Wednesday, June 28, 2023

Hey, CMS Released 5, not 4, TCET Documents! See #5, "Guidance for CED Decisions."

 In my lengthy June 22 blog on CMS releasing "TCET," I had four documents.

  1. TCET proposal in Federal Register
  2. CMS fact sheet summarizing it
  3. Chief Medical Officer's blog on TCET goals
  4. CMS NCD Evidence Review Guidance (General)
Well, there's a FIFTH document, which is a 14 page guide to CMS use of Coverage with Evidence Development.  It has its own web page and its own comment cycle.

How to Find CED Guidance, and Evidence Guidance

Here's the home page for NCD guidance documents:

One new entry is "[PROPOSED] CMS National Coverage Analysis Evidence Review."   The other is "[PROPOSED] Coverage with Evidence Development."   Note that new documents for comment are the first entries on this page since 2006.

Comments til August 21, 2023.

Find the CED GUIDE here:
Comments also til August 21, 2023.

CED Sometimes Criticized

CED has been criticized as often not finished or not effective.  For an academic report, see Zeitler 2022.  See also my citations to Grogan and Peschin on CED - here.  Famously, in January 2021, the Trump-era general counsel of HHS Mr Charrow, wrote a memo that CED was not legal - see the section on "statutory basis of CED" in the new CED document.  (See it as Topic #2 at this blog and seek "cloud copy.")

CED is 4600 words.  Here's an AI summary.

The policy topic of CED receives a new proposed guidance document on Coverage with Evidence Development (CED) in medical policy. It begins with an introduction and background, highlighting the statutory basis and the need for transparent evidence development. The principles governing the application of CED are outlined, emphasizing its role in expanding access to medical technologies and addressing evidence deficiencies. The document presents clinical study standards for CED under Section 1862(a)(1)(E), focusing on study design, population inclusion, data quality, reporting, and governance. The importance of control groups and blinding in CED studies is discussed, along with the process of ending CED and ensuring transparency. The document concludes with a revision history.
  • Purpose: The document aims to address the factors considered in making national coverage determinations (NCDs) using the CED paradigm to provide a predictable and transparent evidence development framework.

  • Statutory Basis: Sections 1862(a)(1)(A) and 1862(a)(1)(E) of the Social Security Act form the basis for CED, allowing Medicare payment for items and services that are reasonable and necessary for research conducted under Section 1142 of the Act.

  • Principles of CED: CED NCDs occur within a transparent coverage determination process, expand access to medical technologies, and require evidence generation to address specific evidentiary deficiencies.

  • Clinical Study Standards: CED studies should be conducted by qualified sponsors/investigators with a written plan, addressing study protocol, milestones, study context, design, population, subgroup analyses, care setting, health outcomes, success criteria, data quality, construct validity, sensitivity analyses, reporting, sharing, governance, and legal requirements.

  • Importance of Control Groups and Blinding: Blinding in randomized controlled trials reduces bias, and control groups are crucial for assessing treatment effectiveness and minimizing confounding factors.

  • Fit-for-Purpose Study Designs: CED studies should be designed appropriately to answer specific CED questions, using randomized controlled trials or advanced observational designs with appropriate controls to minimize bias and confounding.

  • Ending CED: CED requirements should be time-limited to facilitate the timely generation of sufficient evidence. Interim analyses and publication of results should inform coverage decisions, and the completion of CED cycles can be triggered by CMS reconsideration or a planned re-examination of evidence.

  • Transparency of CED: The NCD process is transparent, allowing public comment and participation. Reporting study results and registration with enhances accountability, public access to information, and better-informed decision-making.

  • Revision History: The guidance document was first published in 2006 and revised in 2014.

  • Impact: The proposed guidance aims to enhance the evidence development framework, expedite beneficiary access to new technologies, ensure patient safeguards, and support manufacturers in generating evidence for Medicare coverage.