Health Updates

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CMS and OIG Propose First Major Medicaid Fraud Control Program Changes Since 1978

On September 20, 2016, CMS and the OIG jointly published a proposed rule, available here, to amend the largely unchanged 1978 regulation governing State Medicaid Fraud Control Units (MFCUs). Since the initial issuance of the...more

Small-Breach Focus Shows Growing Scope Of HIPAA Probes

Flexing yet more enforcement muscle under the Health Insurance Portability and Accountability Act, on Aug. 18, 2016, the U.S. Department of Health and Human Services Office for Civil Rights announced that it will more widely...more

Massachusetts Dialysis Unit Licensing Proposed Regulations – Key Take-Aways

As we’ve previously reported, the Massachusetts Department of Public Health (DPH) has recently proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker’s...more

The Oman Update - 1162

Amending MD 174/2014 Issuing the regulations on the work of establishments and companies that operate in contracting. Issued on 31 August 2016. Effective from the day after the date of publication....more

7th Circuit Requires Objective Standards When Pleading Medical Necessity Under the FCA

The Seventh Circuit recently added an arrow to a False Claims Act (FCA) defendant's quiver by requiring relators to plead fraud allegations based on objective criteria pursuant to Fed. R. Civ. P. 9(b). This ruling will...more

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more

Recent Significant Case Law Developments Regarding What Constitutes a Reckless Interpretation of a Law and When Retention of an...

Key Points: - Learn the latest case law developments regarding what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the...more

DOJ & FTC Join Telemedicine Attack on Texas Medical Board

The U.S. Department of Justice and Federal Trade Commission have sided with Teledoc, Inc., one of the country’s biggest telemedicine companies, in its legal battle with the Texas Medical Board. The two agencies filed a joint...more

Zika Virus: What Do Employers Need to Know?

The spread of the Zika virus across South and Central America, Mexico, and the Caribbean as well as locally acquired infections in parts of the United States, raises various issues for employers. On January 22, 2016, the...more

Outdated Business Associate Agreement Leads to Another Six-Figure HIPAA Settlement

On September 23, 2016, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Care New England Health System (CNEHS) agreed to pay $400,000 and enter into a corrective action plan...more

Third Circuit Blocks Hospital Merger in Key Victory for FTC on Geographic Market Definition

On September 27, 2016, the US Court of Appeals for the Third Circuit handed an important victory to the Federal Trade Commission and the Commonwealth of Pennsylvania in a closely watched hospital merger case. The decision...more

Insights Conversations: How Government Health Care Investigations May Be Shifting

The Department of Justice (DOJ) has long had the advantage when investigating False Claims Act (FCA) cases against health care companies. However, recent changes in the courts, including a unanimous U.S. Supreme Court...more

Massachusetts Determination of Need Proposal Would Implement State Health Policy Initiatives in Updating DoN Regulations

On September 21, the Massachusetts Department of Public Health conducted the first of two public hearings on proposed changes to the Determination of Need (DoN) regulations. The Proposal would implement significant changes...more

Billing Companies Beware – OIG Signals a Crackdown on Fraud and Abuse at All Levels

In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for...more

Hot Topics in Employer Health Benefits

As we start looking forward to 2017, and as many employers head into annual enrollment periods this fall, employers need to be aware of recent changes in the law that have a significant impact on health benefit plans. This...more

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.” Today, it announced the beginning of the formal process to make changes to the definition of the...more

Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic...more

CMS to Scrutinize Hospice Election Statements, Physician Certifications

As a result of an Office of Inspector General (OIG) report released in September 2016, hospice providers can expect increased survey focus on the content of their hospice election forms and on physician certifications of...more

Manatt on Health Reform: Weekly Highlights - September 2016 #4

Marylanders can shop for coverage through the Marketplace’s new mobile app; Michigan expansion enrollees report increased access to care and improved health; and survey finds states’ eligibility and enrollment systems...more

Medicare Providers - Beware! CMPs are Increasing

On September 6, 2016, the Department of Health and Human Services published an interim final rule which became effective immediately. The new regulation adjusts for inflation the maximum civil monetary penalty (CMP) amounts...more

Florida Federal District Court Dismisses Plaintiff’s Qui Tam Action Against Hospice Providers

On September 22, 2016, the United States District Court for the Middle District of Florida granted defendant hospice providers’ motions to dismiss plaintiff-relator’s claims under the False Claims Act, Florida’s False Claims...more

Score on Wellness Lawsuits—Wellness Plans 3, EEOC 0?

On September 19, 2017, in the ongoing lawsuit the US Equal Employment Opportunity Commission (EEOC) brought against Orion Energy Systems Inc. (Orion) regarding its wellness program, a Wisconsin federal judge found that...more

October 17th Compliance Deadline for HHS Nondiscrimination Notifications Approaches

On May 18, 2016, the United States Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a final rule implementing Section 1557 of the Affordable Care Act. Among other topics, the final...more

FTC Wins on Appeal in the Third Circuit to Block Hershey Medical Center and PinnacleHealth System Hospital Merger

On September 27, 2016, the U.S. Court of Appeals for the Third Circuit reversed a district court decision that the Federal Trade Commission and the state of Pennsylvania could not block the merger of two hospital systems,...more

FTC Wins Key Appellate Victory in FTC v. Penn State Hershey Medical Center

The Federal Trade Commission (FTC) won a decisive victory today in its efforts to slow the record pace of health care provider consolidation, when the U.S. Court of Appeals for the Third Circuit reversed a District Court's...more

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