CRF Urges CMS to Cut Red Tape, Restore the Rule of Law in Medicare

This week, the CPAC Foundation's Center for Regulatory Freedom (CRF) submitted public comments to the Centers for Medicare & Medicaid Services (CMS) in response to the agency’s request for information regarding Executive Order 14192—President Trump’s directive aimed at reforming federal regulations that burden the healthcare system. CRF’s message to CMS is clear: reduce bureaucracy, stop unconstitutional overreach, and restore Medicare’s alignment with the Constitution, the free market, and patient-centered care.

In its 17-page memorandum submitted on June 10, 2025, CRF identifies the most damaging aspects of Medicare’s current regulatory framework, including the coercive Medicare Drug Price “Negotiation” Program, the duplicative and access-limiting Coverage with Evidence Development (CED) program, and the costly web of prior authorization and reporting mandates. CRF’s recommendations boil down to a constitutional imperative: government cannot regulate what it has no authority to compel, and it must not impose costs that delay or deny care.

Key Themes from CRF’s Comments:

1. Drug Price “Negotiation” Is Coercion, Not Policy

CRF strongly rebukes the so-called “negotiation” framework authorized under the Inflation Reduction Act. As CRF explains, the program uses threats of massive excise taxes—up to 1,900%—to force pharmaceutical manufacturers into submission. This is not voluntary negotiation. It is price control by intimidation.

Worse, it undermines innovation. When intellectual property is devalued and companies cannot recoup the cost of research and development, the incentive to create new treatments disappears. Patients will ultimately pay the price through lost cures and abandoned investment in future therapies.

CRF calls on CMS to use its discretionary authority to pause and reassess the program, citing likely violations of the Takings Clause and Due Process protections under the Constitution.

2. Coverage with Evidence Development (CED) = Bureaucratic Denial by Delay

The CED program requires Medicare patients to enroll in clinical trials to access already FDA-approved treatments. In practice, this restricts care, especially for rural, elderly, and low-income patients who cannot access major academic medical centers.

Even worse, CRF points out that many of these studies produce no usable data. That means patients are denied treatment based on “evidence development” that never happens. CMS isn’t advancing science—it’s hiding behind red tape.

CRF calls for the CED program to be eliminated or strictly limited to extraordinary cases. FDA approval should remain the gold standard, not an invitation for CMS to re-litigate scientific consensus.

3. Prior Authorization: Government Red Tape That Kills Time and Treatment

CRF identifies Medicare’s prior authorization process as one of the single biggest burdens on providers—and one of the most dangerous barriers to timely patient care. Originally intended to prevent fraud and waste, it has become an all-purpose delay tactic that blocks doctors from delivering routine, evidence-based care.

The appeals process for denied authorizations is even worse—slow, opaque, and often futile. CRF notes that these bureaucratic loops violate basic due process and create disproportionate burdens for smaller providers who lack compliance departments and legal counsel.

CRF calls for CMS to eliminate prior authorization requirements for low-risk therapies and high-performing providers and replace redundant appeals with streamlined, automated systems.

4. Reporting Requirements: Expensive, Unnecessary, and Often Useless

CRF also slams the excessive and often irrelevant quality and compliance reporting requirements imposed on Medicare providers. These mandates force practices, especially in rural areas, to divert resources away from patients and toward bureaucratic compliance.

CRF argues that many reporting requirements fail to meet the standards set by the Administrative Procedure Act (APA), which requires regulations to be evidence-based and rational. Instead, CMS collects data that it doesn’t use, on metrics that don’t matter, from providers who can't afford the overhead.

The recommendation: eliminate mandates that have no proven impact on fraud prevention or patient outcomes, and automate what remains using modern electronic health records and AI tools.

5. CMS Needs to Stop Duplicating the Work of Other Agencies

CRF argues that CMS is routinely duplicating the work of the FDA, private insurers, and other regulators, especially in audit and compliance enforcement. The CED program alone is a glaring example of CMS second-guessing FDA decisions by creating unnecessary hurdles for patients to access approved drugs and devices.

CRF also criticizes the lack of interagency coordination, which leaves providers buried under multiple, overlapping audits and compliance regimes. CRF urges CMS to collaborate closely with the Department of Government Efficiency, the Office of Advocacy at the Small Business Administration, and the Office of Information and Regulatory Affairs (OIRA) to eliminate duplication and create a single, coordinated oversight framework.

CRF’s Core Recommendations

Here’s a snapshot of the actions CRF is calling for:

• Pause or terminate the Medicare Drug Price “Negotiation” Program until constitutional concerns are addressed.

• Abolish or radically limit the CED program, especially where it duplicates FDA review or blocks access.

• Streamline or eliminate prior authorization and replace appeals with automated presumptive approvals.

• Cut redundant reporting requirements that don’t improve care.

• Coordinate audits and compliance checks across agencies to reduce unnecessary duplication.

• Protect smaller and rural providers from disproportionate regulatory burdens.

• Prioritize market-based innovation by removing preclearance hurdles to new healthcare technologies.

  
  

A Call for Bold Deregulation and Constitutional Discipline

CRF’s submission to CMS is not just a policy memo—it’s a constitutional statement. Federal agencies are not sovereign rulers. They exist to carry out the will of Congress, within the boundaries of the Constitution. When CMS blocks care, punishes innovation, or imposes coercive economic mandates, it oversteps that mandate.

CRF urges CMS to lead, not through more programs and processes, but by cutting red tape, reducing its footprint, and restoring legal clarity and market freedom to the Medicare program.

CMS has the authority to act. The only question is whether it has the will.

The full comments can be found here: