Obama Administration issues rules requiring parity in treatment of mental, substance use disorders

/PRNewswire/ -- The U.S. Departments of Labor, Health and Human Services (HHS), and the Treasury today jointly issued new rules providing parity for consumers enrolled in group health plans who need treatment for mental health or substance use disorders.

"Today's rules will bring needed relief to families faced with meeting the cost of obtaining mental health and substance abuse services," said U.S. Secretary of Labor Hilda L. Solis. "The benefits will give these Americans access to greatly needed medical treatment, which will better allow them to participate fully in society. That is not just sound policy, it's the right thing to do."

"The rules we are issuing today will, for the first time, help assure that those diagnosed with these debilitating and sometimes life-threatening disorders will not suffer needless or arbitrary limits on their care," said Secretary of Health and Human Services Kathleen Sebelius. "I applaud the longstanding and bipartisan effort that made these important new protections possible."

"Workers covered by group health plans who need mental health and substance abuse care deserve fair treatment," said Deputy Treasury Secretary Neal Wolin. "These rules expand on existing protections to ensure that people don't face unnecessary barriers to the treatment they need."

The new rules prohibit group health insurance plans -- typically offered by employers -- from restricting access to care by limiting benefits and requiring higher patient costs than those that apply to general medical or surgical benefits. The rules implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

MHPAEA greatly expands on an earlier law, the Mental Health Parity Act of 1996, which required parity only in aggregate lifetime and annual dollar limits between the categories of benefits and did not extend to substance use disorder benefits.

The new law requires that any group health plan that includes mental health and substance use disorder benefits along with standard medical and surgical coverage must treat them equally in terms of out-of-pocket costs, benefit limits and practices such as prior authorization and utilization review. These practices must be based on the same level of scientific evidence used by the insurer for medical and surgical benefits. For example, a plan may not apply separate deductibles for treatment related to mental health or substance use disorders and medical or surgical benefits. They must be calculated as one limit. MHPAEA applies to employers with 50 or more workers whose group health plans choose to offer mental health or substance use disorder benefits. The new rules are effective for plan years beginning on or after July 1, 2010.

The Wellstone-Domenici Act is named for two dominant figures in the quest for equal treatment of benefits. The late Sen. Paul Wellstone, D-Minn., who was a vocal advocate for parity throughout his Senate career, sponsored the ultimately successful full parity act. He was joined by former Sen. Pete Domenici, R-N.M., who first introduced legislation to require parity in 1992. Champions of the legislation also included the bipartisan team of Rep. Patrick Kennedy, D-R.I., and former Rep. Jim Ramstad, R-Minn.

The issue of parity dates back more than 40 years to President John F. Kennedy, and also was supported by President Clinton and the late Sen. Edward Kennedy.

The interim final rules released today were developed based on the departments' review of more than 400 public comments on how the parity rule should be written. Comments on the interim final rules are still being solicited. Sections where further comments are being specifically sought include so-called "non quantitative" treatment limits such as those that pertain to the scope and duration of covered benefits, how covered drugs are determined (formularies) and the coverage of step-therapies. Comments are also being specifically requested on the regulation's section on "scope of benefits" or continuum of care.

Comments on the interim final regulation are due 90 days after the publication date. Comments may be emailed to the federal rulemaking portal at http://www.regulations.gov/. Comments directed to HHS should include the file code CMS-4140-IFC. Comments to the Department of Labor should be identified by RIN 1210-AB30. Comments to the Treasury's Internal Revenue Service should be identified by REG-120692-09. Comments may be sent to any of the three departments and will be shared with the other departments. Please do not submit duplicates.

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FDA Launches New Center for Tobacco Products

The U.S. Food and Drug Administration today launched its new Center for Tobacco Products in an historic effort to curb the hundreds of thousands of deaths caused by those products each year.

The Center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009. The FDA’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, and establishing and enforcing advertising and promotion restrictions.

Lawrence Deyton, M.D. M.S.P.H., an expert on veterans’ health issues, public health, tobacco use, and a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences, will serve as the Center’s first director.

“We are thrilled to announce Dr. Deyton’s appointment as director of the Center for Tobacco Products and look forward to him joining the agency,” said FDA Commissioner Margaret A. Hamburg, M.D. “He is the rare combination of public health expert, administrative leader, scientist, and clinician.”

Before coming to the FDA, Deyton was Chief Public Health and Environmental Hazards Officer for the U.S. Department of Veterans Affairs. His responsibilities there included oversight of the VA’s public health programs including tobacco use, the health of women veterans, the long-term health consequences of military service, and the VA’s emergency preparation and response. He was selected after a national search.

The FDA’s Center for Tobacco Products, located on the FDA’s White Oak Campus in Silver Spring, Md., will use the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.

To implement the program, the FDA will start with $5 million from the fiscal year 2009 budget to establish the necessary administrative functions for the Center. As set forth in the Family Smoking Prevention and Tobacco Control Act, funding for the Center and other activities related to the regulation of tobacco will come from user fees paid by manufacturers and importers of tobacco products.

According to the Centers for Disease Control and Prevention, cigarette smoking causes an estimated 438,000 deaths, or about 1 of every 5 deaths, each year. On average, adults who smoke cigarettes die 14 years earlier than nonsmokers.

“As many Americans know, freedom from tobacco dependence is the key to a healthy future,” said Assistant Secretary for Health Howard Koh, M.D., M.P.H. “Dr. Deyton’s public health and tobacco cessation experience will be invaluable as the Department of Health and Human Services and the Food and Drug Administration take on this challenge.”

One of Deyton’s priorities had been revitalization of the VA’s smoking and tobacco use cessation programs. Under his leadership, current smoking among veterans enrolled in the cessation program fell from 33 percent in 1999 to 22 percent in 2007. The VA health care system is the largest integrated provider of health care and medical services in the United States, with more than 1,400 sites serving nearly 6 million veterans in fiscal year 2008.

“I am eager for the challenge of leading the tobacco team at FDA,” said Deyton. “This is a tremendous opportunity for us at FDA to work hand-in-hand with the CDC, researchers at the National Institutes of Health, and public health leaders in the states to make progress in combating tobacco use – the leading cause of preventable death in the United States.”

In 2002, Deyton established the VA’s Public Health Strategic Health Care Group, which encompassed responsibilities for HIV, hepatitis C, tobacco use cessation, bioterrorism, and issues such as SARS, pandemic influenza, and other emerging public health threats. He became Chief Officer in January 2006 and since then has been successful in efforts to address the health needs of veterans.

Deyton has served for 11 years in leadership positions in the National Institute of Allergy and Infectious Diseases at NIH, six years in the Office of the Assistant Secretary for Health at HHS, and as a legislative aide with the House of Representatives Subcommittee on Health and the Environment in the 1970s.

He was a founder in 1978 of the Whitman Walker Clinic, a community based AIDS service organization in Washington, D.C. He is a graduate of Kansas University, the Harvard School of Public Health and the George Washington University School of Medicine. Deyton’s post-doctorate medical training was at the University of Southern California/Los Angeles County Medical Center. He is board certified in Internal Medicine and continues to care for patients on a regular basis.

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CAHI Says Health Insurers Are Not the 'Problem'

/PRNewswire/ -- Today, Dr. Merrill Matthews, executive director of the Council for Affordable Health Insurance (CAHI), released the following statement:

After months of several health care industry groups bending over backward to work with the Obama administration and the Democratic leadership in Congress on health care reform, the Democrats have apparently decided to make a pariah out of one (at least for now) of those groups: health insurers.

"Of course they've been immoral all along in how they have treated the people that they insure," House Speaker Nancy Pelosi was quoted last week as saying. "They are the villains. They have been part of the problem in a major way."

One might have thought all that industry willingness to work closely with Congress and the administration would have earned a little respect. Apparently not.

And these aren't the ramblings of some rogue politician, nor are they off-the-cuff gaffes. I received some internal Democratic strategy memos last week; attacking health insurers is official Democratic policy now.

Democrats are losing their effort to dramatically restructure the health care system -- not just the health insurance industry -- and they have made a political decision to villainize health insurers in hopes of recapturing their earlier momentum.

Well, CAHI intends to defend the health insurance industry, which has been paying health care bills -- about $616 billion in 2008, according to the actuarial firm Milliman -- saving lives and protecting families' assets for decades. And, of course, picking up the cost shift from Medicare and Medicaid underpayments.

The vast majority of health insurers, the people working for them, and the agents who sell their products are dedicated professionals who, unlike most members of Congress and the Obama administration, actually understand the health care delivery and financing systems.

These folks dedicate their lives to making a difference, and those efforts appear in poll after poll showing that the large majority of Americans like their health coverage. It is outrageous that a group of politicians now plan to ridicule and demonize health insurance professionals and agents for no other reason than to pass legislation that won't solve the fundamental problems while costing the country more than a trillion dollars.

Had the Democratic leadership and the Obama administration wanted to simply address the problem of the uninsured, they could have done it with wide bipartisan and public support. Had they wanted to address health insurance access problems or growing health care costs, they could have done it with wide bipartisan and public support.

But they have taken an opportunity to pass needed reforms and turned it into a wish list of everything they could pack in a bill with the hope of slipping it by the public with little or no scrutiny. That plan has backfired. Indeed the public has turned on the plan, so the plan creators are turning on health insurers in an effort to deflect the anger.

Health insurers are not the "problem," as Speaker Pelosi asserts, and they certainly aren't "villains." They have done their best to play a constructive role. What's killing health care reform is the cost and scope of change she and the president are demanding, and the fact that almost everything they claim will improve the health care system will actually make it worse. If the Speaker wants to find a villain in health care reform, she might start with her own party's proposal.

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Congress Must Recognize Homecare as Cost-Effective Part of Health Care Reform

/PRNewswire/ -- In their effort to find savings in the healthcare system, the Obama administration and Members of Congress have been eyeing Medicare's home medical equipment (HME) sector for cuts. This sector provides medical oxygen, respiratory therapy, hospital beds, wheelchairs, walkers and other equipment and services that allow people to get the care they need at home instead of in a hospital or nursing home.

Already in 2009, Medicare payments for the most commonly prescribed home medical equipment categories have been cut by 9.5 percent. Medical oxygen reimbursement has been cut by 27 percent so far this year. Another measure aimed at cutting HME costs further is so-called "competitive" bidding.

"The American Association for Homecare urges Congress to recognize that home care is a cost-effective alternative to more expensive forms of care, and should therefore be a critical component -- not a casualty -- of American health care reform. Current and proposed cuts to Medicare's home medical equipment sector are not an effective way to reduce overall Medicare spending. These cuts are likely to increase Medicare costs over time by forcing more seniors into nursing homes and hospitals, blocking preventative care, and causing more frequent visits to emergency rooms.

"Quality home medical equipment and services facilitate hospital discharges, reduce hospital readmissions and emergency room visits, and help to keep seniors and people with disabilities out of more expensive institutional settings. As Congress debates health care reforms, it is important that it keeps these facts in mind and recognizes home care as a partner in improving the quality of American health care and reducing overall health care costs.

"Most home medical equipment costs just dollars a day. The cost of providing the equipment and service for home oxygen, for example, is less than $7 per day under Medicare. Compare that to the average daily cost of about $200 for a nursing facility and more than $5,000 per day for a hospital stay under Medicare.

"According to a recent study in the New England Journal of Medicine, up to one-fifth of all Medicare patients are readmitted to hospitals within one month of being discharged. These unplanned visits cost Medicare an estimated $17 billion in 2004. One reason for the high readmission rates is the lack of continued interaction and guidance once patients are dismissed. Home medical equipment providers help to fill this gap by smoothing the transition from hospital to home with the equipment and services patients need.

"This year, Medicare payments for the most commonly prescribed home medical equipment categories have been cut by 9.5 percent, including complex rehabilitative power wheelchairs. Medical oxygen reimbursement has also been cut by 27 percent so far this year. Home oxygen is a critical, life-sustaining medical treatment prescribed to nearly 1.5 million Medicare patients each year who suffer from respiratory illnesses such as chronic obstructive pulmonary disease.

"Another measure aimed at cutting HME costs further has been labeled 'competitive' acquisition. A regulation enacted in the final hours of the Bush administration would selectively contract with a small number of home care providers based on a race to bid the lowest payment. Even among those who agree to new bid-determined payment rates, Medicare only allows a select few to provide the items, which will have the long-term result of reducing the number of companies competing to offer home care products.

"These cuts in reimbursement are having a negative impact on the quality of equipment and the level of services that providers are able to furnish to consumers who have severe disabilities and who are in greatest need of mobility products and services.

"Home medical equipment and service is already the most cost-effective slowest-growing portion of Medicare spending, increasing only 0.75 percent per year, according to the latest National Health Expenditures data from Medicare. That compares to more than 6 percent annual growth for Medicare spending overall. Moreover, home medical equipment represents only 1.6 percent of the Medicare budget.

"As Congress deliberates cuts to Medicare, they would do well to recognize that cuts to home medical equipment will increase long-term Medicare costs. The home medical equipment sector should be seen as a key element in reducing overall Medicare costs."

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Stem cell Research could be New Economic Engine

President Obama’s anticipated action on the isolation of new embryonic stem cell lines is welcome news to many, but frankly, it will have little impact on speeding stem cell therapies for the majority of Americans who need them. Those in need of therapies will continue to wait.

The initial outcome of the president’s act is simple: researchers in states such as California and New York that made major investments to fund and create new stem cell lines will have more flexibility. Instead of duplicating laboratories - one for federal funding and one for state funding - labs in these states can combine stem cell lines in one laboratory, freeing resources for additional research.

However, advancing stem cell therapies will require more financial investment from both the public and private sectors.

Little new research will happen in Georgia if only new lines are allowed and dollars aren’t available to turn them into therapies. That isn’t to say we aren’t in the game. Thankfully, despite political setbacks, stem cell researchers in Georgia haven’t sat on the sidelines during the Bush administration. They’ve made major advances.

It’s important to note that although politics put us behind some of the more progressive states, Georgia institutions have a proven, competitive record for being awarded scarce federal stem cell funds. So the notion that Georgia and stem cells don’t mix is wrong.

Significant research funding has been awarded to researchers in the state through several sources, including the National Institutes of Health and National Science Foundation. Even the U.S. Department of Defense is funding regenerative medicine and, indirectly, stem cells. Continued funding is keeping Georgia fiercely competitive in fundamental areas. We are poised and ready to implement advancements in this field.

Progress Report

Georgia researchers are alive and well in the stem cell race. A 2006 study showed that 67 percent of the state is supportive of stem cell research.
The University of Georgia is advancing the basic understanding of stem cells in cancer and drug discovery and is determining the effectiveness of new stem cell therapies. The Medical College of Georgia is advancing nonembryonic stem cell therapies. Emory University recently announced their participation in a cell therapy for amyotrophic lateral sclerosis (ALS) and a few weeks ago hosted a meeting on the use of cellular therapies in the treatment of lung injury.

The Georgia Tech/Emory Center on regenerative medicine is combining stem cells with biomaterials and developing related enabling technologies. GTEC recently brought together industrial and university leaders in a workshop on stem cell biomanufacturing that focused on translating advances in basic stem cell biology into the therapies needed for patients.

So what is the potential impact of future stem cell research in Georgia? Already, through federal research grants, Georgia is training the next generation of stem cell scientists for an ever-expanding commercial market. Economic impact studies suggest that stem cell companies will have sales exceeding $3 billion per year by the end of this year with annual growth between 10 percent and 30 percent.

Brain drain

While some of our trained stem cell graduate students have been recruited to fledgling stem cell companies in Georgia, most of our best students are being snatched up by Ivy League schools and leading stem cell companies in other states as soon as their training is complete. If we don’t create opportunities within our state, we will continue to lose these leaders and fall further behind. We have access to and can train the work force for local stem cell companies. Keeping them in Georgia is the issue.

The stem cell train has left the station, and Georgia’s scientists are on it. We now need the public to get on board. Obama can help stoke the fires on that train with additional funding that will give our state a two-for-one benefit: improving health and improving economic development.

The foundation has been laid in our state and can be leveraged for high-paying stem cell jobs that will help improve the quality of life for Georgians. Georgia’s higher institutions educate students that are going elsewhere for high-paying careers. Our goal should not end at education; rather, we also must attract the companies to the state to keep our best here in rewarding careers. Georgians must actively steer the stem cell economics train toward our state instead of standing on the platform and watching it go elsewhere.

We, as a state, have a competitive set of complementary skills that competes with anyone in the world. To move the momentum forward, researchers across the state have banded together to form the Georgia Stem Cell Initiative. More information about this group, as well as how to get involved, is available at the Web site www.georgiastemcell.org .

By Steven L. Stice
University of Georgia

Robert M. Nerem
Georgia Institute of Technology

Steve L. Stice is a Georgia Research Alliance Scholar and director of the University of Georgia Regenerative Bioscience Center and is the founder of ArunA Biomedical, Inc., a Georgia stem cell company.

Robert M. Nerem is the Parker H. Petit Professor for Engineering in Medicine at the Georgia Institute of Technology and director of the Georgia Tech/Emory Center for the Engineering of Living Tissues, a National Science Foundation-funded engineering research center.

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