Coverage with evidence development proposed for transcatheter valve

In a Feb. 2 draft coverage decision, CMS proposes covering transcatheter aortic valve replacement (TAVR) procedures only within the coverage-with-evidence-development (CED) program and only under specific conditions. For example, TAVR should be used to treat severe symptomatic aortic valve stenosis when all these conditions are met: the procedure is for an FDA-approved indication using a complete valve and implantation system that has earned FDA pre-market approval; the patient has been evaluated for open valve replacement by two cardiac surgeons; the procedure is performed in a facility that meets all CMS requirements for TAVR; the facility collects data for a prospective national study; performing physicians meet strict qualifications and experience criteria; and the patient enrolls in a five-year, outcomes-based national registry. Stricter CED participation requirements are proposed for off-label TAVR procedures. TAVR would be explicitly non-covered in certain patients, such as those with mixed aortic valve disease or isolated aortic regurgitation. Comments are due March 3, and CMS expects to issue a final national coverage decision by May 2. (See Also see "Transcatheter Valve Stakeholders Weigh Merits Of Local Vs. National Coverage" - Medtech Insight, 7 November, 2011..) FDA granted a PMA for the first U.S. transcatheter aortic heart valve, Edward Lifesciences’ Sapien, last November. (See Also see "Edwards Wins Approval For Sapien Just In Time For TCT" - Medtech Insight, 7 November, 2011..)

Extracorporeal photopheresis decision proposal

CMS proposes expanding coverage for extracorporeal photopheresis (ECP) to treat lung allograft patients with progressive bronchiolitis obliterans syndrome (BOS), but only when the procedures are done under strict conditions as part of a clinical research study, according to a Feb. 2 proposed decision memo. The decision would have implications for the Therakos UVAR XTS system, which can be used in the procedure. The therapy involves exposing a patient’s white blood cells to a drug called 8-MOP and then to ultraviolet A light. (See [A#01330010027_b].)

The Medicare agency opened the national coverage analysis last summer at the request of Ramsey R. Hachem, M.D., a professor of pulmonary medicine at Washington University in St. Louis. Comments are due March 3, and CMS plans to issue a final rule by May 2.

NeuroStar depression treatment gains local Medicare coverage

NHIC Corp., a local Medicare contractor serving much of New England, has issued a final local coverage decision supporting the use of repetitive transcranial magnetic stimulation for patients with treatment-resistant depression. The Jan. 27 decision, slated to take effect March 17, 2012, overrides a November 2011 draft policy that would have non-covered Neuronetics’ NeuroStar TMS, which received an FDA de novo clearance in 2008. According to the local coverage decision, repetitive transcranial magnetic stimulation is non-invasive and uses magnetic-resonance-imaging-strength, pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex. It is indicated for the treatment of major depressive disorder in patients who have not responded to antidepressant medication.

The technology has faced a challenging launch. (See Also see "Neuronetics Plans Expanded Marketing For Transcranial Magnetic Stimulation Depression Therapy" - Medtech Insight, 29 August, 2011..) According to the Institute for Clinical and Economic Review, based in Massachusetts, the NHIC decision is the first positive Medicare local coverage decision for transcranial magnetic stimulation. The institute said its New England Comparative Effectiveness Public Advisory Council convened a meeting late last year that ultimately played a role in reversing NHIC's originally proposed non-coverage policy.

CMS moves ahead with controversial demos

The agency announced Feb. 3 it will move ahead with efforts to eliminate Medicare waste, fraud and abuse by launching demonstration projects originally slated to begin Jan. 1 but placed on hold due to industry outcry. (See Also see "CMS Delays Front-End Review Demo Projects Indefinitely" - Medtech Insight, 9 January, 2012..) CMS “significantly revised the Prior Authorization of [power mobility devices] demonstration in response to provider and supplier concerns,” CMS said in a press release. The power mobility device demo, as well as the recovery audit prepayment review demonstration project, is now expected to launch June 1 or later, the agency said. More information is available at http://go.cms.gov/PAdemo.

Round 2 DME competitive bidding begins, amid criticism

The Medicare agency is taking bids through March 30 for the round two and national mail-order competitions of its durable medical equipment, prosthetics, orthotics and supplies competitive bidding program, meant to shave Medicare spending for the category. Successful bidders in the first nine metro areas began marketing select DME items under the program in January 2011, amid ongoing protest from the home care products industry. (See Also see "DME Competitive Bidding: 32% Cost-Cutting Expected From Revived Program" - Medtech Insight, 5 July, 2010..)

University of Maryland economics professor Peter Cramton, a critic of the Medicare DME competitive bidding process, said in January that his preliminary review of data from the round one program found that “the flaws identified in theory, experiment and practice are very much present in the pilot.” He asked CMS and Congress to “move quickly to stop the implementation of the round one rebid and move to design and implement an efficient auction for durable medical equipment.”

CMS spokesperson Ellen Griffith said the agency has seen some decline in DME claims in the first nine markets, but added that “given the lack of evidence of adverse beneficiary impacts, CMS believes this decline may underscore competitive bidding’s value as an antifraud strategy, as well as its value in reducing costs to taxpayers and beneficiaries for the competitively bid items.” She added that the round one markets were chosen based on the extremely high volume of paid DME items relative to other areas.

Griffith said that after careful monitoring to determine whether beneficiaries in competitive bidding areas are having trouble obtaining medically necessary items, “We are finding nothing, and the industry has not presented us with any factual evidence to support Dr. Cramton’s speculation that beneficiaries may not be receiving medically necessary equipment.” She called the Cramton's study methodology “seriously flawed” and its conclusions “grossly inaccurate.”

CMS has posted an online training module for round 2 bidders at www.DMECompetitiveBid.com.

Top HHS OIG challenges

Preventing and detecting Medicare and Medicaid fraud is job two for the U.S. Department of Health and Human Services Office of Inspector General, second only to “implementing the Affordable Care Act,” according to a late 2011 list of top management and performance challenges released last week by OIG. Among the other 12 items were patient safety and quality of care; ensuring integrity in Medicare and Medicaid benefits delivered by private plans; avoiding waste in health care pricing methodologies; and overseeing the approval, safety and marketing of drugs and devices.

OIG noted that CMS sometimes overpays for medical technologies. “Medicare fee-schedule payments for certain types of durable medical equipment bear little resemblance to market prices,” the report suggested. “For example, Medicare reimbursed suppliers approximately $17,000 for individual wound therapy pumps that suppliers, on average, purchased for $3,600. The Medicare payment rate had not been lowered as more wound pump models and manufacturers entered the market and competition drove prices down.”

AHA weighs in on essential health benefits

In Jan. 27 comments to CMS, the American Hospital Association cautions against placing too many restrictions on the services that will be defined as “essential health benefits” under health care reform. CMS' Center for Consumer Information and Insurance Oversight issued a proposed set of essential benefits in a Dec. 16 bulletin.

“The AHA continues to believe that any limits placed on the services included in the essential benefits package should be grounded in clinical best practices, and should include, for example, the number and frequency of diagnostic tests or procedures,” the hospital group says. “Such limits should focus on services that are marginally effective and could change as underlying scientific evidence or comparative effectiveness research informs the creation of, or revisions to, clinical best practices.” AHA adds that the criteria used to define or limit essential health benefits “should consider the rapid pace of change in medical practice, as clinical, technological and pharmaceutical advances are made.”

Premier to test health IT tools

Verisk Analytics’ subsidiary Verisk Health and Premier health care alliance’s Partnership for Care Transformation (PACT) said last week they will design and test new hospital quality-improvement and cost-cutting initiatives, such as those that may be used under the new Medicare Shared Savings Program. “Combining data from inpatient and outpatient settings with claims data will help produce actionable information that supports care interventions to help ensure patients receive the most effective and informed treatments possible,” said Keith J. Figlioli, Premier senior VP of health care informatics, in a Feb. 2 press release.

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