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
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
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
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
The Centers for Medicare & Medicaid Services released the calendar year 2017 final rule implementing changes to the Medicare hospital Outpatient Prospective Payment System, or OPPS, including provisions implementing Section...more
In Depth -
Background -
On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the CY 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes proposed regulations to...more
7/12/2016
/ Ambulatory Surgery Centers ,
Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Hospitals ,
Medicare ,
MPFS ,
Off-Campus Departments ,
OIG ,
OPPS ,
Payment Systems ,
Physician Fee Schedule ,
Proposed Rules ,
Section 340B
In Depth -
On June 16, 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) oversight of billing by...more
In Depth -
The House Ways and Means Committee next week is expected to consider and approve the Helping Hospitals Improve Patient Care Act of 2016, legislation that would create broader exceptions under much maligned...more
For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align...more
On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for...more
On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more
10/30/2015
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Debt Ceiling ,
Federal Budget ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Part B ,
OPPS ,
Pending Legislation ,
Physician Fee Schedule ,
Physicians ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Sequestration
On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more
10/21/2015
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Hospitals ,
HRSA ,
Judicial Review ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
9/1/2015
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
DSH Adjustments ,
GPOs ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
MCOs ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Recordkeeping Requirements ,
Recovery Audit Contractors (RACs) ,
Section 340B
On July 1, 2015, the Centers for Medicare & Medicaid Services (CMS) released proposed updates to the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for Calendar Year...more
7/8/2015
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Hospitals ,
Inpatient Billing ,
Medicaid ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Part A ,
OPPS ,
Physicians ,
Proposed Regulation ,
Recovery Audit Contractors (RACs) ,
Two-Midnight Rule
On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more
On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more
The Centers for Medicare & Medicaid Services (CMS) recently issued the federal Fiscal Year 2015 Medicare Inpatient Prospective Payment System Proposed Rule, which contains a proposal to implement new metropolitan areas...more
Earlier this week, the much-anticipated 340B Drug Pricing Program (340B Program) proposed rule arrived at the Office of Management and Budget for review. Publication of this proposed rule is expected in June and will likely...more
The proposed rule, issued on February 7, 2013, would make reforms to existing Medicare regulations applicable to hospitals, ambulatory surgical centers, intermediate care facilities for individuals who are intellectually...more