Legal and Regulatory Compliance

Some Regulatory Reduction Plans Draw Hospital Concerns

December 12, 2018 11:48 am

But hospitals backed CMS proposals related to quality and infection control.

Some of the latest regulatory rule changes aimed at reducing provider burdens have drawn hospital opposition.

In September, the Centers for Medicare & Medicaid Services (CMS) proposed rule reductions related to Medicare’s conditions of participation (COP), which it estimated would save providers $1.1 billion in compliance costs. The proposed changes are part of the Trump administration’s Patients Over Paperwork initiative, which CMS projected will eliminate more than 53 million hours of burden for providers and save nearly $5.2 billion between 2018 and 2021.

One change would not require ambulatory surgery centers (ASCs) to have written transfer agreements or physician admission privileges with nearby hospitals.

“While rare, complications do occur in ambulatory surgery patients, and when they do, the patient’s life can depend on the existence of a plan in which the ASC team takes appropriate steps in the moment to both stabilize the patient to the extent possible and transfer the patient to a nearby hospital where additional appropriate treatment can occur,” the American Hospital Association (AHA) wrote in a letter to CMS opposing the requirement elimination.

Hospital advocates also raised concerns about the proposed elimination of requirements for preoperative medical histories and physical examinations. CMS recommended that ASCs and hospitals be allowed to establish their own requirements.

AHA wrote that chief quality officers and other clinical leaders have said the transfer and medical history/examination requirements provide important protections for patients when they are undergoing surgery or other procedures.

“These are times when patients may be at risk for medical errors or other problems with potentially severe consequences,” AHA wrote. “Patients rely on hospitals, health systems, and ASCs to have put the right processes in place to avoid such errors to the greatest extent possible.”

The Michigan Health and Hospital Association (MHHA) noted in a letter to CMS that transfer agreements provide receiving emergency departments with key information—including the type of surgery and anesthesia used, and problems encountered—to ensure appropriae provisions are available when patients arrive.

“The transfer agreement is, in essence, the emergency planning document, and relying on the hospital’s obligations under EMTALA to accept the patient is not a substitute for proper prior planning on how to handle ASC patients in the event of an emergency,” wrote Marilyn Litka-Klein, vice president of health finance policy and health delivery for MHHA.

The proposed changes were especially concerning in light of CMS moves to allow ASCs to perform “high-risk procedures,” she wrote.

Barbara Blackmond, JD, of Horty, Springer and Mattern, which represents full-service community hospitals, said that the revised rules would reduce “the perceived burden on ASCs, but it will increase the burden on full-service hospitals and will not improve quality patient care.”

The proposed changes also drew opposition from other healthcare entities, including one of the largest Medicare insurers. SCAN Health Plan, which covers more than 194,000 Medicare beneficiaries and is the third largest not-for-profit Medicare Advantage Prescription Drug (MA-PD) plan, wrote CMS that ASC transfer agreements with hospitals should remain in place to protect patients who may be discharged prematurely from developing more serious health conditions.

Supporters of ASCs praised the proposed changes. “This change is necessary to adequately address the serious issue that arises when hospitals providing outpatient surgical services refuse to sign written transfer agreements or grant admitting privileges to physicians performing surgery in an ASC,” wrote Samuel Pierce, OD, president of the American Optometric Association. “The elimination of this regulation is clearly needed to address efforts to limit competition.”

Patient Status Requirements

The hospital advocates also opposed a CMS proposal to eliminate the 30-day medical history and physical examination pre-op requirements for both ASCs and hospitals.

The proposal would allow organizations to develop their own policy, identifying patients who would be required to have a pre-op history and physical examination and those who would require only a “simplified assessment.”

“However, the patient’s medical history and physical exam are a routine piece of pre-operation processes and often reveal critical health information about a patient prior to surgery,” Litka-Klein wrote.

MHHA opposed the change, noting that when performing a medical history and physical exam in the 30 days prior to surgery, physicians often identify critical knowledge about a patient that potentially would alter the planned procedure.

“Clinicians have indicated that this process is not a significant burden for them,” Litka-Klein wrote.

She also raised concerns that allowing organizations to develop their own policies would create considerable confusion for physicians who have privileges at multiple hospitals or ASCs.

Meanwhile, AHA noted that the appropriate amount of detail of pre-op patient history and the value of physical examinations to obtain a reasonable estimate of perioperative risk remain unclear.

“…We urge you to remain cautious in your approach to this topic and ask that CMS withdraw this proposal until more evidence-based guidelines become available, perhaps in the form of diagnostic and prognostic prediction studies,” AHA wrote.

Supported Changes

AHA backed several of the regulatory-burden reduction proposals, including changes in the ways hospitals are required to address quality assurance and performance improvement (QAPI) and infection control review. A proposed “unified and integrated” standard would allow system-level approaches to quality assurance and improvement projects.

The change would “not only likely reduce burden, but also enable systems to take full advantage of the power they have to use centralized data analytics, standardized approaches, and opportunities to share strategies across the system,” wrote AHA.

AHA also praised CMS for allowing governing bodies to be responsible for QAPI and infection control reporting.

“This proposed change would allow systems to streamline and focus their quality data collection and improvement efforts and alleviate significant stress from and work hours dedicated to hospital-level reporting,” AHA wrote.

Hospital advocates also backed proposed changes to transplant center special requirements, which are required to meet all CoPs that apply to hospitals plus a series of special requirements to receive Medicare approval and subsequent reapproval.

Hospitals said the additional requirements, which come with severe penalties, have produced unintended consequences, such as reluctance by transplant centers to admit riskier patients due to requirements pertaining to Medicare approval and reapproval quality metrics.

The rules have led to designations of patients as too risky even if they have an 80 percent chance of surviving one or more years after a transplant, with transplant centers declining to admit them, according to a published report.

This article originally appeared in HFMA’s Healthcare Business News (

Rich Daly is a senior writer/editor in HFMA’s Washington, D.C., office. Follow Rich on Twitter: @rdalyhealthcare


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