Big Picture -
Last week, Texas AG Ken Paxton (R) sued the Department of Health and Human Services (HHS), alleging that the new HHS final rule amending HIPAA regulations to strengthen protections for reproductive health...more
On August 15, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Funding Opportunity (NOFO) for states participating in the Cell and Gene Therapy (CGT) Access Model. Under this model, CMS will negotiate...more
On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more
7/2/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Electronic Prescribing ,
Final Rules ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Medicare Part D ,
ONC ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs
This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal...more
6/26/2024
/ Breach Notification Rule ,
Code of Federal Regulations (CFR) ,
Consumer Privacy Rights ,
Continuing Legal Education ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Priorities ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Medical Records ,
Patient Privacy Rights ,
PHI ,
Popular ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Substance Abuse ,
Web Tracking ,
Webinars
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more
2/14/2024
/ Controlled Substances ,
Department of Health and Human Services (HHS) ,
Drug & Alcohol Abuse ,
Electronic Health Record Incentives ,
Final Rules ,
Health Care Providers ,
Healthcare ,
HIPAA Breach ,
HITECH Act ,
Pain Management ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Regulatory Reform ,
Substance Abuse
This week, the U.S. Department of Health and Human Services (HHS) took its first step in actually regulating the use of artificial intelligence (AI) in health care. Through its Office of the National Coordinator for Health...more
Last week, California Governor Gavin Newsom signed a package of legislation intended to strengthen the state’s shield laws, which provide protections to patients receiving and providers rendering reproductive health services,...more
10/4/2023
/ Abortion ,
California ,
Confidential Information ,
Electronic Protected Health Information (ePHI) ,
Equal Protection ,
Healthcare ,
Healthcare Reform ,
Human Rights ,
New Legislation ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Women's Rights
More than three years after the federal government issued rules to prohibit “information blocking,” penalties for violating those rules are taking effect. September 1 marks the first day on which certain entities may face...more
Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more
7/26/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
DNA ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Value-Based Payments
Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more
7/20/2023
/ Clinical Trials ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare ,
Human Genes ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medical Reimbursement ,
Medical Research ,
Medicare ,
Pharmaceutical Industry
After a COVID-19-related delay, on June 27, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a long-awaited final rule that establishes monetary penalties for violations of health...more
Covered entities are used to ensuring that many different facets of their operations comply with Health Insurance Portability and Accountability Act (HIPAA) rules. Among other things, covered entities must ensure that they...more
Medicare Advantage (MA) plans now cover about half of Medicare beneficiaries, and with that enrollment growth has come increased scrutiny from federal and state regulators. As federal regulators complete a busy season of...more
3/28/2023
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Continuing Legal Education ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Medical Necessity ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Beneficiaries ,
New Rules ,
Risk Adjustment Formula ,
Webinars
With the enactment of major drug pricing reform—including the Inflation Reduction Act (IRA), which arguably made the most significant changes to U.S. prescription drug pricing regulations in history—the reporting of drug...more
On January 5, the Centers for Medicare & Medicaid Services (CMS) issued guidance for State Health Officials clarifying that Medicaid and CHIP coverage and payment of interprofessional consultations (commonly and hereafter...more
The Big Picture -
On November 28, the Department of Health and Human Services (HHS), through the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released a proposed...more
On October 6, the expanded definition of electronic health information (EHI) under the information blocking rule went into effect, in what the government hailed as “data liberation day.”...more
On September 27, 2022, California Governor Gavin Newsom signed two bills (summarized below) that collectively aim to strengthen privacy safeguards for individuals seeking abortion services. After the U.S. Supreme Court’s...more
On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
On August 16, President Joe Biden signed into law H.R. 5376 , the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
On August 16, President Joe Biden signed into law H.R. 5376, the Inflation Reduction Act of 2022, which makes arguably the most significant changes to U.S. prescription drug price regulation ever, including by...more
The Inflation Reduction Act (IRA) will make arguably the most significant changes to U.S. prescription drug pricing regulations ever, but certainly since the creation of the Medicaid Drug Rebate Program in 1990. For the first...more
8/18/2022
/ Continuing Legal Education ,
Drug Pricing ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Webinars ,
Wholesale
In the wake of the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the Department of Health and Human Services Office for Civil Rights (OCR) yesterday issued guidance addressing how the Health...more
6/30/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
First Amendment ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Human Rights ,
Medical Records ,
New Guidance ,
OCR ,
Patient Access ,
Patient Privacy Rights ,
PHI ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS
The Big Picture -
Last week, congressional leaders released a draft bipartisan bill that, if adopted, would establish the nation’s first comprehensive federal privacy law.
The American Data Privacy and Protection Act...more
6/15/2022
/ Bipartisan Agreement ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Management ,
Data Privacy ,
Data Protection ,
Data Security ,
Information Technology ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards
When Congress prohibited “information blocking” under the 21st Century Cures Act in 2016, it made no reference to patient portals. Similarly, the word “portal” does not appear in the 6,000-word information blocking...more
5/31/2022
/ 21st Century Cures Act ,
Data Protection ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Blocking Rules ,
Information Technology ,
ONC ,
Patient Privacy Rights ,
Portal