On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting...more
In light of the novel coronavirus pandemic, health care practitioners should be aware of relaxed guidelines for prescribing controlled substance. This blog post describes when practitioners can prescribe controlled substances...more
This post provides an update on a number of HIPAA waivers that have just been made available to health care providers: (1) Waivers for hospitals in the initial 72 hours of enacting a disaster protocol; and (2) Waivers for all...more
The Centers for Medicare & Medicaid Services (“CMS”) recently posted two annual updates related to the physician self-referral law (“Stark Law” or “Stark”) on its Stark website: (1) CPI-U updates related to the nonmonetary...more
The False Claims Act (“FCA”) is an ever-present concern among health care providers and counsel, which is why it is no surprise that the Department of Health and Human Services’ (HHS) recent “Regulatory Sprint to Coordinated...more
In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the...more
11/21/2019
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Regulatory Standards ,
Request For Information ,
Stark Law
In 2018, the Department of Health and Human Services (the “Department”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the health care system, with a focus on removing...more
Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal...more
10/11/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
SAMHSA ,
Stark Law
The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. § 220. As part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment...more
For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities. Although these...more
On April 22, 2019, the Centers for Medicare and Medicaid Services (CMS) announced two sweeping new payment innovation models under the Primary Cares Initiatives. The models will seek to incentivize primary care and other...more
4/26/2019
/ ACOs ,
Alternative Payment Models (APM) ,
Cardiac Episode Payment Program ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Episode Payment Models (EPM) ,
Fee-for-Service ,
Health Care Providers ,
Medicaid ,
Medicare ,
Physicians ,
Request For Information ,
Value-Based Care
Today, the Federal Government announced enforcement actions against 60 defendants in eleven federal districts, including 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professional...more
The Centers for Medicare & Medicaid Services (CMS) is “actively working” on updates to regulations under the federal physician self-referral law (or “Stark Law”), according to CMS Administrator Seema Verma during a March 4,...more
The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to...more
Last week, with bipartisan support, both the Iowa House and Senate passed, unanimously, HF 2377 (“An Act Relating to the Regulation of Certain Substances, Including the Regulation of the Practice of Pharmacy, Providing...more
All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made...more
If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a...more
1/24/2018
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Implied Certification ,
Materiality ,
Medicaid ,
Medicare ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
Perhaps lost amid the healthcare news coverage of competing proposals regarding “Medicare for All” and the repeal of Obamacare, the Centers for Medicare & Medicaid Services (“CMS”) last month announced the expansion of its...more
The Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Physician Fee Schedule proposed rule on July 13, 2017. The proposed rule, among other things, proposes to cut Medicare payments for services...more
On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule which, among other proposals, could have a significant impact on 340B...more
On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more
The Centers for Medicare & Medicaid Services (CMS) released an advanced copy of its latest proposed rule revising the Quality Payment Program created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The...more
Compliance programs are an important tool for health care providers. Compliance programs help to prevent fraud, waste and abuse, create a mechanism for catching problems early, and effective compliance programs can also...more
The Centers for Medicare and Medicaid Services (CMS) published its 2017 Medicare Outpatient Prospective Payment System (OPPS) proposed rule on July 14, 2016 (the Proposed Rule). In part, the Proposed Rule addresses CMS’s...more
7/15/2016
/ Alternative Payment Models (APM) ,
Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Hospitals ,
MPFS ,
Off-Campus Departments ,
OPPS ,
Physicians ,
Proposed Regulation ,
Section 340B
On June 16, 2016, the Supreme Court issued a unanimous decision in Universal Health Services, Inc. v. United States ex rel. Escobar upholding the “implied certification” theory of liability under the False Claims Act (“FCA”)...more
6/30/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
Qui Tam ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers