Pardon Our Dust
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This Week: To shut down or not to shut down the issue as Congress tries to wrap up and leave; opioids back in the news; Alexander says he will not run for reelection in 2020.
- Continuing Resolution Passes Senate, but Trump wants Changes
- HELP Chairman Will Not Seek Reelection in 2020
- Sen. Wyden Asks FCC to Adopt Three-Digit Number for Mental Health and Suicide Support
- Sen. Booker Will Introduce Legislation on Medicaid Drug Transparency
- CMS Releases Stats on Open Enrollment
- FDA Advisory Panel Backs Prescribing Overdose Reversal Drug with Opioids and HHS Issues Guidance
- FDA Finalizes Breakthrough Device Guidance
- GAO: Improvements Needed in Suicide Prevention Media Outreach Campaign Oversight and Evaluation (VA Health Care)
After the Senate passed a continuing resolution to fund the government until Feb.8, the President announced he would not sign it. The House then voted 217-185 to send the continuing resolution back to the Senate after adding $5.7billion for border security and $7.8 billion for disaster relief.
At this writing, it was unclear the Senate could pass the House version. In the event of a shut down, the U.S. Department of Health and Human Services is funded. However, the Food and Drug Administration is not because it was not included in the previously passed funding. The agency might have to furlough approximately 40 percent of its staff.
On Dec. 20, the Senate passed a Continuing Resolution, based upon an agreement with the House, Senate and White House. After passage, the President announced he would not sign the package without funding for the wall. The CR funding would run through Feb 8. The Senate passed resolution left the debate over the wall and other issues to the new Congress. Included in the CR:
- Continues appropriations through Feb. 8, 2019, for FY19 appropriations measures that have not yet been enacted (Agriculture, Commerce-Justice-Science, Financial Services, Homeland Security, Interior-Environment, State-Foreign Operations, Transportation-HUD).
Temporary extensions included in previous CRs of expiring authorities
- The National Flood Insurance Program, extended for duration of the CR.
- The Violence Against Women Act, extended for duration of the CR.
- The Pesticide Registration Improvement Act, extended for duration of the CR.
- Temporary Assistance for Needy Families, extended for duration of the CR.
- Immigration extensions (EB-5, E-Verify, Conrad 30 program for international medical school graduates, special immigrant religious workers program and H2B returning worker authority for DHS), extended for duration of the CR.
New temporary extensions of expiring authorities
- The Chemical Facility Anti-Terrorism Standards Act, extended for duration of the CR.
- Two expiring provisions of the Pandemic and All-Hazards Preparedness Act, extended for duration of the CR.
- Medicaid Money-Follows-the-Person and Spousal Impoverishment, extended through March 31 (longer extension necessary for program integrity), with offsets.
- Statutory PAYGO scorecard balance debited to following year.
On Dec. 17, Sen. Lamar Alexander, who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, announced he will not run for reelection in 2020. He will remain chair in the next Congress. Sen. Mike Enzi (R-WY) is next in line to chair the HELP committee, although he would have to give up being chair of the Senate Budget Committee. Sen. Alexander was part of a working group of GOP senators that failed to pass an Affordable Care Act replacement bill last year. Days before announcing his retirement, Sen. Alexander said that the committee would be open to considering a revival of the bill.
On Dec. 17, Sen. Ron Wyden (D-OR) asked the Federal Communications Commission (FCC) to adopt a new three-digit phone number for those needing mental health and suicide support. Sen. Wyden noted in his letter to the FCC that suicide rates are rising nationally with the Centers for Disease Control (CDC) reporting more than 40,000 Americans died by suicide last year.
Read the letter here.
On Dec. 17, Sen. Corey Booker (D-NJ) announced he will introduce the “Medicaid Drug Decisions Transparency Act” this week, requiring more transparency surrounding states’ Medicaid drug decisions. The bill requires pharmaceutical companies to disclose their payments to pharmacists and others who serve on state Medicaid drug boards. The bill also increases penalties for companies that fail to comply with reporting requirements and requires the Department of Health and Human Services (HHS) to provide states with summaries of drug company payments made to members of their Medicaid drug committees.
On Dec 19, the Centers for Medicare and Medicaid Services (CMS) released the weekly enrollment snapshot through the 2019 enrollment deadline, Dec. 15 midnight (eastern time). The preliminary data show open enrollment for 2019 coverage ended with approximately 8.5 million people enrolled compared to 8.8 million people at the same time last year. These numbers are preliminary and do not represent final 2019 Exchange Open Enrollment figures. The preliminary figures show a smaller decline in coverage than expected.
On Dec. 18, an advisory panel to the Food and Drug Administration (FDA) recommended prescribing the opioid overdose reversal drug, naloxone, along with addictive painkillers. The panel voted 12-11 in favor of labeling changes for opioids that recommend co-prescribing the overdose antidote, as a step toward making the potentially lifesaving drug readily available. Currently, naloxone is available in pain clinics, opioid treatment programs and “take-home” programs for high-risk patients.
On Dec. 19, the U.S. Department of Health and Human Services announced guidance recommending that naloxone should be prescribed to all patients at risk of complications from taking the painkillers. HHS specifically suggests targeting naloxone at patients receiving high dosages of opioids—50 morphine milligram equivalents per day or more—and those with respiratory conditions like chronic obstructive pulmonary disease or sleep apnea. Patients who have been prescribed benzodiazepines—sedatives that can make opioid use more dangerous—should also receive naloxone, as should those with non-opioid substance use disorders, patients with excessive alcohol use or those with mental health disorders, according to the guidance.
The document also recommends prescribing naloxone to those using illict drugs or misusing prescription painkillers, patients receiving treatment for opioid use disorder and patients with a history of opioid misuse who were recently released from prison or other settings where tolerance to opioids has been lost.
Some states already have laws mandating naloxone co-prescribing and some states also allow pharmacists to provide naloxone without a doctor’s prescription.
On Dec. 18, the Food and Drug Administration (FDA) finalized guidance on its breakthrough device designation and pitched a new way to reward devices that innovate on safety first, before any major gains in efficacy. The Safer Technologies Program, or STeP, was first outlined in April 2018 in the FDA’s Medical Device Safety Action Plan. STeP picks up what the FDA’s breakthrough designation does not cover: products that may not meet the high criteria for cutting-edge tech, yet offer significant benefits in safety compared to current devices or diagnostics.
Read the final guidance here.
Following the ruling that the Affordable Care Act is unconstitutional, sixteen states and the District of Columbia asked federal judge Reed O’Connor for to permit an immediate appeal of his decision. Because O’Connor did not address several other claims against the law that are part of the lawsuit, he could keep the case until he has finished ruling. The judge has asked all parties in the case for their guidance on next steps and is expected to rule on Dec. 21.
On Dec. 17, the Government Accountability Office (GAO) released a report on veteran suicide, one of the Department of Veterans Affairs’ (VA) highest priorities. The GAO found that the Veterans Health Administration (VHA), in charge of suicide prevention media outreach activities, saw a decline in activity in 2017 and 2018 due to leadership turnover and reorganization. It was also determined that the VHA did not have clear goals for evaluating the effectiveness of its outreach activities.
The GAO recommended that the VHA should establish an approach to oversee its suicide prevention media outreach campaign that includes clear delineation of roles and responsibilities, and establish targets for its metrics to improve evaluation efforts. The VA concurred with the GAO’s recommendations and determined steps it will take to implement them. These include organizational improvements, such as hiring a permanent Director for Suicide Prevention, as well as developing metrics, targets and an evaluation strategy to improve its evaluation of its suicide prevention program efforts by April 2019.
Read the report here.
Happy Holidays to all! The next issue will be January 7, 2019.
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