COA Expresses Alarm To HHS About CMS Guidance That Delivering Medications Is A Stark Violation

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Oncologists Say Seniors Will Face Problems Getting Their Cancer Drugs With Medicare Guidance

WASHINGTON, D.C., UNITED STATES, April 5, 2023/EINPresswire.com/ — The Community Oncology Alliance (COA), the nation’s only non-profit organization dedicated to advocating for independent community oncology practices and the patients they serve, has asked the U.S. Department of Health & Human Services (HHS) Secretary Xavier Becerra to withdraw a Frequently Asked Questions (FAQ) document that interprets the mailing or couriering of oral drugs to be a violation of Stark law, the federal prohibition on self-referral.

– Read the full letter from COA to Secretary Becerra.

In the letter submitted to the HHS Secretary, COA details that guidance by the Centers for Medicare & Medicaid Services (CMS), which would take effect after the Public Health Emergency (PHE) expires on May 11, 2023, would place independent practices at risk of violating Stark law for delivering oral cancer medications to their patients, even if a caregiver picked up a drug for a patient.

Allowing the CMS guidance to take effect after the PHE Stark waiver expires would be extremely disruptive and, more alarmingly, dangerous to patient care, particularly for those in rural communities or who face transportation difficulties. Many oncology practices deliver via mail (or similar means) oral cancer drugs to their patients for care continuity, convenience, affordability, and to make the lives of patients easier. For many rural patients, receiving their medicines by mail is a necessity to receive it in a timely fashion or to overcome transportation challenges.

The CMS FAQ, originally published during the pandemic in 2021, indicates that a dispensing medical practitioner, such as an oncology or urology practice, would violate the Stark law if it offered patients the convenience of receiving their prescription drugs by mail, courier, or similar means that did not require the patient themselves to pick up the prescription from the practice site. Indeed, the way the CMS FAQ is currently worded, practices could be considered in violation of Stark law if a family member or other caregiver picks up a patient’s medication.

“HHS must immediately retract the guidance for the wellbeing of America’s patients with cancer,” said Ted Okon, executive director of COA. “Allowing this guidance to go into effect is courting disaster for cancer patients and others with serious diseases across the country, particularly those in underserved or rural areas and facing health inequities. It is incredibly frustrating that CMS is undermining clinical procedures that have been followed forever and is putting Americans with cancer at risk. I hope HHS Secretary Becerra makes good on his commitment last week to fix this terrible wrong by his agency.”

In addition to the patient care issues, COA notes that CMS misinterpreted or ignored several industry definitions when creating the guidance and did not adhere to the rulemaking process as outlined by the Administrative Procedure Act (APA). CMS’ FAQ regarding mailing represents a substantive rule, as distinct from an interpretive rule, made by the agency without the appropriate notice and comment requirements of the APA.

The CMS FAQ was also discussed at last week’s House Energy and Commerce Subcommittee on Health hearing in an exchange between Representative Diana Harshbarger (R-TN-01) and Secretary Becerra. In it, he committed to working with her to fix this regulatory error by CMS that puts seniors with cancer at risk of not receiving their medications.

Read COA’s full letter to HHS Secretary Becerra: https://mycoa.communityoncology.org/education-publications/comment-letters/coa-comments-to-the-hhs-regarding-delivery-of-oral-medication-and-stark-law.

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About the Community Oncology Alliance: The Community Oncology Alliance (COA) is a non-profit organization dedicated to advocating for community oncology practices and, most importantly, the patients they serve. For more than 20 years, COA has been the only organization dedicated solely to community oncology where the majority of Americans with cancer are treated. The mission of COA is to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities. More than 5,000 people in the United States are diagnosed with cancer every day and, deaths from the disease have been steadily declining due to earlier detection, diagnosis, and treatment. Learn more at www.CommunityOncology.org. Follow COA on Twitter at www.twitter.com/oncologyCOA or on Facebook at www.facebook.com/CommunityOncologyAlliance.

Drew Lovejoy
Community Oncology Alliance
[email protected]