By Leah Voigt*
April 2, 2010
Finance, HELP Committee Leaders Urge Changes to Meaningful Use Rule
The chairmen of the Senate Finance and Health, Education, Labor, and Pensions committees have joined other Senate and House lawmakers in urging that changes be made to the proposed "meaningful use" rule to better reflect congressional intent and to ensure healthcare providers are sufficiently encouraged to adopt electronic health records. Senators Max Baucus (D-MT) and Tom Harkin (D-IA) in a March 30, 2010, letter to U.S. Department of Health and Human Services Secretary Kathleen Sebelius praised the meaningful use rule for laying "important groundwork" for the incentive program that will pay doctors and hospitals for using health information technology (HIT) in a meaningful way.
However, the letter, signed by thirty-five other Democrats in the Senate, called for modifications to the proposed rule, including abandoning the so-called all-or-nothing approach that would require providers to meet all Stage 1 criteria to be eligible for any incentive payments. The Centers for Medicare & Medicaid Services (CMS) released the proposed rule on December 30, 2009, that was later published in the February 13, 2010, Federal Register (75 Fed. Reg. 1844). Comments on the proposal were due to CMS by March 15, 2010, and provider groups almost unanimously asked CMS for similar changes enumerated by lawmakers.
"We recommend that the proposed rule be modified from its current 'all-or-nothing' approach to one that allows providers to defer a limited set of criteria under Stage 1 of meaningful use while preserving a floor of mandatory functional use requirements, as recommended by the HIT Policy Committee," Baucus and Harkin wrote. They said that allowing providers to defer certain criteria until later stages of the meaningful use program was not the same as exempting them from those requirements, adding that all the criteria in the proposed rule should be met by providers "over the course of the incentive payment program."
The letter also called on CMS to change the rule so that physicians working in hospital outpatient departments could be eligible for incentive payments. The proposed rule currently prohibits doctors who provide 90% or more of their services in a hospital setting from being eligible for federal HIT incentives. However, House and Senate lawmakers, along with hospital and physician groups, have said the omission of those physicians is counter to congressional intent.
Kendra Casey Plank, Finance, HELP Committee Leaders Urge Changes to Meaningful Use Rule, BNA's Health Care Daily Report (Apr. 1, 2010) (note: registration is required to view this content).
Pfizer Gives Details on Payments to Doctors
Pfizer, the world's largest drug maker, said Wednesday that it paid about $20 million to 4,500 doctors and other medical professionals for consulting and speaking on its behalf in the last six months of 2009, its first public accounting of payments to the people who decide which drugs to recommend. Pfizer also paid $15.3 million to 250 academic medical centers and other research groups for clinical trials in the same period.
While other pharmaceutical companies have disclosed payments to doctors, Pfizer is the first to disclose payments for the clinical trials. The disclosure does not include payments outside the United States. A spokeswoman for Pfizer said most of the disclosures were required by an integrity agreement that the company signed in August to settle a federal investigation into the illegal promotion of drugs for off-label uses. Pfizer is the fourth major drug company to make such disclosures, following Eli Lilly, Merck, and GlaxoSmithKline. All four websites are searchable by the names of doctors or organizations, but all are set up in ways that make it difficult to download and analyze the entire database.
Beginning in 2012, drug and medical device companies will be required to disclose payments to doctors of more than $10, with the first report available in 2013. The Physician Payment Sunshine Act was passed as part of healthcare reform. Some states also have disclosure laws. Pfizer's reporting also goes beyond the Sunshine law, the company said, by not imposing a delay of up to four years on financial support for clinical trials. Pfizer plans to report the payments without the delay.
Duff Wilson, Pfizer Gives Details on Payments to Doctors, N.Y. TIMES (Mar. 31, 2010).
Flu Vaccine Update Better, But Not Great
Rates of influenza vaccination reached record levels this season, although healthcare workers and the public appeared wary of the pandemic H1N1 vaccine, two recent analyses from the Centers for Disease Control and Prevention (CDC) showed. In a survey of 1,417 healthcare professionals in January, 61.9% reported receiving the seasonal flu vaccine themselves, and another 3.1% said they were planning to be vaccinated, according to CDC representatives.
The coverage rate exceeded the Healthy People 2010 target of 60% for the first time. However, healthcare workers were less likely to have received the pandemic H1N1 vaccine, which became available in October. Only 37.1% said they had received it, with another 10% saying they planned on being vaccinated.
The findings were reported in the April 2, 2010, issue of Morbidity and Mortality Weekly Report (MMWR). In an accompanying comment, the MMWR editors said that healthcare administrators should treat flu vaccination coverage among their workers as an important measure of patient safety and attempt to increase coverage in the future. They raised a question about the inconsistent availability of the H1N1 vaccine during the epidemic period, which might have decreased the number of vaccinated healthcare workers. Since 1986, both the Healthcare Infection Control Practices Advisory Committee and the Advisory Committee on Immunization Practices have recommended that healthcare workers receive flu vaccine every year, but the coverage rate has never exceeded 49%.
Todd Neale, Flu Vaccine Update Better, But Not Great, MedPage Today (Apr. 1, 2010).
FDA Requires Device Manufacturers to Include Information on Pediatric Patients
The U.S. Food and Drug Administration (FDA) on March 31, 2010, announced that it will implement a requirement that device manufacturers provide information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use. The FDA will publish both a proposed rule and a direct final rule on the requirement in the April 1, 2010, Federal Register. FDA said it is issuing a companion proposed rule to provide the procedural framework to finalize the rule, in case the direct final rule receives any significant adverse comment and is withdrawn.
FDA in the direct final rule said it does not anticipate receiving any significant adverse comments. Comments on the rule are due by June 15, 2010. If no adverse comments are received, FDA said the rule will take effect on August 16, 2010.
According to the agency, very few devices are developed or assessed specifically for use in pediatric patients--those twenty-one years of age or younger at the time of treatment or diagnosis. The effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations, FDA said in a statement. The requirements, contained in the Food and Drug Administration Amendments Act of 2007, will also improve the FDA's ability to track the number of approved devices for which there is a pediatric subpopulation who could benefit and the number of approved devices labeled for use in pediatric patients, FDA said.
Under the 2007 legislation, manufacturers must provide certain pediatric information, if readily available, with each premarket approval application or supplement, humanitarian device exemption request, or product development protocol. Under the new requirement, manufacturers now must include a description of any pediatric subpopulations who suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Manufacturers also must include the number of affected pediatric patients, FDA said. If a manufacturer does not submit the required information, FDA said it may not approve the application until it is provided.
Nathaniel Weixel, FDA Requires Device Manufacturers to Include Information on Pediatric Patients, BNA's Health Care Daily Report (note: registration is required to view this content).
New Medical Schools Open, But Physician Shortage Concerns Persist
The number of residents and fellows is increasing, but not enough to match the loss of retiring physicians. Not a single allopathic medical school opened its doors during the 1980s and 1990s. But since 2007, more than a dozen allopathic schools have started the Liaison Committee on Medical Education accreditation process. Another ten are under discussion, and five osteopathic medical colleges have opened.
The surge in new medical schools is taking place as the Association of American Medical Colleges (AAMC) predicts a shortage of at least 125,000 physicians by 2025. Hopes among educators and physician leaders are high that the new schools can help underserved areas and spur local economic growth. But some experts on workforce issues say new schools are not enough. They say that without more federal funding for residency slots or changes in the doctor payment system, the schools are unlikely to avert an overall workforce shortage or address the undersupply of primary care physicians and general surgeons.
Many of the new schools' deans say they hope they can help ease the shortage of primary care doctors in their areas. For example, the Texas Tech University Health Sciences Center Paul L. Foster School of Medicine in El Paso admitted its charter class of forty students in July 2009. The school's founding dean, Jose Manuel delaRosa, MD, said its priority is supplying physicians to meet the needs of El Paso, the Texas-Mexico border area and rural West Texas. The area's physician supply is less than half the national average of 254 doctors per 100,000 residents, he said.
The new schools and expansion at existing schools will increase first-year enrollment by 21% in 2013, according to a May 2009 Center for Workforce Studies report. But the Balanced Budget Act of 1997 capped the number of new Medicare-paid residents that each teaching hospital can claim. The number of residents and fellows increased 8% from 1987-2007, according to an AAMC report, but that growth rate will not be enough to match the loss of baby boomer physicians set to retire soon. The American Medical Association supports lifting the cap on Medicare-supported residency positions. The Association also favors federal legislative initiatives that would provide new money for graduate medical education.
Kevin B. O'Reilly, New Medical Schools Open, But Physician Shortage Concerns Persist, Am. Med. News, (Mar. 29, 2010).
Despite Doubts About CER's Impact, Studies Should Take Place, Researcher Says
While simplistic thinking about the impact of traditionally perceived comparative effectiveness research (CER) may have adverse effects, this does not mean that the research may not have a useful role and that good research should not take place, University of Chicago researchers reported at a Federal Reserve Bank of Chicago/University of Illinois Institute of Government and Public Affairs conference last week.
Researcher Tomas Philipson told the New Perspectives on Health & Health Care Policy conference that a study by the National Bureau of Economic Research, The Impact of Comparative Effectiveness Research on Health and Health Care Spending, suggests several future issues to consider in improving the use of comparative effectiveness research. The study's analysis of the impact of comparative effectiveness research-responsive subsidies suggests a need to better understand how such research should be stratified to obtain the correct treatments for the correct subpopulations rather than focusing solely on the best treatment for all patients.
"There may not be a 'one-size-fits-all' for the entire population so having reimbursement based on such a policy induces inefficiencies,'' the researchers wrote. "In particular, our analysis suggests that the data generated by [comparative effectiveness research] should not only consider aggregate measures of response but more individualized measures beyond standard demographics such as gender, age, or race.'' Also, traditional, randomized controlled trials focusing on intention-to-treat effects are not useful when there is sequencing of treatments over time because randomized controlled trials generate marginal distributions of treatment responses, the researchers suggested.
The researchers said their analysis should be extended to include the impact of market power on the analysis, developed into a more general examination of the value of randomized controlled trials for assessing patient welfare in real world markets, and be developed to create a better understanding of when and in what areas public technology assessments offer an added value beyond similar private market activities. The researchers said they hope that such quantitative frameworks will help make precise assessments of the value of public subsidies for technology assessments not only more feasible, but more common as well.
Thom Wilder, Despite Doubts About CER's Impact, Studies Should Take Place, Researcher Says, BNA's Health Care Daily Report (Mar. 30, 2010) (note: registration is required to view this content).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.