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OCR RFI: Have You Implemented Your Recognized Security Practices?
April 13, 2022 | Blog | By Pat Ouellette
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information security practices and civil money penalties (CMPs) under the Health Information Technology for Economic and Clinical Health (HITECH) Act and the HIPAA Security Rule. OCR is seeking input on how HIPAA covered entities and business associates are operationalizing “recognized security practices” as defined by Public Law 116-321. It is also requesting commentary on the methodologies used to disperse CMPs to individuals harmed by violations of certain privacy or security provisions of the HITECH Act or the Social Security Act, which we will cover in a separate post.
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HRSA Demands Repayment from Providers that Failed to Comply with Provider Relief Fund Reporting Requirements
April 11, 2022 | Blog | By Jean D. Mancheno
Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its Provider Relief Fund (PRF) to certain providers. These providers can then use the funds to support COVID-19 prevention, preparedness, and response, or to alleviate loss of patient care revenue. However, HRSA requires that providers receiving PRF funds comply with certain requirements, including post-payment reporting requirements. HRSA is now notifying providers that failed to comply with the reporting requirements that they must return the PRF funds they received.
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Health Law Diagnosed — Key Takeaways from the 6th Annual Pharmacy & Pharmaceutical Industry Summit
April 7, 2022 | Podcast | By Stephnie John, Bridgette Keller, Hassan Shaikh
The latest episode of Mintz’s Health Law Diagnosed podcast covers key takeaways from our 6th Annual Pharmacy & Pharmaceutical Industry Summit.
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Webinar Recording: Telehealth Risk Management
April 6, 2022 | Webinar | By Nancy Adams, Lara Compton, Todd Rosenbaum, Jennifer Rubin
PBM Regulatory Roundup (Spring 2022): The 8th Circuit Rules and More States Issue Regulations
March 29, 2022 | Blog | By Hassan Shaikh, Bridgette Keller
As states move forward with their 2022 legislative sessions in earnest, we have been examining whether the Wehbi decision has had any initial effects on PBM-focused legislation. This roundup provides a brief recap of the significance of Wehbi, summarizes the Eighth Circuit’s opinion and holding, and highlights some state measures that have been proposed or passed during the flurry of PBM-focused legislation we have already seen in 2022.
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Federal Healthcare Agencies Aim to Prioritize Information Blocking Enforcement in 2022
March 28, 2022 | Blog | By Pat Ouellette
The United States Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) leadership announced during last week’s HIMSS 2022 Conference that the agencies will be focusing on information blocking enforcement for the remainder of 2022. This blog post discusses the importance of closing the enforcement gap and the development of disincentives for health care providers.
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Dr. Lorna Breen Health Care Provider Protection Act Enacted To Address Mental Health and Substance Use Disorders Amongst Health Care Providers
March 25, 2022 | Blog | By Jean D. Mancheno
On March 18, 2022, President Biden signed the Dr. Lorna Breen Health Care Provider Protection Act (Act) into law. The Act is named for Dr. Lorna Breen, who served as the Medical Director of New York-Presbyterian Allen Hospital. Dr. Breen died by suicide in April 2020, as the COVID-19 pandemic was taking hold of the nation and, in particular, New York City. Since Dr. Breen’s passing, her family has established the Dr. Lorna Breen Heroes’ Foundation (Heroes’ Foundation). The Heroes' Foundation’s mission is to reduce burnout, safeguard the well-being of health care providers (HCPs), and reduce the stigma surrounding HCPs seeking help or treatment. The Act is a crucial step in achieving this mission.
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Health Law Diagnosed — Transactions Part 2: The Role of Health Regulatory Diligence and How to Prepare for a Sell-Side Transaction
March 24, 2022 | Podcast | By Tara E. Dwyer, Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart
Telehealth Update: A Federal Appropriations Bill, A Positive OIG Report, and Good News from HHS
March 22, 2022 | Blog | By Ellen Janos, Cassandra Paolillo
Last week saw a lot of great news in the world of telehealth. On March 15, President Biden signed into law H.R. 2471, the “Consolidated Appropriations Act, 2022”, which extends many of the Medicare telehealth flexibilities put in place during the COVID-19 pandemic for a period following the end of the Public Health Emergency (“PHE”). The same day, the OIG issued a report highlighting the positive impact telehealth had on increasing access for beneficiaries during the first year of the pandemic. Then, during a press conference on March 18, HHS Secretary Xavier Becerra said that HHS will seek to sustain and expand access to telehealth services after the public health emergency ends. While these developments signal the continued expansion of telehealth, there is still some uncertainty surrounding coverage, reimbursement and licensure flexibilities that have allowed telehealth to flourish for the past two years.
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Connecticut Proposal to Cap Drug Price Increases Could Portend a Shift in the Drug Pricing Debate
March 17, 2022 | Blog | By Xavier Hardy
On March 15, 2022, a drug pricing bill proposed by Connecticut Governor Ned Lamont’s (S.B. 13) was referred to the state legislature’s nonpartisan legal counsel responsible for drafting and processing official legislation. The proposed legislation, which would cap increases on pharmaceutical drugs to the rate of inflation plus 2%, is notable because it represents a relatively aggressive approach to addressing high drug prices. The legislation would also establish a program to authorize the importation of Canadian pharmaceuticals into the state.
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OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives
March 15, 2022 | Blog | By Rachel Yount
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued another favorable Advisory Opinion on patient incentives (e.g. gift cards or cash equivalents) given as part of patients’ treatment plans. Though the OIG reiterated its concern that cash and cash equivalents given to patients can present substantial fraud and abuse risks, the OIG concluded that the arrangement presented a minimal level of risk.
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DOJ Keeps Focus on COVID-19 Related Fraud with Appointment of Director
March 14, 2022 | Blog
The U.S. Department of Justice (DOJ) has continued to investigate and prosecute alleged COVID-19 related fraud over the past two years since the pandemic began. On Thursday, DOJ announced the appointment of a Director for COVID-19 Fraud Enforcement, who will lead DOJ’s enforcement efforts in this area. Associate Deputy Attorney General Kevin Chambers will fill this position.
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ONC Publishes Report, Commentary on Information Blocking Rule Claims Trends
March 7, 2022 | | By Pat Ouellette
Health care providers, health information networks, health information exchanges, and health IT developers of certified health IT will want to take note of the information blocking claim submission trends recently published by the Office of the National Coordinator for Health Information Technology (ONC).
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Health Law Diagnosed — Transactions Part 1: Regulatory Trends in Recent Health Care Transactions
March 3, 2022 | Podcast | By Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart
2021 was a busy year for Mintz ’s Health Law team, as they helped clients navigate complex health care transactions.
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New York To Require Licensure of Pharmacy Benefit Managers
February 25, 2022 | Blog | By Cody Keetch, Jean D. Mancheno
In an effort to counteract rising prescription drug costs and health insurance premiums, New York Governor Hochul signed S3762/A1396 (the Act) on December 31, 2021. This legislation specifies the registration, licensure, and reporting requirements of pharmacy benefit managers (PBMs) operating in New York. The Superintendent of the Department of Financial Services (Superintendent) will oversee the implementation of this legislation and the ongoing registration and licensure of PBMs in New York. Notably, this legislation establishes a duty of accountability and transparency that PBMs owe in the performance of pharmacy benefit management services.
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Webinar Recording: Health Care Enforcement Year in Review & 2022 Outlook
February 16, 2022 | Webinar | By Grady Campion, Randy Jones, Samantha Kingsbury, Karen Lovitch, Kevin McGinty
In our annual webinar, Mintz’s Health Care Enforcement Defense team reviewed the key health care fraud enforcement developments and trends from 2021, assessed their likely impact in 2022, and provided recommendations to avoid government scrutiny.
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Health Care Enforcement Year in Review & 2022 Outlook
February 11, 2022 |
In our annual Health Care Enforcement Year in Review & Outlook report, we examine the data and explore health care enforcement trends and likely targets of government scrutiny for 2022 and beyond.
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Telehealth Update: New Bill Could Provide Much Needed Certainty to Providers and Patients
February 10, 2022 | Blog | By Ellen Janos, Cassandra Paolillo
On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers for two years after the end of the federal public health emergency (PHE). See our previous coverage of telehealth during the COVID-19 pandemic. The PHE was most recently renewed for an additional 90 days on January 16, 2022. Since January 2020, providers who pivoted to telehealth in order to deliver care to their patients during the pandemic have had to closely monitor the status of the PHE, which the Secretary of HHS is only authorized to extend for 90 days at a time. Passage of the proposed legislation would provide some much-needed certainty and would give providers time to transition back to in-person care where necessary. It would also further the growth and expansion of telehealth services and continued integration into our health care delivery system.
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False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021
February 2, 2022 | Blog | By Laurence Freedman, Jane Haviland
The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year ending September 30, 2021 (FY2021) – the second largest annual total recovery in False Claims Act (FCA) history.
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First Circuit Adopts Deferential Standard for Review of Government Decisions to Dismiss FCA Whistleblower Cases
January 27, 2022 | Blog | By Kevin McGinty, Samantha Kingsbury
In a decision issued late last week, the First Circuit has adopted a deferential standard for review of government decisions to seek dismissal of whistleblower lawsuits brought under the False Claims Act (FCA). The court held that so long as the government explains its decision and provides the whistleblower with an opportunity to respond, the government’s motion must be granted absent evidence of collusion or unconstitutionality. This decision deepens a circuit split on the applicable standard under the FCA when the whistleblower objects to a government motion for dismissal.
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