Medical Device Daily Washington Editor

Alignment of patent regulations continues to be a priority in the developed world, and a recent agreement between the U.S. Patent and Trademark Office (USPTO) and its counterparts from four other nations nudges that agenda along yet a bit farther.

According to an Oct. 31 statement posted at the agency's web site, PTO and representatives of intellectual property offices from the European Union, South Korea, China and Japan have agreed to a blueprint for collaboration "to address the common challenges they are currently facing."

The five government officers met in Jeju, the large island off the southern coast of South Korea, on Oct. 27-28 to put the final touches on the blueprint, the idea of which is to eliminate "unnecessary duplication of work among the offices, enhancement of patent examination efficiency and quality, and guarantee the stability of patent rights."

To that end, the national patent offices are divvying up 10 "foundation projects" that will eventually help international patent applications move along more quickly than they currently do. PTO will take the lead in the two foundation projects that deal with finding a common approach to sharing and documenting patent research strategies and with common search and examination support tools.

The European Patent Office (EPO) will coordinate work on a common documentation database and on a common approach to "a hybrid classification." The Japan Patent Office (JPO) will coordinate work on a common application format, which may result in the use of a web-based application using XML, or extensible markup language.

XML, like the better-known HTML, or hypertext markup language, is an offshoot of the Standard Generalized Markup Language, or SGML, developed in the 1960s to allow the electronic sharing of documents.

According to the PTO statement, the benefits of these projects are "expected to be tangible and substantial," partly because "reutilization of the work of another office" on the more than 250,000 patents received in some national patent offices each year will cut down on redundant work. The PTO statement also noted that a successful collaboration will "increase the efficiency of the patent system and minimize the cost and effort of patent applications with regard to the acquisition and management of patent rights."

OIG work plan for 2009 published

The Office of Inspector General at the Department of Health and Human Services recently published its work plan for 2009, and the agenda is an ambitious one.

Among the items OIG will scrutinize next year is the perennial problem child, durable medical equipment and prosthetics, orthotics and supplies, known as DMEPOS or DME. According to the OIS publication, its recent work, including interviews with home health patients, indicated that there were "unnecessary DME being ordered for beneficiaries."

OIG also intends to "review the appropriateness of Medicare Part B payments to DME suppliers of power mobility devices, hospital beds and accessories, oxygen concentrators and enteral/parenteral nutrition." This pursuit is fueled by DME paid for by CMS that was "not ordered by physicians, not delivered to beneficiaries, or not needed by beneficiaries."

OIG states in the October work plan, which runs 115 pages, that it will investigate reimbursement for continuous positive airway pressure devices that are prescribed for obstructive sleep apnea, partly over concerns that the devices are not used.

The work plan also indicates an interest in price comparisons for negative wound pressure therapy pumps, an interest triggered by the fact that "between 2001 and 2006, Medicare payment for the pump rose 692%."

It will come as no surprise to hospitals that OIG intends to scrutinize "payments made to hospitals for new services and technologies" by determining "whether hospitals have submitted claims in accordance with the criteria." OIG says it will "also review CMS's calculation of the payments" for such services.

The medical device industry is also under the watchful eye of OIG because the office has stated it intends to "review FDA's oversight of medical device postmarketing surveillance studies."

According to OIG, "a 2006 OIG study of FDA's oversight of postmarketing study commitments for drugs found that FDA could not readily identify whether or how timely such post-marketing study commitments were progressing toward completion," thanks in part to incomplete and/or missing information submitted by drugmakers.

OIG states that its review of post-market studies by device makers will "examine the extent to which FDA has required post-marketing studies of medical devices, the level of compliance among sponsors that have been required to perform such studies, and FDA's oversight of sponsors' study commitments."

Court blocks Medicare move on payment

A federal court has ruled that the Centers for Medicare & Medicaid Services cannot try to reduce the growth in Medicare expenditures by "paying for only the least expensive treatments for particular conditions," according to a story in yesterday's online edition of the New York Times.

The case involved reimbursement for DuoNeb, a dual-product nebulizer treatment with albuterol and ipratropium made by Dey (Napa, California), for which CMS apparently attempted to avoid reimbursing.

Judge Henry Kennedy of the U.S. District Court for the District of Columbia said the move "flies in the face of the detailed statutory provisions" set by Congress regarding reimbursement.

CMS argued that the decision would make it difficult to constrain cost escalation in the Medicare program, and Peter Ashkenaz, a CMS spokesman, was quoted as saying that the agency is "considering our options and next steps."

The underlying law states that CMS is to decide which treatments are "reasonable and necessary" for treatment of patients under Medicare, but reimbursement is dealt with separately in the law and is not specifically cited as a consideration on whether to cover a treatment.

Representatives of drug maker Sepracor (Marlborough, Massachusetts) are said to have filed a friend-of-the-court brief that states that because Congress set the payment rate at 106% of the average sales price, the intent was to "entrust the amount of reimbursement to the market, not to a government agency or to its contractors."