On The Hill

This week, President Trump signed H.R. 6, the sweeping opioids legislative package. The legislation comes just a year since the president declared the opioid epidemic a public health emergency, and the bill he signed on Wednesday is one of the most bipartisan bills passed in the 115th Congress. President Trump praised the work of House Energy and Commerce Committee Chairman Greg Walden (R-OR-02) and Senate HELP Committee Chairman Lamar Alexander (R-TN) stood alongside the president as he signed the bill. “Together, we are going to end the scourge of drug addiction,” Trump said.^[1]

In other opioid related news, the Food and Drug Administration (FDA) is cracking down on websites that sell illegal opioids to U.S. consumers from abroad. Actions taken by the agency include warning letters to online networks, monitoring criminal network transactions, and protecting against deceitful marketing tactics. The new efforts are part of Operation Pangea XI, an international coalition of regulatory and law enforcement agencies.^[2] The operation has been responsible for several enforcement actions aimed at illegal distributors of prescription drugs and fentanyl in recent weeks.

●    Read this press release from FDA for more information.

The Attorney General’s office is also ramping up action against those who are exacerbating the opioid epidemic. This week, the Department of Justice (DOJ) held an Opioid Summit, and AG Jeff Sessions announced $27.8 million in grant funding to states via the Anti-Heroin Task Force Program and $36.4 million for the Office for Victims of Crime. In addition to the millions in grant funding, Sessions also announced the creation of the Appalachian Regional Prescription Opioid Strike Force, composed of 12 opioid fraud prosecutors.^[3]

●    Click here to read Sessions’ full remarks.

Medicare Drug Pricing

The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule this week regarding an International Pricing Index model for Medicare Part B drugs. Specific changes proposed include “phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices.”^[4] A report from the Department of Health and Human Services (HHS) claims that prices charged to drug manufacturers and wholesalers for Medicare Part B drugs are 1.8 times higher than other countries, and that “U.S. prices were more likely to be the highest prices paid among countries in (the) study.”^[5] The rule will be published on Tuesday, October 30th. President Trump spoke at HHS on Thursday and blamed “foreign freeloaders” for driving up prices in America. While drug companies and congressional Democrats dismissed this plan, CMS Administrator Seema Verma backed President Trump’s actions, saying “the time has come to fix the perverse incentives in the Medicare program that are fueling price increases.”^[6]

●    Drug pricing report from HHS can be viewed here.

●    Advance notice of the rule can be viewed here.

Health Reimbursement Arrangements

In an effort to expand the use of health reimbursement arrangements (HRAs), the Trump administration is issuing a proposed regulation to undo the prohibition on using HRAs to reimburse employees for the cost of individual health insurance. The regulation would also allow employers to offer an HRA of up to $1,800 for medical expenses, such as premiums for short-term health plans. The goal of the proposed rule is to “expand the flexibility and use of HRAs to provide more Americans with additional options to obtain quality, affordable healthcare.”^[7]

Affordable Care Act Waivers

New guidance from CMS was issued this week to supersede previous guidance on Section 1332 State Relief and Empowerment Waivers. The updated guidance increases flexibility in how a Section 1332 waiver can be approved by the HHS Secretary. According to the guidance document, this action “aims to lower barriers for states seeking to reform their health insurance markets.”^[8]

●    The full guidance document can be read by clicking here.

Medicaid Budget Survey

Last night (October 25th), the Kaiser Family Foundation released a 50-state Medicaid budget survey from fiscal year 2018-19. The study focused alternative payment models (APMs), state Medicaid expansion efforts (including upcoming ballot initiatives), and changes in eligibility via Section 1115 waivers. A large concern from the KFF highlighted is that Section 1115 demonstration waivers could potentially cause enrollment declines.^[9]

●    A summary of key findings can be viewed by clicking here.

References

^[1] Marianna Sotomayor. “Trump signs sweeping opioid bill with vow to end ‘scourge’ of drug addiction.” NBC News, 24 Oct 2018. https://www.nbcnews.com/politics/congress/trump-signs-sweeping-opioid-bill-vow-end-scourge-drug-addiction-n923976

^[2] Jeremy Kahn. “FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids.” FDA, 23 Oct 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624070.htm

^[3] Attorney General Jeff Sessions. “Remarks at the Department of Justice Opioid Summit.” DOJ, 25 Oct 2018. https://www.justice.gov/opa/speech/attorney-general-jeff-sessions-delivers-remarks-department-justice-opioid-summit

^[4] “Medicare Program; International Pricing Index Model for Medicare Part B Drugs.” HHS, 25 Oct 2018. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-23688.pdf

^[5] “Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures.” HHS, 25 Oct 2018. https://aspe.hhs.gov/system/files/pdf/259996/ComparisonUSInternationalPricesTopSpendingPartBDrugs.pdf

^[6] Seema Verma. “HHS Advances Payment Model to Lower Drug Costs for Patients.” HHS, 25 Oct 2018. https://www.hhs.gov/about/news/2018/10/25/hhs-advances-payment-model-to-lower-drug-costs-for-patients.html

^[7] “Health Reimbursement Arrangements and Other Account-Based Group Health Plans.” Departments of the Treasury, Health and Human Services, and Labor, 23 Oct 2018. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-23183.pdf

^[8] “State Relief and Empowerment Waivers.” HHS, 23 Oct 2018. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-23182.pdf

^[9] Kathleen Gifford, Eileen Ellis, Barbara Coulter Edwards, Aimee Lashbrook, Elizabeth Hinton, Larisa Antonisse, and Robin Rudowitz. “States Focus on Quality and Outcomes Amid Waiver Changes: Results from a 50-State Medicaid Budget Survey for State Fiscal Years 2018 and 2019.” KFF, 25 Oct 2018. https://www.kff.org/medicaid/report/states-focus-on-quality-and-outcomes-amid-waiver-changes-results-from-a-50-state-medicaid-budget-survey-for-state-fiscal-years-2018-and-2019/