The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more
3/5/2024
/ ACOs ,
Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Industry Consolidation ,
Medicare ,
Medicare Advantage ,
OIG ,
Patient Privacy Rights ,
Regulatory Oversight ,
Rewards Programs ,
Value-Based Care
The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) on Nov. 6, 2023, issued new General Compliance Program Guidance (GCPG) as a reference guide for the healthcare compliance community....more
The Centers for Medicare and Medicaid Services (CMS) has issued new guidance for frequently asked questions related to Medicare reimbursement for items and services provided in connection with the diagnosis and treatment of...more
The Centers for Medicare and Medicaid Services (CMS) continues to offer guidance related to the coronavirus (COVID-19) outbreak. On March 10, CMS issued a memo to all Medicare Advantage (MA) organizations and Part D sponsors...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more
4/10/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Manufacturers ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Rebates ,
Safe Harbors
Regulation -
OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor -
On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more
12/20/2018
/ Advisory Opinions ,
Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
EPSDT ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Medicare Advantage ,
Notice of Proposed Rulemaking (NOPR) ,
OIG ,
Protected Class ,
Remuneration ,
Safe Harbors ,
Screening Procedures ,
Telemedicine ,
Unfair or Deceptive Trade Practices
The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D sponsors to customize their formularies based not just on the drug, but also...more
Centers for Medicare and Medicaid Services (CMS) has just issued guidance to address Medicare Part D coverage for newer insulin delivery devices for the treatment of diabetes. Medicare Part D has historically covered “medical...more
OIG Advisory Opinions -
Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized -
On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
9/6/2017
/ Anti-Kickback Statute ,
Anti-Steering Rules ,
Appeals ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EMTs ,
Expert Testimony ,
False Claims Act (FCA) ,
False Statements ,
Food and Drug Administration (FDA) ,
FRCP 9(b) ,
Health Care Providers ,
Health Insurance ,
Hip Replacement ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
Misrepresentation ,
OIG ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Defects ,
Qui Tam ,
Retaliation ,
Reversal ,
Witness Preparation
After more than four years since the issuance of its Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) will implement its Final Rule on the reporting and return of Medicare Parts A and B overpayments,...more
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
9/29/2015
/ Audits ,
Compliance ,
Covered Entities ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
Healthcare ,
Hospice ,
Hospitals ,
HRSA ,
MCOs ,
Medicaid ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Skilled Nursing Facility
Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more
7/22/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements
- CMS issues final Medicare Advantage and Part D regulatory changes after a controversial proposed rule was announced earlier this year.
- New requirements for the reporting and return of Medicare Advantage and Part D...more
The Medicare Advantage and Part D Final Call Letter announces requirements for the 2015 contract year, including changes to Part C and Part D star ratings and how CMS will evaluate Part D plan structures submitted for the...more
On May 23, 2013, CMS issued its Final Rule on Medical Loss Ratio (MLR) requirements for Medicare Advantage (MA) and Medicare Part D programs. MLR calculates the percentage of revenue used by MA organizations and Part D...more
The Massachusetts Board of Pharmacy (BOP) enacted emergency regulations effective November 1, 2012, in response to the deadly fungal meningitis outbreak caused by drug contamination at a Massachusetts compounding pharmacy....more