Washington Watch

Carter L. Alleman, J.D.

CMS Releases Pharmaceutical Data

The Centers for Medicare & Medicaid (CMS) made public data on top-cost drugs in Medicare as well as brand and generic medicines that had the biggest price rises last year. The data shows stats on 80 drugs in Part B and Part D that represent $55 billion in spending out of more than $143 billion total. CMS did not release Part D rebates received by the private plans that administer the program and ultimately determine a drug's final cost. The system is not able to easily do price comparisons. CMS aims to publish information on Medicaid drug spending next year.

Status on Medical Marijuana Research Requested

A group of democratic senators is asking the Department of Health and Human Services (HHS), the Drug Enforcement Agency, and the Office of National Drug Control Policy what they are doing to facilitate and coordinate research on the risks and benefits of medical marijuana. In a letter to the agencies, the senators say there are "currently numerous federal and state regulatory barriers to researching marijuana," and that the agencies' "lack of coordination" is exacerbating the problem. They want details about the supply of marijuana for research, an assessment of marijuana rescheduling, among other things. The senators sent a similar letter in July, but the agencies' response did not address some of their key questions.

Medical Case Manager Exempt from Overtime Rules

The U.S. Court of Appeals for the 4th Circuit ruled in December 2015 that a medical case manager working for a health care services provider in Maryland was not entitled to overtime pay, upholding a lower court's decision. The case involved a medical case manager who said she was entitled to overtime under the Fair Labor Standards Act (FLSA) because her duties were primarily clerical. However, a lower court determined she was exempt from overtime because her primary duties, which included assessing and analyzing medical conditions, were "professional." Under the FLSA, an employee who makes more than $23,660 a year and whose duties are judged professional, administrative, or executive, is not entitled to time-and-a-half pay for working more than 40 hours a week.

In the court opinion, Senior Judge Clyde H. Hamilton wrote the plaintiff "failed to come forward with any persuasive evidence" that her employer violated the FLSA by classifying her as a professional employee. Hamilton also noted the plaintiff's salary of more than $80,000 a year, "itself creates doubt as to whether she falls within the FLSA's intended protected class," adding the law "meant to protect low paid rank and file employees."

GAO Releases Report on Site-Neutral Payments

The Government Accountability Office (GAO) released its report on site-neutral payment. The GAO examined areas where hospitals are buying a lot of physician practices and charging higher outpatient department rates, rather than doctor’s office rates - and concluded that given the trends toward consolidation, Congress needs to equalize the payment rates for similar services provided in the different settings, to keep Medicare from paying too much for care. Congress is expected to begin work on a hospital payment reform package when it returns from recess.

Meaningful Use Bill Passes

Congress passed a meaningful use bill requiring CMS to provide a blanket hardship exemption from 2015 meaningful use penalties to all providers who ask for it. The penalties would have been assessed in 2017. Doctors will have until March 15, 2016 to apply for the exemptions and hospitals until April 1, 2016.

CDC Releases Revised Draft Opioid Guidelines

The Centers for Disease Control and Prevention (CDC) released draft opioid guidelines that are essentially unchanged from an earlier version that was sharply criticized by patient advocates and within HHS.

The draft guidelines are based on CDC's determination that "no evidence" shows a long-term benefit of treating chronic pain with opioids. The agency asserts that "extensive evidence" shows potential harms, including abuse and addiction, overdose, and heart attacks, and that "extensive evidence suggests benefits of alternative treatments" with less risk of harm. The draft recommendations maintain, for instance, that physicians and other prescribers should take "additional precautions" whenever prescribing doses greater than 50 so-called morphine equivalents per day and should "generally avoid" prescribing more than 90 morphine equivalents per day - a controversial measure that is opposed by some pain advocates. Pain experts say it's not uncommon for chronic pain patients to take doses above those limits now.

The guidelines, which will be voluntary for physicians, apply to the treatment of pain outside of end-of-life, palliative or cancer care. They're intended to rein in excessive opioid prescribing for non-cancer related pain, which has been identified by CDC and other researchers as a primary driver of the nation's opioid abuse and overdose epidemic. Comments on the guidelines are due January 13, 2016.

PPACA Enrollment Passes 8 Million People

More than 8.2 million people picked plans on HealthCare.gov through Dec. 19, HHS Secretary Sylvia Mathews Burwell recently announced. The numbers account for the boost in enrollment that took place ahead the Dec. 17 deadline to have coverage at the start of next year. Just in the seventh week of open enrollment - between Dec. 13 and Dec. 19 - HHS said 4.1 million people selected plans. The overwhelming majority were consumers renewing coverage rather than new customers (78 percent versus 22 percent).