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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

EMA launched improved version of EudraVigilance

by Hogan Lovells on

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

Corporate Law & Governance Update - December 2017

by McDermott Will & Emery on

Unprecedented 2018 Board Challenges - The health system board should be prepared to address an extraordinary number of significant, enterprise-level challenges that are expected to arise in 2018. These challenges will...more

Texas Hospital Settles Kickback Allegations Relating to Marketing Services Payments

by King & Spalding on

On December 4, 2017, the DOJ announced a $7.5 million settlement with Pine Creek Medical Center, a Dallas-based physician-owned hospital. The settlement resolves allegations that the hospital paid physicians kickbacks in the...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

by McDermott Will & Emery on

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

Six Ways Tax Reform Could Change Healthcare

by Morgan Lewis on

Providers, including charitable hospitals, nonprofit organizations, and academic medical centers, should watch for possible policy changes in the tax reform bill reconciliation process....more

CMS Scraps Cardiac/Hip Fracture Episode Payment Model, Downsizes CJR Program

by Reed Smith on

The Centers for Medicare & Medicaid Services (CMS) has officially cancelled a planned program to require certain hospitals to participate in Medicare episode payment models (EPMs) for acute myocardial infarction, coronary...more

Strengthening Medicaid Long-Term Services and Supports in an Evolving Policy Environment: A Toolkit for States

Low-income adults who need and use long-term services and supports (LTSS) are among the most complex, expensive, and fast-growing populations covered by Medicaid. The challenges of organizing and paying for this much needed...more

Window on Washington - Vol. 1, Issue 38

by Clark Hill PLC on

One Shutdown Averted, Countdown Begins Again: With the government funded through December 22, House and Senate leadership are shifting their focus on how to structure a long-term spending deal that would include an increase...more

FDA Includes Patent Submission Date Updates In Orange Book

by Tarter Krinsky & Drogin LLP on

The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more

Capitol Hill Healthcare Update

by BakerHostetler on

Lawmakers last week approved a stopgap budget bill to keep the government open until Dec. 22, creating a pre-Christmas showdown over a host of spending decisions and key healthcare priorities. Republican leaders on Capitol...more

Blog: OIG Revokes Patient Assistance Program Advisory Opinion Protection

by Cooley LLP on

The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006. Opinion 06-04 had been modified by the OIG on December...more

DHS Issues Draft Opioid Prescribing Guidelines

by Stinson Leonard Street on

In an effort to combat the ongoing epidemic of opioid misuse and opioid-related morbidity and mortality, the Minnesota Department of Human Services (DHS) Opioid Prescribing Work Group (OPWG) recently issued Draft Opioid...more

What Caregivers Can Do to Create a Dependable Bedtime Routine

Adequate sleep is essential to good health. Unfortunately, sleep can be difficult for elderly people and their caretakers, particularly among elderly people who are disabled. Physical pain, emotional stress, or challenging...more

Henry Ford Health System Notifies 18,000+ Patients of Health Data Breach

On December 6, 2017, Henry Ford Health System (HFHS) disclosed that health information of 18,470 patients may have been viewed or stolen. HFHS became aware of the incident on October 3, 2017 after employee credentials were...more

News from Second & State

Back from this weekend’s Pennsylvania Society festivities, the House of Representatives were back to work on Monday morning, convening for their second to last session week of the year. On Monday, the House Appropriations...more

American Indian Law and Policy: 10 Things You Need to Know - December 2017

Congress returned from the Thanksgiving holiday with an intense workload that must be completed by the end of the year. Tax reform remains a focus, and the Republican-controlled Congress is still committed to getting a final...more

Through a Glass Darkly: The Latest Health Care Deals Signal a Further Shift in Control and the Locus of Care

by Epstein Becker & Green on

Two merger announcements this week—one concerning CVS’s intention to acquire Aetna and the other concerning United/Optum’s intention to acquire DaVita’s physician group—have health investors and strategists peering over the...more

IRS Updates Employer Shared Responsibility Payment Information

by Ropes & Gray LLP on

Last month, the IRS provided guidance regarding the procedures it will use to propose and assess employer shared responsibility payments under the Affordable Care Act (“ACA”). More recently, the IRS issued sample Forms 14764,...more

“Tap Here For A Doctor” – The Proliferation of Telemedicine In The Gig Economy

by Fisher Phillips on

Several years ago, many people were leery of the thought of ordering personal drivers through a mobile app and getting into a car of a complete stranger. However, over time, the idea of ride-sharing through Uber or Lyft has...more

The FCC to Propose Major Changes to Its Rural Health Care Funding Programs

The Federal Communications Commission (FCC) is launching a major revision to its Rural Health Care (“RHC”) subsidy programs. These revisions would address two main issues, the level of funding and ways to make the programs...more

Final Senate Tax Bill Targets Health Care, Hospitals

by King & Spalding on

In the early hours of Saturday, December 2, 2017, the Senate approved its version of tax reform legislation, S. 1, the Tax Cuts and Jobs Act, by a vote of 51-49. All Republican Senators except Senator Bob Corker (R-TN)...more

Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

by McDermott Will & Emery on

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to...more

Watch out for IRS letters: IRS Begins Enforcing Employer Mandate

by FordHarrison on

The IRS has recently begun enforcing the “employer shared responsibility” (ESR) provisions of the Affordable Care Act (the "Act"), which require employers having 50 or more full-time employees (or full-time equivalent...more

Americans For Medical Progress Premieres An Extraordinary Video That Describes The Incredible Need For And Contribution Of Animals...

by Fox Rothschild LLP on

Americans for Medical Progress (AMP) “supports research involving animals when it is necessary to advance our understanding of biological processes.” and provides tools for “public outreach that builds understanding and...more

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