Background On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (Final Rule) that requires hospitals to establish, update and make public a list of their standard charges for items and...more
After receiving approval from the Office of Management and Budget (OMB) on April 23, 2020, the Centers for Medicare and Medicaid Services (CMS) released a survey on April 24, 2020, to collect information on 340B hospitals’...more
On February 7, 2020, the Centers for Medicare and Medicaid Service (CMS) published a notice signaling that it has submitted its previously published September 2019 proposed survey of hospital 340B drug costs for Office of...more
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law
On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more
2/5/2020
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Section 340B
Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more
1/14/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
Hospitals ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B
On November 15, the Trump Administration released a final rule requiring hospitals to publicly disclose hospital charges, including negotiated prices with third-party payers by January 1, 2021. We outline key considerations...more
The Centers for Medicare and Medicaid Services has released proposed updates to payment rates and regulations applicable to the Hospital Outpatient Prospective Payment System for Calendar Year 2020, including proposals...more
President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more
6/28/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
American Hospital Association ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Final Rules ,
Healthcare Costs ,
New Legislation ,
Price Transparency ,
Rulemaking Process ,
Secretary of HHS ,
Trump Administration
The Centers for Medicare and Medicaid Services (CMS) announced a new round of competitive bidding for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), with contracts scheduled to become...more
The US District Court for the District of Columbia recently held that the Centers for Medicare and Medicaid Services (CMS) exceeded its authority by reducing Medicare payment rates for 340B drugs, but, because of the...more
On October 31, 2018, the Health Resources and Services Administration (HRSA) at the US Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to move up the effective date of a final rule that...more
On October 25, 2018, the Centers for Medicare and Medicaid Services (CMS) announced an Advance Notice of Proposed Rulemaking with Comment (ANPRM) proposing to implement an international pricing index (IPI) model for Medicare...more
On September 11, 2018, the American Hospital Association (AHA) and several other hospital system and hospital association stakeholders1; (Plaintiffs) filed a lawsuit (Complaint) against the U.S. Department of Health and Human...more