News & Analysis as of

Employee Benefits: Important Wellness Plan and Mental Health/Substance Use Disorder Parity Effective Dates Have Arrived!

Employers and insurers offering medical plans: take note! Two important final regulations issued jointly by the IRS, DOL and HHS (the “Departments”) apply to plan years (or, in the individual market, policy years) beginning...more

HIPAA Violation Results in $4.8 Million Settlement

While most healthcare providers know to pay close attention to the HIPAA rules when setting up their information technology systems, recent events have demonstrated that this close scrutiny should also be applied to computer...more

HIPAA Data Breaches

HIPAA has been on the books since 1996. With the advent of electronic health records, HHS adopted security regulations to require covered entities to protect the integrity, confidentiality, and availability of electronic...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

Lab Arrangements under the Microscope: OIG Issues New Fraud Alert

Arrangements between laboratories and referring physicians/physician group practices (the “physicians”) have long been subject to scrutiny by the Department of Health and Human Services Office of Inspector General (“OIG”). On...more

New HIPAA Reports to Congress Shed Light on OCR Enforcement

The Department of Health and Human Services’ Office for Civil Rights (OCR) has issued two reports to Congress, as required by the HITECH Act. The compliance report details OCR’s enforcement activities for 2011 and 2012 and...more

Promises of Enhanced HIPAA Enforcement by HHS Illustrated by a Recent Record-Breaking Settlement Agreement and Increased Focus on...

An attorney from the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) recently disclosed that covered entities could face increased scrutiny for HIPAA violations in 2014. Specifically, the...more

Closely Held Corporations Can Be Exempt from ACA Contraception Provisions Based on Religious Objections

The Patient Protection and Affordable Care Act (ACA) requires certain employers to cover women’s preventive health care under their nongrandfathered group health plans at no cost to employees. The U.S. Department of Health...more

The Intractable Problem of Medicare Fraud

You have to admire the vigilance and dedication of prosecutors and law enforcement investigators who fight Medicare fraud. There is no question that they have ramped up enforcement and promoted a strong message of deterrence....more

The Affordable Care Act—Countdown to Compliance for Employers, Week 26: Fitting a Round Peg (the Public Health Service Act 90-day...

The Departments of the Treasury/IRS, Labor and Health and Human Services (the “Departments”) recently issued a final regulation under the 90-day waiting period limitation, which is included among the Affordable Care Act’s...more

Healthcare Law: What Every Provider Should Know

Healthcare is an incredibly broad, diverse and dynamic industry. Because of the breadth in the field, providers are surrounded by a wide array of legal issues relating to: employment contracts, taxes, business structure,...more

News from the Health Law Gurus™

Pa. Supreme Court Weighs in on Medical Record Charges — In Wayne M. Chiurazzi Law v. MRO, Chief Justice Ronald D. Castille, writing for the majority of the Pennsylvania Supreme Court, interpreted the Medical Records...more

Health Care Reform Implementation Update - June 2014

Secretary Burwell continues to settle in to her new position as the Department of Health and Human Services (HHS), this week making a number of management changes at the department; CMS released the long awaited proposed rule...more

OIG Releases Special Fraud Alert on Laboratory Payments to Physicians

The Office of the Inspector General (OIG) for the Department of Health and Human Services recently issued a Special Fraud Alert regarding laboratory payments to referring physicians. The Special Fraud Alert reaffirms OIG’s...more

Immigration Options for the Employment of International Physicians

The Patient Protection and Affordable Care Act will do many things to alter health care delivery in the United States. One thing it will not do, however, is significantly increase the supply of physicians. The new law calls...more

Final Regulations on Orientation Periods Released

On June 20, the Federal regulatory agencies in charge of health care reform guidance (the Departments of Labor, Treasury, and Health and Human Services) released final regulations (“Final Regulations”) clarifying the...more

HHS Announces $800,000 HIPAA Settlement in Medical Records “Dumping” Case

On June 23, 2014, The Department of Health and Human Services (HHS) entered into an $800,000 settlement with Parkview Health System, Inc. (“Parkview”), a nonprofit community health system servicing northeastern Indiana and...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA

On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and...more

News from the Health Law Gurus™

News from the Health Law Gurus™ is a weekly summary of notable health law news from around the country with helpful links to related content. Check back every Friday for the latest health law news stories. ...more

Confidentiality of Substance Abuse Treatment Information: HHS Considers Changes to the Part 2 Regulations and Requests Comment

The Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) is considering significant changes to the “Part 2” regulations (the Confidentiality of Alcohol and Drug Abuse...more

Health Care Reform Implementation Update

The Affordable Care Act (ACA) received a great deal of attention this past week in Washington. The House held numerous hearings on implementation issues, including oversight of access to care for ACA enrollees and improper...more

Proposed Regulation Would Significantly Expand OIG’s Exclusion Authority

On May 9, 2014, the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services published a proposed rule that significantly expands the OIG’s exclusion authority. 79 Fed. Reg. 26810. The...more

HHS Poised For Round Two Of Orphan Drug Fight

HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that...more

Health Headlines: Also in the News - June 2014

Burwell Confirmed as HHS Secretary – On June 5, 2014, the Senate voted 78-17 to confirm Sylvia Mathews Burwell as Secretary of HHS. Burwell has served as the Director of the Office of Management and Budget since April of...more

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