Medicare Regulations Amended for Efficiency, Transparency, Burden Reduction

CMS will be publishing a Final rule, amending Medicare and Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations in order to remove unnecessary or excessively burdensome requirements on health care providers and suppliers, and clarifying confusing or conflicting regulations. According to the advanced copy of the Final rule, the changes made to the Medicare and CLIA regulations are in response to Executive Order 13563, as well as CMS’ efforts to limit unnecessary costs and increase flexibility for providers. The final rule is scheduled to be published May 12, 2014.

Major Provisions

Currently, ambulatory surgical centers (ASCs) are required to meet full hospital requirements in order to provide radiological services. However, the Final rule will reduce those requirements to only services ASCs are allowed to perform. In addition, swing-bed services conditions of participation (CoP) will be relocated to Subpart D, thereby classifying swing beds as an optional service and removing the need for swing-bed approval by additional state survey agencies. CMS is also eliminating the requirement that a physician must be onsite at a minimum of once every two weeks under critical access hospital (CAH), rural health clinic (RHC), and federally qualified health center (FQHC) regulations. However, CAHs, RHCSs, and FQHCs must still have a physician onsite for “sufficient periods of time depending on the needs of the facility and its patients.” The final rule will also make changes to hospital registered dietitian privileges, hospital supervisions of radiopharmaceutical preparation, transplant center reports and re-approval processes, the long term care sprinkler deadline, and CAH provision of services.

Clinical Laboratory Revisions

The Final rule will make clarifications and revisions to CMS’ regulations of proficiency testing (PT) referrals under the CLIA, in an effort to prevent laboratory confusion and reduce noncompliance. Specifically, the agency is clarifying that even though PT samples are required to be tested the same way as patient specimens, it does not mean that PT samples may be referred to a different laboratory for testing. The final rule will also establish a narrow exception to CMS’ interpretation of “intentional” referral of PT samples, allowing for alternative sanctions. In addition, the CLIA will be amended to include new terms: reflex testing, confirmatory testing, and distributive testing. Pursuant to the Taking Essential Steps for Testing Act of 2012 (P.L. 112-202), CMS will be amending the CLIA to allow the agency to impose alternative sanctions in lieu of the two-year prohibition that occurs when a CLIA certificate is revoked.

Obsolete Regulations and Clarifying Information

Under the Code of Federal Regulations, CMS will be: (1) clarifying the requirement that a hospital’s medical staff must be composed of doctors of medicine or osteopathy, by allowing non-physician practitioners to be included as “medical staff;” (2) removing the separate review for lung transplant data requirement for transplant centers outcome review; (3) clarifying the transplant volume and clinical experience requirements for transplant centers; and (4) revising the definition of a “physician” in RHC and FQHC regulations so that it conforms with the definition of “physician” in Medicare payment regulations.