U.S. agencies issue new rules important to dermatologists

October 1, 2007

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At FDA, the agency proposed on Aug. 23 a new regulation setting standards for formulating, testing and labeling over-the-counter sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

At CMS, two important Medicare policy changes were implemented also in August, one tightening hospital payment rules to discourage preventable in-hospital errors, injuries and infections, and the other implementing the third phase of the Stark self-referral law.

"The proposed one to four star rating of a sunscreen's UVA protective effect (corresponding to low, medium, high or very high protection) will allow consumers to more easily understand the degree of protection afforded by a particular product against the long wave (UVA) rays of the sun," Dr. Baker says.

"The academy also commends the FDA for requiring the use of a warning label on sunscreen products to emphasize the dangers of sun exposure and to educate the public on how to avoid sun damage," Dr. Baker adds.

"This warning is consistent with the academy's efforts to encourage the public to practice a comprehensive sun protection program and 'Be Sun Smart,'" she adds.

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," says Douglas Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research.

"The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen," Dr. Throckmorton says.

Hospital Payments

The hospital payment rule issued Aug. 1 responds to a congressional directive included in the Deficit Reduction Act of 2005. As a result, Medicare will not pay hospitals for the costs of treating certain "conditions that could reasonably have been prevented" during a hospital stay, including pressure ulcers, injuries caused by falls or catheter–associated infections.

Medicare also says it will not pay for the treatment of "serious preventable events," such as leaving an object in a patient during surgery and providing a patient with incompatible blood or blood products.

"If a patient goes into the hospital with pneumonia, we don't want them (sic) to leave with a broken arm," explains Herb B. Kuhn, CMS acting deputy administrator.

The provisions are contained in the FY 2008 Inpatient Prospective Payment System Final Rule, "Improving the Quality of Hospital Care," which imposes requirements on hospitals for reporting quality data as part of the annual payment update program.

According to Bush administration estimates, the new policy will save Medicare some $20 million annually. According to the Centers for Disease Control and Prevention, patients develop 1.7 million infections in hospitals annually, contributing or causing the death of 99,000 people each year. Hospitals or insurers will be required to bear the costs of any additional testing or lost reimbursement resulting from the rule, as hospitals are forbidden from passing any charges associated with the hospital-acquired complication on to the patient.

Self-Referral Phase III

Issued Aug. 27, the self-referral rules are the third phase of regulations prohibiting physicians from referring Medicare patients for certain items, services and tests provided by businesses in which they or their immediate family members have a financial interest.

"These rules protect beneficiaries from receiving services they may not need and the Medicare program from paying potentially unnecessary costs," Mr. Kuhn says.