On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning...more
The Centers for Medicare and Medicaid Services (“CMS”) has issued a proposed rule which would amend the existing regulations for reporting and returning identified overpayments (the “Proposed Rule”). Specifically, with...more
On June 21, 2022 the Supreme Court granted certiorari in Polansky v. Exec. Health Res., 17 F.4th 376 (3d Cir. 2021), allowing the Court to review the Department of Justice’s (“DOJ”) authority to dismiss qui tam suits brought...more
On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (“CMS”) revised and finalized draft guidance first issued on May 3, 2019, for co-location of hospitals with other hospitals or healthcare providers (the...more
On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more
8/20/2021
/ Administrative Procedure Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Prescription Drugs ,
Proposed Rules ,
Reimbursements
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more
12/23/2020
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Final Rules ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Prescription Drugs ,
Reimbursements ,
Trump Administration
On September 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) filed the unpublished version of the forthcoming Inpatient Prospective Payment Systems (“IPPS”) Final Rule for 2021. One of the more controversial...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a series of temporary regulatory waivers in order to aid the response to the 2019 Novel Coronavirus (COVID-19), as follows.
Increasing Hospital...more
On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted. Organized below are concise summaries of select CARES Act sections that will impact various sectors of the health...more
3/31/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FQHC ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Long Term Care Facilities ,
Material Adverse Change Clauses (MACs) ,
Relief Measures ,
SBA ,
Telehealth ,
Waivers
As discussed in our December 13, 2019 blog post on Surprise Billing, states have taken the lead on protecting patients against surprise bills, as the numerous pending bills before the House on the issue have stalled. Now in...more
“Surprise billing,” also known as “balance billing,” is one of few areas that garners bipartisan support. Surprise billing occurs when a patient inadvertently goes out of his or her insurer’s network, resulting in a “surprise...more
As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...more
On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory...more
10/11/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
A 2016 Final Rule from CMS created a new regulatory requirement for long-term care facilities, 42 C.F.R. § 483.85, that mandates such facilities have in operation, by November 28, 2019, a compliance and ethics program that is...more
On July 16, 2019, the Congressional Budget Office (“CBO”) released a Cost Estimate for Senate Bill S. 1895, the “Lower Health Care Costs Act.” The bipartisan bill, introduced June 19, 2019, intends to end surprise medical...more
On July 11, 2019, the Centers for Medicare and Medicaid Services (“CMS”) announced a proposed rule for home health agency Medicare reimbursement that would increase payments by an aggregate 1.3% for 2020, amounting to $250...more
7/17/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Health Insurance ,
Home Health Agencies ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Patients ,
Proposed Rules ,
Provider Payments ,
Public Comment
When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from customized compounded drugs. Medicare Part D, the prescription drug program,...more
Quality Improvement Programs -
The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes two technical changes to 42 C.F.R. Part 422. The first change...more
11/2/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Fee-for-Service ,
Health Care Providers ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Proposed Rules ,
Quality of Care Standards