Tag Archives: healthcare law

Update on Immigration ~ Issues for Health Care

Epstein Becker Green colleagues Robert S. Groban, Jr. and Matthew S. Groban provide an update to the health care industry in the Immigration Alert: September 2014, including an update on the Sixth Circuit Expanding the Liability of Health Care Employers for Sponsorship Costs.

Based on the Kutty decision, health care employers can expect more aggressive enforcement activity in connection with their employment of foreign nationals (“FNs”) generally and foreign medical professionals sponsored for H-1B classification and J-1 waivers of the two-year foreign residence requirement that many J-1 residents face.  For the full client alert, click here.

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Healthcare Alert: It’s official: Feds acknowledge increased criminal review of civil healthcare cases

The Justice Department’s Criminal Division recently announced that it is committing more resources and “stepping up” its review of cases filed under the civil False Claims Act for potential criminal prosecutions. The announcement formalizes the government’s recent trend to open parallel criminal investigations for qui tam whistleblower lawsuits. Last year alone, approximately 750 qui tam lawsuits were filed by whistleblowers—more than two per day. The potential impact on businesses, particularly healthcare providers with ties to the government, cannot be overstated and emphasizes the need to have effective compliance programs in place.

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Healthcare Alert: FDA to focus on Laboratory Developed Tests

The Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 of its intent to issue draft guidance regarding regulatory oversight of laboratory developed tests (LDTs), including reporting and premarket submission requirements. The FDA treats LDTs as a subset of in vitro diagnostic (IVD) devices, which are currently regulated as medical devices under the Federal Food, Drug, and Cosmetic Act. According to the FDA, it has always had the authority to regulate LDTs, but has chosen to exercise its enforcement discretion.

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ADA Accessibility Attestation Forms for FIDA (Medicare-Medicaid Advantage Duals) Plans

The Financial Alignment Initiative of the Centers for Medicare & Medicaid Services (“CMS”) is a test program designed to better coordinate care for dual Medicare-Medicaid enrollees by aligning the financing of Medicare and Medicaid. Pursuant to this initiative, states may partner with CMS to test one of two model programs for the coordination of Medicare and Medicaid benefits.
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Healthcare Alert: New legislation proposes to eliminate Stark law exception for certain services including anatomic pathology

On August 1, 2013, Representative Jackie Speier (D-CA-14) introduced the Promoting Integrity in Medicare Act of 2013 (H.R. 2914) that proposes to remove anatomic pathology, along with other services including advanced diagnostic imaging, radiation therapy and physical therapy, from the In-Office Ancillary Services Exception to the Stark law. The legislation does not include any grandfathering or exceptions. Thus, it appears that the legislation, if passed, will put an end to the in-sourcing of anatomic pathology by referring physicians. The legislation also directs the government to scrutinize these services more carefully with prepayment reviews, claims audits, focused medical review, and computer algorithms designed specifically to identify payment or billing anomalies.

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OIG’s Special Advisory Bulletin on the Effect of Exclusion—Continuing the Focus on Individual Accountability

On May 8, 2013, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released an Updated Special Advisory Bulletin on the Effect of Exclusion from the Participation in Federal Health Care Programs (“2013 Exclusion Update”),[1] which supersedes the original bulletin released in September 1999 (“1999 Exclusion Update”).
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Affordable Care Act: Important Deadline for Employee Notices of the Health Insurance Marketplace (Exchange) Due October 1, 2013

By Gretchen Harders and Michelle Capezza

On May 8, 2013, the Employee Benefits Security Administration of the Department of Labor (the “DOL”) issued Technical Release 2013-02 (the “Release”) providing important guidance under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Affordable Care Act”) with regard to the requirement that employers provide notices to their employees of the existence of the Health Insurance Marketplace, generally referred to previously as the Exchange. These employee notices must be provided to existing employees no later than October 1, 2013. This deadline is intended to correspond to the open enrollment period for the Marketplace commencing October 1, 2013 for coverage through the Marketplace beginning January 1, 2014. The Release includes temporary guidance and two model employee notices of the Marketplace upon which employers may rely. The Release further provides an updated model election notice for group health plans for purposes of the continuation coverage provisions under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”) to include information of the health coverage options offered to individuals through the Marketplace for comparative purposes.

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Stark Law Really Does Have Teeth

Tuomey Jury Finds Monetary Value of $39 Million for 21,370 Claims Submitted in Violation of False Claims Act On May 8, 2013, the jury in the False Claims Act lawsuit against Tuomey Healthcare Systems, Inc. returned its verdict.  Based on its finding that Tuomey violated the Stark law, the jury found that Tuomey also violated […]

For more information please visit www.omwhealthlaw.com or click on the headline above.

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Healthcare Alert: OIG issues updated advisory

It is more important than ever that healthcare providers ensure that no current employee or contractor has been excluded from the federal healthcare program. The HHS Office of Inspector General (OIG) has statutory authority to exclude people from federal healthcare programs, including Medicare. Any reimbursement claim that derives from goods or services provided by an excluded person will be denied. Moreover, if a healthcare provider employs or contracts with a person who it knows or should know is excluded by the OIG, the provider is subject to fines and treble damages.

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False Claims Act Recoveries Top $14.2 Billion

On May 1, 2013, the  Department of Justice announced a settlement with two Montana hospitals that added $3.95 million to its recoveries under the False Claims Act.  According to the announcement, with this additional recovery,  the Department of Justice has used the False Claims Act to recover more than $14.2 billion in federal healthcare payments […]

For more information please visit www.omwhealthlaw.com or click on the headline above.

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