Health General Business

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Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

Filer Beware! E-Filing Error Can Destroy Trade Secret Status

First rule of thumb in trade secrets litigation? A trade secret must be kept secret. It is painfully obvious, but modern practitioners must not grow complacent due to the convenience of electronic filing. Although trade...more

When Is a Hospital Not a Hospital?

Rebecca was a nurse at North Cypress Medical Center, in Texas. Back in 2011 she was treated for an eating disorder at Timberline Knolls Residential Treatment Center, in Illinois. When she sought reimbursement under the...more

Anthem-Cigna Mega Merger Likely Problematic for Providers

Anthem announced on July 24, 2015 that it would purchase Cigna, just three weeks after Aetna agreed to buy Human for $37 billion. The deal is valued at $54.2 billion, and would create the United States’ largest health insurer...more

Defrauding Medicare — A Little Help from the Private Sector?

The headline on Medicare last week was astounding — $60 billion (not million) was lost each year to Medicare fraud, large numbers of fraudulent providers were providing fake or bad addresses – meaning locations including...more

“Everything Old is New Again” – Issues in Recent Cyber Insurance Litigation

Early days still for coverage litigation about cyber risks – whether under cyber insurance policies or other types of policies. This is not surprising given the relatively short history of cyber risks and even shorter history...more

SEC Settles FCPA Charges Tied to Payments to Health Care Professionals

The SEC filed another settled action in which payments to health care professionals at state owned entities in China were alleged to be violations of the Foreign Corrupt Practices Act. Although the company furnished extensive...more

IREG Update - July 2015

Provider-Sponsored Carriers - A new trend in the provision and financing of health care is the forming of health carriers by health systems and provider groups. This trend follows the emphasis on managing health care...more

The Supreme Court Addresses Scope of Section 11 Liability for Statements of Opinion

As the Supreme Court recently explained in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S. Ct. 1318 (2015), that distinction is significant when it comes to liability under Section 11 of...more

SEC Issues Proposed Incentive Compensation Clawback Rule

In another round of rulemaking related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, the SEC proposed a rule that would require certain executive officers to pay back incentive compensation tied to...more

CMS Proposes Significant Revisions to Requirements that Long Term Care Facilities Must Meet to Participate in Medicare and...

On July 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule to revise the requirements that skilled nursing facilities and nursing homes must satisfy to participate...more

MSSP Final Rule Adopts All Proposed Additional Program Requirements and Beneficiary Protections Provisions

This is the sixth post in Health Care Law Today’s series on the final rule. This post addresses additional program requirements and beneficiary protections. The Medicare Shared Savings Program (“MSSP”) final rule...more

CMS Proposes Significant Revisions to Requirements that Long Term Care Facilities Must Meet to Participate in Medicare and...

On July 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule to revise the requirements that skilled nursing facilities and nursing homes must satisfy to participate...more

CMS Proposes Significant Revisions to Requirements that Long Term Care Facilities Must Meet to Participate in Medicare and...

On July 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule to revise the requirements that skilled nursing facilities and nursing homes must satisfy to participate...more

Lack of Materiality as a Defense in False Claims Act Cases

The False Claims Act (the “Act”) imposes liability on those who “’knowingly’ present, or cause to be presented, ‘a false or fraudulent claim for payment or approval’” to the government. Persons who act in “deliberate...more

Medicare Jurisdictional Bar Limits Bankruptcy Court Authority in Health Care Bankruptcy

In an opinion dated June 26, 2015, the U.S. District Court for the Middle District of Florida ruled that the bankruptcy court administering the Bayou Shores SNF, LLC (“Debtor” or “Bayou Shores”), chapter 11 proceeding lacked...more

Health Care Rep and Warranty Insurance: New Solutions for Private Equity Buyers and Sellers

Whether in an auction or proprietary transaction, risk allocation has typically been a function of indemnities tied to reps and warranties and the type of credit supporting the type of supporting credit. Holdbacks, earnouts,...more

FTC Comment: Minnesota Law Requiring Public Disclosure of Health Care Contract Data Increases Risk of Anticompetitive Behavior

On June 29, 2015, the Federal Trade Commission (FTC) responded to a request for comment from two Minnesota state legislators concerning recently enacted amendments to the Minnesota Government Data Practices Act (MGDPA). Under...more

Massachusetts Hospital Agrees to Six-Figure Payment Related to HIPAA Compliance Allegations

St. Elizabeth’s Medical Center (SEMC), a tertiary care hospital based in Brighton, Mass., agreed to pay $218,400 to address deficiencies in its HIPAA compliance activities. The SEMC settlement continues a pattern of...more

OSHA Targets Inpatient Health Care Facilities and Nursing Homes for Enforcement Actions

On June 25, 2015, the Occupational Safety and Health Administration (“OSHA”) created a new compliance nightmare for inpatient health care facilities and nursing homes. Specifically, Dorothy Dougherty, Deputy Assistant...more

FDA Helps Dispensers Enjoy the Summer with Generous DSCSA Compliance Policy

The federal Food and Drug Administration (FDA) just announced that the Drug Supply Chain Security Act (DSCSA) deadline of July 1, 2015 for dispenser requirements related to capturing and maintaining pedigree information will...more

DOJ and Michigan Sue Four Hospital Systems for Agreeing Not to Compete with Each Other

Together with the State of Michigan, the United States Department of Justice’s Antitrust Division has filed a civil suit against four Michigan hospital systems for allegedly agreeing to limit marketing in each other’s...more

Chasing Payments: District Court Holds that Providers Lack Standing to Sue ERISA Plans for Benefits if the Patients Remain Liable...

A district court in Tennessee recently rejected ERISA claims by healthcare providers against a plan insurer, holding that the providers lacked standing to sue under ERISA as their patients’ assignees. Brown v. Blue Cross...more

Recent DOJ and OIG Actions Show Growing Federal Scrutiny of Physician Financial Arrangements

Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial...more

House and Senate Appropriations Committees Approve Funding Bills with Riders Targeting DOL, NLRB Initiatives

Both the House and Senate Appropriations Committees advanced bills this week to fund various federal agencies for FY 2016. Each chamber approved versions of spending measures that include riders prohibiting funding for a...more

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