CMS Takes Steps to Reduce Regulatory Burden

The Centers for Medicare & Medicaid Services (CMS) proposed two rules and finalized a third rule, Oct. 18, with the intention to “reduce unnecessary, obsolete, or burdensome regulations.” CMS estimates these reforms could potentially save hospitals and health care providers nearly $1.1 billion dollars in the first year alone.

Referring to President Obama’s  Jan. 18, 2011 Executive Order 13563 to “modify, streamline, or repeal” regulations that impose unnecessary burdens, including those imposed on hospitals and other providers that must comply with Medicare requirements, U.S. Department of Health & Human Services (HHS) Secretary Kathleen Sebelius said:

Ambulatory Surgical Center CASCC

“President Obama has been clear: It’s time to cut the red tape. Our new proposals eliminate unnecessary and obsolete standards and free up resources so hospitals and doctors can focus on treating patients.”

Proposed Rule: Reform of Hospital and Critical Access Hospital Conditions of Participation

This proposed rule would revise the Conditions of Participation (CoP) hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. Proposed CoP changes include:

  1. Allowing one governing body to oversee multiple hospitals in a single health system.
  2. Easing the reporting requirements for hospitals when circumstances of a patient’s death involve only using soft two-point wrist restraints and no use of seclusion, and providing additional reporting methods.
  3. Allowing hospitals to grant privileges to physicians and non-physician practitioners (NPPs) to practice within their state scope of practice without necessarily being appointed to the hospital’s medical staff; and expanding the medical staff list responsible for performing certain management tasks to include doctors of podiatric medicine (DPMs).
  4. Allowing for a separate, standalone nursing care plan to be integrated into a hospital’s overall interdisciplinary care plan; and expanding privileges for who is qualified to prepare and administer medications.
  5. Allowing hospitals to use standing orders; eliminating the requirement that NPPs must have special training in administering blood transfusions and intravenous medications; and deferring to hospital and/or state policy for order authentication and timeframe establishment.
  6. Allowing hospitals flexibility in their approach to the tracking and surveillance of infections.
  7. Allowing hospitals to determine the best ways to oversee and manage outpatients by removing the requirement for a single director of outpatient services.
  8. Removing the provision which requires transplant center teams to verify blood type before organ recovery.
  9. Allowing CAHs to provide certain services, including laboratory and radiology services, under arrangement.

The American Hospital Association (AHA) welcomed the proposed changes. “We applaud CMS for addressing concerns heard from America’s hospitals,” AHA President and CEO Rich Umbdenstock said in a statement. “The proposed new conditions of participation better recognize how care is delivered today.”

Proposed Rule: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction

This proposed rule would identify and begin to eliminate duplicative, overlapping, outdated, and conflicting regulatory requirements for health care providers and suppliers, including hospitals, ambulatory surgical centers (ASCs), end-stage renal disease (ESRD) facilities, durable medical equipment (DME) suppliers, and a host of other health care providers and suppliers regulated under Medicare and Medicaid.

Some of the 14 proposed regulatory changes in this proposed rule include:

  • Eliminating obsolete regulations, including expired OMB paperwork control numbers; outmoded infection control instructions for ASCs; outdated Medicaid qualification standards for physical and occupational therapists; and duplicative requirements for governing bodies of organ procurement organizations.
  • Clarifying which higher risk ESRD facilities are required to comply with the full federal Life Safety Code requirements.
  • Eliminating the current Medicare requirement that automatically deactivates a provider or supplier who has not submitted a claim for 12 consecutive months, keeping providers from inadvertently being barred from re-enrolling in Medicare for a certain period.
  • Eliminating the specific list of emergency equipment ASCs must have on hand, and allowing facilities, in conjunction with medical staff and their governing bodies, to develop policies and procedures that specify emergency equipment appropriate to the services they provide.
  • Replacing inflexible time-limited agreements which govern intermediate care facilities (ICFs) for the mentally retarded participation in Medicaid, with open-ended agreements and reducing states’ paperwork burden by requiring inspection of these facilities once a year.  The regulation also takes up a recommendation from stakeholders to replace the term “mental retardation” with the term “intellectual disability,” which has gained wide public acceptance in recent years.
  • Updating e-prescribing technical requirements so Medicare prescription drug plans meet current standards.

Changes to the ASCs Patient Rights Conditions for Coverage

This final rule would update the Conditions for Coverage (CfC) regulations for ASCs based on a proposed rule CMS issued in April 2010.

Specifically, the new regulation allows patient rights information to be provided to the patient, the patient’s representative, or the patient’s surrogate with patient rights information prior to the start of the surgical procedure. ASCs are presently required to notify patients in advance of the date of the procedure.

Also in the final rule, CMS made a “minor” change to the CfC for Patient Rights requirements, as specified in the proposed rule. The new regulations are effective Dec. 23, 2011.


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