News & Analysis as of

Chief Justice Denial of Stay Request Clears Way for New FLSA Regulations Affecting Home Care Agencies to Go Into Effect October...

On October 6, 2015, Chief Justice John Roberts of the Supreme Court of the United States summarily denied the emergency stay application filed by the association plaintiffs in Home Care Association of America v. Weil. In the...more

VA OIG reports patient data at risk with vendor

The Department of Veterans Affairs’ Office of Inspector General recently issued a report, following a complaint that the VA Palo Alto Health Care System put veterans’ health information at risk when it allowed personnel of a...more

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases: October 2015

Trends & Analysis: ..We have identified 15 health care–related qui tam cases that were unsealed since our last Qui Tam Update. Of those, 12 were filed from 2012 to the present. All but two cases had been pending more...more

Also In The News - Health Headlines - October 2015 #2

HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

Judge finds Genesis Healthcare free of any FCRA violations

On October 1, 2015, U.S. District Judge Mark Kearney rules that Genesis Healthcare LLC (Genesis) did not violate the Fair Credit Reporting Act (FCRA) when it employed a third party to conduct a criminal history background...more

CMS Announces Medicare Part D Medication Therapy Management Innovation Model

The latest CMS “innovation model” will test whether providing Medicare Part D prescription drug plan (PDP) sponsors with financial incentives and flexibility with regard to medication therapy management (MTM) program...more

Coming Soon to a Hospital near You: Mandatory Bundled Payments for Common Surgeries

Recent action by the Centers for Medicare and Medicaid Services (CMS) announces significant change in reimbursement methodology for high volume orthopedic surgical procedures in many markets nationwide. Affected stakeholders...more

Senate HELP Committee Approves Mental Health, Opioid Abuse, Drug Scheduling Legislation

On September 30, 2015, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved the following bipartisan legislation: S. 799, the Protecting Our Infants Act (to combat the rise of prenatal opioid abuse and...more

OIG report spurs OCR to announce phase 2 audits

On September 29, it was revealed that the HHS Office for Civil Rights (OCR) will commence Phase 2 of its HIPAA audit program in “early 2016.” OCR’s revelation regarding the Phase 2 audits, which had been the subject of...more

USDOL "Companionship", "Live-In Domestic" Enforcement Coming

The U.S. Labor Department has now announced that, beginning on November 12, it will start enforcing its revised regulations governing the Fair Labor Standard Act's Section 13(a)(15) "companionship" exemption and Section...more

Congressional Health Policy Hearings - October 2015

A number of recent Congressional hearings have focused on health policy issues, including the following...more

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

ONC Releases Final Health IT Strategic Plan, Draft Interoperability Standards Advisory

The Office of the National Coordinator for Health Information Technology (ONC) has released its final Federal Health IT Strategic Plan for 2015-2020. The 50-page document details how the federal government intends to...more

Health Alert (Australia) - October 5, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. Epichealth Pty Ltd v Yang [2015] VSC 516 The Supreme Court has granted an interlocutory...more

Trans-Pacific Partnership May Have Far-Reaching Consequences for U.S. Industry

This week, the 12 Trans-Pacific Partnership (TPP) member countries decided the final terms of what they report is a far-reaching agreement (Agreement or TPP Agreement). The 12 TPP countries are Australia, Brunei Darussalam,...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

New Licensing and Regulatory Requirements for Pharmacy Benefit Managers in Ohio

House Bill 64 recently amended Ohio Revised Code Chapter (ORC) 3959. The relevant code sections amended by House Bill 64 are ORC 3959.111 and ORC 3959.12 and these changes took effect on September 29, 2015. Pursuant to...more

CMS Posts CY 2016 Amount in Controversy Thresholds for Medicare Appeals

CMS has published a notice announcing the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process....more

Twitter Ordered by Irish Court to Disclose Information about Author of Tweet

Twitter International Company (TIC) in Dublin, Ireland was reportedly ordered by a High Court to disclose data about the source of tweets about a whistleblower. The tweets, which included allegations of insurance fraud, are...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Yep, There’s a Billing Code for That

If you think you’re waiting even longer at your doctor’s office these days, you might be right. And it might be due to the overhaul of the medical billing code system that requires providers to enter an alphanumeric...more

Health Facilities May Be Insuring Doctors Without Knowing It

A September 29 ruling by the New Jersey Supreme Court effectively makes a health facility liable for the professional negligence of a medical staff member who doesn’t have malpractice insurance or who has insurance that...more

Some Useful Insights from Steris-Synergy Merger Case

The Federal Trade Commission suffered a rare loss when, on Sept. 24, the U.S. District Court for the Northern District of Ohio denied its request for a preliminary injunction, despite having accepted the FTC’s “actual...more

EXPECT FOCUS: Onboard Technology, NAIC Cybersecurity, DOL, ACA Litigation, SEC Regulation (Vol. III, Summer 2015)

In This Issue: IN THE SPOTLIGHT - - Your Data Breach Collided With My Personal Injury Coverage LIFE INSURANCE - - Phantom Injury Dooms “Shadow Insurance” Case - Latest NAIC Cybersecurity News - A...more

OIG Flags $171 Million in Potentially Questionable Billing for Medicare Ophthalmology Services

The OIG has issued a report entitled “Questionable Billing for Medicare Ophthalmology Services.” The OIG concludes that most Medicare providers billing for ophthalmology services in 2012 did not demonstrate what the OIG...more

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