The Clinical Laboratory Improvement Amendments of 1988 and their associated regulations require laboratories performing moderate- or high-complexity testing to enroll in an approved proficiency-testing (PT) program “for each specialty, subspecialty, and analyte or test for which the laboratory is certified under CLIA.” These regulations were most-recently amended in 2012, and as of January 2017 there [...] Read More
This evening, the Centers for Medicare and Medicaid Services (CMS) released the CY 2019 final payment rule for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) and for the End-Stage Renal Disease (ESRD) program. The rule contains changes to the DMEPOS competitive bidding program as well to DME fee schedule payments where competitive bidding is not [...] Read More
CMS has released a proposed rule concerning several administrative and technical changes to Medicare Advantage (MA) and Medicare Part D plans. Many of the changes were mandated by the Bipartisan Budget Act of 2018 (BBA), while others are intended to reduce administrative burden on providers, plans, and beneficiaries. The rule will appear in the November [...] Read More
On Monday, the Trump Administration released a high-profile proposed rule that, if implemented, would require drug manufacturers to disclose the list prices of prescription drugs in their respective direct-to-consumer (DTC) advertisements (see AP’s summary of the proposal here). Trying to stay ahead of the curve, PhRMA also released voluntary guidelines for member companies in which [...] Read More
Today, the Centers for Medicare & Medicaid Services announced amendments to its Medicare Program Integrity Manual in accordance with the 21st Century Cures Act to modify the procedures by which Medicare Administrative Contractors (MACs) arrive at Local Coverage Determinations (LCDs). While any move in the direction of increased transparency is laudable, it remains to be seen [...] Read More
CMS has informed Medicare Advantage health plans that, as of January 1, 2019, the plans will be allowed to use step therapy with prescription drugs covered under Part B. The agency believes that this change will help to lower drug costs for the almost 40% of Medicare beneficiaries covered by Medicare Advantage (MA). The catch? The [...] Read More
This evening, CMS released its final FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. The final rule updates hospice payment rates for FY 2019 and finalizes CMS’ proposal to allow physician assistants as designated hospice attending physicians effective January 1, 2019. The rule also includes changes to the Hospice Quality [...] Read More
In the Bipartisan Budget Act of 2018 the Congressional Budget Office underestimated – by $4 billion – the amount Medicare would save due to changes in Medicare Part D. Instead of saving $7.7 billion, Medicare will actually save $11.8 billion. The savings come from an increase in the government mandated discount that drug manufacturers must offer enrollees [...] Read More
Here are some reimbursement related reasons why access to biosimilars has been slower than hoped, even though patient out-of-pocket costs are lower. Current System Is an Improvement Over Earlier System, But Could Be Better Part B Is For Biologics (and Some Drugs) When I was working at the Senate Legislative Counsel’s office drafting the Average [...] Read More
This evening, the Centers for Medicare and Medicaid Services (CMS) released the CY 2019 proposed payment rule for the End-Stage Renal Disease (ESRD) program and for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS). The rule contains a payment update for the ESRD Prospective Payment System, changes to the ESRD quality program, and an expansion […]
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