On February 14, 2019, CMS’ Innovation Center announced its Emergency Triage, Treat, and Transport (ET3) Model for EMS / ambulance suppliers to partner with other health care providers such as telehealth entities and urgent...more
5/2/2019
/ 911 Calls ,
Ambulance Providers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Stark Law ,
Waivers
On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Safe Harbors
How Oncology Can Benefit from Digital Technology -
Welcome to Foley’s new health care MarketTrends newsletter. Each edition, we will focus on a different aspect of health care and highlight key trends in the industry. In...more
A new wave of change is poised to disrupt the way health care is delivered in the United States. This time around, the disruption is coming not from lawmakers or the president, who have struggled to repeal or improve upon...more
1/30/2019
/ Affordable Care Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Veterans Affairs ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Internet of Things ,
Legislative Agendas ,
Medicaid ,
Medicare Advantage ,
Popular ,
Request For Information ,
Stark Law ,
Telehealth
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more
8/8/2018
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
OMB ,
Out-of-Pocket Expenses ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Request For Information ,
Safe Harbors
Providers and suppliers who have been assessed overpayments for Medicare services are entitled, by statute, to a stay of recoupment while the provider or supplier’s appeal is pending – but only at the first two levels of...more
7/19/2018
/ Administrative Appeals ,
Administrative Law Judge (ALJ) ,
Centers for Medicare & Medicaid Services (CMS) ,
Due Process ,
Health Care Providers ,
Medicare ,
Medicare Provider Agreements ,
Overpayment ,
Physician Medicare Reimbursements ,
Recoupment ,
ZPIC
Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal...more
7/21/2017
/ Attorney General ,
Department of Justice (DOJ) ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Medicare Fraud Strike Force ,
Medicare Part D ,
OIG ,
Opioid ,
Pharmacies ,
Physicians ,
Prescribing Authority
Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and...more
The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of...more
1/25/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Department of Health and Human Services (HHS) ,
Departmental Appeals Board (DAB) ,
Federal Contractors ,
Healthcare Fraud ,
Irreparable Harm ,
Medicare ,
Medicare Billing Privileges ,
Motion to Dismiss ,
Preliminary Injunctions ,
Revocation ,
TRO
The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more
12/28/2016
/ 21st Century Cures Act ,
Barack Obama ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Hospitals ,
Long Term Care Facilities ,
Medical Research ,
Medicare Part B ,
New Legislation ,
Off-Campus Departments ,
OPPS ,
Outpatient Services ,
Physician Fee Schedule ,
Provider Payments ,
Site-Neutral Exception
The coming year will likely continue to be a tumultuous year for health care providers, suppliers, and payers, as they adapt to meet new challenges and market forces, particularly in light of the open questions as to the...more
11/30/2016
/ Acquisitions ,
Affordable Care Act ,
Bankruptcy Court ,
Commercial Bankruptcy ,
Consumer Bankruptcy ,
Distressed Assets ,
Health Care Providers ,
Health Information Technologies ,
Health IT ,
Jurisdiction ,
Legislative Agendas ,
Medicaid ,
Medical Debt ,
Medicare ,
Nursing Homes ,
Physician Medicare Reimbursements ,
Prescription Drug Coverage ,
Prescription Drugs ,
Provider Payments ,
Reorganizations ,
Repeal ,
Trump Administration ,
Value-Based Purchasing
Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule...more
Governor Brown approved a new law last Friday that limits patient exposure to so-called surprise medical bills. AB 72 caps the cost-sharing obligations of patients who unexpectedly receive care from non-contracted providers...more
9/29/2016
/ Cost-Sharing ,
Employee Retirement Income Security Act (ERISA) ,
Governor Brown ,
Health Insurance ,
Managed Care Contracts ,
Medi-Cal ,
Medicare ,
New Legislation ,
Out of Network Provider ,
Patient Rights ,
Surprise Medical Bills
Despite the July 4 holiday, the past week featured significant regulatory and legislative action addressing the use of opioids and pain management. The changes are in keeping with the Government-wide push to better understand...more
7/14/2016
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Congressional Committees ,
Drug & Alcohol Abuse ,
Hospitals ,
Legislative Agendas ,
Medicare ,
Opioid ,
Pain Management ,
Pending Legislation ,
Prescription Drugs ,
Proposed Regulation ,
Surveys ,
Value-Based Purchasing
CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more
7/13/2016
/ Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Grandfathered Status ,
Health Care Providers ,
Hospitals ,
Medicare ,
MPFS ,
Off-Campus Departments ,
OPPS ,
Proposed Legislation ,
Proposed Regulation ,
Section 340B
In an important win for hospice and other health care providers facing claims under the False Claims Act (FCA), a federal court in Alabama gave a summary judgment victory last week to hospice provider Aseracare Inc.
Key...more
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more
10/12/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CLFS ,
Clinical Laboratories ,
Comment Period ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Insurance ,
Hospitals ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part B ,
Misrepresentation ,
OIG ,
Omissions ,
PAMA ,
Physicians ,
Proposed Regulation ,
Reporting Requirements
President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more
9/21/2015
/ Barack Obama ,
Biotechnology ,
Cancer ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Insurance ,
Healthcare ,
Hospitals ,
Innovation ,
Medicare ,
National Institute of Health (NIH) ,
Personalized Medicine ,
Physicians
A New York Federal District Court issued an Opinion and Order, on August 3, 2015, in a closely-watched False Claims Act (FCA) case, Kane v. Healthfirst, Inc. The Court refused to dismiss the whistleblower complaint in which...more
The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs)...more
On August 1, 2014, the Centers for Medicare and Medicaid Services (CMS) issued its annual final rule for policy and payment changes applicable to inpatient stays in acute care and long term care hospitals (Final Rule). This...more
The Small Business Jobs Act of 2010 (pertinent sections of which are codified at 42 U.S.C. Section 1320a-7m) directed the Centers for Medicare & Medicaid Services (CMS) to use predictive modeling and other analytics...more
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) on May 12, 2014 published a proposed rule (Proposed Rule) that would implement the OIG’s expanded authority under the Affordable Care...more
The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2013 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCU)...more
On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more