HHS Floats $5B Package to Cut 'Burdensome' Hospital Regs

Hospitals may save or divert to patient care $5 billion in resources over five years – money now spent on bureaucratic red tape – thanks to a package of reforms that include two proposed rules and one final regulation, federal officials said Tuesday.

These "redundant and overly burdensome regulations...were getting in the way of (hospitals providing) the best care," Kathleen Sebelius, Secretary of Health and Human Services, said during a news briefing.

"They can use this money to improve care, see more patients and hire more staff," she said, by reducing what's required for Medicare payment and giving them more flexibility on which levels of personnel must provide certain types of care.

Added Donald Berwick, MD, administrator for the Centers for Medicare & Medicaid Services:  "One of the main impacts on personnel is (it provides) the chance for doctors and nurses and pharmacists – people whose time is very valuable – to reallocate their energies away from wasteful procedures to really direct their energy more directly to patient care. This will increase the amount of professionals' time to what they are there to do and what patients want them to do, which is to take care of them."

For example, the proposal would allow advanced practice registered nurses and other non-physician providers to perform services according to the rules of their state, which in most states would mean they could write or verbally give certain standing orders for patient care, rather than having to wait for a physician's signature.

"Now hospitals will have the option to credential and privilege these health professionals to the fullest extent of state law," Sebelius said.

It also would allow critical access and other smaller, rural facilities to contract with pharmacy and laboratory services rather than have those services in-house.

"The standing requirement meant that these hospitals, which operate currently on razor-thin budget, had to employ all their own radiology services as well as countless other staff," Sebelius said. "But under the new rules, they'll be able to contract with companies to do this work and provide the same great care at lower cost."

And it would release hospitals from the obligation of having to write two patient care plans – one a specifically required nursing care plan and the other covering all parts of their hospital stay. Instead, only one integrated plan would be required for each patient.

Officials for the American Hospital Association said they are extremely pleased. "It resonates with us that hospitals will take this regulatory relief and reinvest it in patient care," Lisa Grabert, the AHA's senior associate director of policy said in a telephone interview Tuesday. 

She and Nancy Foster, the AHA's Vice President for Quality and Patient Safety Policy, said the proposals have long been on the AHA's wish list. And they're long overdue.

"The last time they made changes to the conditions of participation (CMS' criteria for a full range of services required before a hospital is eligible for federal reimbursement) was in the 1980s, so we're referring to this as like going from 'the Madonna era' to 'the Lady Gaga era,' " of COP regulation, Grabert said.

The AHA does not see that hospitals will respond to their regulatory relief by laying workers off. Rather, many hours of work now devoted to redundant efforts will be shifted to improve quality.

The proposed rules are now open for comment for 60 days, during which Sebelius and Berwick hope to receive other suggestions for discarding unnecessary requirements.

The new rules are tagged as a response to President Obama's call to reduce needless, expensive workloads required by federal rules that touch most every branch of the federal government.

Cass R.Sunstein, Administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget, said during the briefing that many other efforts are underway. "There are a lot of regulations on the books that have not been subject to ongoing scrutiny. Some of them were really good when they were issued but have been rendered dated or obsolete because of changed circumstances," he said.

Part of the cost-saving package announced Tuesday was the publication of a final rule governing Changes to the Ambulatory Surgical Centers Patients Rights Conditions for Coverage.

This rule is said to "reduce the regulatory requirement for ambulatory surgical centers that will save $50 million a year through "common sense changes to the requirements ASCs must follow to meet federal safety standards.

The proposed rule governing the reform of the conditions of participation of hospital and critical access hospital:

• Removes a requirement that hospital systems with multiple facilities have separate governing bodies taking separate actions to approve hospital programs.
• Redefines the use of the phrase 'medical staff' in a way that allows hospitals more flexibility in the use of APRNs, physician assistants, physical therapists, speech-language pathologists and pharmacists.

It would allow hospitals the ability to grant privileges to both physicians and non-physicians regardless of whether they are also appointed to the hospital's medial staff.

"We believe this proposed language would provide hospitals with the clarity they need to explore new and expanded approaches to care giving," the proposal says.

"Hospitals would be able to increase the number of practitioners who could perform various functions and duties, up to the regulatory boundaries allowed" under their state licensing and scope of practice laws." to include physicians and

• Allows hospitals flexibility to allow patient or his or her caregivers to administer non-controlled drugs and biologicals at the bedside, such as nitroglycerine tablets and inhalers and selected non-prescription medications such as lotions or rewetting eye drops. The rule requires that a practitioner issues such an order that permits self-administration of medications and assesses the patient and caregiver's capacity.
• Removes a one-day reporting requirements for deaths involving patients who were not in seclusion and involved only the use of a soft- two-point wrist restraints.
• Would allow a doctor of podiatric medicine to serve as the chief of a medical staff, expanding the list from physicians, osteopaths and doctors of dental medicine or dental surgery.

The proposed rule governing regulatory provisions to promote program efficiency, transparency, and burden reduction removes expanded safety requirements and rules for staff presence in patient areas for end-stage renal disease facilities. These rules duplicate existing state and local fire safety codes or are irrelevant, because the risk of fire in such facilities is low. Half of the 2,800 ESRD facilities would have to be renovated or upgraded to comply, at a cost if $77,659 per facility or perhaps as much as $217 million nationally.

"These amounts represent a significant financial burden on facilities, with little or no improvement in patient safety from fire for a majority of them," the proposed rule says.

The proposed rules are published in the Federal Register as CMS-3244-P and CMS-9070-P. The final rule is published as CMS-3217-F.