CA), Brian Fitzpatrick (R-PA), Derek Kilmer (D-WA), and Mike Kelly (R-PA) are circulating a “Dear Colleague Letter” to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf sharing concerns with the ongoing oncology drug shortage and asking the FDA to identify additional flexibilities and authorities needed to prevent or mitigate future drug and medical device shortages.

To ask your Member of Congress to sign the Bera/Fitzpatrick/Kilmer/Kelly letter on drug shortages, CLICK HERE.

To watch the Energy and Commerce Subcommittee hearing, CLICK HERE.

To read ASCO’s statement of record from the Energy and Commerce Subcommittee hearing, CLICK HERE.

To watch the HSGAC hearing, CLICK HERE.

To read the HSGAC report on drug shortages, CLICK HERE.

White House, Congress Reach Tentative Debt Ceiling Deal

After weeks of spirited negotiation, President Biden and Speaker of the House Kevin McCarthy (R-CA) announced on May 27 that they reached a tentative deal to raise the nation’s debt ceiling before the federal government is unable to pay all of its obligations in early June. The text of the legislation, which will increase the government’s $31.4 trillion borrowing limit through January 1, 2025 and impose spending caps on discretionary spending in fiscal years 2024 and 2025, still needs to be passed by the House and Senate by June 5.

In exchange for increasing the debt ceiling, Republicans were able to win concessions on some—but not all—of their key priorities. Specifically, the deal calls for rescinding nearly $30 billion in unspent COVID relief funds and attaching work requirements for certain people receiving benefits through the Temporary Assistance for Needy Families (TANF) and the Supplemental Nutrition Assistance Programs (SNAP). It also cuts some funding to the Internal Revenue Service, requires the government to reverse its pause for student loan payments, and preserves funding for veterans’ health care. However, President Biden successfully blocked GOP calls for Medicaid work requirements, and he also secured a cap on defense spending and funds for developing next-generation COVID treatments. The bill does not contain policy changes to Medicare.

Despite the deal reached by President Biden and Speaker McCarthy, it is unclear if Congress will pass the legislation needed to avoid default. A growing number of Republicans, especially members of the House Freedom Caucus, have come out against it. With a slim majority in the House, Speaker McCarthy will need to rely on some bipartisan support to advance the bill through the chamber. On the other side of the aisle, a number of progressive Democrats have also expressed opposition, citing the establishment of work requirements for TANF and SNAP, but the deal was endorsed by the more moderate New Democrat Coalition. The House is set to vote on the bill on Wednesday evening.

To read the legislative text of the deal,  CLICK HERE.

House Energy and Commerce Committee Holds Markup, Advances Site Neutral Policy and 340B Transparency

On May 24, the House Committee on Energy and Commerce marked up a series of health care bills related to changes for pharmacy benefit managers (PBMs), site neutral payments, and the 340B drug discount program.

During the full committee markup, the House Committee on Energy and Commerce unanimously passed The PATIENT Act (H.R. 3561), which would strengthen existing price transparency requirements for hospitals and insurance companies, impose new reporting requirements on PBMs, and expand site neutral payments in Medicare drug administration. The bill also contains language to require the Department of Health and Human Services (HHS) to consider the impact of consolidation during annual payment rules and Center for Medicare & Medicaid Innovation (CMMI) demos. It would also require hospitals to include a unique identifier number on claims for services for each of their outpatient departments.

Despite strong support for the bill’s site neutral policy from Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone (D-NJ), two lawmakers—Representatives Paul Tonko (D-NY) and Yvette Clarke (D-NY)­­­­––raised concerns that these policies would create financial burdens for hospitals, a sign that site neutral policies continue to face strong pushback from hospitals and related stakeholders. Following the passage of The PATIENT Act in the House Energy and Commerce Subcommittee on Health markup on May 17, the Alliance for Site Neutral Payment Reform released a statement calling the move “a meaningful first step,” but also urged the committee to act on comprehensive legislation that would remove the grandfathering exceptions from the 2015 site-neutral pay cuts and implement site neutral payments more broadly.

Meanwhile, the full committee also passed H.R. 3290, which would institute new reporting requirements on providers in the 340B program, in a tight 29 to 22 vote.

To watch the full committee markup, CLICK HERE.

To read the Alliance for Site Neutral Payment Reform’s statement, CLICK HERE.

The Network Signs ASP Coalition Letter on IRA Part B Cuts

The Network joined 61 organizations in sending a letter to congressional leadership advocating for decisive action from Congress to address the harmful Part B payment cuts in the Inflation Reduction Act.

The letter, led by the Part B Access for Seniors and Physicians (ASP) Coalition, urged Congressional leadership to support providers in Medicare’s drug price negotiation process, voicing concerns that CMS is failing to consider the impact of repeated payment cuts on patient care. The letter highlights the pressures independent practices are facing, especially in rural areas, and warns that a new round of IRA-induced cuts could further consolidation into the more expensive hospital setting and impact patient care.

To read the letter, CLICK HERE.

House Oversight and Accountability Committee PBM Hearing Features Testimony from COA President, FTC Expands PBM Probe

Lawmakers on both sides of the aisle criticized pharmacy benefit managers (PBMs) for allegedly profiting at the expense of patients and taxpayers during a House Oversight and Accountability Committee hearing on May 23, the latest congressional inquiry into PBMs. During the hearing, Miriam Atkins, MD, president of the Community Oncology Alliance (COA), testified on the hurdles PBMs place between patients and the “nationally recognized lifesaving treatment and care” they deserve and expect. Dr. Atkins also discussed how PBM policies reduce patients’ access by steering them to mail-order pharmacies owned by or affiliated with a given PBM. In addition, Dr. Atkins gave examples of the harmful effects of step therapy on cancer patients. Meanwhile, lawmakers highlighted concerns about vertical integration and underscored the need for Congress to eliminate clawbacks like direct and indirect remuneration (DIR) fees.

Meanwhile, the Federal Trade Commission (FTC) expanded its probe into pharmacy benefit managers by requiring two group purchasing organizations (GPOs) to provide key details and information on their business practices. The GPOs – Zinc Health Services and Ascent Health Services – negotiate rebates on behalf of PBMs. Zinc operates as the GPO for Caremark, while Ascent provides similar services to Express Scripts, Prime Therapeutics, Humana Pharmacy Solutions, and Envolve Pharmacy Solutions.

To watch the House Oversight and Accountability Committee’s hearing on PBMs, CLICK HERE.

To read the FTC’s announcement on GPOs, CLICK HERE.

Senate Holds Hearing on Denials and Delays in Medicare Advantage

On May 17, the Senate Committee on Homeland Security & Governmental Affairs’ Permanent Subcommittee on Investigations convened to discuss barriers that seniors enrolled in Medicare Advantage (MA) face in accessing necessary care. Witnesses included Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) Chief of Staff Megan H. Tinker, MA enrollee Gloria Bent, Jeannie Fuglesten Biniek of the Kaiser Family Foundation, Lisa M. Grabert of Marquette University, and Christine Jensen Huberty of the Greater Wisconsin Agency on Aging Resources. In his opening statement, Subcommittee Chairman Richard Blumenthal (D-CT) said, “I want to put these companies on notice. If you deny life-saving coverage to seniors, we’re watching, we will expose you, we will demand better, we will pass legislation if necessary. But action will be forthcoming.”

The hearing follows the April 2022 report from the HHS OIG which fond MA insurers have denied some coverage or payment for services that would have been covered under fee-for-service Medicare. In her opening statement, Megan Tinker told lawmakers that around 13% of prior authorization claims denials in Medicare Advantage were for services that met Medicare coverage rules.

The Subcommittee also sent letters to CVS Health, Humana, and UnitedHealth Group seeking internal documents on how the companies decide to approve or deny claims.

To learn more about the Senate Permanent Subcommittee on Investigations hearing on Medicare Advantage, CLICK HERE.