CMS- reverse timeline of Medicare actions and decisions of interest
Below is a timeline of CMS events that interest me. Many of these are related to questions about how CMS decides if there is enough evidence for a treatment to get coverage or special payments. Another topic appearing frequently here is the cost of medicines.
2024
Drugs prices: Sept. 1- The negotiated maximum fair prices for the first 10 drugs selected for the Medicare Drug Price Negotiation Program will be announced, with prices to take effect starting January 1, 2026.
2023
Drug Prices: Sept. 1 – CMS will publish the first 10 Medicare Part D drugs selected for the Medicare Drug Price Negotiation Program.
Evidence questions: July 6- Biogen says the FDA has a deadline of this day for the application for full approval of Leqembi, a decision that will play into the CMS approach to covering the drug.
Evidence questions: April – CMS sets an April target date in the Fall 2022 Unified Agenda for a notice of proposed rulemaking for Transitional Coverage for Emerging Technologies.
March 13 – Comments due on CMS proposal on proposed rule to “streamline processes related to prior authorization” for Medicare Advantage and other health plans.
Evidence questions: Feb. 13- 14: CMS schedules Coverage with Evidence Development (CED) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)
2022
Evidence questions: Dec. 15 – Rep. Eshoo and other members of the House of Representatives send a letter CMS Administrator Chiquita Brooks-LaSure encouraging the agency to issue the Transitional Coverage for Emerging Technologies (TCET) proposed rule by the end of the year. Letter posted by MDMA.
Evidence questions: Oct. 22 – JAMA Internal Medicine publishes Viewpoint article, “A Vision of Medicare Coverage for New and Emerging Technologies—A Consistent Process to Foster Innovation and Promote Value,” written by Lee A. Fleisher and Jonathan Blum of CMS.
Climate change: August 1- CMS unveils final version of the fiscal 2023 inpatient prospective payment system rule. This rule includes:
-a recap of the discussion generated by questions in the draft rule about how health care organizations can address climate change. There was near universal support for the idea that it’s important to set goals to reduce greenhouse gas emissions and increased climate resilience, CMS said. But people and organizations raised concerns about issues such as
• what standardized measures might help in tracking and reporting on emissions, with “mixed views” about whether any such measures should be mandatory or voluntary.
• the importance of looking at supply chains in order to address emissions.
Climate change: April 18- CMS releases proposed fiscal 2023 inpatient prospective payment rule.
–This includes a section opening debate about greenhouse gas emissions from the health care sector. In the the “Quality Data Reporting Requirements for Specific Providers and Suppliers” section of the draft rule, the first item listed was “A. Assessment of the Impact of Climate Change and Health Equity.”
Evidence questions: Feb. 17- CMS holds a webinar about plans for a Transitional Coverage of Emerging Technology rule.
2021
Nov. 15- The Federal Register publishes the final rule repealing the Trump administration’s ‘‘Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘‘Reasonable and Necessary’’ final rule, which was published on January 14, 2021, and was to be effective on December 15, 2021.
2020
Dec. 28- CMS finalized valuation of a new ophthalmology CPT code, IDx-DR, the first AI CPT code (92229) created by the American Medical Association CPT Editorial Panel in 2021 Medicare physician fee schedule. The rule published on Dec. 28.
Sept. 18- CMS publishes fiscal 2021 IPPS with NTAP payment for ContactCT by Viz.ai. Further discussed in AI-driven triage software for large-vessel occlusion, through the NTAP pathway, write Melissa Chen and co-authors in “Who Will Pay for AI?” in Radiology Artificial Intelligence.
Sept. 15- ITEM Coalition submits request to CMS for reconsideration of national coverage determination for mobility assistive equipment.
Aug. 31- CMS post press release and text of draft version of “Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” rule.
2019
June 17- BMJ publishes “Evaluation of technologies approved for supplemental payments in the United States,” by Timothy J. Judson, Sanket S Dhruva and Rita Redberg.
June 3- The Supreme Court issues its decision in the Azar v. Allina case, 7-1, with Justice Breyer dissenting and Justice Kavanaugh taking no part. Excerpt here of Justice Gorsuch’s opinion:
“But as the government knows well, courts aren’t free to rewrite clear statutes under the banner of
our own policy concerns. If the government doesn’t like Congress’s notice-and-comment policy choices, it must take its complaints there.”
AHA statement on the decision: “By evading the notice-and-comment process, HHS failed to consider the real-world impact of its changes, leading to policies that may adversely affect patients as well as providers.”
2018
Oct. 3- CMS announced changes to local coverage determinations (LCD) process, in response to a provision of the 21st Century Cures Act.
2017
Nov. 30- In the second example of a successful Parallel Review program, CMS proposes coverage of FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The FDA had worked with the company to prove a clearance for this product, earlier sold as an LDT.
2008
July 15 – The Medicare Improvements for Patients and Providers Act of 2008 (PL 110-275) is enacted. It includes a direction for Part D plans regarding use of compendia in covering cancer drugs.
June 5- CMS sets this as the effective date for adding the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium
2006
Dec. 6 – The House Ways and Means Committee holds a hearing, “Patient Safety and Quality Issues in
End Stage Renal Disease Treatment,” focused on concerns about Medicare payment for Epogen. “Where we are now is we have a payment policy that perhaps is killing people; and we are using $2 billion, the highest price paid in a relatively narrow area for the use of the drug through the payment policy, that may in fact be doing that,” says then Ways and Means Chairman Bill Thomas (R-CA).
July 12- CMS releases National Coverage Determinations with Data Collection as a Condition of Coverage:
Coverage with Evidence Development
2005
April 7 – CMS releases a draft guidance document on the process for an alternative approach to making Medicare coverage decisions—known as coverage with evidence development (CED).
2002
CMS releases first NTAP awards through the fiscal 2003 inpatient prospective payment system rule. The first award listed is for Xigris, a drug later withdrawn from the market.
2001
July 31- HCFA becomes CMS. The name change announced on June 14 takes effect on publication of a notice in the Federal Register. The Health Care Financing Administration (HCFA), created in 1977, becomes the Centers for Medicare and Medicaid Services (CMS). To this day, it’s a mystery why it’s CMS and not CMMS.