United States: Health Care Policy Newsletter - 02 July 2018

Foley & Lardner LLP's ("Foley") Bipartisan Public Policy Team is pleased to share our "Public Policy Weekly* Health Care Newsletter" in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.

This Week in Health Care Policy (June 25-29, 2018)

Congress

Legislation and Committee Activity

Senate Finance Committee hearing with HHS Secretary Azar – On Tuesday, the Senate Finance Committee held a hearing on Prescription Drug Affordability and Innovation: Addressing Challenges in Today's Market. Health and Human Services (HHS) Secretary, Alex Azar, testified at the hearing. Read More

Modern Healthcare: Senate pushes for stronger drug-pricing policy than Trump proposal Members of the Senate Finance Committee on Tuesday called on the Trump administration to use stronger tactics to curb high drug prices than its tempered strategy unveiled last month. In its first hearing on the White House's drug pricing blueprint, lawmakers on both sides of the aisle pushed for price controls and broad-strokes negotiation. The central focus of the White House's proposal is moving Medicare Part B drug purchasing to the Medicare Part D model, in which prices are negotiated by pharmacy benefit managers. Read More

Wyden Releases Report on High Drug Prices in Medicare On Tuesday, Senate Finance Committee Ranking Member Ron Wyden, (D-OR) released a report outlining the causes and consequences of high drug prices in Medicare. The report shows how the broken drug system delivers massive profits to drug manufacturers, middlemen and insurance companies while sending costs skyrocketing for families and taxpayers. Read More

Senate Committee Clears FY2019 Labor, HHS, & Education Appropriations Bill – On Thursday, the Senate Committee on Appropriations advanced the FY2019 Labor, Health and Human Services, and Education (Labor-HHS) Appropriations Act, which continues investments in critical medical research, opioid abuse prevention and treatment, and education. Read More

The Hill: Senate appropriators wrap up 2019 markups – On Thursday, the Senate Appropriations Committee wrapped up its markups of all twelve 2019 spending bills, advancing the goal of a return to "regular order" in a budgetary process that has been widely derided for decades as dysfunctional. Read More

Senate Hearing on Cost of Health Care in America On Wednesday, the Senate Health Education Labor and Pensions (HELP) Committee held a hearing on How to Reduce Health Care Costs: Understanding the Cost of Health Care in America. Read More

Senate Homeland Security and Governmental Affairs Hearing on Medicaid Fraud On Wednesday, the Senate Homeland Security and Governmental Affairs Committee held a hearing on Medicaid Fraud and Overpayments: Problems and Solutions. Read More

SubHealth Advances Public Health Bills, Including PAHPA and Children's Hospital GME – On Wednesday, the House Energy and Commerce Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), held a markup considering five public health measures. "Some of these bills will equip our health care system with the tools to maintain a robust, well-educated workforce, while the Pandemic and All-Hazards Preparedness Act reauthorization bill will provide a framework for our emergency preparedness infrastructure to plan for threats such as disease outbreaks," said SubHealth Chairman Burgess. "As a physician, I have always supported programs that improve access to care and enhance the patient experience, and the bills before us today seek to accomplish that goal." Read More

Rep. Collins introduces 340B Legislation On Wednesday, Rep. Chris Collins (R-NY) introduced the Drug Discount Accountability Act (H.R. 62040), which would require hospitals to report their total 340B purchases and pay a 0.1 percent user fee to the program. Read More

Rep. Mimi Walters (R-CA) Sponsors Bill to Expand Access to Care for Sexual Assault Victims – On Thursday, Reps. Mimi Walters (R-CA) and Greg Walden (R-OR) introduced the Creating Access to Rape kit Exams (CARE) for Survivors Act (H.R. 6273). This legislation requires 340B Disproportionate Share Hospitals with an emergency department to be a Sexual Assault Forensic Exam (SAFE)-ready facility, which requires a sexual assault forensic examiner to be available at all times. Read More

Senate Health Committee Advances Alexander, Bennet "PREEMIE" Bill to Give Infants Hope for Healthier Lives – On Tuesday, the Senate health committee passed legislation sponsored by Senator Lamar Alexander (R-TN) and Senator Michael Bennet (D-CO) to reduce infant deaths and improve infant health by continuing research and education programs aimed at preventing preterm births. Read More

The Hill: Collins, Murkowski to play pivotal role in Supreme Court abortion battle The high-stakes abortion battle looming over President Trump's next Supreme Court pick will likely be decided by two GOP senators: Susan Collins (R-ME) and Lisa Murkowski (R-AK). Read More

Administration

Justice Department announces crackdown on fraudulent opioid prescriptions Federal agencies on Thursday announced charges in what Attorney General Jeff Sessions called "the largest health care fraud takedown in American history," an investigation into over $2 billion in alleged fraud by doctors, pharmacists, and nurses. Read More

HHS

GAO Sounds the Alarm on Lax Oversight of Contract Pharmacies Within 340B Program – A new report by the nonpartisan Government Accountability Office (GAO) is making seven recommendations that the Department of Health and Human Services' (HHS) Health Resources and Services Administration (HRSA) take additional action to ensure all contract pharmacies are compliant with the 340B Drug Pricing Program (340B Program). Read More

Bloomberg: What Happened to Trump's Drug-Price Promises? Two weeks means 14 days to most of us. But it's now been a month since President Donald Trump promised "voluntary massive drops in prices" from drug companies in two weeks — and there's been no sign of them. Read More

CMS

CMS Approves State Proposal to Advance Specific Medicaid Value-Based Arrangements with Drug Makers On Wednesday, the Centers for Medicare & Medicaid Services (CMS) issued the first-ever approval of a state plan amendment proposal to allow the state of Oklahoma to negotiate supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers . This could produce extra rebates for the state if clinical outcomes are not achieved. The state plan amendment proposal submitted by Oklahoma will be the first state plan amendment permitting a state to pursue CMS-authorized supplemental rebate agreements involving value-based purchasing arrangements with manufacturers. Read More

CMS announces initiatives to strengthen Medicaid program integrity On Tuesday, the Centers for Medicare and Medicaid Services (CMS) announced new and enhanced initiatives designed to improve the Medicaid program's integrity through greater transparency and accountability, strengthened data, and innovative and robust analytic tools. Read More

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online – Opioid addiction and abuse remains an immense public health crisis. We're committed to continuing to take new steps to address these protracted dangers from every possible angle. Read More

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy On Monday, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. Read More

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's new steps to advance health through improvements in nutrition under the agency's Nutrition Innovation Strategy Making healthy choices about diets can have a significant impact on America's health. When we think about advancing health and reducing the death and disability caused by disease, we often think about our investments in new technology and developing the next breakthrough drug. But the cumulative effect of making smart decisions every day about our diets, when spread over a population, can dwarf the impact of any single new medical product. Read More

Veteran Affairs

Preparations for Transitioning to a New Electronic Health Record System Are Ongoing – According to the Department of Veterans Affairs (VA), the Veterans Health Information Systems and Technology Architecture (VistA) and related costs, as approximated by funding obligations, were approximately $1.1 billion, $899 million, and $946 million in fiscal years 2015, 2016 and 2017, respectively. Read More

States

Washington Examiner: Trump administration denies Massachusetts' bid to control drug costs The Trump administration shot down Massachusetts' request to try to rein in high drug costs by restricting coverage of certain drugs under Medicaid. Massachusetts would have been the first state to experiment with creating a closed formulary, or list of approved drugs, if the Centers for Medicare and Medicaid Services had approved it. But the agency said the state would have to forgo all manufacturer rebates under the plan, and even though the state had wanted to continue receiving them. Read More

The Hill: Iowa court rejects law requiring 72-hour waiting period for abortion The Iowa Supreme Court is blocking a recent law that requires women to submit to a 72-hour waiting period before they can get an abortion. The Associate Press reports that the court ruled on Friday that the requirement, which was signed into law in 2017, violated Iowa's state constitution. Read More

Primaries

Vox: 3 winners and 2 losers from the primaries in South Carolina, New York, Utah, and Colorado – There were a lot of primaries Tuesday night sprawled out across a bunch of states, too many for any really clear narrative to emerge across all the results. But one singular result — a top House Democrat's loss to a 28-year-old democratic socialist — stands head and shoulders above the rest as a striking defeat for the Democratic Party establishment. Read More

The Hill: Crowley stunner sets off new scramble among House Dems Rep. Joseph Crowley (D-NY)'s stunning defeat in his primary has created an unexpected opening for a younger, more progressive candidate to challenge the old bulls of House Democratic leadership — Nancy Pelosi (D-CA), Steny Hoyer (D-MD) and Jim Clyburn (D-SC) — who are all in their late 70s. Read More

Foley Health Care Law Today

Our attorneys at Foley pride themselves on having a first-hand understanding of health care's business and legal challenges. Health Care Law Today is your go-to resource for information and perspectives on the latest news and developments in Health care law and how it relates to and impacts the industry and those with related business interests. See below some of the blog's top stories.

Disruption and Innovation on Display at the 2018 CEO/Innovators Roundtable On June 19 and 20, 2018, more than 60 innovators and thought leaders came together for the 13th annual, invitation-only CEO/Innovators Roundtable (Roundtable), hosted by Foley & Lardner LLP and BDC Advisors, LLC. The overall theme of the Roundtable was "disruption and innovation" in health care, and the discussion was divided into panels on five key topics. Read More

New Connecticut Law Allows Telemedicine Prescribing of Controlled Substances Connecticut has taken another step towards expanding the meaningful use of telemedicine in connection with treatment of mental health and substance use disorders. SB 302, signed by Governor Dannel Malloy and effective July 1, 2018, allows providers to prescribe controlled substances via telemedicine for the treatment of psychiatric disabilities or substance use disorder, including medication assisted therapy. Read More

Looking Ahead

The House and Senate are not session this week and will return on Monday, July 9 and Tuesday, July 10. Happy 4th of July!

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