Department of Health and Human Services

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Growing Bullseye on Skilled Nursing Facilities

Although nursing homes appreciate the recent release of $4.9 billion in financial assistance, the bullseye on them continues growing.  Troubles that preceded the COVID-19 crisis have gotten worse for facilities caring for high risk seniors.  They face scrutiny over death rates from COVID-19, as well as how they will use relief money.… Continue Reading

CARES Act Medicare Money – View From Former Prosecutors

The CARES Act requires Medicare providers to attest to multiple certifications.  Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.  Their article can be found here.  … Continue Reading

Updated HHS Guidance on Provider Relief Fund Payments Could Help Providers Navigate Coming Oversight

On May 29, and June 2, the Department of Health and Human Services (HHS) updated its “Provider Relief Fund FAQs” on disbursements made to providers from the $175 billion Provider Relief Fund initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, for expenses and lost revenues attributable to the coronavirus pandemic.  HHS’s … Continue Reading

HHS Expands Coverage for Telehealth in Response to COVID-19

On March 17, 2020, in response to the national COVID-19 public health emergency, divisions of the Department of Health and Human Services (HHS) outlined a series of policy changes regarding telehealth services. In an effort meant to expand the capacity of the healthcare system and protect seniors who are the most vulnerable to COVID-19, the … Continue Reading

Proposed Changes to the Anti-Kickback Statute, Stark Law and Civil Monetary Penalties Law Address Value-Based Healthcare Environment

On October 9, the Department of Health and Human Services (HHS) released proposed rules (the Proposed Rules) aiming to update the Anti-Kickback Statute (the AKS), Stark Law and Civil Monetary Penalties Law (CMPL) to address today’s value-based and coordinated healthcare environment. The proposals reflect a recognition on HHS’s part that the healthcare landscape of today … Continue Reading

HHS Abandons Proposal to Reform Drug Manufacturer Rebate System

On Thursday, July 11, 2019, the White House administration reversed course on the Department of Health and Human Services’ (HHS) recent proposal to reform drug manufacturer rebate system. As we previously reported, HHS’s February 6, 2019 proposed rule sought to modify the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product … Continue Reading

Medical Imaging Company Pays $3 Million Data Security Fine

A medical imaging company is paying for its flawed data security system. In addition to its system failures, the company failed to investigate and respond properly when alerted to problems by the FBI. As a result, the Office of Civil Rights imposed a $3 million penalty and required a corrective action plan. This yet another … Continue Reading

Healthcare Cybersecurity Best Practices Out Now

A new outlook on the most prominent cybersecurity threats in the healthcare industry today and a series of corresponding, risk-prioritized cybersecurity best practices to combat these threats are now available from the Department of Health and Human Services (HHS).  More than 150 private sector healthcare and cybersecurity experts contributed to this guidance as part of … Continue Reading

Health Care Fraud Leads $2.8 Billion Collected for False Claims

The federal government’s civil recoveries for false claims during FY2018 topped $2.8 billion. Health care fraud claims lead the collection. Government Rakes in Billions The Department of Justice (DOJ) recently released statistics for its civil False Claims Act (“FCA”) recoveries during FY2018.   Although that total is lower than in some previous years, the trajectory of recoveries … Continue Reading

Digital Health Update: Recent FDA Cyber Initiatives

The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … Continue Reading

Supreme Court To Decide If HHS May Skip Notice And Comment Requirements For Certain Payment Rules

On September 27, 2018, the U.S. Supreme Court agreed to review a D.C. Circuit Court of Appeals decision that had tossed out a new calculation method, employed by the U.S. Department of Health and Human Services (“HHS”), which had cut Medicare payments to hospitals. Azar v. Allina Health Services (“Allina Health”). HHS itself estimated that … Continue Reading

Unauthorized TV Cameras in Hospitals Yield Costly HIPAA Penalties of $999,000

For the second time in as many years, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into settlement agreements with and levied hefty fines on three hospitals that allegedly impermissibly disclosed patients’ protected health information to ABC News in the course of filming a television network documentary series.  OCR announced … Continue Reading

House Panel Examines 340B Legislative Reforms

On Wednesday, July 11, 2018, House lawmakers again signaled their intent to reform the US Department of Health and Human Services (HHS), Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program (340B) during an Energy and Commerce (E&C) Subcommittee on Health hearing. Since 2015, both E&C and the Senate Health, Education, Labor, and Pensions … Continue Reading

DC Circuit Rejects HHS Rule Barring Hospital Medicare Appeals Challenging Longstanding Erroneous "Predicate Facts"

On June 29, 2018, the DC Circuit ruled that HHS could not apply in PRRB appeals a 2013 “reopening” regulation, which purports to bar the adjudication of “predicate facts” beyond 3 years after the facts had been determined. St. Francis Medical Center v. Azar (D.C. Cir. June 29, 2018). The court held that the agency’s … Continue Reading

How To Avoid Paying $2,000 A Day To Encrypt ePHI

Let’s hope you don’t pay that much to encrypt electronic Protected Health Information (ePHI). How about a total of $4.3 million over two years? Well, that’s the total penalty for encryption violations assessed by Health and Human Services (HHS). An Administrative Law Judge found the penalty could have been much worse. The facts are sobering. … Continue Reading

Right to Try Investigational Drugs Signed Into Law

Right to Try Investigational Drugs Signed Into Law On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act … Continue Reading

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29 The Centers for Medicare & Medicaid Services (CMS) is seeking the submittal of measure proposals for the Annual Call for Measures for eligible hospitals and critical access hospitals participating in the Medicare Promoting Interoperability (PI) Program (formally known as … Continue Reading

HHS OCR Issues New Research Guidance

As part of its ongoing implementation of the 21st Century Cures Act (Public Law 114-255), the Department of Health and Human Services last month released a number of new HIPAA guidance tools, including additional information about research uses and disclosures.  The research guidance contains helpful tips for covered entities regarding authorizations, revocations, and “reviews preparatory … Continue Reading

House Committee Chairman Asks HHS to Develop Health Care Cyber Risk Plan

Last week, the Chairman on the House of Representatives’ Committee on Energy and Commerce, Greg Walden (R-OR), sent a formal letter to the Dept. of Health and Human Services (“HHS”) requesting that HHS “develop a plan of action for creating, deploying, and leveraging [bill of materials] for health care technologies.” Walden gave HHS until December … Continue Reading

Fundamental Right to be a Federal Healthcare Provider?

Rejecting a contrary holding in the Fourth Circuit, the Sixth Circuit decided a healthcare provider has no “fundamental right to participate in federal health care programs.” Accordingly, the Department of Health and Human Services (HHS) was correct to exclude a pharmacist from federal healthcare programs simply because he was convicted of misdemeanor misbranding.… Continue Reading

HHS Task Force Identifies Critical Cybersecurity Recommendations

The recent WannaCry ransomware attack and the bevy of breaches over the past few years demonstrate that cyber risks in the healthcare arena are substantial and widespread. The Department of Health and Human Services (HHS) Health Care Industry Cybersecurity (HCIC) Task Force Report (HCIC Report), required under the federal Cybersecurity Information Sharing Act of 2015, … Continue Reading
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