Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
As Medicare secondary payer penalties take effect this fall, find out what’s new, what’s on the horizon, and what to watch out for to avoid pitfalls. Join Goldberg Segalla partners Philip Unwin and Jennifer Santoro for a free...more
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more
On December 4, 2023, CMS issued an interim final rule (the Interim Rule) (RIN 0938-AV26) to implement new enforcement authorities that CMS may use if states fail to comply with new reporting requirements or with federal...more
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more
On April 4, 2023, CMS issued proposed rules for Fiscal Year (FY) 2024 to update Medicare payment policies for skilled nursing facilities (SNFs) and inpatient psychiatric facilities (IPFs). CMS notes these rules are intended...more
On August 4, 2021, the Centers for Medicare & Medicaid Services (CMS) published proposed changes to enforcement of the hospital price transparency rules that went into effect earlier this year. The proposed changes, part of...more
On July 19, 2021, CMS published a proposed rule to update the payment policies, payment rates and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...more
In a stunning move, the Centers for Medicare and Medicaid Services (CMS) has linked reporting and tracking of the incidence and impact of the coronavirus (COVID-19) disease to satisfaction of the Medicare Conditions of...more
As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more
On August 25, 2020 the Centers for Medicare & Medicaid Services (CMS) issued interim final regulations known as CMS-3401-IFC that become effective immediately upon publication in the Federal Register, scheduled for September...more
On Aug. 25, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (IFR) as an emergency regulation under the public health emergency (PHE). Under the IFR, CMS will require all hospitals to which...more
CMS revised its policy guidance regarding adverse action reporting requirements once again in the Medicare Program Integrity Manual (MPIM) Transmittal 865. This guidance is arguably inconsistent with the regulations and with...more
The Affordable Care Act (sometimes referred to as Obamacare) included a requirement for providers to report and return all Medicare and Medicaid overpayments within 60 days of identification. Although this requirement has...more
On February 12, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule that explains the requirements for providers and suppliers reporting and returning overpayments under Medicare Parts A & B (the...more
Medicare Part A and B providers and suppliers should take note of new regulations recently issued by the Centers for Medicare & Medicaid Services that implement the Affordable Care Act’s 60-day rule on reporting and returning...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
On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more
The Patient Protection and Affordable Care Act (“PPACA”), signed into law on March 23, 2010, included a provision (the “Report and Refund Mandate”), broadly requiring health care providers, suppliers, Part D plans and managed...more