Healthcare Law Insights
Healthcare Law Insights

CMS Proposes New Regulations Regarding Part D Program

Posted in Medicare Part D, Pharmaceuticals and PBMs, Physicians

Scrutiny of physician prescribing (particularly pain management) seems likely to increase in 2015 under new CMS regulations that were published on January 10, 2014. The proposed regulation makes policy and technical changes regarding the Medicare prescription drug program (Part D). Among the changes are the granting of explicit authority to deny (under 42 CFR § 424.530) or revoke (under 42 CFR § 424.535) Medicare enrollment if a provider’s Drug Enforcement Administration (DEA) registration or state registration to prescribe is suspended or revoked.

Further, CMS proposes to allow revocation of Medicare enrollment when “improper prescribing practices” exist. This latter change potentially creates an additional incentive for CMS to analyze its prescription data because CMS can more easily take action against providers it identifies as problematic. Under current regulations, CMS may not have a clear cause for revocation of a provider’s Medicare enrollment even if questionable prescribing habits exist (for example, issuing more than 400 prescriptions to each of 16 beneficiaries) unless a state licensing action or criminal case provided cause under 42 CFR § 424.535 (or exclusion regulations).

As proposed, “improper prescribing practices” include those determined by CMS to be abusive and dangerous to Medicare beneficiaries in consideration of, among others, the following factors:

  1. Whether diagnoses support the indications for which drugs are prescribed;
  2. Whether the practitioner has prescribed controlled substances in excessive dosages that are linked to patient overdoses;
  3. The number and types of disciplinary actions taken against a practitioner and the reasons for the actions; and
  4. Malpractice lawsuits related to prescribing that resulted in a final judgment or settlement.

In addition, a pattern of prescribing drugs for indications that are not medically accepted – that is, indications not approved by the FDA or accepted under sections 1860D-2E(4) of the Social Security Act – would be a basis for revocation.

Comments on the proposed regulation [CMS-4159-P] must be received by CMS no later than 5 p.m. on March 7, 2014.