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Health Updates

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

Recent Case Highlights Considerations for Working with Media Consultants During a Crisis

by Morgan Lewis on

A Pennsylvania Superior Court decision declining to extend attorney-client privilege to media consultants illustrates best practices for how a company should manage communications with outside consultants during a crisis...more

Proposed Rule Would Slash Medicare Payment for 340B Drugs

by Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

Samsung Bioepis and Merck & Co. Launch Renflexis, A Lower-Priced Competitor to Inflectra

by Goodwin on

Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. ...more

Senate to Vote on Motion to Proceed to Debate Healthcare Reform

by King & Spalding on

Following a week in which Senate Republican healthcare reform plans shifted from Affordable Care Act (ACA) repeal and replace, to repeal only, to uncertain, the Senate is expected to vote tomorrow, July 25, 2017, on a motion...more

Fame, reputation and a med school dean’s secret life

Although smaller community hospitals may provide treatments that are as good and as safe, Americans flock to academic medical centers for specialized care and complex procedures. They’re lured to the big, pricey institutions...more

Health Update - July 2017

Contracting With Technology Vendors: Obligations and Compliance Strategies - Editor’s Note: In a recent webinar, Manatt Health examined how to protect privacy when communicating in the digital age. The session revealed how...more

CMMI Focuses on Behavioral Health

by Pierce Atwood LLP on

CMS recently announced that the Center for Medicare and Medicaid Innovation (CMMI) is interested in lowering the cost of care for Medicare and Medicaid beneficiaries with behavioral health conditions while improving the...more

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

The Strange Case of the Overly Informed Surgical Consent

by Faegre Baker Daniels on

The Pennsylvania Supreme Court’s cast its June 20 opinion as standing for the proposition that a surgeon can’t delegate his duty of obtaining informed consent to anyone else—his physician assistant in the case at hand. But...more

Recent Department of Justice Crackdown on Fraud and Abuse

As reported by the New York Times in an article dated July 13, 2017, in an effort to crack down on fraud and abuse, and with a particular focus on opioids, the Department of Justice (“DOJ”) is charging 412 individuals for...more

Health Care E-Note - July 2017

by Burr & Forman on

Everywhere you look these days, there seems to be another report of a cyberattack -- attacks which do not discriminate based on industry type, size of business, or impact. In other words, everyone is vulnerable. In fact, the...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the...more

CMS Summit on Potential Behavioral Health Innovative Payment Model (Sept. 8, 2017)

by Reed Smith on

The CMS Center for Medicare and Medicaid Innovation is holding a public summit on September 8, 2017 to explore creating a behavioral health innovative payment model intended to improve health care quality and access, while...more

CMS Issues Corrections to Medicare/Medicaid LTC Conditions of Participation

by Reed Smith on

CMS has made numerous technical and typographical corrections to its October 4, 2016 final rule revising the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. ...more

No IPAB Medicare Cuts Triggered for 2019, CMS Actuary Rules

by Reed Smith on

The CMS Chief Actuary has officially determined that the projected Medicare per capita growth rate will not exceed the target that would require the Independent Payment Advisory Board (IPAB) to submit plans to reduce 2019...more

CMS Delays Deadline for HHA Conditions of Participation Compliance

by Reed Smith on

CMS is delaying the effective date of its January 13, 2017 final home health agency (HHA) conditions of participation (CoP) rule for six months, until January 13, 2018. ...more

House Committees Examine Health Care Policy Issues

by Reed Smith on

Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following: Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug...more

OIG Claims CMS Paid $729 Million in Erroneous EHR Incentive Payments

by Baker Ober Health Law on

In a June 12, 2017 report entitled, Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did Not Comply With Federal Requirements, the Department of Health and Human Services, Office of...more

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

by Knobbe Martens on

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

Health Care Weekly Preview from ML Strategies – July 2017 #3

We head into the last week of July with the Findings of the Senate Parliamentarian in hand, who ruled late Friday that several provisions in the Better Care Reconciliation Act (BCRA) released on June 26th would be subject to...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Client Alert: Feds Shine a Light on Medicare Advantage Plans and Physicians Related to Risk Adjustment Practices

Although the sufficiency of medical records documentation supporting beneficiary diagnoses for Medicare Advantage (MA) risk adjustment has been on the OIG’s work plan since 2013, the Department of Justice has upped the ante...more

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

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