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Tag archives: HHS

OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

Carol Poindexter (US)Savannah Wiseman (US)By Carol Poindexter (US) and Savannah Wiseman (US) on Posted in Regulatory
On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

Judge declares ACA unconstitutional

Jeff Wurzburg (US)By Jeff Wurzburg (US) on Posted in News from DC
On Friday, December 14, Judge Reed O’Connor of the Federal District Court in the Northern District of Texas issued a declaratory judgment holding the shared responsibility provision (also referred to as the “Individual Mandate”), and with it, the entire Affordable Care Act (“ACA”), to be unconstitutional. The case is Texas v. United States and California … Continue reading

Medicaid update: CMS again approves Kentucky HEALTH Medicaid demonstration

Jeff Wurzburg (US)By Jeff Wurzburg (US) on Posted in News from DC
On November 20, 2018, the Centers for Medicare & Medicaid Services (“CMS”) again approved the Kentucky HEALTH 1115 demonstration.  Kentucky HEALTH  was the first Section 1115 demonstration that CMS approved with a work and community engagement requirement as a condition of eligibility for coverage under Medicaid.  The demonstration requires certain Medicaid beneficiaries to engage in … Continue reading

OIG considers new safe harbors and other incentives to promote coordinated care

Elise LeGros (US)By Elise LeGros (US) on Posted in Regulatory
As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) on August 27, 2018, requesting public input on the following items: Care … Continue reading

HHS requests comments on healthcare innovation and investment workgroup

Jeff Wurzburg (US)By Jeff Wurzburg (US) on Posted in Regulatory
A Request for Information (RFI) published in the June 7 Federal Register seeks comments on the structure of a workgroup to increase innovation and investment in the healthcare industry.  The Immediate Office of the Secretary of HHS seeks comments on how to structure the workgroup  in order to “spur investment, increase competition, accelerate innovation and … Continue reading

OCR proposes to share HIPAA data breach settlements with victims

Robert Kantrowitz (US)By Robert Kantrowitz (US) on Posted in Regulatory
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) plans to issue an advance notice of proposed rulemaking this November on potentially sharing HIPAA breach settlements with victims. The notice would solicit public opinion on creating a process for sharing a percentage of any penalty or settlement with those harmed … Continue reading

Congressional hearings held on the Trump administration’s FY 2019 budget request and health care industry consolidation

Jeff Wurzburg (US)By Jeff Wurzburg (US) on Posted in News from DC
On February 14, 2018, the Centers for Medicare & Medicaid Services (CMS) announced projections that national health care spending is expected to increase an average of 5.5% a year between 2017 – 2026 and will account for almost 20% of Gross Domestic Product by 2026.  This announcement provides context for the continued focus on controlling … Continue reading

HHS OCR issues cyber extortion newsletter

Alexis Wilpon (US)By Alexis Wilpon (US) on Posted in Regulatory
This week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a January 2018 newsletter focusing on “cyber extortion.” Cyber extortion often involves an attacker gaining access to an organization’s computer system, stealing sensitive information, and threatening to publish the information. Healthcare and public health organizations are often the … Continue reading

DOJ charges 412 individuals in largest healthcare fraud takedown in US history

Daniel Fundakowski (US)By Daniel Fundakowski (US) on Posted in Enforcement
On Thursday, the DOJ announced charges against 412 individuals for their alleged participation in healthcare fraud schemes involving approximately $1.3 billion in false billings.  This marks the largest national healthcare fraud takedown in U.S. history—topping the DOJ’s announcement of charges against 301 individuals in June 2016. The enforcement actions spanned across 41 federal districts and … Continue reading

Government agencies finalize updates to Common Rule to protect human research subjects

Wendy Wright (US)Krishna Kavi (US)By Wendy Wright (US) and Krishna Kavi (US) on Posted in Regulatory
On January 19, the U.S. Department of Health and Human Services (HHS) and 15 other government agencies published a final rule updating regulations governing the protection of human research subjects, which is commonly referred to as the “Common Rule.” As described in our September 4 post, these revisions are intended to enhance the current system … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

Sarah Cummings (US)By Sarah Cummings (US) on Posted in Enforcement
In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time … Continue reading

CMS proposes rule regarding changes to Medicare appeals procedures

Mark Faccenda (US)By Mark Faccenda (US) on Posted in Regulatory
The Centers for Medicare and Medicaid Services (CMS) has promulgated a proposed rule that makes numerous revisions to the appeals process for Medicare claims. If finalized, this proposed rule will mainly clarify the existing regulations regarding the Medicare appeals process. It will, however, also add two key concepts to help streamline the appeals process.  … Continue reading

DOJ charges over 300 people in largest healthcare fraud “takedown” in U.S. history

Elizabeth Han (US)By Elizabeth Han (US) on Posted in Enforcement
On Wednesday, the Justice Department announced that it had brought criminal and civil charges against 301 healthcare professionals as part of the largest national healthcare fraud “takedown” in history. A nationwide investigation spearheaded by the Medicare Fraud Strike Force revealed claims amounting to $900 million in the form of alleged kickbacks, money laundering, and other … Continue reading

OIG finds CMS deficient in monitoring compliance by hospitals with provider-based status requirements

Thomas Dowdell (US)By Thomas Dowdell (US) on Posted in Regulatory
On June 17, 2016, the Department of Health and Human Services’ Office of Inspector General (OIG) released a report entitled “CMS Is Taking Steps to Improve Oversight of Provider-Based Facilities, But Vulnerabilities Remain” (OEI-04-12-00380). The OIG reviewed oversight by the Centers for Medicare & Medicaid Services (CMS) of compliance by hospitals with the Medicare provider-based … Continue reading

Senators urge HHS to further expand patient access to opioid drug treatment

Yvonne Puig (US)Mark Faccenda (US)Blake Walsh (US)By Yvonne Puig (US), Mark Faccenda (US) and Blake Walsh (US) on Posted in News from DC, Regulatory
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act.  MAT involves the use of medication in combination with certain behavioral … Continue reading

FTC Guidance for developers of mobile health apps

Lisa Genecov (US)Lane Wood (US)Frances Morgan (US)By Lisa Genecov (US), Lane Wood (US) and Frances Morgan (US) on Posted in Regulatory
In the fall of 2015, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) released an online resource to assist mobile health application developers in determining whether they need to comply with the Health Insurance Portability and Accountability Act (“HIPAA”). This week, the Federal Trade Commission (“FTC”)  announced a new web-based tool … Continue reading

HHS modifies HIPAA rules to facilitate criminal background check reporting

Mark Faccenda (US)Blake Walsh (US)By Mark Faccenda (US) and Blake Walsh (US) on Posted in Regulatory
On January 6, 2015, the Office for Civil Rights (OCR) of the United States Department of Health and Human Services (HHS) issued a final rule modifying certain provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The modifications grant to certain covered entities a narrowly tailored permission to disclose limited … Continue reading
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