While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
With the passage of the Inflation Reduction Act in the U.S. in August 2022, biopharma company leaders have re-evaluated pipelines, sought legal advice, and discussed ways to mitigate the potential impacts the legislation will have on pricing therapies and extending their reach to new indications.
Although the U.S. Inflation Reduction Act charges the Centers for Medicare & Medicaid Services with negotiating prices of the Part B and D drugs with the highest Medicare spend, the first two rounds of negotiations will focus solely on Part D drugs, which are dispensed through pharmacies.
The CMS had floated a coverage concept for devices routed through the U.S. FDA breakthrough devices program shortly before the Biden administration took office, but the change in administration proved lethal to the program in terms of its initial contours. The latest development in this saga would have the program revert to an expanded use of the existing Medicare coverage with evidence development (CED) program, a far cry from the original concept of same-day coverage upon FDA approval or clearance of the device.
The actuary office at CMS reported that U.S. spending on health care grew by a modest rate of 2.7% in 2021, an outcome that would ordinarily prompt cheers by policy wonks who worry about the effect of ever-growing national health expenditures (NHEs) on the larger economy. The problem is that NHE had ballooned by more than 10% in 2020, a rate of growth that was driven in large part by the COVID-19 pandemic, but which statistically overshadowed the growth rate in 2021.
In addition to the Medicare inflation rebate and the other pricing reforms of the Inflation Reduction Act, manufacturers of certain Part B drugs will be subject to a refund provision tucked away in the Infrastructure Investment and Jobs Act that was signed into U.S. law last year.
The U.S. Centers for Medicare & Medicaid Services is finally making a long-expected, and requested, adjustment to Medicare Part B premiums, which were raised nearly 15% for 2022 in the wake of Biogen Inc.’s initial $56,000 annual price tag for its Alzheimer’s drug, Aduhelm (aducanumab).
The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the next Medicare inpatient prospective payment system, and several companies managed to score important rate-setting wins for their devices. Microtransponder Inc., of Dallas, won a new technology add-on payment (NTAP) for its Vivistim device for treatment of stroke, as did W.L. Gore & Associates Inc. for its TAG thoracic branch endoprosthesis (TBE), just two among several winner in the Medicare inpatient final rule for fiscal 2023.
The U.S. CMS released the draft Medicare hospital outpatient rule for calendar year 2023, a document that is replete with information on pass-through payment data for drugs and devices. However, the agency said that the Supreme Court’s ruling regarding rates for drugs covered under the 340B drug pricing program came too late in the annual cycle to be fully accounted for in the outpatient rule for 2023, and thus any such permanent adjustments will have to wait until the outpatient rule for 2024.
The U.S. CMS posted the draft Medicare physician fee schedule (MPFS) for calendar year 2023, and advocates of telehealth will be cheered by a proposed extension of some pandemic-driven telehealth services throughout 2023. The draft is less generous in connection with external electrocardiogram patches in a move that could ding Irhythm Technologies Inc., and its Zio XT device, but analysts at BTIG predict that any hit to reimbursement rates is likely to be offset with greater sales volumes, leaving Irhythm and its investors in a solid place going forward.
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