United States: Health Care Policy Newsletter - 16 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 (July 9-13, 2018)

Congress

Legislation and Committee Activity

Modern Healthcare: House Panel Approves HSA Expansion Package That Also Takes Aim At Obamacare Taxes – A key House health panel on Thursday approved a $92 billion package of bills focused on expanding investments in health savings accounts after a fraught two-day hearing that highlighted fundamental GOP and Democratic disagreements over how Congress should intervene in private insurance markets. Read More

Lawmakers Introduce Legislation to Cap Prescription Drug Copays – On Wednesday, United States Senators Elizabeth Warren (D-MA), Bill Nelson (D-FL), Ranking Member of the Senate Finance Committee Ron Wyden (D-OR) ,Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee Patty Murray (D-WA), along with Congresswoman Jacky Rosen (D-NV), introduced the bicameral Capping Prescription Costs Act of 2018 (S.3194). This is to tackle the problem of high drug costs that families face by placing a monthly cap on their out-of-pocket drug costs. The legislation comes as more than a quarter of Americans taking prescription drugs struggle to afford the costs of their medicine. Read More

Committee Reviews 340B Program and Recent Report on Contract Pharmacies – On Wednesday, the House Energy and Commerce Health Committee held a hearing to learn more about a recent report by the nonpartisan Government Accountability Office (GAO) regarding lax oversight of contract pharmacies within the 340B Drug Pricing Program (340B Program). In addition, the committee received feedback on several bills and discussion drafts that would strengthen the 340B Program. Read More

Modern Healthcare: 340B Drug Discount Limits To Be Considered House Panel – On Wednesday a key House panel considered a new packet of 340B legislation that would go further than previous measures to overhaul the controversial drug discount program. Read More

Full Committee Advances More than One Dozen Bills to House Floor for ConsiderationToday, the Energy and Commerce Committee, chaired by Rep. Greg Walden (R-OR) advanced more than one dozen bills to the House of Representatives for consideration. "Today's bills speak to the hard work of our members and staff on both sides of the aisle to enact meaningful solutions that empower consumers, patients, small businesses, and all Americans," said Chairman Walden. Read More

Pallone Requests Hearing On REMS Abuse – On Monday, House Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) requested Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael Burgess (R-TX) schedule a hearing to examine misuse of the Risk Evaluation and Mitigation Strategies (REMS) program by pharmaceutical manufacturers in an effort to block, impede, or delay generic competitors from coming to market. Read More

Chairman Roe, Ranking Member Walz Name Lawmakers to New Subcommittee on Technology Modernization – On Thursday, the House Committee on Veterans' Affairs approved the creation and leadership of the Subcommittee on Technology Modernization. The subcommittee was announced by Chairman Phil Roe, M.D. (R-TN) and Ranking Member Walz (D-MN) on June 20 and will focus on oversight of Department of Veterans Affairs (VA) technology projects, specifically the Electronic Health Record (EHR) Modernization program. Read More

Politico: Lawmakers Battle Over Busting Budget To Pay For Veterans Healthcare -Spooking House conservatives and risking a presidential veto, Senate spending leaders are proposing to blow past budget limits to fund a popular private health care program for military veterans. Read More

Appropriations

Senate Names Conferees for Minibus Appropriations Bill – On Wednesday, The U.S. Senate announced the members who will participate in the Conference Committee to finalize H.R. 5895, the minibus appropriations bill, which packages the Fiscal Year 2019 funding measures for Energy and Water Development, Military Construction and Veterans Affairs, and Legislative Branch. Read More

Appropriations Committee Approves the Fiscal Year 2019 Labor, Health and Human Services, Education Funding Bill – On Wednesday, the House Appropriations Committee approved the draft for fiscal year 2019 Labor, Health and Human Services, and Education (LHHS) funding bill on a vote of 30-22. The legislation includes funding for programs within the Department of Labor, the Department of Health and Human Services, the Department of Education, and other related agencies. Read More

Supreme Court

The Hill: Kavanaugh Nomination Raises Questions About Obamacare’s Fate – One of Democrats' central messages in fighting Supreme Court nominee Brett Kavanaugh is that he would help overturn ObamaCare's protections for people with pre-existing conditions. But legal experts at both ends of the political spectrum say the chances of a court challenge to ObamaCare succeeding are very small, and that the latest lawsuit challenging the 2010 Affordable Care Act (ACA) is far-fetched. Read More

NPR: Supreme Court Nominee Brett Kavanaugh Could Leave His Mark On Many Healthcare Cases – Judge Brett Kavanaugh, President Trump’s Supreme Court nominee, will have a chance to leave his mark on a series of health care cases, including ones related to Medicaid, the Affordable Care Act and Planned Parenthood. Read More

Administration

HHS

Modern Healthcare: HHS Proposes New Ambulatory Surgery Center Safety Database – HHS is looking to launch a patient safety database for ambulatory surgery centers as more facilities open around the nation. HHS’ Agency for Healthcare Research and Quality has asked the White House’s Office of Management Budget for permission to launch the database, similar to others it has for hospitals, nursing homes and pharmacies. Read More

CMS

Politico: CMS Expected To Propose Cuts To More 340b Providers – The agency is expected to expand the number of 340B health facilities that will be affected by payment cuts for all physician-administered drugs, multiple industry sources tell POLITICO’s Sarah Karlin-Smith. Read More

CMS Proposes Historic Changes to Modernize Medicare and Restore the Doctor-Patient Relationship –On Thursday, the Centers for Medicare & Medicaid Services (CMS) proposed historic changes that would increase the amount of time that doctors and other clinicians can spend with their patients by reducing the burden of paperwork that clinicians face when billing Medicare. The proposed rules would fundamentally improve the nation's health care system and help restore the doctor-patient relationship by empowering clinicians to use their electronic health records (EHRs) to document clinically meaningful information, instead of information that is only for billing purposes. Read More

New CMS Proposals to Modernize and Drive Innovation in Durable Medical Equipment and End-Stage Renal Disease Programs – On Wednesday, CMS proposed innovative changes to the payment rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) and the End-Stage Renal Disease (ESRD) program. The DME proposals in the proposed rule released today aim to increase access to items for patients and simplify Medicare's DMEPOS Competitive Bidding Program (CBP) to drive competition and increase affordability. The rule also includes ESRD proposals, including a proposal to address new renal dialysis drug and biological costs and foster innovations in treatment by incentivizing new therapies for patients on dialysis and a proposal to reduce facility-related documentation burden. Read More

CMS Announces New Funding Opportunity Announcement for the Federally-Facilitated Exchange Navigator Program – On Tuesday, CMS announced the Funding Opportunity Announcement (FOA) for the Federally-facilitated Exchange (FFE) Navigator Program for plan year 2019. Under the 2018 FOA, CMS expects to award up to $10 million for a 1-year period of performance. A minimum of $100,000 will be awarded in each of the 34 FFE states to provide assistance to Exchange consumers, starting in the fall of 2018. Awards will go to eligible grantees, such as chambers of commerce, small businesses, trade associations, and faith-based organizations . Read More

CMS Proposes Rule Change to Protect Medicaid Provider Payments – On Tuesday, CMS proposed changes to the Medicaid Provider Reassignment regulation that would eliminate state's ability to divert Medicaid payments away from providers, with the exception of payment arrangements explicitly authorized by statute. This proposed regulatory change is designed to ensure that taxpayer dollars dedicated to providing health care services for low-income vulnerable Americans are not siphoned away for other purposes. Read More

CNN: Medicaid Website Hides Some Obamacare Information, Group Says – The Medicaid.gov website has hidden a batch of Obamacare information that was once prominently featured, including details on eligibility for Medicaid expansion, according to a group that monitors federal websites. Read More

FDA

Statement By FDA Commissioner Scott Gottlieb, M.D., On Formation Of A New Drug Shortages Task Force And FDA's Efforts To Advance Long-Term Solutions To Prevent Shortages – We've seen the number of new drug shortages steadily decline since a peak in 2011 owing to the work of the FDA, industry and other groups. Despite these efforts, we continue to see ongoing shortages of medically necessary products. Even shortages of a small number of key drugs can place a serious burden on providers. Read More

Statement By Fda Commissioner Scott Gottlieb, M.D., On Balancing Access To Appropriate Treatment For Patients With Chronic And End-Of-Life Pain With Need To Take Steps To Stem Misuse And Abuse Of Opioids – The opioid epidemic continues to take an emotional, physical and financial toll on Americans. The U.S. Food and Drug Administration is committed to taking every possible step to address the many facets of this complex public health crisis. Read More

FDA Updates Warnings For Fluoroquinolone Antibiotics On Risks Of Mental Health And Low Blood Sugar Adverse Reactions – On Tuesday, the U.S. Food and Drug Administration is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection. Read More

DEA

Department Of Justice Announces Regulatory Steps To Address Opioid Epidemic On Wednesday, the Department of Justice today announced the finalization of an April proposal to improve the Drug Enforcement Administration's ability to control the diversion of dangerous drugs in the midst of the national opioid crisis. In April, Attorney General Jeff Sessions announced the final rule sent for publication on Wednesday in the Federal Register establishes that DEA will take into consideration the extent that a drug is diverted for abuse when it sets its annual opioid production limits. Read More

GAO

Improvements Needed in Federal Oversight of Compliance at 340B Contract Pharmacies – To have their drugs covered under Medicaid, the “340B” program requires drug manufacturers to sell outpatient drugs to covered entities—certain hospitals and clinics—at a discount. These entities are increasingly contracting with pharmacies to dispense 340B drugs. Doing so can make it harder to ensure compliance with 340B rules. For example, contract pharmacies may also fill prescriptions for the general public, increasing the risk of dispensing 340B drugs to ineligible patients. Read More

States

Law 360: 2 Proposed Classes Denied Cert. In Aetna ERISA Fight – A New Jersey federal judge has refused to certify a pair of putative class actions accusing Aetna of violating the Employee Retirement Income Security Act by shortchanging its customers on reimbursements for out-of-network services, ruling that there's no common solution since the consumers' benefit plans vary. Read More

NY Senate's Drug Take Back Act Becomes Law – On Tuesday, the New York State Senate announced that the Drug Take Back Act has been signed into law. The measure establishes a unified statewide drug take-back program that will reduce medication misuse, and save government and taxpayer money. Read More

NY Times: Docs Back DeWine After He Commits to Keep Medicaid Expansion – On Wednesday, after the Republican committed to supporting, but improving, Medicaid expansion. Ohio’s largest organization of doctors backed Attorney General Mike DeWine for governor. Read More

News

US News: House Approves Opioid Bill, Rejects Involuntary Treatment – The Massachusetts House has approved new steps to deal with opioid addiction, but without an involuntary treatment provision. The bill passed by the House Wednesday night would instead create a special commission to study Republican Gov. Charlie Baker’s plan for allowing medical professionals to hold patients for up to 72 hours for substance abuse treatment. Read More

Health Affairs Launches Council On Healthcare Spending And Value – The share of U.S. Gross Domestic Product devoted to health care has been termed a "crisis," while growth in spending has been called "unsustainable" for decades—long enough to lead one to question whether either of those claims is true. Today, with health care spending reaching nearly 18 percent of the GDP, it may be time to admit that the phenomenon of ever-growing health spending has proven itself to be sustainable. Read Now

Foley Healthcare 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. For some of the blog's top stories see below:

New Demonstration Program Would Reward Clinicians for Accepting Risk in Medicare Advantage – CMS recently announced that it wants to launch a new demonstration program, the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration. If approved and adopted as a demonstration project, the MAQI Demonstration would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who participate sufficiently in qualifying risk programs of Medicare Advantage plans by making such programs qualify for the Advanced Alternative Payment Model (AAPM) under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Read More

Association Health Plans – The Final Rule Is Issued – Earlier this month, the Department of Labor (DOL) released its Final Rule seeking to expand the scope of participation in Association Health Plans. The Final Rule, titled "Definition of 'Employer' under Section 3(5) of ERISA – Association Health Plans", with a few revisions, codified the Proposed Rule. Read More

Delaware's New Telemedicine Rules: Top Four Changes to Know – The Delaware Board of Medicine recently enacted new regulations pertaining to telemedicine and telehealth. As we previously reported, the new regulations are intended to clarify the language in Delaware's Medical Practice Act, which imposes certain practice standards for what constitutes an appropriate patient diagnosis and treatment via telemedicine, including the allowable modalities and when an in-person examination is required. The new regulations add Rule 19.0 to Chapter 1700 of the Code of Delaware Regulations and became effective June 11, 2018. Read More

Looking Ahead

The House and Senate are in session next week.

On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold a hearing on "Reducing Healthcare Costs: Eliminating Excess Healthcare Spending and Improving Quality and Value for Patients." Read More

On Tuesday, the House Ways and Means Health Subcommittee will hold a hearing on "Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program." The hearing will examine the need for and possible solutions for modernizing physician self-referral law, or "Stark Law," to increase the ability of the Medicare program to successfully move to a system that rewards higher value, coordinated health care over volume. Read More

On Tuesday, the House Ways and Means Oversight Subcommittee will hold a hearing, entitled "Combating Fraud in Medicare: A Strategy for Success." The hearing will focus on how the Centers for Medicare and Medicaid Services (CMS) identifies and manages fraud risk in the Medicare program. Read More

On Tuesday, the House Energy and Commerce Committee will hold a hearing on "Examining State Efforts to Improve Transparency of Healthcare Costs for Consumers." Read More

On Thursday, the House Energy and Commerce Committee will hold a hearing on "21st Century Cures Implementation: Examining Mental Health Initiatives." Read More

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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