Beware of a new model that at least one, if not more, of the BlueCross BlueShield (BCBS) plans are offering to their self-insured employer customers as a way to compete with the alternate funding programs (AFPs) that have been pushed heavily onto those same employers in recent years. Neither model is conducive to good patient care, and both place private profits ahead of the needs of patients and their health. This program appears to have had a fall rollout, at the beginning of the 4th quarter of 2023.
A dominant regional health plan in New York, Excellus BCBS (Excellus), has charted new ground with a disturbing program directed at its business (self-insured) customers. This program claims a position of moral high ground for costly specialty medicines that it suggests have slipped through onto the market with questionable evidence and benefits.
The program is being marketed directly to business customers through a 1-page flyer that pulls no punches:
The Medication Assurance Program [MAP] is designed to reduce spend on specialty medications by holding manufacturers accountable for drugs that are approved through the Food and Drug Administration’s (FDA) Accelerated Approval Program [AAP].
As new (and often expensive) drugs enter the market through the FDA’s AAP, Excellus is working to ensure that the drug manufacturers are held accountable for the efficacy of these medications.
MAP [a program only directed at self-funded plan employers] is Excellus’ promise that a drug prescribed is a drug that works.1
The program calls into question the value of drugs:
Unlike traditional FDA approved drugs, accelerated approval drugs can be prescribed even if they have an unconfirmed clinical benefit. For an accelerated approval drug to remain on the market, the drug manufacturer must agree to continue their clinical studies and confirm clinical benefit, which would ultimately lead to final FDA approval.1
Excellus claims that it intends to police these drugs (a mixture of oral and infusion medications) itself. To manage the cost of a medication that it feels is not proven effective, Excellus states that manufacturers must agree to participate in its MAP program or that drug will be excluded from coverage. Patients will then receive no financial support in any amount under the Excellus health plan for that drug but are indicated to seek support from the manufacturer’s patient assistance programs (PAPs).
If the manufacturer participates, and Excellus decides that the drug has failed the program requirements, Excellus will receive a refund from the manufacturer for the cost of the drug and share 85% of the amount received with the employer group.1
This is yet another program that is separating patients from approved drugs for financial rather than clinical reasons.
This program may have been developed in the wake of a January 2023 report by the United States Department of Health and Human Services. In this report, one model was proposed (called the Accelerating Clinical Evidence Model [ACEM]), which suggested reducing Medicare Part B payments for some drugs approved through the FDA's AAP IF manufacturers failed to complete their postapproval clinical studies in a timely manner. Since that announcement, the ACEM has faced growing criticism as potentially undermining the FDA’s prerogative in approving medicines as safe and effective.
However, in an October 2023 report on the status of pending drug models, the Center for Medicare and Medicaid Innovation (CMMI) basically failed to give the ACEM any attention, thus implying that the program is in limbo, with no planned steps for implementation.
CMMI’s own analysis of the FDA’s AAP suggests that most Part B drugs do, in fact, complete confirmatory studies in a timely manner, negating the need for the federal ACEM. When the federal government cannot find a reason to question the utility of the FDA’s AAP program by implementing its own additional confirmatory challenges, that should speak volumes about the credibility of a private health plan seeking to challenge the AAP program.2
Oncology drugs account for 66% of all FDA accelerated approvals since 2000, with 88 distinct drugs obtaining such approval.3 Infectious disease drugs follow at 15% with 20 drugs and hematologic drugs have 5% of the FDA’s AAP approvals.3 The AAP has helped to bring novel drugs to market for patients in need, including imatinib (Gleevec) for chronic myeloid leukemia. Imatinib served as a gamechanger for patients when it became available under the FDA’s accelerated program. Many of the accelerated approved oncology drugs are small-molecule inhibitors (often with biomarkers that lead the growth of personalized/precision oncology care), monoclonal antibodies, and antibody–drug conjugates. Very few drugs that have received accelerated approval end up being withdrawn because they do not show a benefit in confirmatory trials.3
The Excellus program is likely not sustainable. Many manufacturers have not been made aware of this program nor have they been asked to sign up for it, although Excellus seems to have placed at least 49 drugs on its list (there are 65 on the FDA’s AAP list). If the program rolled out at the beginning of the 4th quarter of 2023, it had the rug pulled out from under it 11 days later with an October 11, 2023, report by CMMI, which indicated no current or planned progress regarding the proposed ACEM model.4 If the federal government does not see value in price adjusting or challenging FDA’s AAP drugs, that leaves Excellus with little credibility for its MAP.
Excellus is still marketing the program, and patients are being affected. Messages being sent from Excellus to manufacturers indicate that it will not cover the drugs at all if manufacturers do not participate. Some manufacturers being recruited to participate in the program are not aware that there is a MAP drug exclusion list, that their drugs are already on it, or that the program will direct patients as uncovered to the manufacturer’s PAPs. Others are being told that this program should be considered an asset to manufacturers because it offers self-funded employers an alternative to participating in AFPs currently on the market. Ironically, both the MAP and the AFPs profit by denying coverage to patients in need of these essential, approved, oncology drugs. There is no benefit under the MAP for patients—it is a deliberate disruption of medical treatment that leads to delays, fear, confusion, and significant financial burden.
Physicians and practices are highly aware of which health plans, pharmacy benefit managers, and specialty pharmacies or benefit designs for each patient’s insurance are problematic and adversely affect patients and their disease journey. We may not track as closely which of these patterns exist for individual employers who select the benefit designs for their employees, and whether they are self-insured or fully insured.
We now need to connect the dots. If we discover that patients are being affected by this program, we need to stand up for them. Although Excellus is a regional BCBS plan, it enjoys significant market domination, and local practices will probably see patients start to present under this program. Since Excellus is part of the BCBS family of plans, the MAP may begin to appear in areas outside of the New York market. The program is being marketed to a wide variety of self-insured employers that likely include state employees, state educational facilities, universities, medical centers, grocery stores, banks, etc.
When we see patients paying good money for premiums that are not delivering sufficient value for their needs, we need to track, aggregate, and engage. We may use this information to approach employers with problematic coverage and offer them support and guidance.
With no existing federal program in place with similar challenges to the credibility of drug approvals under the FDA’s AAP, it should be easy to call out the MAP as a thinly veiled plan to deny coverage of necessary approved drugs to vulnerable patients with cancer.
Many employers may not yet be aware of the implications of these programs on their employees. Most insurance plans or intermediary vendors do not drill down into the level of details of how different coverage policies actually affect patients in the real world.
We are our patients’ best advocates when it comes to challenging models like the MAP that make no sense medically or ethically. I am encouraging providers and other professionals to share comments with me at This email address is being protected from spambots. You need JavaScript enabled to view it.. I would be very interested in hearing whether you are seeing the impact of this program—or similar programs—on your own patients.
1. Excellus BlueCross BlueShield. Medication assurance program. Accessed November 23, 2023. https://excellusforbusiness.com/resources/medication-assuranceprogram/
2. Finkelstein A. CMMI issues report on status of pending drug models. JD Supra. October 31, 2023. Accessed November 23, 2023. www.jdsupra.com/legalnews/cmmi-issues-report-on-status-of-pending-4834466/
3. Schaefer N. Oncology has highest number of FDA accelerated approvals. Clinical Trials Arena. October 12, 2022. Accessed November 23, 2023. www.clinicaltrialsarena.com/comment/oncology-fda-approvals/?cf-view
4. Fowler L. CMS Innovation Center’s one-year update on the executive order to lower prescription drug costs for Americans. Centers for Medicare & Medicaid Services. October 11, 2023. Accessed November 27, 2023. www.cms.gov/blog/cms-innovation-centers-one-year-update-executive-order-lower-prescription-drug-costs-americans
