Washington Watch for April 2018

Carter L. Alleman, J.D.

White House, Congressional Leadership Talk Opioid Epidemic

Officials from the Trump Administration met with leaders on Capitol Hill to discuss the steps taken to address the opioid epidemic since it was declared a public health emergency in October. The President stated that the White House will release an opioid policy over the next three weeks. The Administration’s emergency declaration was renewed in January and will expire on April 23.

During a separate event last week, FDA Commissioner Scott Gottlieb called for a national electronic prescribing platform and interoperable prescription drug management programs (PDMPs) to help combat the epidemic. According to Gottlieb, the agency is also considering whether it could use risk evaluation and mitigation strategies (REMS) to educate doctors about responsible prescribing.

The Government Accountability Office (GAO) announced plans to open an investigation into the White House’s response to the opioid crisis. The investigation was requested by Senate Democrats. The GAO will review the actions taken by the administration to address the crisis since the president’s emergency declaration last October.

Secretary Azar Outlines 4-Point Plan to Accelerate Shift Toward a Value-based System

Last Monday in a speech to the Federation of American Hospitals, HHS Secretary Alex Azar outlined a 4 point plan to accelerate movement toward a value-based system, including: (1) Moving ownership and control of electronic health records from providers to patients; (2) Providing payers and providers with incentives to be more transparent about healthcare costs; (3) Using Medicare and Medicaid to drive industry change; and (4) Reducing regulatory burden.

The Administrator for the Centers for Medicare and Medicaid Services (CMS) Seema Verma announced a new initiative, MyHealthEData, which is designed to improve electronic health record (EHR) patient data access. The initiative is intended to give patients more control of their own EHR data and will do this by breaking down existing barriers to health data access and use. MyHealthEData aims to allow patients to receive copies of their entire EHRs, share their personal health data with anyone they choose, and put themselves at the center of the healthcare system.

W&M Requests Information on Opioids

The House Ways and Means Committee is requesting information from insurers, pharmacy benefit managers (PBMs), and health care providers and prescribers about how to better protect Medicare beneficiaries from opioid dependence and overdose. The Committee is currently drafting its own bipartisan opioid-related legislation and is looking to leverage Medicare to combat opioid abuse and addiction.

Legislators Release CARA 2.0

A bipartisan group of eight senators released follow up legislation to the Comprehensive Addiction and Recovery Act (CARA), which was signed into law in 2016. The bill, dubbed “CARA 2.0,” would establish an initial three-day prescribing limit on opioids for acute pain. It would also strengthen services to promote recovery, such as an initiative aimed at young support services. The bill would require physicians and pharmacists to use their prescription drug monitoring program (PDMP) before prescribing or dispensing opioids. To increase the availability of treatment, CARA 2.0 would allow states to waive the number of patients a physician can treat with buprenorphine. It would increase penalties for opioid manufacturers who fail to report suspicious orders.

The bill authorizes $1 billion in additional funding, which includes $10 million for a national education campaign, $300 million to expand access to medication assisted treatment (MAT), $200 million to build a national infrastructure for recovery support services, and $300 million for expanding first responder training and access to naloxone. The two-year budget deal passed in February included $6 billion for the opioid crisis for fiscal years 2018 and 2019.

Sessions Announces Creation of New Opioid Task Force

The Department of Justice (DoJ) has established a Prescription Interdiction and Litigation (PIL) Task Force to coordinate criminal and civil law enforcement efforts related to opioids and strengthen the Department’s response to the diversion and over-prescribing of pain medication. The Task Force will focus on targeting manufacturers and distributors, including pharmacies, pain management clinics, drug testing facilities, and individual physicians, that could be contributing to the opioid abuse epidemic. It will ensure that companies are following FDA regulations for marketing and evaluate whether changes are needed to the current distribution system. It will also examine lawsuits brought forth by state and local governments.

Public Health Bills Pass House

The House of Representatives passed the following public health. H.R. 880, the Military Injury Surgical Systems Integrated Operationally Nationwide to achieve ZERO Preventable Deaths (MISSION ZERO) Act, establishes a grant program for military-civilian partnerships in trauma care. H.R. 767, the Stop, Observe, Ask, and Respond (SOAR) to Health and Wellness Act provides health care professionals training on how to identify and appropriately treat human trafficking victims. H.R. 1222, the Congenital Heart Futures Reauthorization Act, enhances research and surveillance on congenital heart disease. Finally, H.R. 443 recognizes the importance and effectiveness of trauma-informed care.

UnitedHealth Group to Pass Along Drug Rebates

UnitedHealth Group, the country’s largest insurer, says it will begin passing on rebates it gets from pharmaceutical companies to some customers when they purchase prescription drugs. The insurer says it’s trying to bring greater transparency to drug pricing. It also recently launched a tool that allows doctors to go online and see exactly how much patients will pay for prescription drugs at their preferred pharmacy. U.S. Department of Health and Human Services (HHS) Secretary Azar applauded the move.

Opioid Crisis Worsens

Acting Director of the Centers for Disease Control and Prevention (CDC) Anne Schuchat, MD said that the opioid abuse crisis is worsening, pointing to new emergency room data showing a sharp uptick in opioid overdoses across the country. A new agency report found hospitalizations for opioid overdoses jumped by 30 percent in 45 states between July 2016 and September 2017. The Midwest saw the largest increase (70 percent) in hospitalizations for opioid overdoses, with rates in Wisconsin jumping 109 percent. Illinois was up 66 percent, and Indiana had a 35 percent increase.

National Match Day Celebrates Biggest Numbers in History

On Friday, the National Resident Matching Program (NRMP) released results to applicants seeking medical residency and fellowship training positions. 37,103 applicants applied for 37,162 available positions, signifying the largest ever number of slots offered on match day. Of the available positions, 96.2% were filled, up 0.2% from 2017. Specialties that filled 100% of their available slots include Neurological Surgery, Physical Medicine and Rehabilitation, Integrated Interventional Radiology, and Thoracic Surgery.

According to the Association of American Medical Colleges (AAMC) the U.S. faces a current shortage of up to 104,900 doctors by 2030. A bill to provide increases to graduate medical education (GME) slots, the Resident Physician Shortage Reduction Act (H.R. 2267/S. 1301), was reintroduced in 2017 by Reps. Joseph Crowley (D-N.Y.), and Ryan Costello (R-Pa.), and Sens. Bill Nelson (D-Fla.) and Dean Heller (R-Nev.).

Ways and Means Committee Hosts Red Tape Initiative Roundtable

On Thursday, the House Ways and Means Committee Republicans held a roundtable discussion with various healthcare provider groups to discuss Medicare red tape relief. Participating doctors and healthcare experts shared their stories with committee members about the struggles they face due to the regulatory burdens placed on them by Washington.

According to the Committee, while a variety of policy recommendations were discussed, there were a few common themes, including (1) standardizing documentation guidelines; (2) eliminating unnecessary and duplicative paperwork and reporting burdens in all settings; (3) modernizing laws such as Stark laws that are slowing down providers’ ability to fully work together to create efficiencies and lower costs for the patients and taxpayers; and (4) expanding the use of innovations in healthcare, particularly telehealth.

MedPAC Advises Congress to End MIPS

Medicare Payment Advisory Commission (MedPAC) released its March 2018 Report to Congress: Medicare Payment Policy. The report suggests that Congress scrap the Merit-based Incentive Payment System (MIPS), given that it is too complex and will not help beneficiaries choose a high-quality professional. Instead, they argue, Congress should substitute a new program, known as the voluntary value program. The voluntary value program that MedPAC contemplates “would be a stepping-stone or on-ramp” for physicians who are not ready to join an alternative payment model. With the proposed program, doctors’ care would be measured similar to an advanced alternative payment model.

Congress Passes FY 2018 Omnibus, Avoids Government Shutdown

Congress approved a $1.3 trillion omnibus-spending bill before adjourning for a two-week recess. H.R. 1625, the Consolidated Appropriations Act (a.k.a., the “omnibus”) funds the government through the end of the current fiscal year (FY) -- September 30, 2018. It includes $695 billion in defense funding and $591 billion in nondefense funding. Lawmakers faced a March 23 deadline to pass a funding package to avoid a partial federal government shutdown. The omnibus passed the House of Representatives on Thursday by a vote of 256-167. The Senate passed the bill in the early hours of Friday morning by a vote of 65-32.

The U.S. Department of Health and Human Services (HHS) will receive $88.1 billion in FY 2018, a $10 billion increase compared to FY 2017 levels. The omnibus will increase appropriations for the National Institutes of Health (NIH) to a total of $37 billion in FY 2018. The additional $3 billion is the largest funding increase for the years. The omnibus includes an additional $414 million for additional $40 million for research on a universal flu vaccine, and $140 million more for brain research.

The Centers for Disease Control and Prevention (CDC) will receive $8.3 billion, a $1.1 billion increase over current spending. The Agency for Healthcare Research and Quality (AHRQ) is provided with $334 million, a $10 million increase over FY 2017 levels. The omnibus includes $4 billion to fund prevention, treatment, and enforcement efforts for the opioid epidemic across HHS, Homeland Security, Justice, and Veterans Affairs. This includes $1 billion in new grants for states and tribes, at least $500 million for new opioid research at the NIH, an increase of $350 million for related efforts at the CDC, $130 million for the Rural Communities Opioid Response Program, and a nearly $300 million increase for law enforcement grant funding to combat the epidemic. Congress rejected the White House’s proposal to cut the Office of National Drug Control Policy (ONDCP) by 95 percent. The omnibus includes more than $2.3 billion in new spending for mental health programs and will fund nearly 30 mental health provisions contained in the 21st Century Cures Act, including the Mental Health Block Grant, the National Traumatic Stress Network, the National Child Traumatic Stress Initiative, mental and behavioral health training grants, assisted outpatient treatment, and the National Suicide Prevention Lifeline.

The Senate is scheduled to reconvene on April 9, and the House of Representatives will return on April 10.

White House Unveils Strategy to Combat Opioid Epidemic

The White House released the President’s Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand. The Administration’s three-pronged approach aims to slow overprescribing, reduce the supply of illicit drugs, and increase access to evidence-based treatment for those suffering from addiction. Many of the policies contained in the plan stem from the recommendations of the President’s Opioid Commission released in November. The Administration’s goal is to reduce the number of opioid prescriptions by one third nationwide over the next three years.

The White House proposal would tighten the number of prescriptions that can be reimbursed in the Medicaid program. It would also create and incentivize states to move to a national prescription drug monitoring system. The plan calls for increasing first responders’ supply of naloxone and expanding the use of medication assisted treatment (MAT). All federal inmates would be tested for opioid addiction and provided options for treatment upon completion of their sentences. The plan also includes new public outreach to deter drug use. The Administration expresses opposition to medically supervised drug consumption, noting the lack of evidence supporting the efficacy of such facilities.

The plan would also apply stiffer penalties for drug traffickers, including the death penalty, when appropriate under current law. The Administration calls on Congress to reduce the threshold for mandatory minimum sentencing on fentanyl dealers, and more aggressively police the Internet and mail for fentanyl purchases and shipments.

Administration Teases Drug Pricing Plan

The White House’s strategy to combat the opioid crisis, President Trump also announced that he is planning a major news conference on the issue of prescription drug prices. The President blamed pharmaceutical companies and the drug distribution system for the rising cost of prescription medicines and criticized the high cost of treatments in the U.S. compared with prices for the same products in other countries. The Administration’s plan, expected to be released in about a month, aims to decrease the cost of drugs and reform pharmacy benefit manager (PBM) discounts to the advantage of individual patients. Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar noted that the Administration’s plan will also include a request for input from stakeholders and stated that his goal is to bring down list prices and achieve the best net prices for government programs and private insurers.