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Posts in "Cancer"

March 19, 2015

CMS Weighs Expanding Coverage of PET Cancer Scans

In the latest round of battles over Medicare payments for positron-emission tomography, or PET, scans, federal officials are considering a request to greatly widen coverage for a form of the test to track whether cancers have spread to the bones.

Doctors who oversee a key research body for use of PET scans in cancer patients have asked for national Medicare coverage of a version of test that uses a form of sodium fluoride to check for unusual growths in bones. The Centers for Medicare and Medicaid Services now limits its payment for this product to people who participate in the National Oncologic PET Registry (NOPR), a requirement that is part of the agency’s “coverage with evidence development” approach to evaluating products.

In a letter last month to CMS, the leaders of the NOPR argued that finding from this research effort on the sodium fluoride scans support their request to end the data collection requirement, and allow national Medicare coverage with the product for cancer in general. Reports made by doctors to the NOPR indicate that the scan allowed them to avoid ordering additional noninvasive tests in 71 percent of cases and invasive procedures in 66 percent, according to the letter.

“The NOPR has been successful in meeting the goal for which it was established — providing clear, extensive data on the previously little-researched question of whether there is a clinical benefit” of using the scans to identify bone metastasis,  wrote Bruce E. Hillner, the chair of the NOPR and his cochairs, Barry A. Siegel and Anthony F. Shields, in a Feb. 15 letter to CMS.

CMS formally accepted their request for its national coverage analysis process on March 16, and will accept comments regarding it through April 15. A proposed decision is due Sept. 16, with a final one slated to be completed by Dec. 15.

PET scans seem to have attracted special scrutiny from CMS over the years, with the agency having used the national coverage analysis more than dozen times for different forms and uses of the test, such as checking for signs of Alzheimer’s disease. That makes PET scans one of the technologies most heavily studied by CMS through its NCA process.

In PET tests, a small amount of a radioactive material known as a tracer is injected into a patient. Doctors can then again information about what’s happening in the body through following the path of the materials, such as checking for the spread of cancer.

CMS created the NOPR in 2006 as part of its answer to a request that Medicare cover PET testing with another agent, F-fluorodeoxyglucose (FDG), for more cancers, Hillner, Siegel and Shields noted in their letter. By 2013. CMS approved a request from NOPR to end the data collection requirement and provide coverage for essentially all cancer uses.

By Kerry Young Posted at 9:05 a.m.

February 9, 2015

Medicare Will Cover Limited Lung Cancer Screening

The Centers for Medicare and Medicaid Services will cover screening for lung cancer for the first time for certain beneficiaries, the agency said last week. The coverage for lose dose imaging takes effect immediately.

“This is an important new Medicare preventive benefit since lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States,” said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS.

Under the final decision, Medicare will cover the screening once a year for Medicare beneficiaries who are between 55 years old and 77 years old, and are either current smokers or quit smoking within the last 15 years. To qualify, the beneficiaries also must have smoked an average of one pack a day for 30 years and must get a specific type of written order from a physician or qualified non-physician practitioner.

A trial of about 54,000 people showed that CT scans may allow some cancers to be caught earlier and thus allow people to live longer with the deadly disease. A National Cancer Institute summary of  trial results found about 18 people in 1,000 who were given CT tests died of lung cancer after about 6.5 years, compared with 21 in 1,000 whose lungs were scanned with older X-rays. But 25 in 1,000 people in the CT group had a false alarm leading to an invasive procedure, such as biopsy, or surgery, while the rate was seven in 1,000 in the x-ray group.

Medicare coverage includes a visit for counseling on the benefits and risks of lung cancer screening.

“We believe this final decision strikes an appropriate balance between providing access to this important preventive service and ensuring, to the best extent possible, that Medicare beneficiaries receive maximum benefit from a lung cancer screening program,” Conway said.

“This decision is a triumph for Medicare beneficiaries who are at high-risk for lung cancer and will now have access to life-saving scans,” said Gail Rodriguez, executive director of the Medical Imaging & Technology. “Given the high bar CMS holds in making national coverage determinations, it is clear that the benefits of LDCT [low-dose computed tomography ] scans for those at high risk of lung cancer are indisputable.”

By Rebecca Adams Posted at 9:17 a.m.

February 6, 2015

CDC Issues Alarm on Secondhand Smoke; Suggests Apartment Smoking Bans

The Centers for Disease Control and Prevention this week stated quite definitively that “no level of secondhand smoke exposure is safe.” The statement is a highlight of a report on secondhand smoke, which the CDC claims kills more than 400 infants and 41,000 adult nonsmokers every year. The deaths stem from smoke-related Sudden Infant Death Syndrome, plus lung cancer and heart disease. Overall exposure to secondhand smoke is declining but the decline is not evenly spread across all groups, particularly for people living in rented housing. The report urges renewed state and local efforts to limit indoor smoking plus prohibitions on smoking in multi-unit housing complexes.

By Paul Jenks Posted at 9:30 a.m.

January 28, 2015

Medicare Advisers to Focus on Cancer Tests

A panel of Medicare advisers will review evidence of how well certain tests work in helping doctors gauge the progress of lung, breast and colon cancer and what help these diagnostics can provide in choosing treatments.

A March 24 meeting of the Medicare Evidence Development and Coverage Advisory Committee has been scheduled to look at products that are meant to pick up on genetic variations produced in cancer cells.

Medicare is seeking the opinions of its advisers on about whether such tests can help patients live longer as a result of better treatment decisions and avoid complications from certain chemotherapies.

A report released last year raised questions about the ultimate benefits of some of the tests.

Doctors rely on the products in shaping discussions with patients about whether their prognosis is better or worse than average, according to the report from the Agency for Healthcare Research and Quality. Much of the available evidence focuses on determining prognosis, but there’s been little emphasis on how the information may affect the outcomes of treatment for patients, such as with the selection of medicines, the report stated.

“Such changes in management may be occurring and may be of benefit, or possibly harm, to patients, but they have not been measured and studied, with the notable exception of the Oncotype DX assay in breast cancer,” the authors wrote.

They added that there is “a sizeable body of evidence” to suggest Oncotype DX results in fewer recommendations for chemotherapy, and thus less exposure for some patients to the harms of this treatment, but noted that there are still questions about the effect on this test on outcomes for patients.

The deliberations of MedCAC panels are meant to aid the Centers for Medicare and Medicaid Services in setting payment policies, but are not binding. At the March meeting, the advisers’ discussion is intended to help CMS shape decisions “about the extent to which it may wish to use existing evidence as the basis for any future determinations about coverage for tests that estimate cancer prognosis.”

As part of the discussion, Medicare intends to have this expert panel weigh in on one of the liveliest current topics in the arena of diagnostics.

Among the questions to be considered by the panel is whether the regulatory status of a test should count in considering evidence of how it will work. The Food and Drug Administration last year kicked off what promises to be lengthy tussle with academic health centers and companies that make diagnostic products, by officially unveiling a new framework for regulating certain tests used in cutting-edge medicine.

The FDA is reconsidering what had long been a hands-off approach to lab-developed tests. Decades ago, lab-developed tests often were used by doctors and pathologists working in a single medical center. But advances in genetics have blurred the distinction between the lab-developed tests and other diagnostics. Many large companies now market medical tests nationwide and even globally without getting FDA clearance.

The Oncotype DX diagnostics from Genomic Health, for example, are considered lab-developed tests. Redwood City, California-based Genomic Health calls these a service, through which its laboratory provides through an analysis of the genes expressed in certain tumors. The company has agreements with distributors in more than 90 countries, and reported product revenue of $206.6 million for the nine months ended in September 2014.

By Kerry Young Posted at 10:30 a.m.

July 31, 2014

Congress Presses FDA on Sunscreen; Surgeon General Warns on Skin Cancer

The House earlier this week quietly passed by voice vote a bill that would streamline the Food and Drug Administration application process for sunscreen ingredients. The measure sets a specific timetable to review applications.

Full story

July 29, 2014

Breast Cancer Awareness Has Bipartisan Appeal

It’s difficult to find common ground on many major legislative topics between Sen. Amy Klobuchar, D-Minn., and David Vitter, R-La., and Reps. Debbie Wasserman Schultz, D-Fl., and Renee Ellmers, R-N.C. However, health topics can be a unifying force in Congress.

Full story

By Paul Jenks Posted at 3:50 p.m.

CDC Updates Stats on Low Teen Cancer Vaccination Rates

The Centers for Disease Control and Prevention recently sounded an alarm with new statistics about the low rate of vaccination of teenagers against human papillomavirus. The health monitoring agency noted that teens are getting the HPV cancer vaccine at a lower rate than other vaccines.

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July 22, 2014

Nuclear Agency Adjusts Radiation Treatment Rules

A variety of regulatory agencies supervise the delivery of health care. Perhaps the most overlooked agency is the Nuclear Regulatory Commission. The NRC is responsible for monitoring the safety in the use of radiation treatments using radioactive byproduct materials.

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By Paul Jenks Posted at 8:59 a.m.

July 21, 2014

New Bills: Contraceptive Services and Breast Cancer Detection

Last week’s Senate vote on a measure intended to roll back the Supreme Court’s Hobby Lobby decision prompted new legislation seeking to secure access to contraceptive services from New Jersey Democratic Sen. Cory Booker, plus a bill offered by Illinois Democrat Richard J. Durbin that would confirm recently announced Obama administration guidance on employee notification of omitted contraception coverage.

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