United States: This Week In Health Care Policy

Foley & Lardner LLP's ("Foley") Bipartisan Public Policy Team is pleased to introduce "This Week in Health Care Policy," a new weekly publication providing a compilation of the latest health care policy news and legislation. This newsletter will be provided on weeks that Congress is in session. The first edition appears below.

Congress

Senate Health Committee Unanimously Passes Bipartisan Opioid Crisis Bill – On Tuesday, Senate health committee voted to approve the Opioid Crisis Response Act of 2018, which Chairman Lamar Alexander (R-TN) said will "help create an environment for states to succeed in fighting the opioid crisis." "Over the last six months, this committee has heard from experts on how the federal government can be the best possible partner as we work to combat the nation's largest public health crisis – the opioid crisis," Alexander said. The challenge before us has often been described as needing a moonshot. Solving the opioid crisis might require the energy and resources of a moonshot, but ultimately it is not something that can be solved by an agency in Washington, D.C." Read More.

House Energy and Commerce #SubHealth Votes to Advance 57 Bills to Combat the Opioid Crisis – On Wednesday, the House Energy and Commerce Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), advanced 57 bills to the full Energy and Commerce Committee. Of the bills, 56 were focused on ways to help combat the opioid crisis. #SubHealth also considered the bipartisan, bicameral reauthorization of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). Read More.

House Ways & Means Subcommittee Hearing on Synthetic Opioids in the International Mail System – On Wednesday, the House Ways & Means subcommittee on Trade held a hearing on the opioid crisis: Stopping the Flow of Synthetic Opioids in the International Mail System. Read More.

Veterans' Spending Bill Advances – On Thursday, the House Appropriation Subcommittee on Military Construction, Veterans Affairs, and Related Agencies advanced the measure funding the veterans' health care system. The bill offers $71.2 billion for veteran's health care services, which is a $2.4 billion increase over the fiscal 2018 level. Read More.

House Ways & Means Subcommittee Hearing on Innovation in Health Care – On Thursday, the House Ways & Means Subcommittee on Trade held a hearing on Innovation in Health Care. Read More.

House Energy and Commerce Committee Issues Request for Information Regarding Legacy Technologies in Health Care – Last Friday, the Energy and Commerce Committee posted a request for information regarding the use of legacy technologies in health care. These technologies, which are in use across the sector, have also been a root cause of many health care cybersecurity challenges. The request for information details the committee's interest, saying, "While health care cybersecurity is a complex, nuanced challenge with many different contributing factors, the use of legacy technologies, which are typically more insecure than their modern counterparts, continues to be a root cause of many incidents. The health care sector and medical technologies face the same challenge that has vexed the information technology (IT) industry for decades; digital technologies age faster and less gracefully than their physical counterparts." e committee welcomes all feedback regarding the challenges of legacy technologies, as well as opportunities and suggestions for improvement, by Thursday, May 31, 2018. Read More.

USA Today: Debbie Lesko keeps Arizona 8th in GOP hands in special election – Republican Debbie Lesko defeated Democrat Hiral Tipirneni in the election to fill a vacant congressional seat that spans the west Phoenix area, but her relatively narrow victory margin Tuesday will do little to calm Republicans nervous about the midterm races. Read More.

Legislation

On Tuesday, Rep. Buddy Carter (R-GA) introduced the 340B Optimization Act (H.R.5598), which would require participating hospitals to report how much outpatient care they give low-income patients at all their sites receiving discounted drugs. Read More.

On April 18, Sens. Jeff Merkley (D-OR) and Chris Murphy (D-CT) introduced the Choose Medicare Act (S. 2708), which would establish a Medicare Part E public health plan and reform other provisions of the ACA. Read More.

On April 18, Reps. Frank Pallone (D-NJ) Brett Guthrie (R-KY) introduced the National Centers of Excellence in Continuous Manufacturing Act of 2018 (H.R. 5568), which would allow FDA to partner with universities to further develop and implement continuous manufacturing technology. Read More.

On April 17, Sens. Marco Rubio (R-FL) and Bill Nelson (D-FL) introduced legislation (S. 2690) that would end a provision of the Affordable Care Act that prohibits hospitals from contesting Medicare Disproportionate Share Hospital (DSH) payments once the Centers for Medicare and Medicaid Services (CMS) has rendered a decision, even if CMS makes an error. Read More.

On April 16, Reps. Vicky Hartzler (R-MO), Luis Correa (D-CA) and Mike Bost (R-IL) introduced the VA Hiring Enhancement Act (H.R. 5521), which would establish measures to make VA more competitive in hiring physicians and health care providers. Read More.

On April 16, Sens. Orrin Hatch (R-UT), Tim Kaine (D-VA) and Elizabeth Warren (D-MA) introduced the Ensuring Access to Quality Recovery Living Act (S. 2678), which would give states the resources and guidelines necessary to ensure recovery homes provide a safe space for recovery. Read More.

HHS

HHS Appointments – Last Wednesday, HHS Secretary Alex Azar appointed James Parker to Senior Advisor to the Secretary for Health Reform and Director of the Office of Health Reform at HHS. Read More.

Why Health IT Is So Valuable to the Future of Healthcare – At Datapalooza, Deputy Secretary Hargan previews how HHS work on health IT is a key piece of transforming our healthcare system to one that pays for value. Read More.

Drug Pricing Proposal Should Revamp Medicare, GOP Experts Say – An upcoming Trump administration proposal on lowering drug costs should ask Congress to allow private insurance companies to negotiate prices for drugs administered in a doctor's office or hospital, two Republican policy experts said. The administration's proposal is a request for comment on strategies to lower drug prices and out-of-pocket costs. It was originally expected to be released in tandem with a speech by President Donald Trump on Thursday, but the speech was delayed as Health and Human Services Secretary Alex Azar recovers from an infection. Read More.

CMS

Promoting interoperability: What hospitals are saying about new CMS rule revamping meaningful use – The Centers for Medicare and Medicaid Services late Tuesday announced substantive changes to the meaningful use program and while hospitals appreciate one of them, two others are drawing less enthusiasm. Specifically, CMS is aiming to reduce regulatory burdens on clinicians and hospitals, but the agency is also proposing that they equip themselves, technologically and policy-wise, to grant patients access to their data in EHRs and post pricing for care services in a way consumers can understand. Read More.

CMS releases Medicare Advantage data for first time – The CMS has followed through on its promise to release Medicare Advantage data to researchers in an effort to help them better understand care trends for seniors. CMS Administrator Seema Verma said Thursday that this is the first time the agency has released the data to researchers. The agency has been collecting data on patient conditions and the services they receive since 2012, using it to help calculate payments for Medicare Advantage insurers. CMS Administrator Seema Verma told an audience at the 2018 Health Datapalooza that the agency also plans to release data from Medicaid and the Children's Health Insurance Program (CHIP) in 2019. Read More.

Medicaid Won't Look the Same Next Year – This year could mark a significant shift for Medicaid programs across the country, as some states look to expand the government insurance program to more poor Americans while others seek to add more requirements for people who benefit. Initiatives to get Medicaid expansion put on the November ballot are underway in Utah, Nebraska, Idaho and Montana. And Virginia lawmakers appear on the verge of securing an expansion deal, after years of rejecting the idea. Meanwhile, Indiana, Kentucky and Arkansas are poised to make precedent-setting changes to their programs in the coming months, such as adding work requirements, while other states await word from the Trump administration on whether they can make other revisions. Read More.

CMS Request for on Feedback on New Direction Request for Information (RFI) Released – On Wednesday, the Centers for Medicare & Medicaid Services (CMS) announced that it has released the comments submitted by patients, clinicians, innovators, and others in response to the CMS Innovation Center's New Direction Request for Information (RFI). Last fall, CMS released the RFI to collect ideas on a new direction for the agency's Innovation Center to promote patient-centered care and test market driven reforms that: empower beneficiaries as consumers, provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes. The Innovation Center is a central focus of the Administration's efforts to accelerate the move from a healthcare system that pays for volume to one that pays for value and encourages provider innovation. Comments are due by 11:59 EDT on May 25, 2018. Read More.

Generic-Drug Companies to Face First Charges in U.S. Probe – U.S. prosecutors are nearing their first charges against companies in an almost four-year-old criminal investigation into alleged price-fixing by generic-drug makers, according to people familiar with the matter. At least two companies are on track to be indicted in the coming months, in addition to several executives, said two people, who spoke on condition of anonymity because the investigation is confidential. Another company could agree to plead guilty before then, said one the people. Read More.

Ernst, Grassley Lead Members of Iowa Delegation in Letter Urging CMS to Repeal Guidance Hindering Iowa's Individual Market – Last week, Sens. Joni Ernst (R-IA) and Chuck Grassley (R-IA), along with Reps. Steve King (R-IA), David Young (R-IA), and Rod Blum (R-IA), sent a letter to the Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma urging CMS to repeal guidance that hinders states (like Iowa), with failing individual health insurance markets, from applying for waivers to pursue additional, innovative health care coverage options for individuals. Read More.

FDA

Commissioner Gottlieb pledges to take on updating generic drug labeling – On Tuesday, FDA Commissioner Scott Gottlieb, M.D. testified before the Senate Appropriations Committee on the FDA's FY19 budget and told Senators that he wants to take a greater role in making sure the labels of generic drugs are up-to-date even after the corresponding brand-name drug is no longer sold. Read More.

FDA issues guidance on Opioid Dependence – Last Friday, the FDA released draft guidance on developing Buprenorphine depot products for treatment which outlines the FDA's current thinking about drug development and trial design issues relevant to the study of sustained-release "depot" buprenorphine products, which include modified-release products for injection or implantation. In addition, in the coming months, we will take additional steps, beyond these guidance documents, to help promote the development of better treatments for those suffering from opioid use disorder. Read More.

Foley & Lardner LLP 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 for some of the blog's top stories:

Making a "Tele-Difference" by Using Telemedicine to Aid Medically Vulnerable Populations – More than 74 million individuals are enrolled in Medicaid and the Children's Health Insurance Program (CHIP). Another 28 million are currently uninsured. Due to the repeal of the individual mandate (the requirement under the Affordable Care Act to purchase insurance or face a financial penalty), the uninsured population is projected to increase to 32 million by 2019. Caring for these medically vulnerable populations is a challenge due to significant limitations on access to care as the cost of health care continues to rise. In addition to cost, the number of physicians available to provide care to these populations is limited and may become even more so. More than 36 percent of U.S. physicians are over the age of 55, and a similar proportion of U.S. physicians do not accept Medicaid or uninsured patients, making access to quality health care even more limited. Read More.

7 Things to Know About Physician Practice Recapitalization Transactions – A tremendous amount of capital has been, and continues to be, dedicated by private equity sponsors, and private equity backed companies, toward the recapitalization of physician practices. Here are seven important high-level considerations that may impact your approach to these transactions: Read More.

Iowa's New Telehealth Law: What You Need to Know – Iowa Governor Kim Reynolds recently signed a new bill into law requiring commercial health insurers in the Hawkeye State to cover health care services provided via telehealth to the same extent those services are covered via in-person care. The law, passed under HF 2305, takes effect January 1, 2019 and applies to all policies delivered, issued, or reissued in Iowa after that date. Iowa telemedicine providers, entrepreneurs, and patients will soon enjoy telehealth insurance coverage, joining the national majority of states with similar laws. Read More.

The Week Ahead

The House and Senate are not in session and will return on Monday, May 7^th.

Trump to deliver first-time speech on drug prices in early May – The White House has targeted May 8 as the date for the address, according to sources with close ties to the drug industry and the Department of Health and Human Services. The administration didn't confirm or deny the date. The speech was scheduled for last week, but postponed after HHS Secretary Alex Azar was hospitalized for an intestinal illness. Read More.

On Tuesday, May 8^th, Indiana, North Carolina, Ohio and West Virginia will head to the polls for state primaries. Read More.

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