Senate Plans to Act on Opioid Legislation
Senate Majority Leader Mitch McConnell (R-KY) signaled that passing opioid-related legislation will be a priority for the Senate after Labor Day. Senate leaders are negotiating legislative language, and it is anticipated that most of the legislation will be similar to the bill that the House of Representatives passed in June 2018. Early reports indicate that the bill will include at least $500 million in opioid-related grant funding for states and the Synthetics Trafficking and Overdose Prevention (STOP) Act of 2017, S. 372, which would target the flow of illegal opioids into the U.S. from overseas. The House of Representatives-passed bill, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, H.R. 6, was approved with a bipartisan vote of 396-14. The provisions included in the bill focused on treatment, prevention, safe disposal of opioids, prescription drug monitoring program enhancements, and electronic prescribing for controlled substances under Medicare Part D.
CMS Releases CY 2019 OPPS/ASC Proposed Rule
The Centers for Medicare & Medicaid Services (CMS) released the proposed calendar year (CY) 2019 Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) payment rule. Under the OPPS proposed rule, CMS projects an overall 1.25 percent payment increase for most hospital outpatient departments in CY 2019.
Under the ASC rule, CMS estimates an increase of 2.0 percent in payment for CY 2019 for services provided under the ASC payment system. CMS proposes to review all procedures added to the ASC list of covered surgical procedures in the last three years to reassess recent experiences with the procedures in the ASC and to determine whether such procedures should continue to be on the list. CMS also proposes changes to the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. The proposed rule would remove 15 quality measures from these programs. CMS based this proposal on certain “removal factors”—if the measure is duplicative, “topped out,” or the costs of reporting are greater than their benefits. The proposed rule is available for public review.
HHS Releases New Report on Drug Pricing
There have been 60 percent fewer branded drug price increases since the release of the Trump administration’s drug pricing blueprint earlier this year compared to last year, according to a new report cited by HHS Secretary Alex Azar. The report credits the release of the blueprint with 54 percent more generic and brand-drug price decreases than during the same period in 2017. The Report on 100 Days of Action on the American Patients First Blueprint, compiled by Dan Best, Senior Advisor to the Secretary for Drug Pricing Reform, also outlines the actions the department has already taken to increase competition, improve negotiation, incentivize lower list prices, and reduce out-of-pocket (OOP) costs.
FDA Issues Draft Guidance on OUD
The Food and Drug Administration (FDA) issued draft guidance last week on treatments for individuals with opioid use disorder (OUD). The new scientific recommendations are aimed at encouraging more widespread innovation and development of medication-assisted treatment (MAT) drugs. The draft guidance was praised by Republican leadership on the House Energy and Commerce Committee as a potential means to stem the opioid epidemic, in combination with the measures contained in the House-passed SUPPORT for Patients and Communities Act (H.R. 6).
House Letter on Prior Authorization
Rep. Phil Roe, MD (R-TN) and Rep. Ami Bera, MD (D-CA), urged their congressional colleagues to join them in sending a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma, MPH, requesting that CMS provide guidance to Medicare Advantage (MA) plans regarding the use of prior authorization (PA). Specifically, the letter asks that CMS ensure that these requirements do not create inappropriate barriers to care for Medicare patients. The letter also requests that CMS collect data on the scope of PA practices, including denial, delay, and approval rates. In addition, the letter asks that CMS issue a report describing its oversight of preapproval policies in MA plans, the use of PA for Part A and Part B services, and descriptions of audit protocols that focus on this area.
At present, some plans require repetitive prior approvals that are not based on evidence and may delay patient access to medically necessary care. Many of these PA requirements are for services or procedures performed in accordance with an already-approved plan of care or for services with low PA denial rates.
CMS Releases CY 2019 OPPS/ASC Proposed Rule
The Centers for Medicare & Medicaid Services (CMS) released the proposed calendar year (CY) 2019 Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) payment rule. Under the OPPS proposed rule, CMS projects an overall 1.25 percent payment increase for most hospital outpatient departments in CY 2019.
Under the ASC rule, CMS estimates an increase of 2.0 percent in payment for CY 2019 for services provided under the ASC payment system. CMS proposes to review all procedures added to the ASC list of covered surgical procedures in the last three years to reassess recent experiences with the procedures in the ASC and to determine whether such procedures should continue to be on the list. CMS also proposes changes to the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. The proposed rule would remove 15 quality measures from these programs. CMS based this proposal on certain “removal factors”—if the measure is duplicative, “topped out,” or the costs of reporting are greater than their benefits. The proposed rule is available for public review.
Trump Administration to Expand Availability of Short-Term Health Plans
The Trump administration has issued regulations that will allow individuals to purchase health care insurance plans that do not comply with the Affordable Care Act’s (ACA) consumer protections. The final rule will allow the sale of short- term limited-duration plans for a 12-month coverage period, with the option of renewal for up to 36 months. The plans typically don’t cover individuals with pre-existing conditions and do not have to cover the comprehensive benefits required by Obamacare. The administration argues that these plans will serve as affordable alternatives for people who do not qualify for subsidies in the ACA’s individual market, and the move has been praised by Republican lawmakers as an alternative to the ACA’s one-size-fits-all approach.
E&C Republicans Continue Examination of 340B
Republican leadership on the House Energy and Commerce Committee have written to nine contract pharmacies participating in the 340B Drug Pricing Program regarding the growth and oversight of 340B. The lawmakers request information on contracting practices, the distance between covered entities and contract pharmacies, to what degree contract pharmacies prevent duplicate discounts and diversion, and whether they ensure low-income patients do not experience high drug costs despite the program discount.
Senate Passes Suicide Hotline
The Senate passed S. 1015, the National Suicide Hotline Improvement Act, by unanimous consent. The bill is aimed at making the U.S. suicide prevention hotline more user-friendly and accessible; it would direct the Federal Communications Commission (FCC), in consultation with the Substance Abuse and Mental Health Services Administration (SAMHSA), to study and report on the feasibility of designating an N11 dialing code to be used for a national suicide prevention and mental health crisis hotline system.
Senator John McCain Passes
Sen. John McCain (R-Ariz.) died at the age of 81. Senator McCain had served his country for sixty years as a naval aviator, war hero, congressman, senator, and presidential candidate. His naval honors include the Silver Star, Bronze Star, Legion of Merit, Purple Heart, and the Distinguished Flying Cross. McCain’s family had announced that the senator had decided to discontinue medical treatment for his brain cancer the previous day. McCain was diagnosed in July 2017 with glioblastoma and had been absent from the Hill since last December. He was the chairman of the Senate Armed Services Committee and one of the strongest Republican critics of President Trump in the Senate. His legislative legacy includes initiatives regarding defense and national security, human rights, veterans’ services, campaign finance reform, and government reform. Congress named the National Defense Authorization Act, which became law earlier this month, after Senator McCain.
Sen. McCain laid in state in the Capitol Rotunda, a rare honor, and receive a full-dress funeral service at the Washington National Cathedral before his burial at the U.S. Naval Academy Cemetery in Annapolis, Maryland.
Arizona Govenor Doug Ducey appointed former Senator Jon Kyl, who will serve until the 2020 election.; the winner of that election will serve the remainder of McCain’s term through 2022.
FDA, NAS to Develop New Opioid Prescribing Guidelines
The Food and Drug Administration (FDA) has announced the award of a contract to the National Academies of Sciences, Engineering, and Medicine for the creation of new opioid prescribing guidelines. The National Academies are tasked with the development of guidelines for the treatment of acute pain. The guidelines will make recommendations for specific conditions and procedures. According to FDA Commissioner Scott Gottlieb, the forthcoming guidelines will include specific scenarios for prescribers treating pain, unlike the recent guidelines from the Centers for Disease Control and Prevention (CDC), and could potentially be used to inform drug labeling.
Lawmakers Introduce Pre-Existing Conditions Bill
Republican senators have introduced a bill (S. 3388) that would require health insurers to cover everyone, regardless of health status. The legislation would amend the Health Insurance Portability and Accountability Act (HIPAA) to guarantee the availability of health insurance to all Americans, including those with pre-existing conditions, and prevent insurers from increasing premiums because of pre-existing conditions. Insurers, however, would still be allowed to exclude coverage of pre-existing conditions.