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Health Updates

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

Medicaid Fraud Control Units Report Focus on Personal Care Services

by Ruder Ware on

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released a report summarizing activities of State Medicaid Fraud Control Units (MFCUs or Units) for fiscal year 2016. The OIG is the...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

Who Do You Want To Be Your Voice for Medical Matters?

by Pessin Katz Law, P.A. on

In the recently completed legislative session, a bill was passed to revoke the ability of certain individuals to serve as an Agent under a Medical Directive. A Healthcare Directive informs your health care provider about your...more

Melinta Therapeutics Receives FDA Approval for Baxdela in Skin Infections

by Knobbe Martens on

On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone antibiotic, Baxdela® (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Approval...more

The Better Care Reconciliation Act of 2017

On June 22, Senate leadership released their proposed substitute for the House-passed American Health Care Act (AHCA), the Better Care Reconciliation Act of 2017 (BCRA), as a discussion draft. The BCRA was updated on June 26,...more

Immigration Updates: June 26, 2017

by Miller Canfield on

The United States Supreme Court has allowed portions of President Trump’s travel ban to take effect; citizens from Iran, Libya, Somalia, Sudan, Syria, and Yemen may be denied admission to the United States if they lack any...more

Employer Health Insurance Legislation Update: The Better Care Act

by Davis Brown Law Firm on

Last week the Senate released draft legislation entitled “The Better Care Act.” aimed at repealing and replacing the Affordable Care Act. Below is a summary of the Act and its potential impact on Iowa employers. ...more

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

by Hogan Lovells on

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

OIG Report Details Decline in Healthcare Fraud Recoveries

by King & Spalding on

Last week OIG released its semiannual report to Congress, which details the results of OIG’s operations for the first half of the 2017 federal fiscal year. Healthcare fraud recoveries by OIG totaled $2.04 billion during the...more

Healthcare Business Associates

by Bryan Cave on

The Health Information Technology for Economic and Clinical Health (“HITECH”) Act modified the Health Insurance Portability and Accountability Act (“HIPAA”) by expanding the definition of Business Associates (“BA”) and their...more

Manatt on Health Reform: Weekly Highlights - June 2017 #4

Manatt Health Introduces Two New Publications: Ongoing Insights into the Latest Healthcare Issues and Actions - In this time of uncertainty for healthcare, real-time, insightful information on key developments is more...more

CMS Requests Dismissal of Its Nursing Home Arbitration Appeal

by King & Spalding on

On June 2, 2017, CMS filed a motion to dismiss its appeal to the U.S. Circuit Court for the Fifth Circuit of a U.S. District Court decision blocking the agency’s ban on mandatory nursing home arbitration. CMS’s motion did...more

Draft Senate Health Bill Finally Revealed—Vote Could Take Place as Early Next Week

by Hogan Lovells on

On June 22, 2017, Republican Senators released a “discussion draft” of the Better Care Reconciliation Act (BCRA). The draft is the first public glimpse at the Senate version of the American Health Care Act bill, which...more

USCIS Makes H-1B Premium Processing Available for Physicians Under the Conrad 30 Waiver Program

On March 3, 2017, U.S. Citizenship and Immigration Services (USCIS) unexpectedly announced that it would temporarily suspend its premium processing service for all H-1B petitions received on or after April 3, 2017. The...more

Washington, D.C. Update – June 2017

by Baker Donelson on

Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...more

Senate Releases Repeal and Replace Legislation on ACA: The Better Care Reconciliation Act of 2017

by Foley & Lardner LLP on

After weeks of secrecy, the Senate has released a discussion draft of legislation that is the counterpart of the American Health Care Act (AHCA) previously passed by the House. The Senate legislation, entitled the Better Care...more

The Circuits are Split: The Ambiguity of a Regulation May Not ‘Foreclose a Finding of Scienter’ in False Claims Act Cases

by K&L Gates LLP on

A split now exists among the circuit courts as to whether a defendant’s assertion of a “reasonable interpretation defense” precludes a finding of a “knowing” mens rea under the False Claims Act (the “FCA”). On May 26, 2017,...more

USCIS Resumes H-1B Premium Processing for Conrad Waiver Program Physicians

On Monday, U.S. Citizenship and Immigration Services (USCIS) resumed premium processing for all H-1B petitions filed for physicians under the Conrad Waiver program, as well as interested government interagency waivers....more

Here We Go Again - The Senate’s Health Reform Bill

by Winstead PC on

Late last week the Senate released its version of a health reform bill (the “Better Care Reconciliation Act of 2017” or the “Senate bill”) to fix the Patient Protection and Affordable Care Act (the “PPACA”). The Senate Bill...more

House Committee Issues Letter to HRSA Requesting Audit Documentation Regarding 340B Drug Pricing Program

by King & Spalding on

The House Committee on Energy and Commerce (Committee) sent a letter dated June 1, 2017, to the Health Resources and Services Administration (HRSA) Administrator expressing concerns about the growth and oversight of the 340B...more

House Bill Would Narrow Orphan Drug Exception

by Arnall Golden Gregory LLP on

A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more

Is the Senate's "Better Care" a Better Way to Repeal Obamacare?

by Locke Lord LLP on

On June 26, 2017, the U.S. Senate leadership released a “discussion draft” of The Better Care Reconciliation Act of 2017 (the “Better Care Act”) — i.e., legislation to repeal and replace the Affordable Care Act, better known...more

FTC Challenges North Dakota Healthcare Provider Merger

by King & Spalding on

On Thursday, June 22, 2017, the Federal Trade Commission (“FTC”) and the North Dakota Attorney General filed a complaint challenging the merger of North Dakota providers, Sanford Health, Sanford Bismarck (together “Sanford”),...more

Anthem Settles Data Breach Suit for Record $115 Million

Anthem Inc. has reportedly agreed to pay a settlement of $115 million to its customers that were affected by what is being called one of the largest data breaches in U.S. history....more

M.C. Escher and Erwin Schrodinger Walk into A Bar … Or Are They Walking Out? And How Can The CBO Be Sure?

by Balch & Bingham LLP on

The pundits and political partisans apparently stopped reading before the heading on page 9 of the CBO’s June 26 report on the Better Care Reconciliation Act (BCRA) Discussion Draft, “Uncertainty Surrounding the Estimates,”...more

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