A Medical Device Daily

Leave it to government and private industry to look at the same creature and see two entirely different animals.

The Centers for Medicare & Medicaid Services reported this week that it has finalized the rule for prospective payment for home healthcare for FY08, and between changes to the PPS rule for home healthcare and the market basket update, CMS anticipates that it will “disburse an additional $20 million in payments to home health agencies in [calendar year] 2008.”

However, an industry association claims the adjustments net out at a loss of $7 billion.

CMS’ Aug. 22 notice states that home health payment rates are adjusted by the market basket calculation, which uses quality data required by the Deficit Reduction Act of 2005 for the current and subsequent fiscal years. According to CMS, the market basket update is 3% for calendar year (CY) 2008, but providers who fail to submit the appropriate quality data can expect to lose two-thirds of that update, leaving them with only a 1% increase.

The agency notes that it has also added two new measures of quality endorsed by the National Quality Forum, specifically, measures for treatment of emergent care for wound infections and changes in the status of surgical wounds, bringing the total number of quality measures to 12.

The press statement describing the final rule says that its analysis of home health claims from CY05 indicated that the case mix index — an average of diagnostic-related group scores — rose 12.78% from CY00 levels, but that 11.75% of that total “is due to changes in coding practices and documentation rather than to treatment of more resource-intensive patients.

CMS initially proposed the rule in late April (Medical Device Daily, May 3, 2007).

In reaction to the CMS announcement, the National Association for Home Care and Hospice (NAHC; Washington) issued a statement decrying the rule as “undermining access to care in patients’ homes and diminishing the importance and value” of reforms to the payment rubric.

Val Halamandaris, NAHC’s president, claimed that the payment schedule amounts to a cut of $7 billion a year and said that availability of “cost efficient care for the elderly and disabled is at stake with Medicare’s action.” Halamandaris also said that unless Congress intervenes, “over 50% of all home health agencies will be paid less than it costs to deliver care.

“No health care provider can sustain that impact,” Halamandaris said.

FDA seeks input on OA treatments

FDA has to take into account many factors when developing guidances for the industries it regulates, not the least of which is changes in technology. Thus, the agency recently published a request for assistance in its efforts to finalize a 1999 draft guidance on clinical development of drugs, biologics and devices designed to treat osteoarthritis (OA).

The guidance says that “before the agency can issue such a guidance, a critical appraisal of certain fundamentals of the science related to OA is needed” —thus, the need for the notice. FDA is inviting “any interested parties” to “conduct and manage the coordination of this appraisal,” suggesting that perhaps the first step should be “a public meeting” to discuss issues related to such product development, including clinical trial design.

FDA is accepting comments for 60 days subsequent to the Aug. 13 date of publication of the notice.

The agency said that the feedback it received on its guidance concerning rheumatoid arthritis led it to take a similar tack concerning OA, and it expects that a public meeting “will lead to conceptual advances not now present” which would make their way into peer-review publication and feed further exploration.

FDA is looking for feedback to determine several issues, including whether the scope of the guidance should be restricted to OA alone or perhaps should include “particular clinical subgroups of OA that need to be explicitly considered.”

The agency is looking for input on the question of what might serve best as clinical outcomes and trial designs to establish symptomatic relief as a therapeutic endpoint. Withdrawals from the trials and renewed flare-ups of the condition are currently used as the basis for trial designs, but according to FDA, these two, “while believed to be predictive, lack generalizability.”

The agency also wants to look at the value of claims of a decreased rate of progression of the disease, as well as claims of prevention or risk reduction.

Agency publishes jurisdictional update

FDA also recently published a notice of jurisdictional update for applications for devices that are used to process human cells and tissues into human cellular and tissue-based product, or HCT/Ps. The agency’s Office of Combination Products, which is responsible for assigning combination product applications to a center, was the source of the notice.

The notice says that the agency has received requests for designation for devices intended to process such tissues “at the point of care,” and questions as to whether review of such products should go to the Center for Biologics Evaluation and Review (CBER) or to the Center for Devices and Radiological Health (CDRH).

FDA says that products intended to “create a therapeutic article ... where the intended therapeutic effect is mediated by the biological output of the device” have gone to CBER. As an example, the announcement gives the case of devices that process autologous blood or tissue products for processing into a new HCT/P “at the point of care for direct readministration into the patient.” Likewise, any such devices, such as cell sorters, “used at the point of care to isolate and/or concentrate autologous stem cells or hematopoietic progenitor cells for in vivo use have also gone to CBER.

On the other hand, cell sorters designed to isolate or concentrate these two classes of cells for use in an in-vitro diagnostic has typically ended up at CDRH.

The notice states that anyone with questions could e-mail the agency at combination@fda.gov.