FDA could mandate opioid prescription training

 

At the agencies

On May 4, an advisory panel recommended that the Food and Drug Administration (FDA) require mandatory training for doctors who prescribe opioid painkillers. The panel voted unanimously to mandate the training after a two-day hearing on how the FDA can improve the safety of opioid prescriptions. The FDA does not have to follow the recommendation of these types of advisory panels, but it often does. 

The Centers for Disease Control (CDC), released a study that examined the appropriateness of the annual amount of outpatient antibiotic prescriptions. The report found that approximately 30 percent of antibiotic prescriptions may be unnecessary and much will need to be done to meet the Obama Administration’s goal of reducing these prescriptions 50 percent by 2020. The study estimates that there are over 500 antibiotic prescriptions per 1,000 US patients annually and specifically found that 50 percent of antibiotic prescriptions for acute respiratory conditions were likely unnecessary. The study did not include survey of urgent care or dentist offices which, if included, may have found even higher rates of unnecessary antibiotic prescriptions.

On May 13, the Department of Health and Human Services (HHS) released a final rule that implements nondiscriminatory practices as put forth by the Affordable Care Act. The “Nondiscrimination in Health Programs and Activities” rule prohibits providers and healthcare plans from denying healthcare services or coverage based on an individual’s gender identity.

Specifically, the rule mandates that providers deliver services for sex-specific conditions like ovarian or prostate cancer even if the patient identifies themselves as a different gender. The rule also contains provisions intended to protect non English speakers or individuals with disabilities. 

 

On the Hill

The Senate Finance Committee released a paper that reports that surgeons who participate in physician owned distributorships (PODs) may be motivated to perform more surgeries because of increased profits. These arrangements create an intermediary between device makers and providers, with the owners receiving commission on additional sales. The committee report questions how many of these surgeries are actually medically necessary, and it offers several recommendations to increase transparency and scrutiny of PODs. It also recommends that the Centers for Medicare and Medicaid Services (CMS), the Inspector General for the HHS, and the Government Accountability Office investigate the issue further.

On May 2, a group of more than 240 members of the House of Representatives sent a letter to CMS in which they requested that the agency withdraw its proposed changes to Medicare Part B under which providers would receive lower reimbursement rates for higher cost drugs. Although the group of members was largely Republican, there were many Democrats who also signed the letter. Senate Republicans sent a similar letter in the week prior. CMS is intending to launch the new payment program for Part B this summer.

 

In the courts

On May 11, the Federal Trade Commission (FTC) requested that a Third Circuit judge stay his decision, made just two days prior, to clear the merger between Penn State Hershey Medical Center and Pinnacle Health System. The FTC is claiming the merger is a threat to affordable care in Harrisburg and that the judge, John E. Jones III, may not have used the correct approach when he determined the number of consumers that could be affected by the merger. The FTC is ultimately concerned that patients will actually end up paying more if the hospitals combine. On May 12, Judge Jones III decided to delay his final decision for two weeks, at which time the merger will go through if the FTC fails to make its case.


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