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OIG Gives Green Light to Hospice Provider’s Payment to Nursing Facilities

August 1, 2016 | Blog | By Lauren Moldawer

Last week, the OIG issued a favorable opinion to a hospice provider seeking to make supplemental payments to skilled nursing facilities. Under the proposed arrangement, the hospice provider would make a supplemental payment to the nursing facility for dual-eligible individuals electing the hospice benefit that would be in addition to and separate from what the managed care organization (“MCO”) pays the nursing facility.
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Mintz BNA Article Discusses PAMA Final Rule

July 28, 2016 | Blog

Expanding on our recent blog post discussing CMS's final rule (the "Final Rule") implementing portions of the Protecting Access to Medicare Act of 2014 related to clinical laboratories, my colleague Karen Lovitch and I published an article in BNA’s Medicare Report entitled CMS Regulations Overhaul Medicare Clinical Laboratory Fee Schedule.
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Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ's Yates Memo

July 27, 2016 | Blog | By Laurence Freedman, Samantha Kingsbury

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates Memo.
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New Materials Help Covered Entities Comply with Nondiscrimination Rules

July 25, 2016 | Blog | By Bridgette Keller

Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557.
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FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

July 22, 2016 | Blog | By Benjamin Zegarelli

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous year in 2009, 2010, 2013, and 2014, with 467 applications submitted in 2014.
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The Emerging HIPAA Security Threat Presented by . . . Pikachu?

July 21, 2016 | Blog | By Dianne Bourque

Health care providers and other HIPAA-regulated entities should take note of the story on our companion blog, Employment Matters, regarding the augmented reality video game craze Pokémon Go.
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Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group

July 21, 2016 | Blog | By Theresa Carnegie, Karen Lovitch

Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group.
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FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

July 21, 2016 | Blog

On July 14, 2016, the U.S. Food and Drug Administration (the "FDA") released draft guidance on the co-development of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the therapeutic products will be safe and effective.
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FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

July 19, 2016 | Blog

In our Israel Connect Summer 2016 edition we summarized the FDA's post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally commercialized.
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FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

July 15, 2016 | Blog

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State of Union Address.
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OCR Sends Notification Letters to Phase 2 HIPAA Auditees

July 14, 2016 | Blog

On July 12, 2016, HHS's Office for Civil Rights (OCR) distributed an e-mail discussing recent developments in Phase II of its HIPAA audit program.
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CMS Releases Proposed Outpatient Payment System Rule for 2017, Leaving Hospitals Unhappy

July 14, 2016 | Blog

Last week, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for 2017.
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D.C. Circuit Strikes a Potential Blow to the Affordable Care Act

July 13, 2016 | Blog | By Lauren Moldawer

Earlier this month, the Court of Appeals for the D.C. Circuit issued its decision in Central United Life Insurance Co., v. Burwell, striking down a Department of Health and Human Services (HHS) rule prohibiting the sale and marketing of “fixed indemnity” plans to consumers who did not otherwise have minimum essential coverage.
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“Your Money or Your PHI”: OCR Releases Guidance on Ransomware

July 12, 2016 | Blog | By Dianne Bourque

On Monday, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health information (ePHI) that has been encrypted on a covered entity’s systems, but potentially not accessed by the hacker, has been breached for HIPAA purposes. 
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Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

July 8, 2016 | Blog | By Brian Dunphy

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached another milestone.
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Senate Committee Releases Report on Potential Stark Law Changes, Hearing Scheduled

July 7, 2016 | Blog | By Laurence Freedman

On June 30, 2016, the Senate Finance Committee's Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law, also known as the Stark law.
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6-Month Notice from a Biosimilar Sponsor Always Required -- Says Federal Circuit

July 6, 2016 | Blog | By Joanne Hawana

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new abbreviated FDA licensure pathway for highly similar biological products called biosimilars.
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OIG Advisory Opinion Approves Drug Discount Program

July 5, 2016 | Blog | By Tara E. Dwyer

Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug. 
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DOJ Announces Dramatic Increase in False Claims Act Penalties

June 30, 2016 | Blog | By Samantha Kingsbury, Laurence Freedman

On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA.
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Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief

June 30, 2016 | Blog | By Dionne Lomax, Carrie Roll

On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying out their governmental functions.
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