Tag Archives: HHS

REMINDER: November 6 Deadline for New CARES Act Funding Approaches

Health care providers interested in applying for additional CARES Act Provider Relief funding from the Phase 3 General Distribution have until November 6, 2020 to submit an application to the Department of Health & Human Services (HHS).…

HIPAA Business Associate Pays $2.3 Million Settlement After Hackers Target PHI of Over 6 Million Individuals

Health care providers and contractors continue to be a popular target for hackers. Recently, CHSPSC LLC (CHSPSC), which provides various services to hospitals and clinics indirectly owned by Community Health Systems, Inc. of Tennessee, agreed to pay $2,300,000 to the Office for Civil Rights (OCR) in settlement of potential violations of HIPAA’s Privacy and Security Rules. The OCR investigation and settlement stemmed from a data breach affecting over six million people.…

COVID-19 Pandemic Brings Telehealth into U.S. Homes

Excerpt of a contributed article published in Medical Economics on August 13, 2020.

The public health emergency (PHE) caused by the COVID-19 pandemic has resulted in systemic changes throughout the nation’s health care system. Almost overnight, health systems, providers and the government were forced to collaborate to ‘stand up’ field hospitals, testing sites, and quarantine procedures, while postponing or cancelling certain elective procedures and ceasing in-person encounters. One of the most significant developments in the response to COVID-19 has been government support for the expansion of telehealth services, which represents …

HHS Issues Guidance for Providers on Soliciting COVID-19 Blood and Plasma Donations

On June 12, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued timely HIPAA guidance (Guidance) regarding solicitations of blood and plasma donations from recovered COVID-19 patients.

In the Guidance, OCR affirms that health care providers can use patient information to identify patients that have recovered from COVID-19 to provide information about how they may donate plasma or blood with COVID-19 antibodies to support treatment of other patients with COVID-19. OCR explains that this use of protected health information would be permissible …

HHS Announces Additional Distribution of $10 Billion to Safety Net Hospitals, and $15 Billion to Medicaid and CHIP Providers Left Out of General Distribution

On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced that it would distribute up to $25 billion of CARES Act Provider Relief Funds to safety net hospitals and state Medicaid and Children’s Health Insurance Program (CHIP) providers. …

HHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments

On May 22, 2020 the U.S. Department of Health and Human Services (HHS) issued a 45-day extension of the deadline for providers who receive payments from the CARES Act Provider Relief Fund to accept the Terms and Conditions attached to such payments. Providers now have up to 90 days from the date a payment is received to accept the Terms and Conditions or return the funds to HHS.  In its announcement, HHS reiterated its prior position that “Providers that do not accept the Terms and Conditions after 90 days of …

Departments of Labor, Health and Human Services, and the Treasury Issue FAQ guidance on the FFCRA, the CARES Act, and other health coverage issues related to COVID-19

On April 11, 2020 the U.S. Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) issued guidance in the form of frequently asked questions (the “FAQs”) regarding the Families First Coronavirus Response Act (the FFCRA), the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), and other health coverage issues related to COVID-19.  The guidance states that the FAQs “answer questions from stakeholders to help individuals understand the law and benefit from it, as intended.” Certain guidance offered by the FAQs is summarized …

HHS Waives HIPAA Penalties for Operation of a Community-Based COVID-19 Testing Site

On April 9, 2020 the Department of Health & Human Services Office for Civil Rights (OCR) issued another Notification that it will exercise its enforcement discretion and not impose penalties for HIPAA violations in connection with good faith participation in the operation of COVID-19 testing sites during the COVID-19 emergency.…

OCR Issues Additional Guidance on HIPAA for Providers and First Responders on COVID-19 Front Lines

On March 24, 2020, the U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued new HIPAA guidance to help providers and first responders in efforts to combat the COVID-19 pandemic. …

COVID-19: HHS Issues FAQs on HIPAA and Telehealth to Help Providers Maintain Access to Care During the Pandemic

On March 20, the U.S. Department of Health and Human Services (HHS) issued additional guidance in the form of Frequently Asked Questions (FAQs) on HIPAA and telehealth services to help providers furnish care during the COVID-19 pandemic.

The FAQs follow and provide further information on the Notification of Enforcement Discretion issued by HHS on March 17 (Notification), in which HHS indicated that it would not penalize providers for using popular video chat applications, such as FaceTime and Skype, in good faith to provide telehealth services amid the COVID-19 …

Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector …

HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies …

CMS Issues Final Regulations for Hospital Price Transparency

On November 15, 2019, the U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) announced final regulations implementing greater price transparency requirements for hospitals. Issued on the heels of a Trump Administration Executive Order directing HHS to propose regulations on increased price transparency, the new regulations modify and finalize CMS’ earlier guidance implementing section 2718(e) of the Public Health Service Act, to further expand price transparency requirements for hospitals. (See our previous analysis of the Executive Order here.) Effective January 1, 2021, the …

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known commonly as the Stark Law (AKS proposed rule available here; PSR proposed rule available here). In an earlier blog post, we described each of the proposed rules. Among the proposed changes are a new safe harbor/exception that would generally permit entities to donate certain cybersecurity technology and related services to physicians, subject to compliance with …

Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …

HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual

On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to purchase real estate from a limited liability company (LLC) owned and managed by an individual excluded from participation in federal health care programs (Proposed Arrangement). The OIG indicated the Proposed Arrangement would not result in the imposition of sanctions under the civil monetary penalties law because no claims for reimbursement from federal programs would be sought by …

HHS Issues Favorable Advisory Opinion for Online Health Care Directory Charging Per-Click Fees

On September 5, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion 19-04 (Advisory Opinion). The Requestor asked OIG if providing an online health care provider directory (Directory) to federal health care program beneficiaries (beneficiaries) would violate the Anti-Kickback Statute (AKS) or constitute a prohibited Beneficiary Inducement. The online directory would allow beneficiaries to search and book medical appointments, and the Requestor would charge health care professionals a per-click or per-booking fee to be listed in the directory. The directory …

For First Time Ever, Government Brings HIPAA Enforcement Action Alleging Violations of Right to Access Medical Records

On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual right to access health information under HIPAA. OCR entered into a settlement with Bayfront Health St. Petersburg (Bayfront) in response to allegations that it failed to provide a mother with timely access to medical records concerning her unborn child. Under the terms of a resolution agreement, Bayfront agreed to pay $85,000, and enter into a …

D.C. Circuit Court of Appeals Allows HHS Rule that Includes Payments Received from Third Parties in DSH Payment Cap Calculation

On August 13, 2019, the D.C. Circuit Court of Appeals (the D.C. Circuit) issued an opinion in Children’s Hospital Association of Texas v. Azar (No. 18-5135), allowing the Department of Health and Human Services (HHS) to include payments from third parties, including Medicare and private insurers, in calculations of Disproportionate Share Hospital (DSH) payment caps. The D.C. Circuit had previously ruled against HHS’ implementation of its 2017 rule, which included third-party payments in the calculation of the hospital-specific caps on allowable DSH payments. …

Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company

In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached.…

Supreme Court Rejects HHS Proposal that Could Have Significantly Lowered Certain Medicare DSH Payments to Hospitals

In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share Hospital (DSH) payments to thousands of hospitals for care furnished to low income patients in 2012.

In Azar v. Allina Health Services, Et Al., the Supreme Court held that HHS needed to comply with statutory notice and comment rulemaking procedures under the Social Security Act (Act) when making interpretive changes, because HHS sought …

OIG Issues Alert to Warn of ‘Free’ Genetic Testing Scams Seeking to Steal Information

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert). According to the OIG, fraudulent actors are using the provision of free genetic testing kits to obtain Medicare information from unwitting consumers, and then using the stolen information for purposes of fraudulent billing and/or identity theft.…

OCR Issues Fact Sheet Listing Circumstances in which Business Associates May Face Direct Liability for HIPAA Violations

In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct Liability of Business Associates under the Health Insurance Portability and Accountability Act (HIPAA).

The Fact Sheet provides an important reminder to covered entities, business associates, and their counselors regarding the circumstances in which OCR may – and may not – take enforcement actions directly against business associates for …

HHS Exercises Discretion to Reduce Maximum Annual Civil Money Penalties for Certain HIPAA Violations

On April 26, 2019, the U.S. Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion (Notice) regarding imposition of Civil Money Penalties (CMPs) under HIPAA. In the Notice, HHS announces that it has revisited its prior interpretation of the standards for assessment of CMPs under the HITECH Act, and is exercising its discretion to reduce the maximum amount of CMPs that may be assessed annually for HIPAA violations based on culpability.

The official version of the Notice is dated April 30, 2019 and is available here

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