MANAGED CARE May 1998. ©1998 Stezzi Communications

A group of physicians calling itself the "Terbutaline Strategy Group" has petitioned the U.S. Food and Drug Administration to reverse itself, after the agency mailed a "Dear Colleague" letter warning practitioners about use of terbutaline sulfate for prevention of preterm labor. The doctors worry that the FDA action could remove one of their most effective — and cost-effective — strategies for managing tens of thousands of high-risk pregnancies outside of the hospital each year.

Subcutaneous terbutaline therapy for preterm labor — an off-label use of a drug approved for treatment of asthma — has spread in recent years, as studies have demonstrated safety; in 1993, the FDA asked terbutaline manufacturers to remove pregnancy contraindications from product labeling. But in its letter last November, the FDA questioned the methodology of some of those studies. The 1995 death of a woman receiving this therapy appears to have prompted the FDA's concern, though her death has not been linked to terbutaline use.

Fung Lam, M.D., a San Francisco perinatologist who pioneered the therapy and one of the physicians petitioning the FDA, says only a few drug therapies exist for at-home management of preterm labor — and all are off-label. "None is without complications. Is the FDA going to issue warnings for other medications, too?" he asks. "We want to continue to prescribe judiciously, the way we always have."

Lam, a district chairman of the American College of Obstetricians and Gynecologists, is also concerned health plans will be frightened away. "For the last five to ten years, we have been working diligently with payers on this," he says, and with neonatology stays costing up to $3,000 a day, "Over time, more of them have been covering it."

But Sidelines, which provides support to women with high-risk pregnancies, says patients have notified it of at least five HMOs that have either stopped or restricted coverage, and five more are considering doing so. Lam says the more hospitals that are capitated by HMOs for obstetrical care, the more likely plans are to drop coverage: "HMOs have no incentive to pay for outpatient services."

The FDA has not responded to the petition.

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.