Tag archives: HHS

Judge declares ACA unconstitutional

By Jeff Wurzburg (US) on December 17, 2018 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

By Jeff Wurzburg (US) on November 26, 2018 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

By Elise LeGros (US) on September 5, 2018 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

CMS issues final rule to adopt risk adjustment methodology for 2017

By Jeff Wurzburg (US) on July 25, 2018 Posted in Regulatory

CMS has issued a Final Rule to adopt the risk adjustment methodology for the 2017 benefit year. The rule was issued without a notice and comment period and will become effective upon publication in the federal register. The risk adjustment program is a premium stabilization program established by Congress in section 1343 of the Affordable … Continue reading

CMS suspends 2017 benefit year risk adjustment payments

By Jeff Wurzburg (US) on July 12, 2018 Posted in News from DC

On Saturday, July 7, 2018, the Centers for Medicare & Medicaid Services (CMS) announced the suspension of risk adjustment payments for the 2017 benefit year until the resolution of risk adjustment litigation following the decision in New Mexico Health Connections v. United States Department of Health and Human Services et al., in the United States … Continue reading

HHS requests comments on healthcare innovation and investment workgroup

By Jeff Wurzburg (US) on June 11, 2018 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

By Robert Kantrowitz (US) on May 22, 2018 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

By Jeff Wurzburg (US) on February 19, 2018 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

By Alexis Wilpon (US) on February 1, 2018 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

By Daniel Fundakowski (US) on July 17, 2017 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

By Wendy Wright (US) and Krishna Kavi (US) on January 26, 2017 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

By Sarah Cummings (US) on September 26, 2016 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

HHS announces near-doubling of civil penalties for numerous infractions

By Elizabeth Han (US) on September 12, 2016 Posted in Enforcement

Last week, HHS, OIG, CMS, the Office of the Assistant Secretary for Financial Resources, and the Administration for Children and Families issued an interim final rule (the Rule) that adjusts maximum civil monetary penalties for inflation.… Continue reading

HHS update: Looking toward audits and increased enforcement

By Anna Rudawski (US) and Mark Faccenda (US) on September 8, 2016 Posted in Enforcement

The Department of Health and Human Services and its Office of Civil Rights (OCR) are capping off a very active 2016. In the last 6 months, the OCR has released a new audit protocol, announced new rounds of HIPAA audits, and stepped up enforcement. The flurry of activity comes after a prolonged period of anticipation in … Continue reading

CMS proposes rule regarding changes to Medicare appeals procedures

By Mark Faccenda (US) and Chaula Mehta (US) on June 29, 2016 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

By Elizabeth Han (US) on June 23, 2016 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

By Thomas Dowdell (US) on June 17, 2016 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

By Yvonne Puig (US), Mark Faccenda (US) and Blake Walsh (US) on June 10, 2016 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

FDA approves first implantable buprenorphine maintenance treatment for opioid addiction

By Yvonne Puig (US), Mark Faccenda (US) and Lidia Niecko-Najjum (US) on May 27, 2016 Posted in Regulatory

On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.… Continue reading

FTC Guidance for developers of mobile health apps

By Lisa Genecov (US), Lane Wood (US) and Frances Morgan (US) on April 6, 2016 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

DOJ announces new regional elder justice task forces to target nursing home fraud

By Megan Engel (US) on March 31, 2016 Posted in Enforcement

Yesterday, the Department of Justice launched 10 regional task forces aimed at identifying fraud at nursing homes that provide inferior care to elderly residents. Referred to as the Elder Justice Task Forces, the DOJ plans to launch the 10 regional task forces in the following districts across the country:… Continue reading

Government healthcare fraud-and-abuse recovery drops to $2.4 billion in FY 2015

By Krishna Kavi (US) on March 2, 2016 Posted in Enforcement

In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015. The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014. Over the last three years, the return on … Continue reading

HHS modifies HIPAA rules to facilitate criminal background check reporting

By Mark Faccenda (US) and Blake Walsh (US) on January 8, 2016 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

The University of Washington Medicine settles alleged HIPAA breach for US$ 750,000

By Mark Faccenda (US) and Blake Walsh (US) on January 7, 2016 Posted in Enforcement

The University of Washington Medicine (“UWM”) has agreed to settle charges that it violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule for US$ 750,000, following a breach report first submitted by UWM on November 27, 2013. In addition to settlement, UWM has entered into a Resolution Agreement with the United … Continue reading