This Week: Committees prepare for markups on opioid legislation…OMB says rescissions package is being prepared (the first since 2000).

1. Congress

House

Energy and Commerce Subcommittee Announces Opioid Markup

The House Energy & Commerce health subcommittee will mark up opioid legislation on April 25. The markup is scheduled for the day after the Senate Health, Education, Labor and Pensions Committee will vote on their legislation, the Opioid Crisis Response Act of 2018.

Energy and Commerce’s health subcommittee has before it more than 60 bills intended to address the opioid crisis before it.

Senate

Senate Finance Holds Hearing on Opioids

On April 19, the Senate Finance Committee held a hearing on opioids. Among policy changes to be considered by the Senate Finance Committee are ways to facilitate prescriber and patient education about proper opioid use, as well as ways to enhance drug management protocols. The panel will also evaluate access and usage of non-opioid treatment options for pain.

In addition, the committee will look at proposals to improve access to “evidence-based care”—including screening, assessment and treatments—for patients suffering from substance use disorder and opioid use disorder.

At the hearing, ranking member Sen. Ron Wyden (D-OR) called for executives of companies that manufacture and distribute powerful opioid painkillers to be called to testify before the panel.

New Medicare Buy-in Proposal Introduced

Sens. Chris Murphy (D-CT) and Jeff Merkley (D-OR) introduced a new health care proposal that would allow all individuals, regardless of age, with private or public insurance to buy in to Medicare. The lawmakers described their proposal as “the public option on steroids.”

The proposal, called the Choose Medicare Act, would offer Medicare coverage as an option for all individuals and for private businesses to offer their employees. The legislation would create a “Medicare Part E,” because new benefits such as maternity and pediatric care would have to be added to the Medicare program, and it would be offered on all state and federal exchanges.

Unlike the more liberal Medicare for All proposal offered by Sen. Bernie Sanders (I-VT), Murphy and Merkley’s proposal would give consumers the option to buy in to Medicare Part E or to remain on other insurance.

Senators Introduce Legislation to Address Mental Health Services for Farmers

Sens. Tammy Baldwin (D-WI) and Joni Ernst (R-IA) introduced legislation April 19 to provide more mental health services for farmers, citing the high suicide rate among agricultural workers.

The FARMERS FIRST Act would provide seed funding through USDA to establish mental health support and resources such as helplines, suicide prevention training for farm advocates and support groups.

A 2016 CDC report found that suicide rates among those working in farming, fishing and forestry were the highest for any occupation. That could be a result of chronic exposure to pesticides that might affect the neurological system and lead to depression, the study said. Other contributing factors may be social isolation, financial hardships or unwillingness to seek mental health services that can be scarce in rural areas.

The bill also would re-establish the Farm and Ranch Stress Assistance Network, which coordinates stress assistance programs for farmers and ranchers. It was authorized in the 2008 farm bill but never received funding.

The measure would form a committee to learn how agricultural workers’ mental health affects rural development and provide recommendations for how to address these needs.

2. Administration

OMB Prepares Rescissions Package

The White House is reviewing the recently passed omnibus as it creates a rescissions proposal. Senate Republican leadership has already said they do not plan to consider such a package. However, OMB Director Mick Mulvaney’s statement that money would be frozen for six weeks has created concern.

The agencies and programs that are being considered for rescissions are not known. Rescissions haven’t been used since 2000. The White House wants to send its request in early May, which would start a 45-day clock on Capitol Hill. Under law, this means 45 legislative days, but it could be 45 calendar days if Congress simply remains in session during that time.

Meanwhile, the House and Senate Appropriations panels will be far into fiscal 2019 markups at that point.

HHS Proposes Delay in Common Rule

HHS is proposing a delay in general compliance with the so-called Common Rule, which governs research performed on human subjects, until January 2019, according to a proposed rule released April 19.

The proposal responds to complaints from the academic and research community over uncertainty about when the rule would take effect. A long-awaited revision to the Common Rule had been proposed at the end of the Obama administration, but the Trump administration paused it, leaving uncertainty. Then the Trump administration went forward with the rule, but the research community asked for a delay in order to comply with its provisions.

The new proposal responds to those concerns, setting a general compliance date of Jan. 21, 2019. Studies launched around that date will have to comply with the new regulatory requirements, which among other things simplify consent for broad use of biospecimens and electronic records.

HHS is also proposing interim requirements whereby researchers could, if they choose to, comply with certain “burden-reducing provisions” of the new rules. HHS is soliciting comment on the exact implementation of the rule until May.

FDA Panel Recommends Medications From Marijuana to Treat Two Forms of Epilepsy

An expert panel that advises the Food and Drug Administration voted 13-0 to recommend the approval of a medication made from marijuana to treat two rare forms of epilepsy. The FDA is expected to announce by the end of June its decision on whether to approve the drug, which could be the first drug derived from the marijuana plant to get government approval. The drug made by GW Pharmaceuticals PLC, if approved, would be the first drug derived from the cannabis plant to get U.S. government approval.

CMS Posts Updated Opioid Mapping Tool

April 17, the Centers for Medicare & Medicaid Services (CMS) released an updated version of the Medicare Part D opioid prescribing mapping tool. The mapping tool is an interactive, web-based visualization resource that presents geographic comparisons—at the state, county and ZIP Code levels—of Medicare Part D opioid prescribing rates. It allows users to understand and compare opioid prescribing at the local level and better understand how this critical issue affects communities across the country.

The updated version of the mapping tool presents Medicare Part D opioid prescribing rates for 2016 as well as the change in opioid prescribing rates from 2013 to 2016. In total, for Medicare Part D, there were approximately 78 million opioid claims for 97 distinct opioid products in 2016, accounting for $4 billion in spending.

The updated Medicare Part D Opioid Prescribing Mapping Tool can be accessed at: https://go.cms.gov/opioidheatmap

3. Reports

Opioid Prescribing Down

According to a study from the IQVIA Institute for Human Data Science, doctors are prescribing far fewer pain pills amid increased scrutiny of how the medicines are contributing to the opioid epidemic. There was a 10 percent drop in opioid prescriptions in 2017, far more than the 1.5 percent decrease in 2016. The report also found that doctors are cutting back on the dosage of the opioids that they prescribe. Dosage volume fell 12 percent in 2017—the largest annual drop in more than a quarter-century.

The study also found a small increase in spending on medicines, though that translated to a 28 percent drop once discounts, rebates and other price concessions were factored in. List prices jumped 58 percent over the last five years, but patients’ out-of-pocket costs still ended up declining—further evidence of the complexities of determining the actual cost of a drug.

To read the study: https://www.iqvia.com/institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022

GAO WatchBlog “Illicit Synthetic Opioids (Podcast and Infographic)”

Federal agencies collaborate with each other and with some foreign governments, such as China, Mexico and Canada, to combat the production and availability of illicit synthetic opioids. This GAO blog looks at some of these cooperative activities, such as sharing information on emerging trends and helping to expand the regulation of illicit substances. It also reviews other federal efforts to prevent illicit opioid use in the U.S., such as treating overdose deaths as crime scenes in order to investigate and identify the source of the drugs.

For more information: https://blog.gao.gov/2018/04/19/illicit-synthetic-opioids-podcast-and-infographic/