Published 9/1/2008

Second Look – Reimbursement & Regulation

FDA can’t keep up with drug company marketing abuses
A draft report from the U.S. Government Accountability Office states that it takes the Food and Drug Administration (FDA) an average of 7 months to issue a warning if the agency finds a drug manufacturer marketing prescription medications for off-label use and that the FDA has no staff exclusively assigned to monitor whether the rule against marketing drugs for unapproved uses is being violated. Some senators are concerned that federal programs such as Medicare and Medicaid may be paying billions of dollars for medications prescribed for questionable off-label uses. A 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.

AAHC report calls need for healthcare workforce initiatives “critical”
Intensifying health workforce needs will outpace available resources unless the United States develops and implements an integrated, comprehensive national health workforce policy, according to a report issued by the Association of Academic Health Centers (AAHC). Recommendations in the report, “Out of Order, Out of Time: The State of the Nation’s Health Workforce,” include addressing these issues immediately in order to avert crises in capacity and infrastructure; developing an integrated, comprehensive national health workforce policy that recognizes and compensates for the inherent weaknesses of current decentralized multistakeholder decision-making; and creating a national health workforce planning body.

Pfizer eliminates direct support of CME programs
Citing potential conflict-of-interest concerns, Pfizer, Inc., has announced that the company will no longer directly fund physician continuing medical education (CME) programs provided by medical education and communication companies—although it will continue to honor existing commitments. Pfizer says it is developing stricter criteria for CME programs, including instituting a competitive grant review period to encourage more innovative, high-quality grant applications; supporting the medical community’s call for balanced funding in CME by establishing financial caps on grant support, and requiring that all major grant applicants meet criteria equivalent to the Accreditation Council for Continuing Medical Education’s highest level of accreditation.

DEA controlled substance proposal raises concerns
Modern Healthcare
reports that a rule proposed by the U.S. Drug Enforcement Administration (DEA) that would allow physicians to electronically prescribe Schedule II controlled substances such as OxyContin and Vicodin may require physicians to register in person with law-enforcement agencies and submit to routine audits of their prescription records. A spokesperson for the American Academy of Family Physicians says the organization supports e-prescribing, but is concerned that too many federal barriers could rein in the increases in safety and efficiency afforded by the technology.

Court supports “loss of chance” concept
The Boston Globe reports that, for the first time, the Supreme Judicial Court of Massachusetts has recognized a legal doctrine known as “loss of chance.” Under the doctrine, even a patient whose odds of recovery are 50 percent or less can sue for and receive damages for any negligence by healthcare providers that reduced those odds.

Senate to consider restrictions on imaging self-referrals
According to Modern Healthcare Online, Sen. Chuck Grassley, R-Iowa, is planning to introduce a bill that would require referring physicians to disclose any ownership interest they may have in an imaging service and to offer a list of alternative providers to Medicare beneficiaries. The so-called Medicare Imaging Disclosure Sunshine Act of 2008 is based on recommendations from the Medicare Payment Advisory Commission. The AAOS supports appropriate disclosure to patients of physician ownership interest in ancillary services. The AAOS believes, however, that the increases in medical imaging utilization are driven by good patient care and that patients’ access to healthcare services may suffer if restrictions are imposed on physicians’ ability to provide in-office imaging.

Study looks at influence of specialty hospital ownership on practice patterns
A study published in the journal Medical Care finds that physician ownership of specialty hospitals may alter the frequency of use for some procedures rendered at those hospitals. The researchers compared the practice patterns of physician owners of specialty hospitals in Oklahoma, before and after ownership, to the practice patterns of physician nonowners working in similar markets without physician-owned specialty hospitals. They found that the introduction of financial incentives linked to ownership coincided with a significant increase in the frequency of use of surgery, diagnostic, and ancillary services used in the treatment of injured workers with back/spine disorders. No such changes were found in the control group.

According to the AAOS Position Statement on Specialty Hospitals, “The AAOS believes that specialty hospitals treat patients in a safe, high quality and efficient setting. Physicians should always consider the best interests of the patient in making the determination as to the facility in which the care is provided. The provision of services to the patient should not be based on financial criteria. The selection of the best facility for the patient should be based on medical criteria and facility capabilities.”

Pain pump suits may combine in class action
A group of attorneys plans to ask a judicial panel to consolidate more than a dozen federal lawsuits against medical device-makers and anesthetic innovators into one class action, according to the Maryland Daily Record. The lawyers allege that manufacturers of pain pumps advised physicians to use the devices intra-articularly—a practice that does not have federal approval. Multiple medical papers have linked intra-articular pain pumps with the onset of postarthroscopic glenohumeral chondrolysis. At least one manufacturer claims it cannot be held liable because of the “learned intermediary doctrine,” which puts the burden of warning a patient about the dangers of a device on the physician, as long as the physician is advised about a device’s potential risk.

CMS considers reviewing hospitals’ HIPAA security compliance
The Baltimore Business Journal reports that the Centers for Medicare and Medicaid Services (CMS) may soon begin auditing hospital compliance under the Health Insurance Portability and Accountability Act (HIPAA) security rule. HIPAA security provisions encompass three principal areas—administrative, physical, and technical—and require covered entities to maintain written or electronic documentation that includes policies, procedures, actions, activities, or assessments. Documents must be retained for at least 6 years from the date of creation or when they were last put into effect. Covered entities must also periodically review their documentation and revise and update it as needed.

AMA apologizes to African-American physicians
The American Medical Association (AMA) has issued a formal apology for that organization’s history of racial bias against African-American physicians. Two accompanying articles released online in the Journal of the American Medical Association look at the history of discrimination and lay the groundwork for ensuring that the medical community of the future “accurately represents the diversity of America’s patients.” “African American Physicians and Organized Medicine, 1846-1968” is a review of discrimination in organized medicine in the United States, based on the findings of a panel of experts that examined source materials from the archives of the AMA, the National Medical Association, and various periodicals. “Achieving Racial Harmony for the Benefit of Patients and Communities” is a commentary that examines some of the complex issues behind discrimination and current programs to address them.