By Leah Voigt Romano*
Stanford University to Limit Drug Maker Financing
Stanford University was expected to announce this week that it will severely restrict industry financing of doctors' continuing education at its medical school. The policy is another step the University is taking to limit the influence drug companies have on medical education.
Nearly all physicians must take annual refresher courses that are historically paid for by drug makers. While the industry says its money is intended solely to keep physicians up to date, critics charge that companies agree to support only classes that promote their products. Stanford plans to announce that it will no longer let drug and device companies specify which courses they wish to finance. Instead, companies will be asked to contribute only to a schoolwide pool of money that can be used for any class, even ones that never mention a company's products.
With its approach, Stanford becomes the sixth major medical school—including those at the universities of Massachusetts, Pittsburgh, Colorado, Kansas, and California Davis—to form schoolwide pools for university contributions to medical education, according to the Prescription Project, a nonprofit organization that largely opposes industry financing of medical education. The Memorial Sloan-Kettering Cancer Center, meanwhile, has banned all industry support for its doctor classes.
Dr. David Korn, chief scientific officer of the Association of American Medical Colleges, said Stanford's new policy was "an extremely important step forward." The association recommended in June that medical schools pool contributions from companies as a means of shielding teachers from commercial influences. Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said that "America's pharmaceutical research companies have taken positive steps to help ensure they provide nothing but accurate and balanced information to healthcare providers."
Gardiner Harris, Stanford to Limit Drug Maker Financing, N.Y. TIMES,
Aug. 25, 2008.
AHA Urges CMS to Reconsider Quality-Reporting Initiatives
In a letter to acting CMS Administrator Kerry Weems, the American Hospital Association (AHA) urged the agency to reconsider its quality-reporting requirements, among other payment methodologies, in its proposed outpatient prospective payment system rule for 2009.
In addition, CMS has not adequately demonstrated that creating two cost centers for drugs, which will lead to extra resource burden on hospitals, will result in improved payment accuracy, according to the AHA. The proposed payment rate for separately covered outpatient drugs is based on a methodology that contains flaws, as well, the AHA wrote. The association said it supports CMS' process for validating outpatient quality data and its proposal to pay for partial hospitalization program services using two new ambulatory payment classifications.
Jean DerGurahian, CMS Urged to Reconsider Quality-Reporting Moves, Modern Healthcare's Daily Dose, (Aug. 28, 2008) (note: registration is required to view this content).
Older Smokers' Quit Rate Improves with Patches, Telephone Counseling
A recent Medicare demonstration program showed that older smokers doubled their quit rate when given nicotine patches and access to telephone counseling. The one-year quit rate was 20% compared with 10% for smokers who received a brochure about smoking cessation (the usual method of care). Physician counseling and the combination of counseling and medical therapy also led to higher quit rates compared with usual care.
According to the authors of the study report, "The results of this study suggest that a fully integrated [Medicare] benefit structured around low-cost pharmacotherapy in conjunction with available free 'quit line' services would substantially reduce the prevalence of smoking and smoking-related illness among elderly beneficiaries motivated to quit, at a relatively modest cost." Smoking-cessation efforts have primarily targeted the young, before they become habitual smokers. However, increasing evidence suggests that quitting smoking after decades of exposure can substantially reduce smoking-related illness, the authors noted.
Most private and public health plans do not fully cover smoking-cessation services, in part because of a lack of evidence that insurance coverage increases long-term abstinence, particularly among older adults who often have smoked for decades.
The Medicare Stop Smoking Program is the first large-scale demonstration to test the effectiveness and cost-effectiveness of Medicare coverage for smoking cessation. The study involved 7,354 persons ages sixty-five and older in seven states (Alabama, Florida, Ohio, Oklahoma, Missouri, Nebraska, and Wyoming).
Charles Bankhead, Older Smokers' Quit Rate Rises with Patches and Phones, MedPage Today, Aug. 25, 2008.
California Bill Targets Snooping in Medical Records
In response to a recent rash of hospital workers snooping into the medical records of celebrities such as Britney Spears and Farrah Fawcett, the California State Senate passed a bill that would provide more oversight and penalties for such privacy breaches.
The legislation would require healthcare providers, including hospitals, to implement safeguards to protect patients' medical information. The measure would establish a statewide Office of Health Information Integrity within the state Health and Human Services Agency. The director of that office could assess fines of up to $250,000 against those who violate patient privacy rules and make recommendations on further investigations, discipline or licensing reviews.
Lawmakers passed the bill by a vote of twenty-nine to seven and it now moves to the state Assembly. Backers of the bill include Gov. Arnold Schwarzenegger—whose wife Maria Shriver was a target of medical files snooping—and the California Hospital Association.
UCLA Medical Center, where as many as 127 workers peeked at confidential medical records, according to the state, submitted a plan of correction to the state Department of Public Health over the issue and remains under investigation. The 595-bed hospital is retraining physicians, employees, and medical students on privacy rules and has enhanced information systems, said a hospital spokeswoman.
Rebecca Vesely, Calif. Bill Targets Snooping in Medical Records, Modern Healthcare's Daily Dose, (Aug. 27, 2008) (note: registration is required to view this content).
HHS Releases Proposed Rule on Conscientious Objections that Would Protect Providers Who Refuse to Perform Abortions
Secretary of Health & Human Services Mike Leavitt announced late last week plans to implement a regulation intended to protect healthcare providers and other workers from disciplinary measures if they refuse to provide abortions or refer patients to other providers for abortions because of personal, religious, or moral reasons. Under the proposed regulation, federal officials could withdraw federal funding from more than 584,000 hospitals, clinics, health plans, physicians, and other entities if they do not accommodate employees who refuse to participate in a procedure or medical service to which they object.
If the proposed regulation takes effect, health institutions would have to certify in writing that they are complying with the rule. The proposed regulation also would establish a system for enforcing conscience protections in three separate federal laws. The rule could go into effect after a thirty-day public comment period and could cost more than
$44 million to implement.
An earlier draft of the proposed regulation included language that defined abortion—for the first time in a federal law or regulation—as anything that interferes with a fertilized egg after conception. That language was eliminated, but supporters and opponents maintain that the proposed regulation remains broad enough to protect healthcare providers who decline to provide oral contraception, Plan B emergency contraception, and other types of contraception. The proposed rule also would allow healthcare providers to decline giving patients information about such treatments or services.
Kaiser Daily Health Policy Report, HHS Releases Proposed Rule on Conscientious Objections that Would Protect Providers Who Refuse to Perform Abortions, Henry J. Kaiser Fam. Fdn. (Aug. 25, 2008).
FDA Approves Molecular Rejection Test for Heart Transplants
The FDA has approved a non-invasive molecular test for signs of rejection after a heart transplant. The so-called AlloMap, made by XDx of Brisbane, California, measures expression of twenty genes in immune cells, leading to a score that can give clinicians guidance as to the likelihood of rejection, the agency said.
The test uses a real-time, quantitative polymerase chain reaction assay to measure the gene expression in white cells in a blood sample, which is then combined with a proprietary mathematical algorithm to generate the score, the company said. Scores range from zero to forty, and the lower the score—compared with patients in the same post-transplant period—the lower the probability of rejection at the time of testing. "AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing postoperative heart transplant rejection," according to Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.
Currently, clinicians often monitor patients for rejection with heart biopsies, but such procedures are difficult and can be risky. According to the National Heart, Lung, and Blood Institute, the FDA said, half of all rejections happen during the first six weeks after surgery and 25% of patients have signs of possible rejection at least once during the first year following a transplant.
Michael Smith, FDA Okays Molecular Rejection Test for Heart Transplants, MedPage Today, Aug. 27, 2008.
Alabama Agency Approves Plan to Charge State Employees for Obesity, Other Health Problems
Last week, the Alabama State Employees' Insurance Board approved a plan that will require state employees who are obese or have health problems to make progress to address those issues or pay a monthly charge for health insurance.
Under the plan, state employees must undergo a health screening at no cost by January 2010 or pay a $25 monthly charge for health insurance, which all workers currently receive at no cost. In the event that the screenings find serious problems with blood pressure, cholesterol, glucose, or obesity, state employees will have one year to visit a physician at no cost, enroll in a wellness program, or take steps on their own to improve their health. If follow-up screenings do not indicate progress, state employees will have to begin to pay the monthly charge in January 2011. The board will consider state employees with a BMI of at least 35 obese. The board has not determined the amount of progress that state employees will have to make to avoid the monthly charge.
According to William Ashmore, executive director of the insurance board, the plan will cost an estimated $1.6 million next year for screenings and wellness programs but likely will result in significant savings over the long term. Ashmore said that individuals with a body mass index of 35 to 39 account for $1,748 more in annual healthcare costs than those with a normal BMI of less than 25.
Kaiser Daily Health Policy Report, Alabama Board Approves Plan to Charge State Employees for Obesity, Health Problems, Henry J. Kaiser Fam. Fdn. (Aug. 26, 2008).
*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.