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
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
On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more
8/17/2016
/ Administrative Proceedings ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Affordable Care Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Government Claims ,
HRSA ,
Manufacturers ,
Prescription Drug Coverage ,
Prescription Drugs ,
Proposed Rules ,
Section 340B ,
Statute of Limitations
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
On March 1, 2016, the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) entitled “Medicare, Medicaid, and Children’s Health Insurance...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 December 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its final rule establishing a prior authorization program for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)...more
In November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...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
Among the proposed changes to Medicare regulatory requirements related to billing and coverage of physician services set forth in the 2016 Medicare Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for...more
7/21/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Proposed Regulation ,
Stark Law ,
Supervision
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 June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more