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Practice Industry: Healthcare & Pharmaceuticals, Life Sciences, Taxation
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Waller | April 2020

On April 6, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule in the Federal Register that, among other initiatives and changes to existing policy, allows certain inpatient hospital services to be provided “under arrangements” outside of the hospital. The “March 2020 IFC” is intended to give healthcare providers increased flexibility to respond to the public health emergency created by COVID-19 ...

Dinsmore & Shohl LLP | November 2018

In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...

On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020 ...

On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life ...

Dinsmore & Shohl LLP | September 2021

Recently, the Centers for Medicare & Medicaid Services (CMS) announced it is rescinding the audit determinations for providers notified in January 2021 that had failed to qualify for the “mid-build” exception. CMS took this action due to questions raised by these providers regarding the audit process ...

Dinsmore & Shohl LLP | April 2021

On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year.  This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184 ...

Dinsmore & Shohl LLP | March 2020

The Centers for Medicare & Medicaid Services (CMS) announced during a March 19, 2020 teleconference for physicians and teaching hospitals that it does not have the authority to postpone the statutory timeline for the Physician Payments Sunshine Act (Sunshine Act) ...

Waller | March 2020

On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced updates to its survey process in response to COVID-19 (press release,press release, andmemo). Specifically, as authorized pursuant to section 1135(b)(5) of the Social Security Act, CMS is prioritizing certain surveys and exercising enforcement discretion for all certified provider and supplier types for the next three weeks ...

Waller | August 2020

A new reimbursement model intended to address healthcare access and availability in rural communities was introduced by The Centers for Medicare & Medicaid Services (CMS) Innovation Center. The Community Health Access and Rural Transformation (CHART) Model will “provide up-front investments and predictable, capitated payments that pay for quality and patient outcomes,” according to CMS ...

Dinsmore & Shohl LLP | June 2020

The Centers for Medicare and Medicaid Services (CMS) announced on March 13, 2020 enhanced penalties for infection control survey non-compliance amid the COVID-19 pandemic.[1] On June 1, 2020, CMS announced significant changes related to nursing home surveys. The new changes require states to complete 100 percent of their Focused Infection Control nursing home surveys by July 31, 2020 ...

Haynes and Boone, LLP | September 2011

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) have responded to the U.S. Senate’s request for information on physician-owned distributorships (PODs). Earlier this summer, a bi-partisan U.S. Senate committee asked CMS and the OIG to study the proliferation of PODs, citing a lack of regulatory guidance on how these arrangements square with existing federal law ...

Haynes and Boone, LLP | November 2015

CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...

Waller | March 2020

On March 30th, the Centers for Medicare and Medicaid Services (CMS) announced a number of regulatory reforms aimed at giving healthcare providers more tools to combat COVID-19 ...

Waller | March 2020

On March 30th, the Centers for Medicare and Medicaid Services (CMS) announced a number of regulatory reforms aimed at giving healthcare providers more tools to combat COVID-19 ...

ENSafrica | August 2017

The window period for South African residents to regularise their unauthorised foreign assets under the Special Voluntary Disclosure Programme (“SVDP”) closes on 31 August 2017. The current SVDP is the latest in a series of such opportunities offered by the Financial Surveillance Department of the South African Reserve Bank (“SARB”), beginning with the 2003 exchange control amnesty ...

On March 3, 2022, President Biden signed the long-titled Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021. Seen as a result of the #MeToo movement, this fairly simple amendment to Title 9 of the United States Code prohibits private employers from mandating that employees submit to arbitration of sexual assault and sexual harassment claims ...

PLMJ | April 2021

Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...

This is a briefing on the issuances as of July 22, 2020 on the following matters in relation to the COVID-19 pandemic: A. Intellectual Property Office (IPOPHL) Suspends Services at its Main Office from July 20 to 27, and Extends Deadlines B. BIR Amends Reportorial Requirements of Banks and Other Lenders that Granted a Grace Period on Loans that were due during the Enhanced Community Quarantine C. New Bureau of Internal Revenue (BIR) Form for Related Party Transactions   A ...

If you are a U.S. business with international operations, here are four questions you should consider: Does your company have more than two foreign subsidiaries, at least one of which is profitable? Do you have a profitable foreign subsidiary that guarantees any U.S. debt? Are you considering the purchase of a company located outside the U.S.? Does your U.S ...

The Department of Defense (DoD) and the Civilian Agency Acquisition Council (CAAC) have both issued new Class Deviations from the FARs that implement Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors (i.e., the federal contractor vaccine mandate) ...

Lavery Lawyers | March 2024

Quebec is a fertile ground for class actions, with over 550 active cases and between 50 to 100 applications for authorization filed each year. While 2023 marked the fifth anniversary of the ?new? class action division: what is there to watch in 2024? Read on to find out. Opioids and the State: Sanis Health v ...

Lavery Lawyers | November 2023

On November 2, 2023, in response to certain controversy, the Canada Revenue Agency (?CRA?) sought to clarify the application of the new disclosure rules, in force since June 22, 2023. The CRA?s comments relate, in particular, to the impact of reporting obligations on severance agreements, a topic we initially covered a few weeks ago1. We believe it is appropriate to go over these clarifications ...

ALTIUS/Tiberghien | June 2023

On 16 March 2023, in Joined Cases C‑438/21P to C‑440/21P, the Court of Justice of the European Union (CJEU) interpreted the concept of a ‘global marketing authorisation’. It held that Article 6(1) of Directive 2001/83 (the Community Code) sets out exhaustively the line extensions for which the marketing authorisations (MAs) will fall under the same global MA as the initial MA ...

Arendt & Medernach | February 2019

In this context, the judgements provide useful guidance on the concepts of abuse and beneficial ownership. Abuse concept According to the CJEU, it is settled case-law that there is, in EU law, a general legal principle that EU law cannot be relied on for abusive or fraudulent ends ...

Carey | June 2020

On May 25, 2020, the Chilean IRS issued instructions on the temporary decrease to 0% of the Stamp Tax rate accrued between April 1 and September 30, 2020 (the "0% Rate Term"). In general terms, the Circular establishes the following: Although this is a transitory decrease, it benefits extensions and renewals made during the 0% Rate Term, which are linked to documents originally granted and taxed. This represents a change of criteria by the Chilean IRS ...

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