The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on February 7, 2013 that it estimates would save health care providers $676 million annually by streamlining unnecessary, obsolete, or excessively burdensome regulations and making reforms to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The provisions of the wide-ranging proposal would affect numerous policy areas; among other things, the proposed rule would:
- Revise the requirements ambulatory surgical centers (ASCs) must meet in order to provide radiological services that are integral to procedures offered by the ASC and provide that a qualified doctor of medicine or osteopathy must supervise the provision of radiologic services (eliminating the requirement that ASCs meet the hospital condition of participation (CoP) requirement to have a radiologist supervise the provision of radiologic services);
- Permit qualified dietitians to order patient diets under the hospital CoPs;
- Revise the nuclear medicine services CoP to remove the requirement for direct supervision of hospital in-house preparation of radiopharmaceuticals;
- Eliminate a requirement that critical access hospitals (CAHs), rural health clinics (RHCs), and federally qualified health centers have a physician on site at least once in every two-week period, and eliminate the requirement that a CAH develop its patient care policies with the advice of at least one member who is not a member of the CAH staff;
- Allow long-term care facilities to apply for an extension of the August 13, 2013 deadline for installing automatic sprinkler systems;
- Eliminate a transplant center data submission requirement and an automatic re-approval survey process.
- Make a number of clarifications pertaining to CMS regulations governing proficiency testing referrals under CLIA, including establish policies under which certain PT referrals by laboratories would not generally be subject to revocation of a CLIA certificate.
- Address a variety of other issues, such as hospital reclassification of swing-bed services, hospital medical staff, hospital governing bodies, practitioners permitted to order hospital outpatient services, and potential changes to reduce barriers to the provision of telehealth, hospice, or home health services in an RHC.
CMS will accept comments on the proposed rule until April 8, 2013.