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
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 ,
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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
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
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
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Comment Period ,
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Health Care Providers ,
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Healthcare Reform ,
Medicaid ,
Medical Loss Ratio ,
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Medicare Advantage ,
Medicare Part D ,
Prescription Drug Coverage ,
Prescription Drugs
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
Editor’s Note: Over the past decade, both public and private payers have sought to develop payment policies that emphasize the value of the services provided instead of the quantity. These value-based purchasing (VBP)...more
Editor’s Note: People eligible for both Medicare and Medicaid experience co-occurring substance use disorders (SUDs) and chronic pain at rates that are two to six times higher than Medicare-only beneficiaries or Medicaid-only...more
The Search for Savings and Value: The Federal Perspective -
President Trump’s “American Patients First” blueprint outlines several initiatives to lower drug prices and reduce patients’ out-of-pocket costs. Shortly after...more
Editor’s Note: State Medicaid programs continue to balance serving eligible beneficiaries and controlling costs. In an environment sharply focused on the cost of drugs, it is increasingly critical to understand the Medicaid...more
Over the past five years, the budgets of state Medicaid programs have been challenged by the introduction of new high-cost drugs into the marketplace. Many of these drugs have important clinical benefits, and some are even...more
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
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
On May 26, 2015, the Centers for Medicare and Medicaid Services (CMS) released a notice of proposed rulemaking (NPRM) to overhaul the regulations governing Medicaid managed care and make conforming changes to the rules that...more
6/13/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Grievance Process ,
Managed Care Contracts ,
Medicaid ,
Medical Loss Ratio ,
Medicare ,
Medicare Advantage ,
NPRM ,
Prescription Drug Coverage ,
Quality of Care Standards
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