Categorized | Pushback

Medicare Proposal Would Cover Aduhelm If Beneficiaries Enrolled In Clinical Trials

caregiver, Aduhelm

On Jan. 11, CMS issued a proposal that drugs  for Alzheimer’s, like Aduhelm, would be covered for people with Medicare “only if they are enrolled in qualifying clinical trials.”

By Al Norman

On Oct.13, 2021, 64 million Americans received some good news from the Social Security Administration: Social Security checks would rise by a 5.9 percent cost-of-living adjustment (COLA) beginning in January, 2022 — an increase for the average retired worker of $92 per month — the largest increase in four decades. The estimated average Social Security benefits payable in January 2022 for all retired workers will be $1,657 per month. Likewise, 8 million people on Supplemental Security Income (SSI) also received word that they would get a 5.9 percent increase in their benefits as of December 30, 2021.

The good news lasted 30 days. Then the other federal shoe dropped.

On Nov. 12, the Center for Medicare and Medicaid Services (CMS) announced the Medicare Part B (doctor’s care) premium rates for 2022 would rise from $148.50 per month in 2021, to $170.10 in 2022 — a 14.5 percent premium hike — costing beneficiaries $21.60 more per month. This Medicare B premium hike is the largest Part B premium increase in the 57-year history of the Medicare program. Add to this, the annual deductible for all Medicare Part B beneficiaries will rise to $233 in 2022 — an increase of $30 over the annual deductible of $203 in 2021.

This historic increase in the Medicare B premium was caused in part by the controversial action of another Federal Agency: the Food & Drug Administration (FDA). On June 7, 2021, the FDA granted “accelerated approval” for a new Alzheimer’s disease drug called Aduhelm, manufactured by the Biogen company of Cambridge, MA.

patient-centered, Social Security, ageist, nursing, COVID, Trump, vaccineThe controversy arose because the FDA’s Advisory Committee recommended that the FDA not approve the new drug, after studies failed to show strong evidence of the drug’s effectiveness. (See my Recorder column of Sept. 13.) Biogen announced that Aduhelm would carry a list price of $56,000 a year.

CMS provided several reasons for the Medicare Part B Premium increase, including the Adulhelm cost impact. “Additional contingency reserves,” CMS wrote in November, “due to the uncertainty regarding the potential use of the Alzheimer’s drug, Aduhelm, by people with Medicare.”

Last July, CMS began a National Coverage Determination analysis process to determine whether and how Medicare will cover Aduhelm. It is uncertain whether Medicare will even cover Aduhelm in 2022. “Our projection in no way implies what the coverage determination will be,” CMS admitted, “however, we must plan for the possibility of coverage for this high cost Alzheimer’s drug which could, if covered, result in significantly higher expenditures for the Medicare program.”

The Chairman of the U.S. Senate Committee of Finance, Sen. Ron Wyden, D-OR, called Aduhelm’s price tag “astronomical.” On Dec. 10, Chairman Wyden sent a sharply-worded letter to the Secretary of the federal Department of Health & Human Services (DHHS) “to express my concern about the scheduled increase in Medicare Part B premiums in 2022 and urge you to limit these premium increases associated with uncertainty about anticipated Medicare spending on new Alzheimer’s disease drugs, such as Adulhelm. Medicare beneficiaries cannot afford to be saddled with a record increase in monthly premium costs — especially when those premium costs are being driven by uncertain expectations of sky-high Medicare costs for an outrageously expensive drug like Aduhelm that has presented limited clinical evidence of its effectiveness.”

Ten days later, Endpoints News carried a story which began: “In a surprise move, Biogen announced that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000. The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief.”

According to Wyden’s letter, “CMS is adding $11 per month to the Part B premium to fund an increase in Medicare’s contingency reserve” to cover the future Medicare costs of covering Aduhelm. Readers should call their U.S. Senators at 202-224-3121 and ask them to: “support Sen. Wyden’s request that CMS reduce the amount of premiums collected for the drug Adulhelm, and allow for more time to project expected Medicare costs with a higher level of certainty. Given the sudden 50 percent list price drop for Aduhelm, Medicare should not be imposing a high contingency reserve charge for this drug in 2022 until its cost and effectiveness can be better projected.”

On Jan. 11, CMS issued a proposal that drugs for Alzheimer’s would be covered for people with Medicare “only if they are enrolled in qualifying clinical trials.”

This would significantly reduce the number of patients able to get Aduhelm — and likely result in Medicare adjusting downward the Medicare Part B premium. Medicare recipients could receive a rebate later this year if that happens.

The CMS proposal is open to public comment until Feb. 10. Comments can be submitted at: https://www.cms.gov/medicare-coverage-database/search.aspx. A decision on the CMS proposal will be announced on April 11.

“While there may be the potential for promise with this treatment,” CMS said, “there is also the potential for harm to patients.”

Al Norman worked as an elder advocate in the Massachusetts home care field for nearly four decades. He has written opinion columns for FiftyPlus for more than 30 years.

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