Rheumatologists who administer medications in their office for Medicare patients, specifically those that are infused, have in recent years encountered problems providing certain medication formulations as well as coding and billing for their administration. In attempting to resolve these issues, rheumatologists and their professional organizations have found themselves caught in a morass of Medicare agency “ping-pong,” where it is unclear who the decision makers are.
The private health care insurers that process medical claims for Medicare beneficiaries, called A/B Medicare Administrative Contractors or more commonly known as MACs, are the operational intermediary between the Centers for Medicare & Medicaid Services’ fee-for-service program and the physicians enrolled in it. The country is divided into 12 sections, each with a MAC that has jurisdiction over that area. Among other things, the MACs establish local coverage and payment policies based on their understanding of CMS’ rules, regulations, and the Medicare statute, and therein lies the problem: When a physician has a question on a policy or decision that was made by a MAC, it is very difficult to determine the origins of the issue and who can address the problem. It’s a lot of “running in circles” between the MACs and CMS headquarters, hoping that someone will take the time to listen to your concern, but more importantly, work toward resolving the problem.
Dr. Madelaine Feldman
Who can address problems?
Meaningful, solutions-driven engagement with the MACs and CMS has become frustrating for physicians and advocacy organizations attempting to address a host of problems. The two issues alluded to above include the Self-Administered Drug Exclusion List (SAD List), which excludes certain Part B medication formulations from coverage under certain conditions and the “down coding” of certain infusion administration codes when specific drugs are delivered. These problems are compounded by the curtailment of physician stakeholder input via Contractor Advisory Committees (CACs). Each state has its own CAC, but the CAC meetings have been restructured as a result of the 21st Century Cures Act, and ultimately eradicated the involvement of these physician advisers in policy development at the local level.
This has left many of rheumatology representatives to the CACs demoralized and generally unhappy about certain decisions being made without their input. There is also inconsistency in terms of coverage and payment policies throughout the country. For example, in one MAC jurisdiction, a certain medication may be on the SAD List and excluded from Part B coverage, meaning beneficiary access is only available through Part D (and assuming they can afford it), while in an adjacent MAC jurisdiction, both formulations are covered.
The Coalition of State Rheumatology Organizations, along with the American College of Rheumatology and other specialty groups, is attempting to address these issues from many different angles. There is not enough space to explain the nuances of local coverage policy development, but the timeline below highlights the long and winding road that we have travelled to resolve these issues.
- February 2021: CSRO meets with CMS’ Coverage and Analysis Group (CAG) to raise concerns about ustekinumab (Stelara) and its inclusion on the SAD List.
- April 2021: CSRO follows up with CMS’ CAG on SAD List concerns in a letter.
- May 2021: Most MACs issue or revise local coverage articles, or “billing and coding” articles, that down code the administration of certain biologic medications, with some expanding the list of biologic medications subject to the policy, prompting a strong response from CSRO.
- September 2021: CSRO meets with multijurisdictional MAC Contract Medical Director (CMD) work group to discuss down coding, SAD List, and physician/CAC engagement.
- October 2021: At the suggestion of the CMDs, CSRO re-engages with CMS’ CAG to raise concerns about down-coding policies and physician/CAC engagement, and continue the SAD List discussion.
- November 2021: CSRO is connected with CMS’ “payment ombudsman” on down coding and the SAD List.
- January 2022: CSRO signs on to multispecialty coalition effort aimed at improving local coverage and payment policy and restoring the importance of the CAC.
- February 2022: CSRO participates in CMS CAG meeting with multispecialty coalition, raising concerns about the down-coding and SAD List policies.
- March/April 2022: Through its coalition partner, the Alliance of Specialty Medicine, CSRO meets with the principal deputy CMS administrator and raises awareness to these issues.
- May 2022: CSRO participates in follow-up discussion with CMS’ CAG as part of multispecialty coalition, reiterating concerns about the down coding and SAD List policies. With the assistance of the CMS’ Office of the Administrator, CSRO meets with CMS’ Center for Program Integrity to seek a “pause” in down-coding policies for certain biologic medications.
- June 2022: CMS notifies CSRO of a “temporary pause” in medical review while the agency reviews various manuals and policies to determine the appropriate steps forward. To assist the agency, CSRO works with practices to develop a resource that CMS can use to establish criteria for determining when a medication warrants use of complex drug administration codes. CSRO re-engages with multijurisdictional MAC CMD workgroup to continue discussions on SAD List.
- July 2022: CSRO meets with new multijurisdictional MAC CMD workgroup focused on improving the process for developing local coverage and payment policy.
Our dialogue with CMS leadership and staff continues. In the most recent communication, staff in the CMS administrator’s office informed us that the issue is complicated and crosses several different parts of the agency, and they are still determining next steps.
The rheumatology community’s journey toward solving the challenges facing practices and patients is emblematic of the communication problem between provider groups and the CMS-MAC establishment. While we understand this is how bureaucracy works, it is not to the benefit of Medicare beneficiaries to have a system that is so difficult to navigate, even by the best of the regulatory gurus. This is not an indictment of any specific group but a call to action on the part of the government and their contractors to create a clear, transparent path to getting answers when we have a problem.
And by the way, we do have another meeting with yet another CMS “center” regarding the SAD List in August.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is president of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.