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
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
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
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
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
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
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
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
In January 2021, Manatt Health described the ten health care imperatives essential for improving our health care system and advancing health equity in the 2020s. Now two years into the decade, we have released our 2022...more
5/3/2022
/ Coronavirus/COVID-19 ,
Digital Health ,
Disparate Impact ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Healthcare Workers ,
Hospitals ,
Long Term Care Facilities ,
Mental Health ,
Patient Access ,
Pharmaceutical Industry ,
PHI ,
Physicians ,
Public Health ,
Webinars
On January 12, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs proposed rule,...more
1/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medical Loss Ratio ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Prescription Drug Coverage ,
Prescription Drugs
Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more
10/28/2021
/ Biologics ,
Biotechnology ,
Drug Pricing ,
Financing ,
Genetic Materials ,
Genetic Testing ,
Health Care Providers ,
Healthcare Reform ,
Human Genes ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Reinsurance ,
Value-Based Purchasing
Scientific advances in understanding how to manipulate genes to alter the course of disease are now starting to bear fruit. Cell and gene therapies will bring hope to those with conditions once thought to be incurable or...more
After a six-month delay due to the COVID-19 pandemic, the first provisions of the interoperability rule issued by the Centers for Medicare & Medicaid Services (CMS) took effect on July 1. The new requirements are the first of...more
7/19/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Data Management ,
Data Protection ,
Data-Sharing ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Medicare Advantage Organizations (MAOs) ,
Price Transparency ,
Qualified Health Plans ,
Regulatory Requirements
What New Obligations Do Health Plans and States Face Under the Latest Interoperability Requirements—and What’s the Best Path to Compliance? Learn the Answer at a New Manatt Webinar.
Historically, privacy rules have focused...more
3/1/2021
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Continuing Legal Education ,
Data Privacy ,
Data-Sharing ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Medicaid ,
New Rules ,
Physicians ,
Prior Authorization ,
State Health Plans ,
Webinars
Expansion of telehealth services during the COVID-19 pandemic has been critical to maintaining continuity of care and enabling providers to connect with patients virtually during a time when in-person interactions raise the...more
As this decade begins, Americans are increasingly apprehensive about the privacy of their personal information. A recent survey found that approximately four out of five Americans are concerned about how their data is used,...more
7/9/2020
/ Consumer Privacy Rights ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Collection ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Infectious Diseases ,
Internet of Things ,
Personal Information ,
Shared Responsibility Rule
As this decade begins, Americans are increasingly apprehensive about the privacy of their personal information. Nowhere is this issue more important than in regard to health data, a type of information that can contain...more
7/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Consumer Privacy Rights ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
FTC Act ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Patient Privacy Rights
On July 9, Judge Amit P. Mehta of the U.S. District Court, District of Columbia vacated an administration final rule that would have required drug manufacturers to disclose wholesale acquisition prices in their television...more
In 2016, 11.5 million Americans were misusing prescription opioids, with the abuse reaching epidemic levels in 2017. The opioid crisis has accelerated the need for healthcare stakeholders to play a more active role in...more
As the old model of patient care silos—where behavioral health providers treat patients separately from the rest of the healthcare system—breaks down, participants from across healthcare are attempting to access...more
In its April 25, 2016 Medicaid managed care final rule, the Centers for Medicare and Medicaid Services (CMS) provides a revised framework for determining how managed care plans should be paid by state Medicaid programs. A...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure -
As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
9/25/2015
/ Affordable Care Act ,
Amarin ,
Anti-Bribery ,
Anti-Competitive ,
Anti-Corruption ,
Audit Policies ,
Bribery ,
Centers for Medicare & Medicaid Services (CMS) ,
Class Action ,
Clinical Laboratories ,
Clinical Trials ,
Compensation Standards ,
Compliance ,
Corporate Integrity Agreement ,
Cost-Sharing ,
Damages ,
Department of Justice (DOJ) ,
Dodd-Frank ,
False Claims Act (FCA) ,
FERA ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Fraud Abuse and Waste ,
Government Investigations ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
HEAT ,
Hiring & Firing ,
Hospitals ,
KBR v ex rel Carter ,
Kickbacks ,
Medicaid ,
Medicaid Expansion ,
Medicaid Reimbursements ,
Medicare ,
Medicare Advantage ,
Non-Compete Agreements ,
Nurses ,
Off-Label Promotion ,
OMIG ,
Penalties ,
Physician Compensation Arrangements ,
Public Health Insurance Marketplace ,
Qui Tam ,
Recordkeeping Requirements ,
Recruitment Policies ,
Relators ,
Required Documentation ,
SCOTUS ,
Self-Reporting ,
Tuomey ,
Value-Based Purchasing ,
Wage and Hour ,
Whistleblowers