MRI and Pacemakers

MEDICARE EXPANDS COVERAGE FOR PATIENTS WITH PACEMAKERS THAT ARE FDA-APPROVED FOR USE WITH MRI EXAMS

The Centers for Medicare & Medicaid Services (CMS) today expanded Medicare coverage of Magnetic Resonance Imaging (MRI) for beneficiaries with implanted pacemakers when used according to FDA-approved labeling in an MRI environment. A final National Coverage Determination (NCD) posted today provides access to the MRI environment for patients with FDA-approved pacemakers.

On February 8, the Food and Drug Administration (FDA) approved the RevoMRI SureScan Pacing System, which is designed for use in the MRI environment for certain MRI exams. Currently, there are no other pacemakers or implantable cardioverter defibrillators that are FDA-approved for use in the MRI environment.

“This swift action by CMS provides patients who need a pacemaker with greater access to MRI exams,” said Donald M. Berwick, M.D., CMS administrator. “The expedited review of this decision demonstrates our commitment and support of new technology that will help improve the health of our beneficiaries.”

MRI is a noninvasive method of imaging that has the capability of demonstrating a wide variety of soft-tissue lesions in various parts of the body. It is used to diagnose many medical conditions, such as cancer, and is used to look at various parts of the body, including the head, central nervous system, and the spine. MRI also has advantages over other imaging techniques such as computed tomography (CT) and conventional radiographs, including no radiation exposure and easier visibility of soft tissue.

However, MRI exposes the patient to high magnetic and radio-frequency fields that may cause the movement or heating of implanted medical devices that are ferromagnetic (e.g. surgical clips) or that have ferromagnetic components (e.g. pacemakers, prostheses). The American College of Radiology’s (ACR) guidance document on safe MRI Practices (Kanal, 2007) explicitly discusses the need to address potential risks of exposure for patients that may have ferromagnetic foreign bodies or implants.

The final coverage policy issued today follows a proposed decision issued in April 2011. The final decision memorandum is available on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Magnetic%20Resonance%20Imaging%20(MRI)%20(3rd%20Recon)&bc=ACAAAAAAIAAA&NCAId=252&.

Private Non-Profit Health Plans

NEW PRIVATE NONPROFIT HEALTH PLANS

Today (July 18, 2011), the Centers for Medicare & Medicare Services (CMS) took steps to encourage the creation of Consumer Operated and Oriented Plans (CO-OPs), new private non-profit, consumer-governed health insurance plans that will help increase competition and give consumers and small businesses additional affordable health insurance choices. CMS is proposing standards for CO-OPs, and for qualifying for $3.8 billion in repayable loans to help start-up and capitalize these new health plans. All CO-OP loans must be repaid with interest and loans will only be made to private, nonprofit entities that demonstrate a high probability of becoming financially viable.

CO-OPs are designed to give consumers and small businesses control over their own health insurance. CO-OPs are private, non-profit insurers governed by their members and offering affordable, consumer-friendly health insurance options. CO-OPs will use any profits to benefit its members, including actions to lower premiums, improve health benefits, improve the quality of members’ health care, expand enrollment, or otherwise contribute to the stability of coverage for members.

“CO-OPs will provide consumers more choices, greater plan accountability, and help ensure a more competitive insurance market,” said Steve Larsen, Director of the Center for Consumer Information and Insurance Oversight. “Today’s announcement shows how the Affordable Care Act is bringing new choices and giving consumers a voice in insurance markets throughout the nation.”

Working from the recommendations of the public advisory committee, the rules proposing the framework were developed with significant input from many stakeholders, including testimony at public meetings from consumers, small businesses and health care providers. The proposed rule is only a first step. CMS is taking public comment on the proposal and expects to release a Funding Opportunity Announcement regarding the availability of loans to start up CO-OPs soon.

The CO-OP program provides for loans to private entities with the goal to create a new CO-OP in every State to expand the number of Exchange health plans with a focus on consumer accountability. The CO-OP program contains extensive provisions to protect against fraud, waste, and abuse. Loan recipients are subject to strict monitoring, audits, and reporting requirements for the length of the loan repayment period plus 10 years. Recipients must submit semi-annual program reports and quarterly financial statements. Additionally, CMS will conduct audits, including site visits, as appropriate. CO-OPs must meet a series of milestones as laid out in their loan term agreements before drawing down any money from the program.

CO-OPs will sell coverage through the State’s Affordable Insurance Exchange as well as have the opportunity to sell coverage to small businesses through the State’s Small Business Health Option Programs (SHOP Exchanges).Several successful health insurance cooperatives currently exist around the country, covering nearly 2 million individuals. A number of diverse groups are organizing to take advantage of this new opportunity. In one state, primary care providers are working to create a CO-OP to focus on care for rural areas. In another, a CO-OP steering committee has been formed by interested physicians, technology and business experts, and community groups.

¿Habla usted español?

Es.Medicare.gov speaks your language.

You already know that Medicare.gov has a wealth of current information: everything from basic costs and coverage to details about screening tests and visits to help you stay healthy.

Es.Medicare.gov is one of many ways we’re sharing Medicare information so everyone can better understand their health care options and get the best care. Now, Es.Medicare.gov also includes everything you need to know about preventive benefits, like recommended cancer screenings and discounts on brand-name drugs in the donut hole.

Here’s what you’ll find:

• · Details about exactly what Medicare covers and what you pay, including for preventive tests and screenings
• · Helpful Web sites and phone numbers for people who can answer your questions
• · “Medicare & You” handbook
• · Fact sheets and publications with specific details about the Medicare Program
• · Step-by-step information about how to file an appeal
• · Forms to apply for Medicare , file claims, and more

Visit Es.Medicare.gov, and tell your friends and family. Because when you share the news, you share the health.

Medicare Will Pay for Prostate Cancer Drug

New York Times
June 30, 2011, 6:38 pm

By ANDREW POLLACK

Medicare confirmed on Thursday that it would pay for Provenge, the prostate cancer drug whose $93,000 price had set off debate about the cost of cancer treatments.

The Centers for Medicare & Medicaid Services said in a final decision that the evidence was adequate to conclude that Provenge “improves health outcomes for Medicare beneficiaries’’ and was therefore “reasonable and necessary” for their treatment.

However, reimbursement would be only for men who matched the criteria in the drug’s label, meaning they had few or no symptoms and cancer that had spread beyond the prostate gland and was no longer controlled by hormone therapy.

The final decision follows a yearlong review and confirms a tentative decision announced three months ago. Most men with prostate cancer are covered by Medicare.

Provenge, developed by Dendreon, based in Seattle, is one of a series of new prostate cancer drugs that have been shown to prolong men’s lives and in some cases relieve symptoms, but whose costs are raising questions.

The announcement that Medicare would undertake the a “national coverage determination’’ had drawn an outcry from some men with the disease and investors in Dendreon, who saw it as a warning by Medicare about high prices.

But Medicare officials denied that cost was the issue. One reason for the review, they said, was that it was unclear if Provenge was a drug or a treatment process.

Provenge, which was approved by the Food and Drug Administration in April 2010, is the first cancer treatment that works by training a patient’s own immune system to fight the disease. White blood cells are taken from each man, processed by Dendreon, and then infused back into his body.

In its largest clinical trial, men who received Provenge lived a median of 25.8 months compared with 21.7 months for those who got a placebo.

Medicare Will Continue to Cover 2 Expensive Cancer Drugs

New York Times
June 30, 2011

By ANDREW POLLACK

Medicare confirmed on Thursday that it would continue to pay for two expensive cancer drugs that had been at the center of debate — Avastin from Genentech for breast cancer and Provenge from Dendreon for prostate cancer.

A spokesman for the Centers for Medicare and Medicaid Services said the agency would continue to pay for Avastin for breast cancer, even if the Food and Drug Administration revoked the drug’s approval as a treatment for that disease.

“The label change will not affect our coverage,” the spokesman, Don McLeod, said.

An advisory committee to the F.D.A. voted unanimously Wednesday in favor of rescinding the breast cancer approval, saying the latest evidence suggested the drug was not effective. The final decision will be made by the F.D.A. commissioner, Dr. Margaret A. Hamburg, after a public comment period ends on July 28.

Avastin would retain approval for other cancers so doctors could still use it off label for breast cancer. But some women fear that insurers will no longer pay for the drug, putting the medicine, which costs about $88,000 a year, out of reach for most women.

Mr. McLeod’s statement could allay those concerns, at least for women covered by Medicare. He said that Medicare commonly paid for off-label use of cancer drugs.

Still, Mr. McLeod said that while there were no plans for one right now, he could not totally rule out that Medicare might one day undertake a national coverage determination to decide whether to pay for Avastin. That process would take at least a year and involve public input.

Such a national coverage determination was undertaken for Provenge, which costs $93,000 for a complete course of treatment.

The final decision, issued Thursday, said the evidence was adequate to conclude that Provenge “improves health outcomes for Medicare beneficiaries” and was therefore “reasonable and necessary” for their treatment.

The result confirmed a preliminary decision announced three months ago.

The decision applies to men who meet the criteria in the drug’s label, meaning the cancer has spread beyond the prostate gland, it is no longer controlled by hormone therapy and the men have few or no symptoms.

The national coverage determination drew outcries from some men with prostate cancer, investors in Dendreon and critics of health care reform, who said the government was singling out the drug because of its cost and was on its way to rationing health care. Similar accusations about rationing greeted the F.D.A.’s proposal to remove the breast cancer approval for Avastin.

Both Medicare and the F.D.A. said the costs of the drugs were not a factor in their deliberations.

Private insurance companies must also decide whether to continue paying for Avastin as a breast cancer treatment.

WellPoint said it would review the medical necessity after the F.D.A. makes its final determination.

Cigna and the Health Care Service Corporation, which operates Blue Cross and Blue Shield plans in Illinois, Texas, Oklahoma and New Mexico, both said they would evaluate their coverage positions after the F.D.A. made a final decision.

UnitedHealthcare said its chemotherapy coverage decisions were based on a reference published by the National Comprehensive Cancer Network. That reference lists Avastin as a valid treatment for breast cancer.