Although delayed as a result of the COVID-19 public health emergency, there are persistent and ongoing efforts to reform the Medicare Part D benefit. Since its June 2016 Report to Congress, the Medicare Payment Advisory...more
During the Medicare Payment Advisory Commission’s (MedPAC’s) January 16 public session, MedPAC staff continued their drumbeat for reforming the Part D benefit following recommendations previously made in their June 2016...more
High out-of-pocket costs can be a significant barrier to access for Part D enrollees, especially for non-low-income subsidy (LIS) enrollees with a condition that requires an expensive specialty drug for treatment. The 2019...more
Current Medicare Part D policy requires sponsors to cover with limited exceptions “all or substantially all” drugs in six “protected” classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment...more
On November 26 2018, the Centers for Medicare & Medicaid Services (CMS) released the Proposed Rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. The proposed rule would...more
Hospitals and Health Systems Prepare for a Value-Based Future -
Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...more
2/22/2018
/ Antitrust Division ,
Cost-Sharing ,
False Claims Act (FCA) ,
Hospitals ,
Information Sharing ,
Medicare ,
Medicare Part D ,
No-Poaching ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Substance Abuse ,
Universal Health Services Inc v United States ex rel Escobar
Vaccination utilization among U.S. adults is low, and well below the Healthy People 2020 Targets, despite widespread availability of safe and effective vaccines and long-standing use recommendations by the Centers for Disease...more
The Eight Key Elements of Effective Compliance Programs -
Editor’s Note: In a recent webinar for Bloomberg BNA, Manatt examined game-changing fraud and abuse trends and cases—and revealed strategies for avoiding False...more
Part 1: Megatrends Reinventing How Patients Think -
Editor’s Note: In a recent webinar for PharmaVOICE, Manatt Health revealed the megatrends reinventing the life sciences industry—and how they relate to new thinking by...more
Using Telehealth as a Tool for Health System Integration -
As discussed in our August Health Update article on patient engagement and digital health—the first in our new digital health series—the advent of digital and...more
Next Steps on Healthcare Reform -
Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more
8/8/2017
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Cost-Sharing ,
DSH ,
Health Insurance ,
Healthcare Reform ,
HOPPS ,
Pharmaceutical Industry ,
Repeal ,
Section 340B ,
Tax Reform ,
Waivers
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
BCRA Implications: Affordability of Coverage -
In making the case for repealing and replacing the Affordable Care Act (ACA), the president and congressional leadership have cited “rising premiums,” “unaffordable...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
Top Five Healthcare Antitrust Trends to Watch in 2017 -
Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more
1/24/2017
/ Abbreviated New Drug Application (ANDA) ,
Anti-Steering Rules ,
Antitrust Provisions ,
Artificial Intelligence ,
Big Data ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospital Mergers ,
Internet of Things ,
Mergers ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Social Services
Post-Election Analysis: Healthcare Antitrust in a Trump Administration -
In a Republican sweep of all the elected branches of the federal government, Donald Trump won the presidential election and Republicans retained...more
11/23/2016
/ Affordable Care Act ,
Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Data Collection ,
Data Security ,
Enforcement ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Internal Revenue Code (IRC) ,
IRS ,
Marketing ,
Medicare Access and CHIP Reauthorization (MACRA) ,
MIPS ,
Presidential Elections ,
Public Concern ,
Reinsurance ,
Section 501r ,
Trump Administration
The Department of Health and Human Services (HHS) has proposed a major, national payment model that would, if implemented, significantly impact how Medicare pays for drugs provided through the Part B program. Under the...more
Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace -
Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more
7/23/2015
/ Admissions ,
Affordable Care Act ,
Anticompetitive Agreements ,
Attorney General ,
Biologics ,
Biosimilars ,
Caregivers ,
Centers for Medicare & Medicaid Services (CMS) ,
Decision-Making Process ,
Department of Justice (DOJ) ,
DSRIP ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Healthcare.gov ,
Home Health Care ,
Home Healthcare Workers ,
Hospitals ,
Long-Term Care ,
Medicaid ,
Medical Malpractice ,
Medicare ,
Medicare Part B ,
Nurses ,
Patient Rights ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Public Health Insurance Marketplace ,
Qualified Health Plans ,
Settlement ,
Sherman Act ,
State Health Insurance Exchanges
On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will...more
Examining Fee Splitting Statutes in the Context of Value-Based Healthcare -
Editor’s note: One of the goals of the Affordable Care Act (ACA) is to align incentives among provider communities and their patients and...more
6/23/2015
/ Affordable Care Act ,
Cardinal Health ,
Federal Trade Commission (FTC) ,
Fee-Splitting ,
Hospital Mergers ,
Hospitals ,
Licensing Boards ,
Medicare Shared Savings Program ,
Mergers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Radiopharmaceuticals ,
SCOTUS ,
Value-Based Fees
Phoebe Putney: A Collision of Federal Antitrust and State Certificate of Need Laws -
On March 31, 2015, the Federal Trade Commission (FTC) announced that it had entered into a consent agreement with Phoebe Putney Health...more
The President has signed into law the bipartisan bill H.R. 2, the “Medicare Access and CHIP Reauthorization Act of 2015,” which permanently repeals the flawed Sustained Growth Rate (SGR) formula and replaces it with a stable...more
Let’s Get to Work: OIG Releases 2015 Work Plan, Focusing on Long-Term Care and Health Reform -
The U.S. Department of Health and Human Services (HHS)--Office of Inspector General (OIG) released its 2015 Work Plan (Work...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
The Five Megatrends Shaping Pharma’s Next Decade: Sustaining Success in a New Market Landscape -
Disruptive trends in the healthcare system will force companies to change their strategies. With new care models...more