Medicare Part B

It appears that for the first time, HHS will be able to negotiate prices of some prescription drugs in Medicare. The pharma industry has long resisted such efforts, and it remains to be seen what the impact of the legislation, if passed, will be on manufacturers’ drug discounts and rebates.
On Aug. 7, the Senate passed the Inflation Reduction Act of 2022 (IRA) 51-50 with Vice President Kamala Harris casting the deciding vote. The House is expected to vote on the bill Friday. If it passes as anticipated, President Joe Biden is projected to sign it into law shortly thereafter.

Democrats are once again seeking to pass drug pricing reform with a new proposal published earlier this month. While the bill is similar to previous ones, most notably with having Medicare conduct drug price negotiations, it also offers some changes from past efforts, including not basing those drug prices on an international reference model. Still, many pharma stakeholders expressed disappointment over aspects of the bill, and while its odds of passing have slightly improved more recently, industry experts are somewhat divided on the bill’s chance of approval.

The newest proposal was released on July 6 after negotiations with Sen. Joe Manchin (D-W.Va.), who squelched earlier administration attempts at drug pricing reform.

As Medicare Advantage plans and their providers operate under a new normal two-and-a-half years into the COVID-19 public health emergency (PHE), CMS is resuming its regular pace of auditing MA organizations as another program audit cycle gets underway, according to compliance experts. During a June 21 session of AHIP 2022, held in Las Vegas, panelists observed that CMS continues to be focused on ensuring seniors’ smooth access to prescription drugs and emphasized the importance of audit readiness.

CMS’s audit activity was limited during the previous cycle, especially in 2020, and its latest audit report reflected that. Released in June, the 2021 Part C and Part D Program Audit and Enforcement Report said CMS imposed 16 civil monetary penalties amounting to roughly $1 million and, between 2019 and 2021, it audited about 20% of currently active sponsors representing approximately 89% of Parts C and D enrollment — which is lower than CMS’s typical goal of 95%.

Medicare will cover monoclonal antibodies targeting amyloid for Alzheimer’s disease treatment that receive traditional FDA approval under coverage with evidence development (CED), according to an April 7 final National Coverage Determination (NCD). In addition, for drugs that have not shown a clinical benefit or that receive accelerated approval, Medicare will cover them in FDA- or National Institutes of Health-approved trials. CMS will cover the medication and any related services for Medicare beneficiaries participating in these trials. The move follows a proposed NCD released Jan.11, which received more than 10,000 stakeholder comments.

Horizon Blue Cross Blue Shield of New Jersey filed a lawsuit (No. 1:22-cv-10493) against Regeneron Pharmaceuticals Inc. regarding Eylea (aflibercept), a medication approved for certain retinal diseases, including wet (neovascular) age-related macular degeneration. The suit alleges that Regeneron transferred funds to the Chronic Disease Fund, which offset patient out-of-pocket costs for Eylea but not its competitors. The lawsuit argues that this is an illegal kickback under the Racketeer Influenced and Corrupt Organizations (RICO) Act.

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-c).

To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.

There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.

In a highly anticipated but not-so-surprising move, CMS on Jan. 11 released a proposed National Coverage Determination (NCD) that would restrict Medicare coverage of Biogen and Eisai, Co., Ltd.’s Aduhelm (aducanumab-avwa) and any other FDA-approved monoclonal antibodies that target beta amyloid plaque for the treatment of Alzheimer’s disease. Industry experts say the coverage proposal — coupled with a recent price cut on Aduhelm — is unlikely to alter commercial payers’ hesitancy toward covering the drug, while one actuary says the decision supports Medicare Advantage plans’ expectations that coverage would be limited.

According to the proposed NCD, which is now open to a 30-day comment period, Medicare would cover the therapies under Coverage with Evidence Development (CED), requiring that patients be enrolled in approved randomized controlled trials that are conducted in a hospital-based outpatient setting. Participants must have a “clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia; and evidence of amyloid pathology consistent with AD.” The NCD also would allow coverage of one beta amyloid positron emission tomography (PET) scan per patient as part of the protocol.

To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.

There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.

CMS issued a final rule on Dec. 29 that rescinded the Most Favored Nation model. The mandatory model would have priced Medicare Part B drugs on the U.S. market based on their prices in certain countries. An interim final rule that was published in November 2020 had been blocked from being implemented on Jan. 1, 2021.

CMS published a proposed rule on Jan. 12 that would rein in direct and indirect remuneration (DIR) fees, which pharmacies have long complained about. The proposal would save consumers about $21.3 billion but cost the federal government $40.0 billion from 2023 through 2032.

CMS on Jan. 11 issued its long-awaited proposed National Coverage Determination (NCD) for Aduhelm (aducanumab), the Alzheimer’s drug that has been the subject of controversy since the FDA approved it last June. In what officials acknowledged was an unusual decision, CMS said Medicare will cover Aduhelm — and any other FDA-approved monoclonal antibodies that target amyloid plaques — only for people who are enrolled in qualifying clinical trials.

Health insurer trade groups praised the decision, which comes after Aduhelm manufacturer Biogen cut the price of the drug approximately in half in a bid to encourage both provider uptake and payer coverage.