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Under section 11403 of the Inflation Reduction Act, Medicare payment for certain biosimilar biological products is required to be the average sales price (ASP) plus 8 percent (rather than 6 percent) of the ASP of the reference biological for a 5 year period defined in the statute. For existing qualifying biosimilar biological products for which payment was made using ASP as of September 30, 2022, the applicable 5-year period begins on October 1, 2022. For new qualifying biosimilar biological products for which payment is first made using ASP between October 1, 2022 through December 31, 2027, the applicable 5-year period begins the first day of the calendar quarter of such payment. A qualifying biosimilar biological product is defined as a biosimilar with an ASP that is not more than the ASP of the reference biological.
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Section 401 of the Consolidated Appropriations Act (CAA), 2021 amended section 1847A of the Social Security Act (the Act) to add new section 1847A(f)(2) of the Act, which requires manufacturers without a Medicaid drug rebate agreement to report average sales price (ASP) information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. This is discussed in further detail in the Physician Fee Schedule 2022 Final Rule.
CMS is reaching out to manufacturers with the letter below included in the download section. The letter is titled Manufacturers Reporting Requirements Under the Consolidations Appropriations Act (CAA) 2021.
Section 303(c) of the Medicare Modernization Act of 2003 (MMA) revised the payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. In particular, section 303(c) of the MMA amended Title XVIII of the Act by adding section 1847A, which established a new average sales price (ASP) drug payment system. Beginning January 1, 2005, drugs and biologicals not paid on a cost or prospective payment basis will be paid based on the ASP methodology, and payment to the providers will be 106 percent of the ASP. There are exceptions to this general rule which are listed in the Medicare Claims Processing Manual, Pub. 100-04, Chapter 17. The ASP methodology uses quarterly drug pricing data submitted to the CMS by drug manufacturers. CMS will supply contractors with the ASP drug pricing files for Medicare Part B drugs on a quarterly basis.
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The new Pride Edition band for the Apple Watch showcases the pride flag rainbow colors and five others. According to the company, black and brown symbolize Black and Latin communities, plus those who died from or are living with HIV/AIDS. Light blue, pink and white represent transgender and nonbinary individuals.
The new Pride Edition sport band, priced at $49, will be available via apple.com and in the Apple Store app beginning Tuesday, May 23, with retail availability at Apple store locations starting Wednesday, May 24. The new band is available in 41mm and 45mm sizes (requires Apple Watch Series 3 and later).
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