Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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House Republicans and Trump Administration File Joint Motion to Delay Suit Challenging Obamacare Subsidies

An interesting development transpired Tuesday, February 21, 2017 in a case pending in Federal District Court in the District of Columbia that challenges subsidy payments from the Federal Treasury to support Obamacare. The...more

CMS Releases Proposed 2018 Medicare Advantage/Part D Reimbursement Methodologies and Policies

CMS has released its 2018 Advance Notice and Call Letter, which outline proposed updates to Medicare Advantage (MA) and Part D plan reimbursement methodologies and policies. CMS notes that it its proposed policies focus on...more

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are...

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”)....more

CMS Proposes Affordable Care Act Exchange, Individual, and Small Group Insurance Market Changes

Not relying on Congress to take action on the Affordable Care Act, the Centers for Medicare and Medicaid Services (“CMS”) has proposed new regulations intended to attract health insurance issuers back into ACA health...more

CMS Schedules 2017 Meetings to Consider HCPCS Code Applications

CMS has just announced the dates for its annual meetings to discuss pending applications for new and revised HCPCS codes: - May 16 – 18, 2017: Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents - June...more

Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases

Court of Appeals panel rules use of statistical sampling is inappropriate for interlocutory appeal, leaving FCA litigants without any direct appellate court guidance. In the closely watched case United States ex rel....more

DOJ Issues New, Practical Guidance on Effective Corporate Compliance Programs

On February 8th, the Department of Justice (DOJ) Criminal Division, Fraud Section issued new guidance on how it evaluates the effectiveness of a corporate compliance program when conducting an investigation of a corporation....more

Reducing the Regulatory Stranglehold on Federally Facilitated Exchanges: Will It Work?

The Centers for Medicare and Medicaid Services (CMS) recently issued a proposed rule aimed at improving the individual and small group markets that have been plagued with instability as issuers continue exiting the Exchanges....more

W2 Phishing Scam Hits Citizens Memorial Hospital

We continue to see all industries hit with W2 phishing scams, including the health care industry. Citizens Memorial Hospital, located in Bolivar, Missouri, was hit with the scam when one of its employees believed that an...more

District Court Allows Medicare Beneficiary Class Action to Proceed

On February 8, 2017, the United States District Court for the District of Connecticut declined to fully dismiss allegations filed by a class of Medicare patients against HHS in Alexander et al. v. Cochran (formerly Bagnall et...more

Medicaid Financing Reform: Per Capita Caps vs. Block Grants

In the coming weeks, it is highly likely that House Republicans will come forward with Medicaid financing reform proposals, such as block grant or a per capita cap proposal, or some combination of both. How should these...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Medicare & Medicaid Remain Vulnerable to Fraud and Abuse, GAO Warns

The Government Accountability Office (GAO) is out with the latest installment of its “High-Risk Series,” which identifies federal programs “that are especially vulnerable to waste, fraud, abuse, and mismanagement, or that...more

CMS Teleconference to Discuss SNF Value-Based Purchasing Program (March 15)

On March 15, 2017, CMS is hosting a call to discuss the Skilled Nursing Facility (SNF) Value-Based Purchasing (VBP) Program, which is scheduled to begin in fiscal year 2019. The call will focus on confidential quarterly...more

CMS Proposes Changes to Stabilize ACA Health Insurance Markets

At the same time Republican Congressional leaders are attempting to develop legislation to repeal and replace the Affordable Care Act (ACA), CMS has published a proposed rule that is intended to help stabilize the Affordable...more

Ethicon To Acquire Torax Medical, Inc

Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc. According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical...more

Health Law Insights: February Newsletter

ALERT: Technical Noncompliance with HIPAA Can Lead to Big Penalties- As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance...more

$3.2M Fine for Failure to Protect Electronic Records

The Department of Health and Human Services Office of Civil Rights (“OCR”) fined a Texas hospital $3.2 million for its impermissible disclosure of unsecured electronic protected health information (ePHI) and non-compliance...more

CMS Recommendations Regarding Protection from Cybersecurity Risks

On January 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued Recommendations to Providers Regarding Cyber Security. In general, the Recommendations are intended to remind providers and suppliers to keep...more

RxIP Update - February 2017

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a significant...more

Obamacare Reform Watch: Reimbursement Strategies in an Environment of Growing Out-of-Pocket Costs and an Expanding Self-Pay...

The increase in patient financial responsibility for health care costs in the past ten years has outpaced consumer growth in wages. This escalation of out-of-pocket costs represents a major revenue cycle challenge for health...more

DOJ Successfully Blocks Insurance Mergers: What Are the Takeaways?

In July 2016, following a lengthy review, the Antitrust Division of the Department of Justice (DOJ), together with several states, sued to block two proposed health insurer mergers: Aetna/Humana and Anthem/Cigna. On January...more

Florida Supreme Court Rules That Hospital "Adverse Medical Incidents" Reported to a PSO Are Not Privileged From Discovery: Impact...

Southern Baptist Hospital of Florida (Hospital) was sued in a medical malpractice action in which the plaintiff sought to discover records relating to "adverse medical incidents" that occurred at the Hospital and involved any...more

SAMHSA Issues Final Rule Modernizing Confidentiality Requirements for Patients Receiving Substance Use Disorder Treatment

Last month, the U.S. Department of Health and Human Services (“HHS”) Substance Abuse and Mental Health Services Administration (“SAMHSA”) released a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient...more

Justice Department Joins Whistleblower Suit Accusing UnitedHealth Group of Overcharging Medicare by “Hundreds of Millions”

The U.S. Department of Justice (DOJ) has joined a whistleblower lawsuit, United States of America ex rel Benjamin Poehling v. Unitedhealth Group Inc., No. 16-08697 (Cent. Dist. Cal. Sep. 17, 2010), ECF No. 79, against...more

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