DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services [CMS-3254-N] Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

SUMMARY: This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for "reasonable and necessary" determinations under Medicare. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. CMS-3254-N 2

DATES: Nominations will be considered if postmarked by Monday, January 30, 2012 and mailed to the address specified in the ADDRESSES section of this notice.

ADDRESSES: You may mail nominations for membership to the following address: Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Attention: Maria Ellis, 7500 Security Boulevard, Mail Stop: South Building 3-02-01, Baltimore, MD 21244.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for the MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The Secretary signed the initial charter for the Medicare Coverage Advisory Committee (MCAC) on November 24, 1998. A notice in the Federal Register (63 FR 68780) announcing establishment of the MCAC was published on December 14, 1998. The MCAC name was updated to more accurately reflect the purpose of the committee and on January 26, 2007, the Secretary published a notice in the Federal Register (72 FR 3853), announcing that the Committee's name changed to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The charter for the committee was renewed by the Secretary on November 24, 2010. The current charter is effective for 2 years. CMS-3254-N 3 The MEDCAC is governed by provisions of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formulation and use of advisory committees, and is authorized by section 222 of the Public Health Service Act as amended (42 U.S.C. 217A). The MEDCAC consists of a pool of 100 appointed members including: 94 voting members of whom 6 are designated patient advocates, and 6 nonvoting representatives of industry interests. Members generally are recognized authorities in clinical medicine including subspecialties, administrative medicine, public health, biological and physical sciences, epidemiology and biostatistics, clinical trial design, health care data management and analysis, patient advocacy, health care economics, medical ethics, or other relevant professions. The MEDCAC works from an agenda provided by the Designated Federal Official. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. The MEDCAC may also advise CMS as part of Medicare's "coverage with evidence development" initiative.

II. Provisions of the Notice

As of June 2012, there will be 30 membership terms expiring. Of the 30 memberships expiring, 1 is a nonvoting industry representative, 4 are voting patient advocates and the remaining 25 membership openings are for the general MEDCAC voting membership. CMS-3254-N 4 Accordingly, we are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore, we encourage nominations of qualified candidates from these groups. All nominations must be accompanied by curricula vitae. Nomination packages must be sent to Maria Ellis at the address listed in the ADDRESSES section of this notice. Nominees for voting membership must also have expertise and experience in one or more of the following fields:

• Clinical medicine including subspecialties

• Administrative medicine

• Public health

• Biological and physical sciences

• Epidemiology and biostatistics

• Clinical trial design

• Health care data management and analysis

• Patient advocacy

• Health care economics

• Medical ethics

• Other relevant professions

We are looking for experts in a number of fields. Our most critical needs are for experts in hematology; genomics; Bayesian statistics; clinical epidemiology; clinical trial CMS-3254-N 5 methodology; knee, hip, and other joint replacement surgery; ophthalmology; psychopharmacology; rheumatology; screening and diagnostic testing analysis; and vascular surgery. We also need experts in biostatistics in clinical settings, cardiovascular epidemiology, dementia, endocrinology, geriatrics, gynecology, minority health, observational research design, stroke epidemiology, and women's health. The nomination letter must include a statement that the nominee is willing to serve as a member of the MEDCAC and appears to have no conflict of interest that would preclude membership. We are requesting that all curricula vitae include the following:

• Date of birth

• Place of birth

• Social security number

• Title and current position

• Professional affiliation

• Home and business address

• Telephone and fax numbers

• E-mail address

• List of areas of expertise

In the nomination letter, we are requesting that the nominee specify whether they are applying for a voting patient advocate position, for another voting position, or as a nonvoting industry representative. Potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts in order to permit evaluation of possible sources of conflict of interest. CMS-3254-N 6 Members are invited to serve for overlapping 2-year terms. A member may serve after the expiration of the member's term until a successor is named. Any interested person may nominate one or more qualified persons. Self-nominations are also accepted. The current Secretary's Charter for the MEDCAC is available on the CMS website at: http://www.cms.hhs.gov/FACA/Downloads/medcaccharter.pdf, or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR

FURTHER INFORMATION section of this notice. CMS-3254-N

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare--Supplementary Medical Insurance Program.)

Dated: October 18, 2011

___________________________

Patrick Conway

CMS Chief Medical Officer and Director

Office of Clinical Standards and Quality

Centers for Medicare & Medicaid Services

BILLING CODE: 4120-01-P

[FR Doc. 2011-29784 Filed 11/17/2011 at 8:45 am; Publication Date: 11/18/2011]

by Dr. Georges Benjamin on Dec 15, 2011 • 3:13 pm 1 Comment

Georges C. Benjamin, MD, is Distinguished Joan H. Tisch Fellow in Public Health at Hunter College and executive director of the American Public Health Association.

Our nation is undergoing a significant debate about how best to improve the health of its citizens. Much of that debate has been around insurance coverage and reform. While this is an important debate, much of what influences the degree of healthiness of individuals and communities is outside the traditional health system.

Health is about our housing; where we dump our trash; access to clean, affordable and safe food, water and air; how we build our communities in terms of their ability to support active living and the presence of economic opportunity. These factors are affected by public policy decisions and therefore can be used strategically and on a population basis to improve health.

New York City has used this approach to great effect. They have relied on the findings of community health surveys to determine their health priorities and then developed many of the city’s most significant policy initiatives, including food environment policies such as banning trans fats at restaurants and requiring calorie-count restaurant displays, increasingly aggressive anti-smoking policies, increased bicycle paths, improved access to fresh fruits and vegetables, and a novel registry to track diabetes control.

I had the pleasure this week of moderating a discussion with three distinguished figures from the worlds of health policy, health administration, philanthropy and media at the Joan H. Tisch Forum in Public Health at Hunter College. Together, we discussed some of these initiatives and explored the valuable and necessary role of public policy as a health improvement tool.

James S. Marks, MD, MPH, senior vice president and director of the Health Group at the Robert Wood Johnson Foundation, reminded the audience that the World Health Organization defines health as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. He further discussed the importance of addressing the social determinants of health and their impact.

Richard E. Besser, MD, MPH, chief health and medical editor with ABC News, talked about the importance of using sound evidence to make informed decisions to improve and maintain health and the challenges of explaining those decisions to the public. He also pointed out that it is often not that the decision is wrong but it is in the execution of explaining it to the public that derails many interventions.

Bruce Vladeck, PhD, senior advisor to Nexera Inc., discussed the importance of the linkage between health care services and public health. He also pointed out the role income inequality has on health and that many of the social determinants are surrogate markers for this important disparity.

We had a spirited discussion and debate about the relative importance of these various determinants of health. In the end, it was clear that the benefits of using broad public policy to improve health are significant and are essential to improving the health of our nation.

More about the Joan H. Tisch Forum in Public Health, “The Role of Public Policy as a Health Improvement Tool,” held Dec. 14, 2011, can be found online.

http://www.publichealthnewswire.org/?p=2035

Read more: http://www.foxnews.com/health/2011/12/19/health-panel-takes-heat-on-cancer-screening-advice/#ixzz1h4yyyLg0

Dr. Ned Calonge knows firsthand how hard it is to tell Americans they'd be better off with fewer routine medical tests.

A long-time family doctor in Colorado, Calonge presided over the U.S. Preventive Services Task Force, an influential government-backed panel of health experts, when it said that most women under 50 could skip their regular mammograms.

The recommendation two years ago challenged the conviction of many breast cancer patients that they survived precisely because they were screened early. It unleashed a public fury that has weighed on the panel's deliberations ever since.

"We blew the message," said Calonge, now president and CEO of the Colorado Trust foundation. "The nuance was completely gone."

Two men phoned in death threats to Calonge. Protesters showed up by the offices of the government agency that supports the panel, tucked away in a Maryland suburb. The furor slowed down work on a decision to limit prostate cancer screenings as President Barack Obama fought to pass his signature healthcare law and his Democratic party faced a mid-term election challenge in 2010.

"There was a lot of pressure from above to be more careful politically and orchestrate things better," said Dr. Kenneth Lin, who at the time was an officer at the Agency for Healthcare Research and Quality (AHRQ), a Department of Health and Human Services entity that supports the panel. "Everything with the word 'cancer' got shoved back."

Calonge rotated off the panel this past March after eight years, while Lin quit AHRQ late last year in protest over the delay to prostate cancer screening guidelines that were only released in October. A White House official noted that Calonge has attributed the delay in a final decision on prostate cancer screenings to scheduling conflicts.

"We have a public health measure that we know is effective. Why is it continually being questioned?"

- Dr. Carol Lee, breast imaging commission chairwoman at the American College of Radiology.

Their experience shows just how difficult it will be to curb spiraling costs in the world's most expensive healthcare system by determining what screenings work, based on a rigorous study of clinical evidence, and what can lead to unnecessary and risky procedures.

"More screening is not always better," said Dr. Christine Laine, a general internist and editor of the Annals of Internal Medicine who is not part of the panel. "That message is lost in health care in general."

The U.S. Preventive Services Task Force is right on the firing line. For much of its 27-year history, it helped convince millions of Americans to get screened early for disease.

Now the panel of primary care doctors, nurses and academics has reviewed a growing body of research that shows some early screening harms more people than it helps. But it has struggled to convince patients and doctors.

In the wake of the mammogram guidelines, the rate of such screenings for women aged 40 to 69 was barely changed in 2010 compared with 2009, according to the National Committee for Quality Assurance.

"We have a public health measure that we know is effective. Why is it continually being questioned?" said Dr. Carol Lee, breast imaging commission chairwoman at the American College of Radiology.

BROACHING THE NEGATIVES

The public at large is no less skeptical. A recent Gallup poll showed that nearly 60 percent of Americans believed that standard cancer screenings - including mammograms and prostate specific antigen (PSA) blood tests - were performed often enough. Thirty-one percent thought they should be conducted more frequently. Only 7 percent said they were done too often.

"It's extraordinarily hard to give up the notion that there's a way to protect yourself from dying from cancer... Our goal here is to make it a matter of evidence, not a matter of opinion," said Virginia Moyer, a pediatrician from Baylor College of Medicine, who now chairs the 16-member panel.

"Our successes are measured in positives," she said of the public's growing awareness of screening in the last three decades. "We are just beginning to approach the negatives."

Burned by the experience with mammograms, the task force is looking for a better way to deliver the message, consulting with powerful consumer interest groups, hiring public relations professionals and reworking some of the language tied to its system of letter-based recommendations.

"We're spending more time paying attention to how we say things to make sure it's understood well," said long-time panel member and current co-vice chair Dr. Michael LeFevre, a professor of family medicine at the University of Missouri School of Medicine. "We have no interest in being some wizard behind the curtain."

The panel now issues its recommendations in draft form first and solicits public comment before making them final. In about a year, the public may have a chance to chime in early on the evaluation process, including posing questions for researchers and reviewing the evidence report draft used by the panel.

Task force officials concede that the comments are unlikely to change the recommended letter grade, unless they introduce crucial new evidence. But they can point to misunderstandings and help the panel better craft its message.

In late October, the panel met with consumer interest groups, including retired persons lobby AARP and the Consumers Union, to get input on how to frame recommendations that was once reserved for patient advocates.

The public's participation has been unprecedented. The panel is now finalizing its PSA prostate cancer recommendation and public comments on the subject have reached into the thousands, LeFevre said.

WEIGHING THE EVIDENCE

The 2009 mammogram guidance from the task force was based on the panel's assessment of new research that showed most women over 40 face a 3 percent risk of dying from breast cancer if they have not been screened. Beginning mammogram screening at age 50 and following up every other year reduced that risk to 2.3 percent, compared with 2.2 percent risk starting at age 40.

An extra decade of screening could invite harms such as unnecessary biopsies and tests, the possible treatment of non-deadly cancers and radiation. Women in their forties are also more likely to receive false positive results.

Another view of the data showed that starting screening at age 40 led to 5,000 more mammograms, 500 false positive results and 33 biopsies for every breast cancer death prevented, according to LeFevre.

"If it was just how many deaths do you cause versus how many deaths you prevent, that would be too easy, that would be simple math," LeFevre said. "We start with somebody who feels well, and we risk making them feel worse."

The panel voted on a "C" recommendation, which calls for patients to decide on the screening with their doctor. But when the recommendation came out in November 2009, it started with a sentence saying the panel "recommends against" routine mammograms for most women under 50, and that language triggered the controversy.

Under pressure, the task force dropped the phrase "recommends against" a month later. Its rating on mammograms remains a "C."

The American Cancer Society questioned the evidence, saying the panel focused on gold-standard clinical trials but weeded out newer observational studies that showed better results.

"Screening is not perfect and it's not error-free, but the question is... do you take protective measures against the unlikely probability that you develop cancer... or do you take your chances?" said Robert Smith, director of cancer screening at the ACS.

That calculation still appears to be guiding doctors, either out of concern of missing an early sign of disease or fear of lawsuits, health experts said.

"Shared decision-making (between doctors and patients) sounds nice, but in practice usually you just end up doing the test," said Dr. Roger Chou, an internist and researcher at the Oregon Evidence-Based Practice Center. Chou authored the report on prostate cancer behind this year's task force recommendation.

POLITICAL RUMBLINGS

The heat over mammograms weighed on deliberations over prostate cancer screening. In 2008, the task force gave an "I" recommendation on the PSA test in healthy men under 75, which meant it had insufficient evidence to make a call.

The panel usually updates its recommendations every five years, but new research published in 2009 warranted an earlier evaluation. One U.S. study showed a slightly higher risk of death for men with no symptoms of illness who received a PSA test, while European research showed a slightly lower risk of death.

Although the PSA blood test itself is innocuous, data reviewed by the task force also showed that 90 percent of American men who tested positive got treated, even if they may have been able to forego it, LeFevre said. Out of 1,000 men treated, five would die, 70 would have serious complications and 200 to 300 would be impotent or incontinent.

Given the possibility of false positives in the screening and the fact that prostate cancer can take many years to progress and show symptoms, the question is whether those risks are greater than the risk of doing nothing.

"It looks like your chance of being alive and well is greater if you don't get screened than if you do get screened," LeFevre said.

In November 2009, task force members voted on a stronger "D" rating on PSA tests, meaning they recommended against the prostate cancer screening in men under 75.

But the timing was poor as Obama struggled to win over a majority of lawmakers for his healthcare overhaul and Congressional elections loomed large. Once the law was passed in March 2010, it brought more attention to the task force by mandating insurance coverage of services it does recommend.

Republicans opposed to the bill used the mammogram example to show how government could intrude on life or death decisions. The task force's "C" and "D" recommendations don't dictate insurance coverage, but Congress quickly turned around legislation to make sure insurers covered mammograms for women in their forties.

"The thought that my work was being use as a fulcrum by one party to kill the most substantial part of healthcare legislation since I've been in practice? I've got to tell you, that's something to lose sleep over," Calonge said.

Officials working with the panel heard that more controversy could threaten the task force budget, up for Congressional approval. In 2010, Health Department funding for the panel was $4.3 million. This year, the agency overseeing the panel spent about $11 million on work related to the task force.

Calonge says the panel wanted more evidence of how the tests could harm healthy patients, and ordered further research. He canceled a new vote on PSA screenings in November 2010, citing scheduling problems, a decision that was widely criticized.

"In my heart of hearts I'd really like to believe that we'd delay it anyway," without the surrounding politics, Calonge said. "We were trying to make the recommendations solid."

That was too much for Lin, who believed the evidence was already enough to show the public was at risk. After talking with his pastor and his wife, he quit AHRQ.

"Even delaying it for a few months, much less a year, it was really relegating the men to the harms they were exposed to," Lin said.

Read more: http://www.foxnews.com/health/2011/12/19/health-panel-takes-heat-on-cancer-screening-advice/#ixzz1h4yiyrcG

False positives show need to adjust expectations for cancer screening tests

By Manoj Jain, Published: October 31, The Washington Post

Several years ago, during an annual mammogram, my wife, who is in her 40s, was told a mass had been found in one of her breasts. Anxious and uncertain, she had a biopsy, and we braced for the worst.

My father-in-law, when in his 50s, went through a similarly harrowing experience when a prostate specific antigen (PSA) test given during a routine physical exam came out positive, and he underwent a prostate biopsy. 

Fortunately, both my wife and father-in-law were found to be victims not of cancer but of false positives. It’s a common outcome — about three of every 10 mammograms and about seven of every 10 positive PSA tests result in false alarms. Like my wife and father-in-law, many people may feel that the short-term pain of these tests is worth the reassurance that they are cancer-free. But lately the idea that screening tests are a surefire weapon against cancer has been undermined.

New guidelines, new fears

We have been programmed to believe that early detection through screening saves lives. Seventy-five percent of men over the age of 50 have had a prostate specific antigen (PSA) test; 67 percent of women over the age of 40 have had a mammogram in the past two years; and 55 percent of women get a Pap smear every year.

New guidelines and studies, however, have raised new questions and re-ignited debate over whether these tests may in fact do more harm than good. Earlier this month, the U.S. Preventive Services Task Force (USPSTF), a government-appointed scientific advisory board, recommended against routine PSA tests to screen for prostate cancer. The same panel also suggested that a Pap test every three years is as good as an annual test. Two newly published studies suggest reducing the number of mammograms in women under 50; one went so far as to conclude that “most women with screen-detected breast cancer have not had their life saved by screening. They are instead either diagnosed early (with no effect on their mortality) or overdiagnosed.”

How can this be? We have relied on these tests for decades to screen for cancer in otherwise healthy individuals. The truth is that PSA, mammogram and the Pap smear are poor screeners — and always have been. The levels of prostate specific antigen — the marker for cancer — can be elevated for a variety of reasons, like a benign prostate enlargement or a prostate infection. A mammogram can be read as suspicious due to a cyst, a benign fluid collection; a Pap smear is often reported as abnormal due to abnormal cells caused by a local infection.

The fallacies of these screening tests extend beyond the false positives or excessive mistaken alerts. These tests frequently miss the diagnosis of cancer or result in false negatives. The PSA will be normal in two of every 10 patients with prostate cancer and the mammogram will be normal in two of every 10 patients with breast cancer. The Pap smear will miss cervical cancer in three of 10 patients.

The tests are also potentially harmful. They lead to subsequent testing such as a biopsy, which can cause complications such as infection or lead to treatment of a cancer that would not have otherwise caused any harm.

‘We need better tests’

It’s hard to argue with my wife’s plea: “We need better tests.” But until new screening methods are developed, we need to adjust our expectations of the ones we have. As Virginia Moyer, a professor at the Baylor College of Medicine and head of the USPSTS, puts it, we need to get away from the false notion that “if some prevention is good, then more is better.”

So what would “a better test,” as my wife puts it, look like? It should be accurate, inexpensive, easy to administer and noninvasive, like the HIV blood test, which is 99 percent accurate and costs only about $15. Researchers are pursuing a variety of improvements for cancer screening tests, including one for prostate cancer that tracks blood calcium levels following a PSA test and another that tests urine for a genetic marker. But such tests are years away from being available to the general public.

In the meantime, should we throw away the PSA test, mammography and the Pap smear? Absolutely not. But we should certainly rethink their administration — limiting these tests to those who may be at higher risk of cancers because of their age, family history or presenting symptoms.

The PSA test has more value in the urologist’s office than in the primary care doctor’s office. It is helpful in patients who have an abnormal rectal exam or a family history of prostate cancer. A routine mammogram saves lives both in women over 50 and younger women with a family history of breast cancer. And a Pap smear done regularly reduces the risk of cervical cancer incidence and mortality by at least 80 percent.

A case-by-case decision

We should also remember that guidelines are just that — recommendations. Doctors need to tailor them to each patient’s situation. When a patient is anxious and requests an inexpensive, noninvasive test, I am willing to agree to it, as long as the patient is informed about the limitations. The question is whether insurers and Medicare are willing to pay for such tests.

Ultimately, the new guidelines and studies add a wrinkle to the already complex medical decision-making process: Are we willing to undergo an imperfect screening test? Or should we forgo it?

My wife has elected to continue with mammograms in her 40s despite the new research. “But if I miss a year or two, I am less worried,” she said.

As for me, when I turn 50 in a few years, I plan to skip the PSA test.

Jain is an infectious-disease specialist in Memphis and an adjunct assistant professor at the Rollins School of Public Health at Emory University in Atlanta.

Why Nicotine is a Gateway Drug

A new study in mice shows how tobacco products could act as gateway drugs, opening the door to use of illicit drugs. Nicotine, the researchers found, makes the brain more susceptible to cocaine addiction. The finding suggests that lowering smoking rates in young people might help reduce cocaine abuse.

http://www.nih.gov/researchmatters/november2011/11212011nicotine.htm 

Screening for Testicular Cancer:  U.S. Preventive Services Task Force Reaffirmation

The U.S. Preventive Services Task Force has reaffirmed its 2004 recommendation against screening for testicular cancer in adolescent and adult males without any symptoms.  This is a grade D recommendation.  The recommendation was published in the April 5 issue of Annals of Internal Medicine.  Select to access the recommendation.  

ONS Prevention/Early Detection SIG members are encouraged to submit nominations for new clinical preventive health topics for consideration by the US Preventive Services Task Force.  Please read the notice for submission instructions.