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
On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more
10/1/2019
/ Affiliates ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Document Retention Policies ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Opt-Outs ,
Physicians ,
Public Comment ,
Reporting Requirements
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The Centers for Medicare and Medicaid Services has issued long-awaited draft guidance addressing the use of shared space and contracted services. Though aiming to increase transparency into the scope and interpretation of its...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
The Centers for Medicare & Medicaid Services (CMS) released its 2019 Hospital Outpatient Prospective Payment System Final rule, which, among other things, expands “site-neutral” payments to additional hospital outpatient...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
The Centers for Medicare & Medicaid Services (CMS) has historically prohibited “new” teaching hospitals from sharing graduate medical education (GME) full time equivalent (FTE) slots with another hospital under a GME...more
Following our inaugural installment of the Health Care Enforcement Quarterly Roundup, we are pleased to be back this quarter with another overview of key enforcement trends in the health care industry. In this issue, we...more
After an already active first half of 2018 for 340B Program developments, 340B Program stakeholders are not getting a summer respite. In just the past week, the US Government Accounting Office (GAO) released its...more
The Helping Ensure Low-income Patients have Access to Care and Treatment (HELP ACT) is the third 340B-related legislation to be introduced this month. The HELP ACT goes well beyond the 340B PAUSE Act in the scope of its...more
In late December 2017, Republican Rep. Larry Bucshon (with bi-partisan support) introduced the “340B Protecting Access for the Underserved and Safety-net Entities Act” (340B PAUSE Act), legislation that would implement a...more
On November 1, 2017, the US Department of Health and Human Services released a Final Rule implementing a payment reduction for most covered outpatient drugs billed to Medicare by 340B-participating hospitals from the current...more
The Centers for Medicare and Medicaid Services released guidance on September 6, 2017, intended to clarify the definition of “hospital.” The guidance provides factors that may be considered to determine whether a hospital is...more
As part of the CY 2018 proposed updates to the Medicare Hospital OPPS, the US Department of Health and Human Services has proposed to decrease Medicare Part B payments to hospitals for 340B drugs by almost 30 percent. The cut...more
With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more
As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency
The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more
On December 19, 2016, the US Department of Health and Human Services Office of Inspector General (OIG) posted a report examining the Centers for Medicare & Medicaid Services’ (CMS’s) “2-Midnight Rule.” The OIG concluded that...more
On December 8, 2016, the Centers for Medicare and Medicaid Services (CMS) published the Medicare Outpatient Observation Notice (MOON), which educates Medicare beneficiaries on the effect of outpatient status, particularly as...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more