Medical Device Daily Washington Editor

FDA and CMS exhibit a keen interest in parallel review, making it a topic at this year's edition of Transcatheter Cardiovascular Therapeutics just after posting a notice in the Federal Register for comment from affected parties (Medical Device Daily, Sept. 21, 2010). Two medical device associations have posted their observations on the idea, expressing guarded optimism about the idea, but questions linger about what industry has to gain from such a program.

Both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (both Washington) responded with Dec. 16 letters addressed to the docket, and the concerns expressed by both parties run fairly parallel. The immediate no-brainer found in both missives is that industry is decidedly disinterested in more user fees to support a parallel review program. Also, both associations noted that even though having to go through both regulatory approval and reimbursement processes can drag out the time to market for a device application, a parallel review mechanism might not be especially expeditious, either, especially given that local carrier coverage is still an option.

Both letters emphasize the voluntary nature of parallel review, which the FR notice stated would be a feature of such a mechanism, despite that CMS has in the past unilaterally undertaken a review. In one of the more notorious recent FDA approvals, that of the Menaflex 510(k), CMS undertook a coverage analysis without notification, decreeing the data behind the device lacking insufficient to support coverage. Officials with the device's manufacturer, ReGen Biologics (Hackensack, New Jersey) told Medical Device Daily that they had not requested a coverage decision (MDD, June 1, 2010).

The MDMA letter, signed by the association's VP for government relations, Thomas Novelli, notes that in addition to the voluntary nature of parallel review, firms should be able to opt out of the mechanism and that a third party ought not to be able to initiate such a review. The concern regarding a third-party request is that a competitor could force “the product into the review process before the company is able to support the costs of the necessary trials.“

The AdvaMed letter, signed by Janet Trunzo, executive VP for technology and regulatory affairs and Ann-Marie Lynch, executive VP for payment and healthcare delivery, signals a similar concern. They write that a third party “may request parallel review in an effort to limit access to or coverage of the technology, or simply to complicate and slow down the regulatory process.“ However, they add the possibility that a third party might want access to any intellectual property associated with the competitor's application, a possibility based on the disclosure requirements behind coverage analyses.

Both associations also express concerns about protection of intellectual property as well, stating that the statutory requirement of disclosure that goes with a national coverage analysis could prove harmful, especially to smaller firms. AdvaMed's letter notes that this could be another inducement for third parties to request parallel review of a competitor's application.

Both association's take up the issue of coding and reimbursement, with the AdvaMed letter urging CMS to “update the coding systems under its control . . . more often than annually. The two coding systems cited here are the ICD-9 CM and the HCPCS (healthcare common procedure coding system), although ICD-9 will be supplanted by 2013 by its successor, ICD-10.

The MDMA letter goes into more detail on the coding/reimbursement question, stating that the time required to obtain a HCPCS code – as well as a code under the common procedural terminology (CPT) coding system – “is substantial for medical device manufacturers and even has increased in many cases.“ Novelli acknowledges that the CPT coding mechanism is under the control of the American Medical Association (Washington), but remarks that obtaining a CPT code can take as long as 21 months. CMS's administration of the HCPCS code is handled via annual meetings and offers no appeal process for a failed first attempt, which MDMA says is a condition that leaves industry with a long window for reimbursement if the application should fail on the first go-round.

The AdvaMed letter makes note of the question of whether parallel review should include an examination of any potential off-label uses of a device. Trunzo and Lynch write that CMS should “remain silent or neutral in relation to physician-directed uses to allow local [Medicare] contractor flexibility“ in coverage.

Some of the background noise behind parallel review is that CMS's coverage decisions exercise a profound influence on private payer coverage, hence another reason for industry to avoid the process altogether. The possibility that CMS could deter FDA from clearing or approving a device based on CMS's attitude toward coverage is certainly not lost on industry, either. In an era of profound budgetary concerns regarding Medicare, the idea that parallel review would constitute regulation-on-steroids is surely making the rounds in executive suites by now.

The AdvaMed letter seems to take aim at this latter possibility, making note of a need to establish a functional firewall between CMS and FDA in a parallel review mechanism. The letter states that the association's members are concerned “that creating a parallel review process may result in CMS influencing or providing input into FDA's reviews of products, determinations of safety and efficacy, or orders.“ AdvaMed added that a parallel review process “may lead to denial of patient access“ to medical technology.

MDMA President/CEO Mark Leahey told Medical Device Daily in a brief interview that industry is not dead-set against the idea of regulatory review, but that concerns about the idea run deep.

“I think the idea of trying to expedite the regulatory review and reimbursement processes is commendable, but we have significant issues,“ Leahey said. “Our primary concern is that formalizing this process in such a way that the company does not have autonomy over their own regulatory and reimbursement processes could erect significant barriers that would slow diffusion of new technology to patients and clinicians who need them,“ he summarized.

CMS seeks nominees for MedCAC

The Centers for Medicare & Medicaid Services has said it is accepting nominations for the Medicare Coverage and Evidence Development Advisory Committee (MedCAC), which will lose as many as 19 members as of next June. According to the announcement in last Wednesday's edition of the Federal Register, the agency has to fill slots for both voting and non-voting members on the panel, which is charged with determining whether a treatment or diagnostic qualifies as “reasonable and necessary,“ the two general criteria used in reimbursement decisions.

Two of the voting positions are for patient advocates while the two non-voting slots are for industry, the FR notice states. CMS indicates that nominees are selected because of their qualifications, not “as representatives of professional associations or societies.“ the agency is also encouraging nominators to bear in mind the need to represent the interests of “both women and men, members of all racial and ethnic groups, and physically challenged individuals.“ Interested parties can nominate themselves.

Nominations will be accepted until Jan. 31, 2011. For further information, contact CMS's Maria Ellis (410-786-0309,

CMS announces APC advisory meeting

The Centers for Medicare & Medicaid Services announced yesterday the three dates for next year's first of two meetings for the advisory panel for ambulatory payment classification groups. The agency's announcement, posted in yesterday's edition of the Federal Register, lists the dates of Feb. 28-March 2, 2011. The deadline for hardcopy comments and hardcopy for presentation at the meeting, which will take place at the agency's headquarters in Baltimore, is Feb. 7, 2011, while those interested in attending should register by Feb. 23. For further information, contact CMS's Sheri Ackerman-Ross (410-786-4474,

Mark McCarty, 703-268-5690