April 20, 2018
Next week is shaping up to be a big week for healthcare in Washington. The Senate Committee on Health, Education, Labor, and Pensions (HELP) is scheduled to markup S. 2680, the Opioid Crisis Response Act of 2018, next Wednesday. This bill is comprised of 40 different proposals mostly from Senators serving on the HELP Committee. The legislation will make changes at 5 federal health agencies: Food and Drug Administration (FDA); Centers for Disease Control (CDC); Health Resources and Services Administration (HRSA); the National Institutes of Health (NIH); and the Substance Abuse and Mental Health Services Administration (SAMHSA). However, it does not propose any changes to the Medicare and Medicaid programs which both lie in the Senate Finance Committee’s jurisdiction.
The House Energy and Commerce Committee is also marking up a legislative package of proposals next Thursday. The committee is looking to package 34 separate proposals from Members of Congress serving on the panel. The bill which has not yet been introduced is expected to – at least – temporarily repeal the restriction on using Medicaid funds for inpatient treatment of addiction. The bill is also expected to make it easier to treat opioid abuse with telehealth under the Medicare program.
The President is planning to make a speech on drug pricing next Thursday. It is also expected that we will see the release of a Notice from the Department of Health and Human Services (HHS) on a strategy to lower drug prices and reduce out-of-pocket costs. HHS submitted the draft Notice to the Office of Management and Budget this past Tuesday. The Notice is expected to be a Request for Information on how to lower drug prices and the administration is expected to take more specific actions on drug pricing this summer.
HHS Secretary Azar announced this week that James Parker will serve as his Senior Advisor for transforming our health care system to a value-based system rather than a fee-for-service system. Parker most recently served as the Chief Executive Officer of an Indiana based managed care organization MDwise, Inc.
- Trump plans first major speech on drug prices next week – Politico (Apr 16)
“President Donald Trump is set to deliver his first major speech on drug prices on April 26, revisiting an issue he campaigned on but that is unlikely to yield major legislative changes. The strategy is unlikely to call for actions of the sort Trump touted on the campaign trail like allowing the government to negotiate the cost of drugs for Medicare, but based on the president’s fiscal 2019 budget request could advocate for Medicare and Medicaid demonstrations to test new ways of paying for drugs on a smaller scale, like allowing some states to try negotiating drug costs in Medicaid.”
- NIH abruptly changes course on industry opioids partnership after ethics flags raised – Stat (April 19)
“Dozens of drug companies were on the verge of teaming up with [NIH], which researchers hope will lead to the discovery of new medicines to treat addiction or serve as alternatives to opioids. But in an abrupt shift, the agency announced late last week that it won’t accept funds from drug makers after all. Citing recommendationsissued earlier this month by an NIH advisory panel, Collins said the agency will exclusively use taxpayer money to fund a comprehensive research initiative on pain and substance use disorder treatment.
- GOP in retreat on ObamaCare – The Hill (Apr 20)
Republicans are retreating from calls to repeal ObamaCare ahead of this year’s midterm elections. Less than a year after the GOP gave up on its legislative effort to repeal the law, Democrats are going on offense on this issue, attacking Republicans for their votes as they hope to retake the House majority.
April 13, 2018
A big focus this past week was the opioid epidemic. The Energy and Commerce Committee’s Health Subcommittee held a hearing examining 34 bills that the committee hopes will shape a comprehensive legislative package the Majority is hoping to bring to the floor before the Memorial Day recess. Democratic members on the committee are concerned about the committee moving too quickly and the possibility of a partisan opioid bill if they are not earnestly engaged in the drafting of the legislation. There are a number of issues on the table including allowing Medicaid to pay for inpatient addiction treatments and tracking prescriptions electronically in the Medicare program to help prevent abuse.
The Senate Committee on Health, Education, Labor, and Pensions (HELP) released a bipartisan draft bill to address the crisis. The bill is a product of 29 proposals put forward by nearly every member of the HELP Committee. The bill seeks to give the National Institutes of Health the flexibility necessary to develop non-addictive pain killers a move that Chairman Alexander (R-TN) dubbed the “Holy Grail” of tackling the opioid epidemic. Other provisions would give the Food and Drug Administration (FDA) greater authority to require drug manufacturers to package opioids in packaging for a set duration of time like a 3 or 7-day packet and to give consumers safe ways to dispose of unused opioids.
FDA Commissioner Scott Gottlieb had some strong words about drug pricing at the Community Oncology Alliance’s meeting held in Maryland. Commissioner Gottlieb took issue with raising co-pays and co-insurance requirements that are putting patients in precarious financial situations as they are seeking treatment for their lethal diseases. The cost of pharmaceuticals is one of the top priorities for Health and Human Services (HHS) Secretary Azar and we are likely to see administrative actions to address pricing.
We are also hearing the final rule on Association Health Plans may emerge from the Department of Labor in the next month or two. It will be interesting to see how aggressive the Department of Labor will be with the final rule. It is likely that the final rule will be challenged in the courts.
- Top House, Senate Dems warn administration on short-term insurance – The Hill (April 13)
“The ranking Democrats of five House and Senate committees are calling on the Trump administration to withdraw a proposal that would expand access to plans that don’t meet ObamaCare’s consumer protection rules. Led by House Energy and Commerce Committee ranking member Frank Pallone Jr.(N.J.), the Democrats warned Health and Human Services Secretary Alex Azar and other administration officials in a Thursday letter that the rule would “encourage the sale of junk health plans that will undermine consumer protections, sabotage the Affordable Care Act (ACA) marketplaces, and expose consumers to great financial risk.””
- NIH director: Agency is looking at alcohol industry influence ‘in a very aggressive way’ – STAT (April 11)
“The controversy over research conducted by the National Institutes of Health on the health impacts of moderate drinking has reached Capitol Hill, where a lawmaker on Wednesday stridently questioned the agency’s director, Francis Collins, over the NIH’s reportedly cozy relationship with the alcohol industry. In response to a question about reports that the NIH had allowed industry partnerships to influence research into alcohol use and the impact of alcohol marketing, Collins told Rep. Lucille Roybal-Allard (D-Calif.) that the NIH is “looking into this in a very aggressive way.””
- About half of Americans support single-payer health care – Washington Post (April 12)
“As President Trump’s administration tries to chip away at the Affordable Care Act by giving more authority to states to regulate private insurance, a new poll finds a slight majority of Americans support a move in the opposite direction, with everyone getting health insurance from a national government-run program. A Washington Post-Kaiser Family Foundation poll finds a 51 percent majority of Americans support a national health plan, also known as a single-payer plan, while 43 percent oppose it.”
April 6, 2018
This week an internal memo issued by the Secretary of Health and Human Services (HHS) Alex Azar surfaced outlining how the Secretary plans to run the department. The main takeaway from this appears to be that power and influence is being consolidated under Azar’s Deputy Secretary and close confidant Eric Hargan. The two served together at HHS during President George W. Bush’s administration and are known to have a strong rapport. Under this reorganization, Deputy Secretary Hargan will be the lead on all regulatory matters and will be the primary liaison between the Office of Management and Budget (OMB) and the White House. The memo also addresses the consolidation of staff and the removal of up to 40 percent of policy staff to streamline decision making.
Secretary Azar identified his top four priorities for the department: combating the opioid crisis; bringing down the cost of prescription drugs; addressing the cost and availability of health insurance; and transforming our health care system to a value-based system. Azar is creating several “Senior Advisors” – a new position – to help guide action on each of these priorities. Two of those advisors were named (Daniel Best for drug pricing and Dr. Brett Giroir for opioids); the other two will be named soon.
If you would like a copy of the memo, please email firstname.lastname@example.org.
Elsewhere in healthcare, Surgeon General Jerome Adams issued a rare public health advisory this week urging friends and family of people who are at risk of opioid overdose to carry with them naloxone which is used to treat overdoses. While first responders and many police officers carry naloxone, they often arrive too late in cases of overdoses. The last public health advisory from the Surgeon General’s office came in 2005 to warn against the dangers of drinking during pregnancy. This action by the Surgeon General indicates how severe the opioid epidemic has become.
- Senate Panel Unveils Draft Bill to Combat Opioid Addiction – Roll Call (Apr 5)
“The Senate health panel on Wednesday released a discussion draft intended to curb opioid addiction. The development comes as other House and Senate committees also prepare legislation. The Senate Health, Education, Labor and Pensions Committee plans to discuss this legislation at an upcoming hearing on April 11. The panel has already held six hearings on the opioid crisis so far this Congress featuring representatives from agencies including the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention, as well as governors from states affected by the crisis.”
- Heller promised Obamacare repeal in Las Vegas speech to GOP club – Las Vegas Review Journal (Apr 5)
“…Heller predicted that Republicans will pick up a handful of Senate seats in the midterm elections, and that would be the path to fulfilling that long-held promise of a repeal. “I think at the end of the day we end up with 53, 54 seats,” Heller said. “If we can do that, then we can repeal and replace and change the ACA as we know it today.” Heller was not among the original supporters of Trump, and was especially critical of then-candidate Trump during the 2016 campaign season.”
- In rare advisory, surgeon general urges public to carry overdose-reversal medication – STAT (Apr 5)
“Surgeon General Jerome Adamsis issuing a rare public health advisory on Thursday, calling for friends and family of people at risk for opioid overdoses to carry the OD-reversal medication naloxone. He likened the treatment to other livesaving interventions, such as knowing how to perform CPR or use an EpiPen.”
Rich Meade, a Vice Chairman at Prime Policy Group and Chair of the firm’s Healthcare Practice has over 25 years of experience in legislative, regulatory, political and public relations strategy. He previously served as Chief of Staff to the House Budget Committee. Rich has helped his clients navigate many complex regulatory and legislative landscapes to achieve many public policy successes including transitioning to a new Medicare payment and quality system, and developing, with the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC), a health information exchange (HIE) on the Nationwide Health Information Network (NwHIN).
Elizabeth Hart Thompson has nearly two decades of experience as a senior staff member on Capitol Hill and a lobbyist. She joined Prime from Crossroads Strategies, where she focused on health care, financial services and technology. Building on her extensive knowledge of the political and legislative processes, as well as, her dedication to team work, Elizabeth is particularly adept at developing and executing advocacy strategies that deliver meaningful results to clients.
Mitchell has been delivering trusted counsel across a diverse practice of legislative, policy and political issues for more than a decade. During his long-standing tenure both in Congress and throughout the political and policy sphere of Washington, he has tackled some of the largest healthcare, energy and regulatory issues presented before the federal government. He has a massive range of relationships and strategic congressional partnerships has paid dividends for consecutive congressional sessions. Mitch is a member of Prime Policy Group’s healthcare practice.