News in brief - Jan. 30, 2012

HHS finalizes women's health coverage rules

The Dept. of Health and Human Services will require insurance plans to cover a full range of preventive health services for women without patient cost-sharing, including approved forms of contraception, under a final rule released Jan. 20.

HHS finalized coverage requirements recommended by the Institutes of Medicine in July 2011. Services such as HIV screening and counseling for sexually active women, domestic abuse care, and lactation support and counseling must be covered by insurance plans. The list also includes contraception, such as birth control pills and the "morning-after pill," approved by the Food and Drug Administration.

"Women will not have to forgo these services because of expensive co-pays or deductibles, or because an insurance plan doesn't include contraceptive services," HHS Secretary Kathleen Sebelius said. "This rule is consistent with the laws in a majority of states, which already require contraception coverage in health plans."

HHS received more than 200,000 comments on an interim final rule establishing the requirements that was published in August 2011. Nonprofit, religious employers that do not provide contraception coverage would have until Aug. 1, 2013, to comply with the new law. The Obama administration at one point had floated the idea of carving out an exception for these employers.

Religious organizations that object to contraception called the HHS decision unconscionable and vowed to fight the new mandates. "This is nothing less than a direct attack on religion and First Amendment rights," said Franciscan Sister Jane Marie Klein, chair of the Franciscan Alliance, representing 13 Catholic hospitals. "I have hundreds of employees who will be upset and confused by this edict."

The U.S. Conference of Catholic Bishops indicated after the final rule was released that it might sue the administration to block the requirements.

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New Jersey ends cosmetic procedures tax

New Jersey Gov. Chris Christie on Jan. 17 signed a bill phasing out a 6% tax on gross receipts from cosmetic procedures. The New Jersey House had adopted the measure unanimously on Jan. 9, and the Senate approved it 33-2 on Sept. 26, 2011.

The repeal was supported by Stop Medical Taxes, a coalition largely of physician organizations that oppose taxes on medical procedures. Members include the American Medical Association and the American Society for Dermatological Surgery. The Medical Society of New Jersey also actively supported the repeal, said Lawrence Downs, the association's CEO and general counsel.

The repeal will reduce state tax revenues by about $10.8 million a year starting in 2014, the first year of full repeal. The bill reduces the cosmetic procedures tax to 4% retroactive to July 1, 2011, 2% on July 1, 2012, and fully repeals it on July 1, 2013.

New Jersey authorized the tax in 2004. Its repeal leaves Connecticut as the only state with a tax on cosmetic procedures.

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DEA, drug companies blamed for ADD and ADHD drug shortages

Four House Democrats have questioned the Drug Enforcement Agency and two drug companies about shortages for drugs used to treat attention deficit and attention-deficit/hyperactivity disorders.

A Jan. 17 letter from Reps. Henry Waxman (D, Calif.), Diana DeGette (D, Colo.), Frank Pallone Jr. (D, N.J.) and Chris Van Hollen (D, Md.) accused the DEA of miscalculating and mismanaging quotas for ADD and ADHD medications. Citing a recent New York Times article, the Democrats stated that the drug companies Novartis and Shire Pharmaceuticals may have taken advantage of the quota system and created shortages of generic versions of the drugs. This has forced some patients to purchase the more expensive brand-name versions.

The DEA has denied that such a drug shortage exists.

Novartis spokeswoman Julie Masow issued a company statement that said the company will cooperate with the inquiry and is taking the matter seriously. "We are also working diligently to increase supply of our generic ADHD medicines to meet customer demand and are committed to helping ensure the appropriate patients have the ability to fill their prescriptions."

A spokesman for Shire Pharmaceuticals did not respond to a request for comment by this article's deadline.

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American Red Cross fined for unsafe blood practices

After a seven-month investigation, the Food and Drug Administration has fined the American Red Cross more than $9 million for unsafe blood donation practices.

The agency inspected 16 Red Cross blood services facilities between April and October 2010 and found significant violations, according to an FDA letter sent Jan. 13 to the Red Cross. Violations included inadequate managerial control, inadequate donor register recordkeeping and failure to comply with reporting requirements (www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM287834.pdf).

The Red Cross is required to fix the errors within 60 days of the FDA's letter. In a statement, the Red Cross said it was disappointed the FDA "believed it necessary to issue a fine for an inspection conducted so long ago." The organization already has taken corrective steps to address the issues reported, the organization said, noting it was not aware of any adverse donor reactions or other patient issues due to the problems listed in the FDA report.

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