To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more
11/13/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Healthcare Reform ,
Incentives ,
Patients ,
Physicians ,
Proposed Rules ,
Regulatory Burden ,
Reimbursements ,
Safe Harbors ,
Self-Referral ,
Stark Law ,
Value-Based Care ,
Webinars
On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more
The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more
10/11/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
OIG ,
Physicians ,
Proposed Rules ,
Public Comment ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
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
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more
8/16/2019
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Certification Requirements ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Fees ,
Health Care Providers ,
Medicare ,
Physician Fee Schedule ,
Physicians ,
Proposed Amendments ,
Proposed Rules ,
Public Comment ,
Self-Referral ,
Stark Law
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 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
On August 24, 2018, the Office of Inspector General (OIG), Department of Health and Human Services (HHS) published a request for information, seeking input from the public on potential new safe harbors to the Anti-Kickback...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
The Centers for Medicare and Medicaid Services (CMS) recently posted revisions to the Voluntary Self-Referral Disclosure Protocol (SRDP). In an attempt to streamline the self-disclosure process, CMS requires the use of new...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
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 Centers for Medicare & Medicaid Services issued its long-awaited final rule on long-term care facility reform, which represents the first comprehensive change to long-term care conditions of participation since 1991. The...more
On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more
12/14/2016
/ Affordable Care Act ,
Ambulance Providers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Medicare ,
OIG ,
Pharmacies ,
Remuneration ,
Safe Harbors
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
In Depth -
On December 7, 2016, the Office of the Inspector General (OIG) of the US Department of Health and Human Services (HHS) issued a policy statement increasing its thresholds for gifts that are considered...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
McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more
10/31/2016
/ ACOs ,
Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Commercial Reasonableness ,
Compliance ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Medical Reimbursement ,
Physicians ,
Shared Savings Program ,
Stark Law ,
Waivers
The Centers for Medicare & Medicaid Services (CMS) recently published a letter to State Survey Agency Directors describing revisions to Chapter 7 of the State Operations Manual (SOM) to reflect mandatory disciplinary...more
In Depth -
The Medicare Physician Fee Schedule proposed rule released by the Centers for Medicare & Medicaid Services (CMS) on July 7, 2016, (the Proposed Rule) requires certain providers and suppliers furnishing health...more
7/26/2016
/ Centers for Medicare & Medicaid Services (CMS) ,
Enrollment ,
General Services Administration (GSA) ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part D ,
OIG ,
Physician Fee Schedule ,
Prescription Drug Coverage
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
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
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
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