2023 Federal Legislation Is Having an Impact on Oncology Practices and Patients


The CMS FAQ ruling is resulting in barriers to care for patients.

As a pharmacist elected to serve in Congress, Rep. Earl L. “Buddy” Carter (R, Georgia) delved into key legislation that impacts patients with cancer and oncology practices at the 2023 NCODA International Fall Summit in Orlando, Florida. Moderated by Barry D. Brooks, MD, a physician shareholder and founding member of Texas Oncology, the session addressed current legislation in Congress pertaining to pharmacy benefit managers (PBMs), CMS guidance on Stark Law, drug shortages, and the Inflation Reduction Act (IRA). Carter, one of 2 pharmacists in Congress currently, specifically discussed the introduction of legislation that addresses gaps in the US health care system.

Physicians looking at CT scans

Image credit: Gorodenkoff | stock.adobe.com

During the session, Carter provided some background on his experience in the pharmacy field and how it has impacted his work in Congress. After he graduated from the University of Georgia with a bachelor of pharmacy degree, Carter went on to own 3 independent community pharmacies at one point in time. However, it was during his experience as a consultant pharmacist that he developed a passion for shaping legislation pertaining to PBMs. According to Carter, PBMs control a significant portion of the US health care market, which has a direct impact on drug pricing. Because of this, Carter explained that he worked to develop strategies that help mitigate drug pricing by focusing on supporting accessible, affordable, and quality health care.

Carter also discussed how the CMS guidance on Stark Law will negatively impact oncology practices, and in particular will have an impact on patients based in rural settings. According to Carter, he coauthored a bipartisan letter with Rep. Diana Harshbarger (R, Tennessee) to CMS and HHS that expresses their position that CMS should reverse the Stark Law ruling.

Additionally, with 25 major drug shortages this year alone, including for platinum-based agents, Brooks asked Carter to discuss some of the legislation addressing drug shortages. According to Carter, multiple legislative proposals have been introduced to address this issue. The first is the State Strategic Stockpile Act of 2023, which complements existing federal stockpiling practices by enabling states to stockpile their own drugs based on the frequency of use. The second legislative proposal is the Essential Medicines Stockpile Act of 2023, which was also introduced to allow stockpiling of generic medications to address shortages of generic drugs.

Another bill that was introduced is the Manufacturing API, Drugs, and Excipients (MADE) in America bill, which will address outsourced manufacturing of drugs, according to Carter. He explained that Congress has realized oncology drugs are being manufactured in countries that have differing guidelines from the United States, so this bill was introduced to repatriate drug manufacturing through incentives (eg, tax incentives) that encourage their return to the United States.

Brooks also asked about the progress made with the Help Ensure Lower Patient (HELP) Copays Act, which aims to ban co-pay accumulators. The bill would require health plans and PBMs to count the value of copay assistance towards a patient’s cost-sharing requirements, preserving the original intent of the copay assistance program. According to Carter, there is now bipartisan consensus to rein in PBMs, with nearly double the number of cosponsors that supported the bill and Republican support increasing by over 600%.

Carter also addressed the PBM Accountability Act and the Drug Price Transparency in Medicaid Act, which will prohibit spread pricing for Medicaid patients. He explained that there was a study done in March 2022 that showed only 37% of the price of the drug goes to the pharmaceutical manufacturer, while the other 63% goes to the PBM. For this reason, the PBM Accountability Act will increase transparency regarding discounts PBMs are receiving from drug manufacturers. Although PBMs may argue their rebates are used to reduce patients’ insurance premiums, Carter noted that this is unfortunately not something patients have experienced.

Brooks also asked for Carter’s perspective on the provisions of the IRA. Carter explained that he views the provisions as having the potential to harm research and development for new cures. According to Carter, the Congressional Budget Office has said the IRA will result in 10 to 13 fewer drugs in the market in the next decade.

Carter explained further that the prescription drug portion of the IRA lists 10 drugs that require the affected pharmaceutical companies to submit proposals for the expected sale price to the government. If companies do not comply, the penalties will be devastating. Many pharmaceutical companies and the US Chamber of Commerce have filed lawsuits against this prescription drug portion of the IRA. He noted that he adamantly opposed this bill.

Carter also discussed how health care professionals can influence legislation, specifically citing the importance of educating members of Congress on the issues facing the delivery of health care and treatment to patients. According to Carter, members of Congress need the expertise of health care professionals and can even be invited to the practice setting for in-person exposure to health care challenges.

Patient Perspective on the CMS FAQs Ruling

Following the conversation between Brooks and Carter, the session was joined by Yen Nguyen, PharmD, Director of Pharmacy at Oncology Consultants in Houston, Texas, who addressed the impact of the CMS guidance on Stark Law on patients. Nguyen noted that a single sentence in a CMS FAQ document drastically shifted the oncology health care landscape by preventing delivery of lifesaving medications to patients and pickup of these medications from practices by family members of patients.

Nguyen played a voicemail from a patient with cancer who shared their experience. As a result of the CMS guidance, Nguyen’s team was unable to deliver this patient’s medication to his home. In the voicemail, the patient expressed their frustration, noting the negative impact on his quality of life. According to the patient, he struggles to afford transportation services to pick up his medication, as he is visually impaired, making it challenging to travel to the clinic. The patient added that his medication falling in the FDA Risk Evaluation and Mitigation Strategy program added further complexities to his care.

The History Behind the Stark Law

Nguyen stressed that while the Stark Law is important and beneficial, it was passed into law prior to the approval of the first oral anticancer drug. In the past 30 years, over 150 oral anticancer therapies have come on the market, with no expectation of declining. The Stark Law was intentionally created for intravenous medications and, for this reason, should be updated to reflect the current treatment landscape.

Harshbarger and Rep. Debbie Wasserman Schultz (D, Florida) recently introduced the Seniors’ Access to Critical Medications Act (HR5526) to address some of these challenges. Specifically, HR5526 supports the delivery of medications to patients homes or to family members picking up the medications, noting that this would not violate the Stark Law. Additionally, HR5526 looks to retract the CMS FAQ document starting on May 11, 2023. Nguyen explained that the intention of HR5526 is to protect pharmacists who are unable to decline delivering a patient’s medication despite the CMS FAQ ruling.

Nguyen ended with a call to action to educate legislators to garner their support for HR5526. According to Nguyen, there needs to be a unilateral, national effort to advocate for patients who are being impacted. Nguyen noted that to promote co-sponsorship of HR5526, health care professionals should contact their representatives in Congress.

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