The Four Key Elements of Breach Determination -
Under the Health Insurance Portability and Accountability Act (HIPAA), a breach is defined as “the acquisition, access, use or disclosure of protected health information in a...more
Editor’s Note: Cybercrime Magazine predicts that global ransomware attacks will reach $11.5 billion in 2019 and that ransomware attacks will hit a business every 14 seconds by next year, with a new report revealing that 45%...more
In response to the opioid epidemic, states and the federal government have sought to increase the availability of substance use disorder (SUD) treatment. Through medication-assisted treatment (MAT) programs and other efforts,...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
CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations -
On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more
4/25/2017
/ Affordable Care Act ,
Anti-Steering Rules ,
Antitrust Provisions ,
Centers for Medicare & Medicaid Services (CMS) ,
Deceptive Intent ,
Department of Justice (DOJ) ,
Drug Pricing ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Pharmacist ,
Self-Referral ,
Stark Law ,
Telehealth ,
Trump Administration
Balancing Gene Therapy’s Promise and Price -
Editor’s Note: Exciting advances in science have led to developing treatment breakthroughs, such as gene scripting therapies, that could represent the first potential cures...more
12/20/2016
/ Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Final Rules ,
Healthcare Reform ,
Hospice ,
MCOs ,
Medicaid ,
Medicare ,
Non-Discrimination Rules ,
OCR ,
OIG ,
Safe Harbors ,
Telehealth
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
Editor's Note: This "Manatt on Medicaid" is the sixth in a series of updates focused on CMS's new Medicaid/CHIP managed care regulations. In the coming weeks, Manatt will continue to explore key provisions of the regulations...more
Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...more
5/23/2016
/ ACOs ,
Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Antitrust Violations ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Fraud and Abuse ,
Hospital Mergers ,
Hospitals ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Physicians ,
Sherman Act ,
Stark Law
How to Prepare for "Phase Two" HIPAA Compliance Audits: Tips on Getting Ready for Scrutiny -
Editor's Note: Now that the Department of Health and Human Services (HHS) has announced that it is beginning the next round of...more
Better Late Than Never: CMS Provides Much-Needed Clarity on the 60-Day Overpayment Refund Requirements -
On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the long-awaited final rule (Final...more
2/26/2016
/ 60-Day Rule ,
ACOs ,
Affordable Care Act ,
Antitrust Violations ,
Centers for Medicare & Medicaid Services (CMS) ,
Certificate of Need ,
Health IT ,
Interstate Commerce ,
Knox Keene ,
License Agreements ,
Look-Back Measurement Period ,
Medicaid ,
Medicare Shared Savings Program ,
Overpayment Recovery Time Limits ,
Risk Allocation ,
Telehealth
Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal -
Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more
12/22/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Contraceptive Coverage Mandate ,
Department of Health and Human Services (HHS) ,
Freedom of Religion ,
Hospital Mergers ,
IRS ,
Long-Term Care ,
Medicare ,
Medicare Part B ,
OIG ,
Prescription Drugs ,
Public Health Insurance Marketplace ,
SCOTUS ,
Section 340B ,
Split of Authority ,
Stark Law ,
Waivers
Managed care is the dominant delivery model in state Medicaid programs, and is rapidly growing with the Affordable Care Act bringing over 8 million new beneficiaries into Medicaid in 2014. Today, 39 states (including the...more
In the fall of 2014, the Department of Health and Human Services Office of Inspector General released its 2015 Work Plan, which highlighted HHS’s compliance focus areas in the upcoming year.
As in past years, areas of...more
Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk -
Editor’s note: At the request of 23 public and private sector sponsors—including major life sciences companies, as well as U.S. and international...more
Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign -
Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more
Avoiding the Regulatory Land Mines of Commercial ACOs -
While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more
7/23/2014
/ ACOs ,
EHR ,
Halifax Hospital ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medicare ,
Medicare Shared Savings Program ,
Regulatory Standards ,
Reporting Requirements ,
Social Networks ,
Stark Law
Litigation Arising from the Affordable Care Act: The Blessing and Curse of Interesting Times -
The Affordable Care Act (ACA) has brought the most sweeping changes to the healthcare delivery and payment systems in the...more
Integrating Physical and Behavioral Health: Strategies for Overcoming Legal Barriers to Health Information Exchange -
A growing number of Medicaid officials believe that coordinating care across the physical and...more
2/26/2014
/ Affordable Care Act ,
CLIA ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Hospital Mergers ,
Medicaid ,
Medical Records
Going Digital with Patients: Managing Potential Liability Risks of Patient-Generated Electronic Health Information -
Patients are increasingly using new electronic tools, such as personal health records and mobile...more
On November 8, 2013, over three years after issuing interim final regulations, the Obama administration released final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of...more
On October 21, Florida-based health insurer AvMed, Inc. (AvMed) settled a data breach class action lawsuit for $3 million, even though no plaintiffs in the class demonstrated that they had suffered identity theft or any other...more
On October 30, 2013, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius sent a letter to U.S. Representative Jim McDermott stating that HHS does not consider qualified health plans (QHPs) sold...more
Originally published in Health IT Law & Industry Report, on January 23, 2013.
On Jan. 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services (‘‘HHS’’) issued a long-awaited omnibus rule...more