Confirming that hospital merger enforcement continues to be a priority under the new administration, the Federal Trade Commission (FTC) and the North Dakota Attorney General recently challenged Sanford Health’s proposed...more
Contracting With Technology Vendors: Obligations and Compliance Strategies -
Editor’s Note: In a recent webinar, Manatt Health examined how to protect privacy when communicating in the digital age. The session revealed how...more
7/25/2017
/ Antitrust Division ,
Business Associates ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Employee Retirement Income Security Act (ERISA) ,
Fair Credit Reporting Act (FCRA) ,
Federal Trade Commission (FTC) ,
Health Insurance ,
Medicare ,
Mergers ,
Physician Fee Schedule ,
Spokeo v Robins ,
Vendors
Conspiracies between competitors can be hard to prove, even when other parties to the alleged conspiracy have settled. On May 31, 2017, a federal judge denied summary judgment and ruled that the Department of Justice (DOJ)...more
HIPAA and Emerging Technologies -
Editor’s Note: According to a HIMSS Mobile Technology Survey of healthcare provider employees, about 90% say they are using mobile devices to engage patients in their healthcare—and 36%...more
6/23/2017
/ Anticompetitive Agreements ,
Breach Notification Rule ,
Bring Your Own Device (BYOD) ,
Cost-Sharing ,
Department of Justice (DOJ) ,
Email ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internet of Things ,
Marketing ,
Medicare Part D ,
Mobile Apps ,
PHI ,
Text Messages
Mapping the Healthcare M&A Landscape Under the New Administration -
Editor’s Note: The healthcare M&A market continues to be among the most active sectors. In a recent webinar, Manatt examined how the policies and goals of...more
5/25/2017
/ Acquisitions ,
Affordable Care Act ,
American Health Care Act (AHCA) ,
Antitrust Provisions ,
Centers for Medicare & Medicaid Services (CMS) ,
DSH ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare Reform ,
Hospitals ,
Mergers ,
Trump Administration
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
The Department of Justice's (DOJ) case against Carolinas Healthcare System's (CHS) anti-steering contract clauses has survived initial attempts by CHS to dismiss the case. Despite the reversal of the DOJ's win in the American...more
Under the Hart-Scott-Rodino (HSR) Act, parties to transactions meeting certain size thresholds are required to notify the Antitrust Division of the U.S. Department of Justice and the Federal Trade Commission and to observe a...more
9/1/2016
/ Acquisitions ,
Antitrust Violations ,
Civil Monetary Penalty ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Exemptions ,
Federal Trade Commission (FTC) ,
Hart-Scott-Rodino Act ,
Investors ,
Mergers ,
Passive Activity ,
Voting Securities
Section 1332 Waivers: Will We See More State Innovation? -
Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more
8/25/2016
/ 1332 Waiver ,
Assisted Suicide ,
Customer-Loyalty Programs ,
Department of Health and Human Services (HHS) ,
Discounts ,
Dispute Resolution ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Long Term Care Facilities ,
Medicaid ,
Off-Label Promotion ,
Patient Privacy Rights ,
PHRMA ,
Prescription Drug Coverage ,
Section 340B ,
Unfair or Deceptive Trade Practices
The Vulnerability of Healthcare Information -
According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more
7/28/2016
/ Abortion ,
Affordable Care Act ,
Anti-Steering Rules ,
Antitrust Violations ,
Attorney's Fees ,
Bad Faith ,
Brandt Fees ,
Children's Health Insurance Program (CHIP) ,
Compensatory Damages ,
Contraceptive Coverage Mandate ,
Cybersecurity ,
Data Protection ,
Denial of Benefits ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
Employee Retirement Income Security Act (ERISA) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Gobeille v Liberty Mutual Insurance Com. ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Justice Scalia ,
Market Power ,
Materiality ,
Medicaid ,
Medical Devices ,
Medicare ,
Nurses ,
OCR ,
Patient Privacy Rights ,
PHI ,
Preemption ,
Punitive Damages ,
Religious Institutions ,
Right to Privacy ,
SCOTUS ,
Undue Burden ,
Universal Health Services Inc v United States ex rel Escobar ,
Wearable Technology ,
Whole Woman's Health v Hellerstedt ,
Zubik v Burwell
Real-Time Data Analytics in Government Investigations and Reducing Exposure -
It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more
6/24/2016
/ ACOs ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Government Investigations ,
Healthcare Fraud ,
HEAT ,
Hospital Mergers ,
IRS ,
MCOs ,
Medi-Cal ,
Medicaid ,
Medicare Advantage ,
OIG ,
Section 340B
A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more
Actions to Advance Infant and Early Childhood Mental Health -
Editor's Note: Children's earliest experiences—both positive and negative—impact their brain formation and in turn their social and emotional, physical,...more
5/24/2016
/ Employee Retirement Income Security Act (ERISA) ,
Federal Trade Commission (FTC) ,
Gobeille v Liberty Mutual Insurance Com. ,
Health Insurance ,
Long-Term Care ,
Manufacturers ,
Mental Health ,
Pay-For-Delay ,
Preemption ,
Public Health Insurance Marketplace ,
SCOTUS
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
Liberating Data to Enable Healthcare Market Transparency: A Guide for Regulators and Policymakers -
Editor's Note: We are on the cusp of a transparency revolution in which consumers will have the data and tools to make...more
On March 12, the West Virginia legislature passed a bill that would exempt state healthcare providers from federal antitrust scrutiny when acting under the jurisdiction of the West Virginia Health Care Authority (Authority)....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
The Megatrends Reshaping Healthcare: Managing Change and Maximizing Opportunity -
Editor's Note: In 2013, Manatt Health identified 10 megatrends that would reinvent the healthcare marketplace across the next decade. In a...more
1/23/2016
/ Affordable Care Act ,
Antitrust Investigations ,
Biologics ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
Federal Trade Commission (FTC) ,
Genome Project ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Out of Network Provider ,
Provider Payments ,
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
On November 13, the Solomon Center for Health Law and Policy at Yale Law School held its inaugural conference, "The New Healthcare Industry: Integration, Consolidation, Competition in the Wake of the Affordable Care Act." The...more
Best Practices for Using Social Media in Healthcare: Maximizing Impact, Mitigating Risk -
Editor's note: In a generation more likely to seek health information online than see a doctor, social media is playing an...more
11/23/2015
/ Affordable Care Act ,
Ann Taylor ,
Federal Trade Commission (FTC) ,
Form 1095 ,
FTC Endorsement Guidelines ,
HCQIA ,
Health Information Technologies ,
Health Insurance Exchanges ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hyundai ,
IRS ,
Licensing Boards ,
Marketing ,
NC Board of Dental Examiners v FTC ,
Peer Review ,
Reporting Requirements ,
SCOTUS ,
Social Media ,
State Action Immunity