U.S. Rep. Lynn Jenkins and U.S. Sen. Jerry Moran are leading a congressional effort to delay enforcement of Medicare regulations requiring physician supervision of outpatient treatments like chemotherapy and intravenous infusions.
The rules are intended to improve patient safety. But Jenkins, Moran and several advocacy groups, including the Kansas Hospital Association, say they would burden rural providers without benefiting patients.
“It really has put a lot of burden onto the hospitals for supervision of services we just had historically done and had not had any quality issues,” says Tish Hollingsworth, the hospital association’s senior director of finance and reimbursement.
The Centers for Medicare and Medicaid Services has enforced the physician supervision rule since Jan. 1. Hospitals that violate the rule risk losing Medicare reimbursement for the services provided.
Hollingsworth says her group was not aware of any hospitals being penalized yet.
“I have not heard that hospitals have had claims withheld or claims denied, because it is not the focus of any kind of audit right now,” Hollingsworth says. “But whenever there’s a regulation in place like that, we don’t know when it could become an issue.”
The U.S. House of Representatives earlier this month passed H.R. 4067, co-sponsored by Jenkins, which would delay enforcement of the regulations until next year. Jenkins introduced the bill in February, but it moved slowly through the legislative process.
“Medicare policy change is not taken lightly by Congress, and bills like H.R. 4067 are a laborious process,” Tom Brandt, a spokesman for Jenkins’ office, said in an email. “This bill was also in the jurisdiction of two separate House Committees — Ways and Means, and Energy and Commerce. This made the process more complicated.”
The bill awaits action in the Senate, which passed similar legislation promoted by Moran earlier in the year.
Chad Austin, senior vice president of government relations for the hospital association, says those companion bills to delay the Medicare regulations are part of a “two-pronged approach” that also includes clarifying the regulations long-term.
The long-term fix, Austin says, is contained in Senate Bill 1143, which Moran introduced. It would, in part, clarify that the physician supervision required in the new regulations is consistent with other Medicare regulations that require critical access hospitals to have a physician able to respond within 30 minutes.
“While CMS believes they’re providing some guidance, there’s still some clarification from our perspective that needs to be resolved,” Austin says.
Specifically, Austin says, hospitals are unsure what level of physician supervision has to be provided to comply with the regulations.
Julie Brookhart, a CMS regional spokeswoman, said in an email that for most of the outpatient therapies affected, the standard is “direct supervision,” in which “the physician or non-physician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure.”
But some procedures call for modified levels of supervision, like “general supervision,” in which the “procedure is furnished under the physician’s overall direction and control but the physician’s presence is not required during the performance of the procedure,” or “personal supervision,” in which the physician must be physically present in the room for the duration of the procedure.
CMS announced the rule in 2009 but exempted rural critical access hospitals until this year and made changes at those hospitals’ suggestion in the interim.
“We issued non-enforcement instructions of these requirements in critical access hospitals and small rural hospitals for a few years to allow them time to meet the requirements,” Brookhart says. “These non-enforcement instructions ended at the end of 2013. We are currently enforcing these requirements in these hospitals.”
Austin says because hospitals remain unsure what it means to have a physician “immediately available” under the direct supervision guidelines, Kansas’ 84 critical access hospitals should be protected from any attempts to recoup Medicare reimbursements related to such procedures until the rules are revised.
His group joined the American Hospital Association, National Rural Health Association and Anderson County Hospital in writing letters supporting the delay in the bill Jenkins co-sponsored.
Anderson County’s letter says that by applying the supervision rules even to hospital-employed practitioners in rural health clinics, CMS made it nearly impossible to comply.
Dennis Hachenberg, the hospital's CEO, wrote that the CMS rule presented a “significant hardship and expense to rural hospitals.”
“It will limit the ability to provide our outpatients with basic therapeutic services such as IV infusions, initial antibiotic therapy, emergency cardiac drugs and blood transfusions,” Hachenberg wrote. “These are services that have been provided in rural communities safely through the years and will ultimately impact access to important services for the patients and communities we serve.”