On May 7, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule entitled “Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II.” The primary purpose of this final rule is “to reform existing rules to reduce unnecessary costs and increase flexibility for health care providers” under Executive Order 13563, which calls on federal agencies to modify and streamline regulations on business.

The final rule reduces regulatory burden for Hospitals, Clinics and Surgery Centers, and it provides a number of clarifications and changes governing proficiency testing (“PT”) under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) to “establish policies under which certain PT referrals by laboratories may not generally be subject to revocation of a CLIA certificate, or a two-year prohibition on laboratory ownership or operation that may be applied to an owner and an operator when a CLIA certificate is revoked.”

The final rule’s major provisions related to Hospitals, Clinics and Surgery Centers include:

  • Reducing the currently “full-hospital requirements” for ambulatory surgical centers (“ASCs”) providing radiology services to reflect only those services that ASCs are permitted to perform;
  • Permitting registered dietitians and other clinically qualified nutrition professionals to order patient diets under the hospital conditions of participation (“CoPs”);
  • Revising the nuclear medicine services CoPs to no longer require the presence of a pharmacist, MD, or DO during the delivery of off-hour nuclear medicine tests;
  • Reclassifying swing-bed services as “optional services” to allow a CMS-approved accrediting organization to evaluate regulatory compliance instead of specifically requiring a State survey agency for the “swing bed” approval;
  • Eliminating redundant data submission requirements for transplant programs and the automatic 3-year re-approval cycle that subjects transplant centers to an automatic onsite review of compliance;
  • Extending the August 13, 2013 deadline for long term care (“LTC”) facilities to install automatic sprinkler systems by up to 2 years, if certain conditions apply, with a possible additional extension of up to 1 year;
  • Eliminating the Critical Access Hospitals (“CAHs”) CoPs requirement for the development of patient care policies to include the advice of “at least one member who is not a member of the (CAHs) staff;”
  • Eliminating the requirement that a physician must be onsite at least once in every 2-week period for CAHs, Rural Health Clinics and Federally Qualified Health Centers.

The final rule will take effect on July 11, 2014.

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