Health Policy Report – February 20, 2024

In New Op-Ed, Dr. Les Busby Urges Lawmakers to Address White Bagging Mandates

Dr. Les Busby of Rocky Mountain Cancer Centers (RMCC) recently authored an op-ed in Colorado Politics illustrating how white bagging mandates are causing dangerous delays in treatment for Coloradans battling cancer. In the piece, Dr. Busby outlined how on-site drug inventories allow for personalized care adjustments based on individual patient needs. White bagging policies, however, disrupt this standard practice by requiring oncologists to order chemotherapy from specialty pharmacies owned or affiliated with insurers – resulting in greater out-of-pocket costs and unnecessary delays for cancer patients.

“Despite these risks, white bagging policies and practices are accelerating. In a recent poll of Association of Community Cancer Centers (ACCC) members, more than 87% report ‘white bagging is an insurer mandate for some of their patients.’ Without action from policymakers, this trend will only continue, jeopardizing the health and safety of Coloradans fighting to overcome cancer,” Dr. Busby wrote.

Dr. Busby urged Colorado lawmakers to take action to protect cancer patients from the harmful effects of white bagging by supporting HB 24-1010, which would prohibit insurers and affiliated PBMs from requiring patients with chronic, complex, rare, or life-threatening medical conditions seeking care in community practices to receive their physician-administered drugs from a specialty pharmacy.

The op-ed is very timely as the Colorado legislature is set to hold a hearing on HB 24-1010. The Network remains committed to working alongside practices to help ensure that cancer patients can access the timely, personalized care that gives them the best chance at recovery and remission.

To read Dr. Busby’s op-ed, CLICK HERE

To read more information about HB 24-1010, CLICK HERE

The Network’s State Policy Team Continues to Advance Patient-Centric Policies

The State Policy team continues to make meaningful steps to advance The Network’s key priorities in statehouses across the country. In Texas, Texas Oncology and The Network’s State Policy team recently honored Senator Charles Schwertner, M.D. with the “Heroes Who Conquer Cancer” award. He was recognized for his pivotal role in sponsoring HB 1647, a recently passed bill that safeguards patient choice by restricting PBM and insurers’ use of white bagging arrangements. 

Meanwhile, in Virginia, Dr. Rich Ingram from Shenandoah Oncology gave a virtual testimony on behalf of the Virginia Association of Hematologists and Oncologists (VAHO) in support of HB 1006. This bill extends Virginia’s Patient Choice in Pharmacy laws to protect a patient’s right to choose where they access their infusion medications, allowing patients to reject white bagging, brown bagging, and home infusion policies at their discretion.

In Maryland, Dr. Kashif Firozvi from Maryland Oncology Hematology (MOH) recently joined a panel of witnesses in the Maryland Senate Finance Committee to provide in-person testimony on SB 526, which extends Maryland anti-pharmacy steering statutes to protect patients with complex, chronic, or life-threatening conditions from PBM specialty pharmacy steering related to infusion, injectable, or certain medications in the physician office setting. Courtney Horn, PharmD joined virtually to provide additional insight on how expanded access to MID medications would benefit MOH’s patient population. 

The bill awaits an executive meeting in the committee for further consideration; however, the bill’s cross-filed companion in the House, HB 876, will be heard on February 29 in the House Health and Government Operations Committee.

In Oregon, Dr. David Cosgrove from Compass Oncology, Dr. Matthew Lonergan from Willamette Valley Cancer Institute (WVCI), and Dr. Bud Pierce from Oregon Oncology Specialists testified in support of HB 4012 during a committee hearing of the Oregon House Committee on Behavioral Health and Health Care. HB 4012 protects patients’ access to high-quality oncology care by prohibiting insurance companies and PBMs from mandating that patients receive their physician-administered drug from payer’s specialty pharmacies in the physician office setting.

To read more about Sen. Schwertner’s award and HB 1647, CLICK HERE.

To read HB 1006 in Virginia, CLICK HERE.

To watch the Virginia testimony, CLICK HERE.

To read SB 526 in Maryland, CLICK HERE.

To read HB 876 in Maryland, CLICK HERE.

To watch the Maryland testimony, CLICK HERE.

To watch the Oregon testimony, CLICK HERE.

To read HB 4012 in Oregon, CLICK HERE.

Judge Grants Biden Administration Motion to Dismiss Legal Challenge from PhRMA

On February 11, a federal judge dismissed a drug industry trade group’s legal challenge to halt Medicare drug price negotiations, ruling that it lacked standing. The complaint was filed by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Global Colon Cancer Association (GCCA), and the National Infusion Center Association (NICA) in June of last year.  

In response to a motion to dismiss led by the Biden administration, Judge David Alan Ezra dismissed NICA from the case, writing that it “lacked subject matter jurisdiction,” because it doesn’t make or sell prescription drugs that could be subject to the negotiations. Since NICA was the only plaintiff in Texas, the court’s decision effectively closed the case but left open the possibility to potentially pursue a claim in a different jurisdiction.

The decision is a major win for the Biden administration, marking the first time that a court has thrown out a lawsuit to overturn the Medicare drug negotiation program included in the Inflation Reduction Act.

To read the complaint, CLICK HERE.

To read the dismissal, CLICK HERE.

To read more, CLICK HERE.

Senate Working Group on 340B Reform Releases Legislative Discussion Draft 

On February 2, the Senate 340B working group issued a legislative discussion draft, called the Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B (SUSTAIN 340B) Act, which would clarify the intent of the 340B Drug Pricing Program and create additional guardrails for participating entities. 

The draft comes months after the bipartisan working group – comprising Senators John Thune (R-SD), Debbie Stabenow (D-MI), Shelley Moore Capito (R-WV), Tammy Baldwin (D-WI), Jerry Moran (R-KS), and Ben Cardin (D-MD) – released a Request for Information (RFI) asking for stakeholder input on policies that Congress should consider to improve oversight of the program, which resulted in over 250 responses. 

Along with the draft legislation, the senators also released a one-pager letter to 340B stakeholders expressing their view that “it is necessary to pass legislation in the 118th Congress that provides clarity, transparency, and accountability in the 340B program in order to ensure the program remains strong, long into the future.” 

While not formally introduced, the discussion draft includes language that would impose new 340B reporting requirements, provide a clear definition of “patient” in the 340B statute, clarify the role of contract pharmacies in the 340B program, and clarify the eligibility of “child sites.” The lawmakers continue to seek more input from stakeholders to further refine the draft bill’s policies. 

To read the SUSTAIN 340B Act, CLICK HERE.

To read the letter to stakeholders, CLICK HERE.

To read the RFI, CLICK HERE.

Bipartisan Group of Senators Announce Medicare Reform Working Group

A bipartisan group of senators – including Catherine Cortez Masto (D-NV), Marsha Blackburn (R-TN), John Barrasso (R-WY), Debbie Stabenow (D-MI), Mark Warner (D-VA), and John Thune (R-SD) – have formed a Medicare payment reform working group to address long-term reforms in physician payments.

The group is aiming to propose changes to the Physician Fee Schedule (PFS) and update the Medicare Access and CHIP Reauthorization Act (MACRA) to better align payment incentives with patient outcomes. The group acknowledges that despite efforts like MACRA, the current physician payment system has not kept pace with the evolving healthcare landscape, necessitating further action to address reimbursement challenges.

This announcement follows months of lobbying from provider groups urging Congress to address the 3.4% Medicare payment rate cut that went into effect on January 1. Advocates against these cuts have emphasized the financial strain on independent practices and the overall decline in Medicare reimbursement rates. Despite previous attempts to include relief for payment cuts in stopgap funding bills and support for bipartisan legislation, no successful resolution has yet been reached, though the Preserving Seniors’ Access to Physicians Act (H.R. 6683), remains in consideration ahead of the March funding deadlines. 

To read more, CLICK HERE.

To read H.R. 6683, CLICK HERE.

Senate HELP Committee Holds Drug Pricing Hearing

On February 8, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing focused on the drivers of high drug prices. In the nearly four-hour-long, two-panel hearing, lawmakers, led by Senator Bernie Sanders (I-VT), the committee’s chairman, pressed the CEOs of Merck, Johnson & Johnson, and Bristol Myers Squibb on increasing drug prices and overall Pharmacy Benefit Manager (PBM) reform. 

Ahead of the hearing, Johnson & Johnson and Merck’s CEOs both initially declined to testify but reversed their decision following Sanders’ announcement that he would hold a vote to subpoena them.

During the hearing, the CEOs acknowledged that drug prices were often higher in the U.S. than in other countries but noted that lower prices in Europe and Canada came with longer waits for new drugs. The CEOs further argued that, although their list prices have increased, their revenues have remained the same and that more money is going toward paying rebates to PBMs.

The hearing comes directly after the Biden administration sent out initial offers to manufacturers under the Medicare drug price negotiation program. The three companies at the hearing have each brought lawsuits challenging the program.  

To read more about the hearing, CLICK HERE.

To watch the hearing, CLICK HERE.

House Oversight Committee Advances PBM Delinking Measure

On February 6, the House Committee on Oversight and Accountability advanced the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283) in a bipartisan vote of 28-10. The bill restricts PBMs from charging fees based on drug list prices – the first of its kind within Congress’ vast array of PBM reform efforts. 

The DRUG Act, which was introduced by Representative Mariannette Miller-Meeks (R-IA), would only allow PBMs to charge a flat service fee, separating those fees from list prices, and would ban so-called “spread pricing,” or when PBMs charge insurers more than they pay pharmacies. However, the changes would only apply to the Federal Employees Health Benefits program, which covers more than 8 million of the nearly 160 million Americans who are covered by health insurance from their employer. 

Though Congress has devoted much attention to PBM reform, it has been wary of measures that ban PBMs from charging administrative fees based on a drug’s list price. Members of the Senate Health Committee wanted to add a similar measure to the commercial-market PBM bill they passed last year, but this policy was ultimately excluded. Likewise, the House passed PBM reform provisions in the Lower Costs, More Transparency Act (H.R. 5378), but it doesn’t include any such measure for the commercial market or Medicare. 

To read the DRUG Act, CLICK HERE.

To read a recap of the markup, CLICK HERE.