On July 11, 2014, amendments designed to reform Medicare regulations that the Centers for Medicare and Medicaid Services (CMS) has identified as "unnecessary, obsolete, or excessively burdensome on health care providers and suppliers" became effective. Published as final rules in the May 12, 2014 Federal Register, the amended regulations affect a broad range of providers and suppliers, including hospitals, long-term care facilities, rural health and primary care facilities, clinical laboratories, transplant centers and organ procurement organizations, ambulatory surgical centers (ASC), and intermediate care facilities for individuals who are intellectually disabled.

In its summary to the final rule, CMS noted that the amendments are intended to increase "the ability of health care professionals to devote resources to improving care, [sic] by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care."

A few examples of the reduced burden include the following:

  • Limiting the conditions that ASCs must meet in order to provide radiologic services. (42 C.F.R. § 416.49(b))
  • For hospitals, removing the requirement that a medical staff member must serve on the governing body, but adding a requirement that the governing body consult directly with the chief of staff (or its equivalent), with details about what that consultation must entail. (42 C.F.R. § 482.12(a)(10))
  • Allowing hospitals within a system to have a unified and integrated medical staff, as long as it is permitted by state and local laws, the medical staffs have voted to accept a unified and integrated medical staff, and the unified and integrated medical staff meets other requirements enumerated in the regulation. (42 C.F.R. § 482.22(b)(4))
  • In hospitals, allowing qualified dieticians or qualified nutrition professionals to order patient diets (including therapeutic diets) if authorized by the medical staff and permitted by state law. (42 C.F.R. § 482.28(b)(2))
  • For critical access hospitals, removing the requirement that a physician co-sign a sample of outpatient records of certain physician-extenders, and instead deferring to state law for supervision requirements. The amendments also remove the requirement that a doctor of medicine or osteopathy be present at least once in every two weeks. (42 C.F.R. § 485.631(b)(1)(vi), (b)(i)(v) and (b)(2))
  • For rural health clinics and federally qualified health centers (FQHCs), expanding the definition of "physician" to include doctors of dental surgery or dental medicine, doctors of optometry, doctors of podiatry or surgical chiropody, or a chiropractor. (42 C.F.R. § 489.2)
  • For rural health clinics, reducing the requirement that a nurse practitioner, physician assistant, or certified nurse-midwife be available to furnish patient care services from at least 60 percent of the time the rural health clinic operates, to at least 50 percent of the time the rural health clinic operates. (42 C.F.R. § 491.8(a)(6))

Notably, although in its introduction CMS focuses on the revisions intended to reform unnecessary, obsolete, and burdensome regulations, a significant number of the amendments merely standardize language or confirm internal citations or references. Of course, any effective measures CMS takes to reduce the regulatory and cost burden on health care providers are welcome. Even with these most recent changes, however, the burden of local, state, and federal regulatory compliance continues to divert resources away from patient care.

Hopefully, these amendments reflect an ever-forward progress in reducing the regulatory burden on health care providers, and not an end to the process. There no doubt are many more "unnecessary, obsolete, or excessively burdensome" regulations — both in and beyond the conditions for coverage and the conditions for participation — that could be amended or deleted to reduce the financial burden providers face without negatively impacting patient care quality.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.