News in brief - Dec. 19, 2011

HHS keeps emergency contraception behind the counter

Health and Human Services Secretary Kathleen Sebelius overruled a Food and Drug Administration recommendation that would have allowed the contraceptive drug known as the "morning-after pill" to be sold on drug store shelves.

"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental drug application by Teva Women's Health, Inc.," Sebelius said in her Dec. 7 decision. Sebelius later indicated that Teva could reapply and submit additional data.

Teva Women's Health had applied to eliminate prescription dispensing requirements for the contraceptive, which can prevent pregnancy if taken within 72 hours of sexual intercourse. Plan B One-Step is sold behind the counter in pharmacies, but women ages 17 and older who show identification can purchase the drug without a prescription.

A Teva Women's Health spokesperson did not respond to a request for comment by this article's deadline. Women's health groups and some Democratic lawmakers reacted negatively to the decision, saying the FDA recommendation should have been followed.

President Obama said during a Dec. 8 briefing with reporters that he did not get involved in Sebelius' decision but that he supported it.

"I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine," Obama said. "And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able -- alongside bubble gum or batteries -- be able to buy a medication that potentially, if not used properly, could end up having an adverse effect."

The drug has been deemed to be safe by the FDA and still will be available to women 17 and older without a prescription, he noted.

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House bill to repeal Medicare IPAB reaches 218 sponsors

Legislation to eliminate the Medicare Independent Payment Advisory Board had more than 218 co-sponsors in the House as of Dec. 7, passing a threshold that likely guarantees its passage in that chamber once it is put to a vote.

The American Medical Association and other physician organizations support repealing the payment control board established by the health system reform law. The IPAB would have broad authority to slash Medicare pay if spending were projected to exceed predetermined targets, unless overridden by substantial majorities in Congress. Rep. Phil Roe, MD (R, Tenn.), introduced the Medicare Decisions Accountability Act of 2011 on Jan. 26 and has built support for the legislation throughout the year.

"The IPAB is simply the wrong solution for addressing budgetary challenges in our Medicare system, and its repeal must be considered with urgency before it gets too expensive to overturn," Dr. Roe said. "By repealing the IPAB now, we will ensure that medical decisions are made between patients and their doctor, not unelected Washington bureaucrats."

The legislation had 220 co-sponsors, including 15 Democrats, on Dec. 12, according to Dr. Roe's office. It remains unclear whether the bill would gain the 60 votes in the Senate needed to overcome an objection in the upper chamber.

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Bill would create Medicare direct primary care pilot project

A bill unveiled in November would create a pilot program in which Medicare pays certain practices up to $125 per patient per month for providing medical homes through a version of retainer care called direct primary care.

Rep. Bill Cassidy, MD (R, La.), is sponsoring the bill, called the Direct MD Care Act of 2011. Direct primary care practices offer unlimited or less-restricted access to physicians for a set fee, sometimes less than $100 a month.

Dr. Cassidy said health insurance reform isn't enough to improve health care. "We need a system that leads to greater access for patients and lower costs."

The measure would create at least one pilot project in which Medicare pays direct primary care practices with more than 3,000 patients up to $100 a month to provide comprehensive primary care to beneficiaries. The fees would increase to $125 a month for patients eligible for Medicare and Medicaid. Each direct primary care medical home would be required to offer a typical range of primary care services, plus office appointments seven days a week, email consultations, and 24-hour phone consultations. The practices would report their patients' emergency department visits, hospitalizations, surgeries, specialist visits and use of advanced radiology.

HHS has awarded or will award several grants created by the national health system reform law to support innovation in health care delivery. Some of these could involve direct primary care practices, but none would focus on the specific impact of such practices on patients' health the way this bill would, according to Erika Bliss, MD. She's president and CEO of Qliance Medical Management, a direct primary care practice in Seattle.

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Md. audit finds Medicaid keeps paying for dead people

Maryland's Medicaid agency has not ended payment of Medicaid fees for all enrollees who die outside the state, according to an audit released Dec. 2 by the Maryland Dept. of Legislative Services' Office of Legislative Audits.

Auditors found that the state paid at least $426,403 in Medicaid fees between Jan. 1, 2008, and Aug. 31, 2011, relating to the coverage of 10 people who had died. Most of the improper payments were monthly capitation fees paid to Medicaid managed care organizations.

State auditors found the discrepancies by comparing state Medicaid enrollee records with death records kept by the Social Security Administration. They found 323 possible cases in which Medicaid fees appear to have been paid after a Maryland enrollee died out of state. However, auditors found that only 10 of the first 20 cases they reviewed in detail were actual payment errors.

The Social Security death record database does include a small number of people who are still alive, but that error rate typically is less than one-quarter of 1%, according to the audit. Auditors recommended that state Medicaid officials regularly cross-reference Medicaid enrollee records with the federal database.

The Maryland Dept. of Health and Mental Hygiene plans to begin using the SSA data to verify Medicaid enrollment, said Charles Milligan, the department's deputy secretary for health care financing. The SSA database has fewer errors than it once did, he said.

Maryland's Medicaid program cost $7.7 billion in fiscal year 2011, more than half of which was paid for by the federal government, according to the audit, which is available online (www.ola.state.md.us/reports/performance/dhmh-dhr-dmf11.pdf).

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Medical supplier pays $5 million to settle Medicaid fraud claims

Shield Healthcare, a California medical supply provider, has paid $5 million to the government and California to resolve a lawsuit alleging that the company submitted inflated bills to the state's Medicaid program.

Shield, the largest supplier to the state of incontinence supplies such as adult diapers and waterproof sheeting, was accused of providing false claims in violation of a regulation designed to eliminate excessive markups charged to the Medi-Cal program, according to the federal Dept. of Justice. The federal government will receive $2 million of the settlement, and $3 million will go to California.

Shield has denied any wrongdoing, saying it conducts business in compliance with governing regulations.

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