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HHS-OCR Publishes Final HIPAA Privacy Rule Expanding Reproductive Health Care Privacy and Further Supporting Patient...

On April 26, 2024, almost a year after issuing a notice of proposed rulemaking to modify the Privacy Rule, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized the HIPAA Privacy Rule to...more

Washington’s My Health My Data Act Comes Into Force - What You Need to Know, and Do

On March 31, 2024, the Washington My Health My Data Act (MHMDA), a comprehensive consumer health privacy law, will come into force. Small businesses – defined as those processing consumer health data of fewer than 100,000...more

In Updated Guidance on Use of Tracking Technologies by HIPAA Regulated Entities, HHS-OCR Takes Expansive View of When Information...

On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (HHS-OCR) revised its controversial December 2022 bulletin (the December 2022 Bulletin) regarding the use of tracking technologies by...more

New York Enacts Requirement for Healthcare Entities to Provide Notice of “Material Transactions”

On May 3, 2022, the New York Legislature passed legislation to regulate certain “material transactions” involving healthcare providers and others who provide administrative or management services to other healthcare...more

DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances

Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more

DEA Announces Temporary Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those...more

Maine Proposes Regulatory Approval Scheme for “Material Change Transactions” Involving “Health Care Entities”

On March 28, 2023, the Maine Legislature proposed legislation that would prohibit certain “health care entities,” including medical and other professional practices, licensed health care facilities, and providers of...more

New York Legislature Considers Proposal to Require Burdensome Regulatory Approval Process for “Material Transactions” Involving...

New York Gov. Kathy Hochul’s Executive Budget Proposal for FY 2023-2024 includes a proposal to require Department of Health (DOH) approval of certain mergers, acquisitions, and other significant transactions involving medical...more

DEA Proposes Rules to Allow Prescribing Controlled Substances via Telemedicine, Subject to Significant Limitations

Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced...more

Telehealth Issues to Watch in 2023

During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more

In the Metaverse, Existing Healthcare Rules Apply

Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

Five Key Regulatory Considerations for Virtual Ketamine Clinics

The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more

Federal District Court Ruling May Jeopardize Insurance Coverage of More Than 50 Recommended Procedures, Screenings, and Treatments

Under the Affordable Care Act, group health plans and health insurance issuers are required to provide health insurance coverage based on recommendations made by healthcare coverage professionals. The covered categories...more

U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022

​​​​​​​On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

President Biden Signs Into Law Medicare Telehealth Coverage Extension Post-Public Health Emergency

On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional...more

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

CMS Continues to Modernize by Expanding Reimbursement for Digital Health Services

The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated...more

Changes to Stark Law Special Compensation Rules for Group Practices Go into Effect on January 1, 2022

The final rules regarding special compensation under 42 U.S.C. § 1395nn, the Physician Self-Referral or Stark Law, go into effect on January 1, 2022 and will require many physician group practices to modify their compensation...more

Heating Up: Federal Sunshine Act Enforcement on the Rise

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

OIG Advocates for Increased Oversight of Medicaid Telehealth Services in Behavioral Health

Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of...more

Pharmaceutical Manufacturers Beware: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more

Attention Pharmaceutical Manufacturers: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more

An Emerging State Trend: Increasing Oversight of Physician Group Practice Transactions

On October 1, 2021, Nevada became the latest of a small but growing number of states extending regulatory oversight of healthcare transactions involving physician practices. Over the past decade, several states have passed or...more

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