Results of Regulations

Home medical equipment (HME) providers who deal in respiratory assist devices (RADs), also know as non-invasive positive pressure ventilators (NPPVs) and BiPAP S/Ts, must follow stricter guidelines established by the Health Care Financing Administration (HCFA) if they want reimbursement.

A cursory survey of HME providers across the country revealed new government regulations have simply created more paperwork and documentation without really benefiting the patients.

Jim Mitchell, owner, Steuben Healthcare, Bath, N.Y., said HCFA regulations have not really affected his business one way or the other. "I had to walk the doctor through the whole thing, but (other than that) the biggest (challenge) is doing the paperwork."

"There's so much testing and documentation and that isn't always convenient," said Cindy Borota, RRCP, Avera-RCS, Yankton, S.D.

In October of last year HCFA passed new regulations regarding reimbursement for RADs, NPPVs and BiPAP S/Ts outlining specific criteria patients, physicians and HME providers must meet for the devices to be covered under reimbursement.

HCFA determines coverage based on various diagnoses having specific requirements unique to the diagnosis. According to Medicare, for the product to be covered it must:

  • be eligible for a defined Medicare benefit category
  • be reasonable and necessary for the diagnoses or treatment of illness or injury or to improve the functioning of a malformed body member
  • meet all other applicable Medicare statutory and regulatory requirements.

Other related aspects of reimbursement include, but are not limited to length of use, the specific condition/disorder for which the doctor prescribed the machine, as well as any accessories the patient may require. HME providers must also comply with the new HCFA regulations when serving patients by following these strict guidelines and documenting information.

"If you look at some of that criteria you will find a lot of discrepancies," said Borota.

Mitchell said he had a patient who had been on a BiPAP S/T for a year and had his doubts the patient would be covered under the new regulations due to the strict guidelines.

However, Mitchell said he feels that the regulations are just adding a few steps to an already lengthy process.

"If you are already doing A, B and C, adding D E, and F shouldn't really make it that more difficult," he said.

Some HME providers feel that the new regulations have made it more difficult for patients who really need the device to have access to it.

Borota said she understands why Medicare made the cutbacks because often there is abuse when prescribing these machines, "but it does make it tough for those patients that really need the treatment."

One example of this is a patient who requires a BiPAP S/T from the start must be placed on a regular BiPAP for 30 days under the new guidelines.

"If you have someone who has severe neuromuscular disease that can cause difficulties," Borota said. Another difficulty lies in the fact that also under these new guidelines, patients must use the device at least six hours a day and according to Borota, some patients may not be able to tolerate the RAD for six hours due to the severity of the disease.

"They may only be able to stand it for 4 or even 2 hours a day, but the doctor still wants them to have it because it is better than nothing. This can put the physician in a difficult position," Borota said.

While HCFA and Medicare continue to make cutbacks in an attempt to safeguard against abuse it is ultimately the patients who suffer. If physicians and HME providers are unable to qualify the patient's need for the machine, the patient loses which means physicians and HME providers do too.

Home Health Products, Vol. 8, No. 4, p. 16.

This article originally appeared in the April 2000 issue of HME Business.

About the Authors

David Drab serves as a principal of information and content security services for Xerox Global Services, where he develops security technologies for a wide range of customers.

Dr. Patrick J. Sullivan, a soil chemist and partner in Forensic Management Associates Inc., a company in San Mateo, Calif. that provides litigation support and expert witness services related to environmental disputes.

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