February 2001 Bulletin

In Brief

GAO finds flaws in malpractice data base records

A General Accounting Office report on the National Practitioner Data Bank "confirms our worst fears [that] the mechanisms to ensure the quality and accuracy of reported information have never been put into place in the 10 years the data bank has been in operation," William W. Tipton Jr., MD, AAOS executive vice president, said at a Washington, D.C. press conference. "Reliability, verification and maintenance processes are nonexistent, according to the study."

The GAO said the data on medical malpractice payment reports were incomplete and reports of state licensure actions were inaccurate or misleading on the severity or number of times practitioners had been disciplined. Also, about one-third of the 79 clinical privilege restriction reports that were reviewed had inaccurate information.

The GAO said the data bank has not addressed problems of underreporting of clinical privilege restrictions by hospitals and has not implemented a 13-year-old law to include information on nurses and other health care practitioners.

The AAOS said the majority of reports in the data bank pertain to malpractice claims, yet malpractice claims can be very misleading and provide no real indication that practitioners are providing substandard care. Few judgments generally include a finding of negligence and reporting does not take into consideration many issues that can significantly affect the number and amounts of malpractice judgments and settlements including the types of treatment and the nature of the practitioner’s specialty.

HCFA issues regs on self-referral

The Health Care Financing Administration issued final regulations for the physician ownership and referral statute known as Stark II.

Consistent with the proposed rule, the final rule prohibits physicians from making referrals for the targeted services to most entities which the physicians own in whole or in part. However, the final rule generally permits physicians to refer to entities with which they have a compensation relationship, as long as the compensation paid to the physician is no more than would be paid to someone who provided the same services but was not in a position to generate business for the entity.

The final rule also clarifies some of the exceptions to the self-referral prohibition and offers guidance regarding how to structure financial arrangements to comply with the exceptions.

The Legal Issues column on page 29 examines some provisions. The AAOS Washington office staff is reviewing the rule and will post its analysis on the AAOS home page at www.aaos.org. The regulation is in the Jan. 4, 2001 Federal Register at http://www.access.gpo.gov/su_docs/fedreg/a010104c.html (See Health Care Financing Administration)

IG finds deficiencies in tissue banks’ testing

Federal authorities got a pat on the back for the absence of new cases of disease transmission through human tissue since the Food and Drug Administration’s 1993 regulation, however, the same report cited serious deficiencies in tissue banks’ screening and testing practices.

A report by the Office of the Inspector General (IG) of the Department of Health and Human Services found at least 36 tissue banks have never been inspected by the FDA out of the 154 tissue banks that the IG was able to identify. Of the 118 tissue banks that FDA has inspected, 68 have been inspected only once. Information is lacking about the number of tissue banks in operation and the products they produce and distribute.

The IG said the American Association of Tissue Banks accredits 58 tissue banks; the IG identified 90 tissue banks that were not accredited. Only two states inspect tissue banks–Florida and New York.

In those tissue banks that were inspected, the report cited numerous safety and quality issues found by FDA inspectors and adverse event reports to states. These included routine acceptance of tissue for further manufacturing without records to document that the donor’s serum specimen had been tested and found negative. Also, confirmatory testing was repeated until negative result was obtained for hepatitis B surface antigen and hepatitis C antibody. The IG cited release of tissue from donors who had tested repeatedly reactive for hepatitis B surface antigen. The IG also cited acceptance of foreign tissue with donor records not translated into English and without documented medical/social histories.

The IG recommended FDA expedite publication of its regulatory agenda that requires registration of tissue banks, enhanced donor suitability screening and testing, and the use of good tissue practices. FDA also should set a realistic, yet aggressive date by which it would complete initial inspection of all tissue banks and should determine an appropriate minimum cycle for tissue bank inspections.

Names in the news

Appointments to the new congressional committees finds Rep. Bill Thomas (R-Calif.) as chairman of the House Ways and Means Committee. Rep. Thomas said his priorities would include Medicare reform and adding a prescription drug to the Medicare program. He named Rep. Nancy Johnson (R-Conn.) to succeed him as head of the Ways and Means health subcommittee.

Rep. Ralph Regula (R-Ohio) is chair the House Appropriations Labor-Health and Human Services Subcommittee. Now in his 14th term in Congress, Rep. Regula was vice chairman of the Appropriations Committee.

No one needs to be reminded that former first lady Hillary Rodham Clinton played a major role in an attempt to revamp health care in the United States during the first term of the Clinton administration. Now Sen. Clinton (D-N.Y.), she was appointed to serve on the Senate Health, Education, Labor and Pensions Committee.

Donna Shalala, Secretary of Health and Human Services will become president of the University of Miami on June 1, 2001. Her eight-year tenure makes her the longest-serving Secretary of HHS. Wisconsin Gov. Tommy Thompson is President Bush’s nominee to head HHS.

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