Access Denied: CMS’ Action Hurts Patients With Cancer in Rural America

ABSTRACT

In 2020, cancer claimed more than 600,000 lives in the US. Cancer is an unyielding public health crisis. Cancer treatments typically involve multidisciplinary approaches, including surgery, radiation therapy, chemotherapy, and oral medications. For patients, especially those in rural areas, obtaining multiple oral medications can be inconvenient. The adoption of delivering cancer medications from medically integrated pharmacies (MIPs) has become popular in recent years. On May 12, 2023, CMS introduced guidelines restricting MIPs from delivering cancer-specific medications by mail or to oncology satellite offices and also requiring patients themselves to pick up the medications in person. This regulatory change has had a devastating impact on patients with cancer in rural and underserved communities, exacerbating existing health care disparities. This commentary explores the negative impacts of the policy change by CMS in rural America.

Am J Manag Care. 2024;30(5):206-208. https://doi.org/10.37765/ajmc.2024.89537

Takeaway Points

This commentary discusses how recent CMS regulations restricting the delivery of cancer medications from medically integrated pharmacies (MIPs) have negatively impacted rural patients with cancer. It highlights the need for policy changes to ensure equitable access to vital cancer treatments.

• The CMS regulations have disrupted the convenience and accessibility of cancer medications for rural patients, increasing their burden and potentially hindering their treatment adherence.
• These policy changes exacerbate existing health care disparities in rural areas, where limited health care infrastructure and socioeconomic factors already hinder access to care. Policy makers should consider these disparities when crafting health care regulations.
• MIPs play a crucial role in enhancing the quality of health care, reducing drug wastage, and improving patient satisfaction. Recognizing their value can inform future policy decisions.
• Legislative efforts like the Seniors’ Access to Critical Medications Act of 2023 aim to address the negative impacts of these regulations. Advocacy for equitable access to cancer medications in rural areas is crucial for improving patient outcomes.

Patients with cancer have complex medical needs often compounded by the severe toll of their illness and the adverse events of cancer treatments. These challenges, both physical and emotional, place a heavy burden on patients and their families. This burden is even more pronounced in rural communities due to a variety of geographic and economic factors. Rural areas tend to have lower population densities, resulting in limited health care infrastructure, including hospitals, clinics, and specialist services. Additionally, a shortage of health care professionals such as doctors, nurses, and pharmacists, combined with the geographical distance between rural communities and health care facilities, leads to increased travel times and transportation costs for patients. Socioeconomic factors such as lower income levels and a higher percentage of uninsured individuals further hinder access to affordable health care services.¹

Illinois CancerCare

Illinois CancerCare (ILCC) has been serving the central Illinois region for more than 40 years, catering to a rural and sparsely populated area with 14 office locations. In 2022 alone, our oncology providers drove nearly ¹ million miles to reach our satellite offices and provided care to our patients in far-flung areas. Since its establishment in 2008, ILCC’s medically integrated pharmacy (MIP) has been a trusted provider of specialized pharmacy services. The comprehensive services it provides to patients with cancer include handling prior authorizations, facilitating financial support, ensuring medication availability, and going the extra mile to deliver medications directly to patients by either mail or courier, thus alleviating the patient’s and their family’s burden and enhancing their overall care experience.

In 2022, we filled a total of 48,841 prescriptions, 8086 of them exclusively oncology specific. We made 11,469 deliveries, covering 208,015 miles. Our pharmacy division currently serves more than 4800 patients across 320 towns, with 60% of the patients being by Medicare, Medicaid, or TRICARE. The ILCC MIP prioritizes safety, accuracy, and timely delivery, all the while maintaining a compassionate approach toward our patients.

Benefits of MIPs

Between 2010 and 2019, the percentage of oncologists in practices with MIPs significantly increased. Community oncologists’ share rose from 7.6% to 28.3%, and hospital-based oncologists’ share increased from 18.3% to 33.4%. Dispensing oncologists had higher patient volumes and fewer Medicare beneficiaries and treated patients with higher risk and comorbidity scores who lived in areas with a higher Black population compared with nondispensing oncologists.²

In a recent study by Prime Therapeutics, MIPs received high satisfaction ratings, with members reporting a 95% satisfaction rate, surpassing industry standards. Additionally, MIPs achieved a remarkable Net Promoter Score (NPS), an industry benchmarking metric measuring customer satisfaction, of 80. This is substantially better than the average NPS of 38 for health care as a whole and the NPS of 34 for mail order or retail pharmacy services.³ MIP programs not only enhance the quality of health care but also have demonstrated their ability to lower health care costs by reducing drug wastage.⁴

Impact of CMS Regulation

In 2021, CMS released a frequently asked questions document asserting that independent community oncology practices delivering oral drugs through courier or mail would violate the federal prohibition on self-referral as outlined in the Stark Law. However, during the COVID-19 pandemic, CMS temporarily waived this ruling, allowing medication delivery. This waiver expired on May 11, 2023, abruptly halting services to sick and disadvantaged patients. On May 12, 2023, CMS issued guidelines barring pharmacies, including ILCC Pharmacy, from delivering medications to patients personally or by mail. The latest regulation mandates that medication can be given to a patient only when they are physically present at the medical office.⁵

A June 12, 2023, Wall Street Journal article paraphrased a CMS spokeswoman as saying that the agency does not expect the CMS restrictions on MIPs to hinder patient access to medications, citing the ban as long-standing policy.⁶ She also said Medicare patients with cancer can still obtain their medications in person at health care provider offices, at retail pharmacies, or through mail order pharmacies within their Medicare Part D plan’s network. Nonetheless, depending exclusively on third-party specialty pharmacies for Medicare beneficiaries to obtain cancer medications and mandating in-person medication pickups at an oncology care office overlooks health care disparities in rural regions, leading to inefficiencies and increased expenses.

The impact of these CMS regulations has been profound, effectively dismantling the entire pharmaceutical delivery system provided by organizations like ILCC throughout the US. Before these regulations, patients could conveniently receive their medications through pickup services at oncology offices or via mail delivery from an MIP. Now patients must travel to clinic locations, posing a major problem, especially for those residing in distant rural towns. This ruling has a detrimental impact on many patients with cancer, hindering the equitable delivery of vital cancer medications and increasing health care disparities in rural and underserved communities.

CMS’ implication that oncology practices that are deeply engaged in their patients’ care somehow undermine the health care system remains unclear, considering the substantial benefits that delivery services offer to sick patients with cancer.⁷

Entities Unaffected by CMS Regulations

Remarkably, CMS regulations selectively exempt large health care systems, mail order pharmacies, and pharmacy benefit manager (PBM) systems, allowing them to continue operations without disruption. These health care systems often possess the resources and influence to secure exceptions to the Stark Law, enabling them to function within the regulatory framework. Furthermore, some of these systems participate in programs such as the 340B Drug Pricing Program, which has faced criticism for its potential to increase the cost of health care delivery.

Impact of 340B and PBMs on Drug Pricing

The 340B Drug Pricing Program, a federal initiative designed to aid eligible health care organizations in serving vulnerable populations, enables participating hospitals to acquire prescription drugs at reduced rates. The primary goal of this program was to decrease medication costs and enhance health care access. However, concerns have arisen regarding the program’s transparency and accountability, with some arguing that the cost savings are not consistently passed on to patients. Furthermore, the program’s expansion may lead to higher drug prices for other consumers.⁸

In the US, many specialty pharmacies are operated by PBMs known for inflating prices. On November 21, 2023, in a letter to Christi Grimm, inspector general of HHS, Senators Elizabeth Warren (D, Massachusetts) and Mike Braun (R, Indiana) highlighted this issue well and raised concerns about significant markups on generic drugs at specialty pharmacies owned by CVS Aetna, Cigna, and UnitedHealth, which are often affiliated with their own PBMs.⁹

It doesn’t seem logical for CMS to declare that a pharmacy chain that manages a PBM, functions as a health insurer, and has thousands of retail pharmacies is in compliance, whereas a small MIP like the one overseen by ILCC is deemed a significant violation.

Adapting to Regulatory Changes

In response to the new regulations, ILCC has proactively transitioned the management and fulfillment of affected patients to mail order specialty pharmacies. As part of this transition, we actively cultivated relationships with mail order pharmacies and implemented a regular check-in system with select providers to minimize potential delays. Regrettably, despite our diligent efforts, occasional shipment delays occurred, which were attributed to inconsistent communication between patients and the mail order pharmacies.

Additionally, ILCC Pharmacy has set up 2 small dispensaries in rural locations to offer medications for managing typical chemotherapy-related adverse events. However, these dispensaries have been insufficient in meeting our patients’ needs. The establishment of comprehensive pharmacies at multiple sites continues to pose challenges due to strict regulations and a shortage of pharmacists in the US.

Several organizations are collaborating to address this issue, as exemplified by the Community Oncology Alliance’s lawsuit against HHS regarding the restrictions on delivering cancer drugs to patients.¹⁰ Legislators have been responsive to their constituents’ concerns and are actively working to address the issues as well. The Seniors’ Access to Critical Medications Act of 2023 (HR 5526) is a bipartisan bill introduced in the US House of Representatives by Representatives Diana Harshbarger (R, Tennessee) and Debbie Wasserman Schultz (D, Florida). This bill proposes the removal of the frequently asked questions and answers that were posted on the CMS website on September 20, 2021, and May 19, 2023.¹¹

Conclusions

Services provided by practices like ILCC are driven by a genuine commitment to patient well-being. These services come at no additional cost to patients or the health care system. It is imperative that CMS recognize the value of such services. The CMS regulations have disrupted essential medication delivery services, negatively impacting patients’ convenience and access to vital cancer medications. The current policy disproportionately affects those who are already vulnerable, exacerbating health care disparities in rural America. CMS should reverse this decision and help provide equity to rural patients with cancer.

Author Affiliations: Illinois CancerCare (PK, SP, DW), Peoria, IL.

Source of Funding: None.

Author Disclosures: The authors are employed by Illinois CancerCare, whose patients are the focus of this commentary.

Authorship Information: Concept and design (PK); acquisition of data (PK, SP, DW); analysis and interpretation of data (PK, SP); drafting of the manuscript (PK, SP); critical revision of the manuscript for important intellectual content (PK, DW); statistical analysis (SP, DW); and supervision (PK).

Address Correspondence to: Pankaj Kumar, MD, Illinois CancerCare, 8940 N Wood Sage Rd, Peoria, IL 61615. Email: pkumar@illinoiscancercare.com.

REFERENCES

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8. 340B Drug Pricing Program. Health Resources & Services Administration. Accessed November 1, 2023. https://www.hrsa.gov/opa

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10. COA files lawsuit against HHS FAQ limiting cancer drug delivery to patients. Community Oncology Alliance. July 28, 2023. Accessed November 1, 2023. https://communityoncology.org/featured/coa-files-lawsuit-against-hhs-faq-limiting-cancer-drug-delivery-to-patients/

11. Seniors’ Access to Critical Medications Act of 2023, HR 5526, 118th Cong (2023). Accessed November 1, 2023. https://www.govtrack.us/congress/bills/118/hr5526/text