Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

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Health Industry Washington Watch

CMS finalizes rule to expand and modify Comprehensive Care for Joint Replacement Model

By David Hartmann

May 5, 2021

On May 3, 2021, the Centers for Medicare & Medicaid Services (CMS) published an 81-page final rule to both extend and change the Comprehensive Care for Joint Replacement (CJR) model. We previously reported on the proposed rule here. The CJR model was initially implemented by way of notice-and-comment rulemaking in April 2016; the recent final rule will extend the CJR model by an additional three years through December 31, 2024. Purpose of CMS’s CJR…

Health Industry Washington Watch

CMS acknowledges improvement in nursing home COVID-19 response, eliminates certain blanket waivers

By James F. Hennessy, Kelly Kearney & Sonia Nguyen

April 29, 2021

The 2019 Novel Coronavirus pandemic (“COVID-19”) introduced several unfamiliar hardships adversely impacting the long-term care industry, especially for nursing homes. Acknowledging these hardships, the Centers for Medicare & Medicaid Services (“CMS”) enacted several temporary emergency blanket waivers effective March 1, 2020, lending flexibility to nursing homes in their COVID-19 response efforts. Since that time, according to CMS, many nursing homes have adapted by developing new COVID-19 related policies and practices that CMS believes: (a) mitigate…

Health Industry Washington Watch

Recent budget reforms to impact New York’s nursing homes

By Alfred Kyle & Joseph M. Marger

April 23, 2021

On April 19th, 2021 Governor Andrew Cuomo (D) signed the state’s Budget for Health and Mental Hygiene (A3007C/S2507C), which includes several significant changes impacting the state’s nursing home operators and investors. Most notably, the legislation’s principal provisions require reinvestment of revenue into each nursing home facility and a cap on the profit the facility can make calculated on an annual basis. More specifically, every residential health care facility is required to spend a minimum of…

Health Industry Washington Watch

Plausibility Pleading in the Digital Age: Federal appellate courts take fresh look at Rule 8 in FCA context

By Ryan Pate

April 9, 2021

In recent years, the U.S. Department of Justice (“DOJ”) has increasingly leveraged data analytics to combat fraud. Principal Deputy Chief of DOJ’s Fraud Section, Joe Beemsterboer, described the department’s data-mining capabilities as the “foundation of how [DOJ] investigate[s] and analyze[s] cases,” and explained that digital forensics equips the department with “powerful” tools for identifying “trends,” “spikes” and “outliers.” Just over a year later, in December 2020, Michael Granston, Deputy Assistant Attorney General of DOJ’s Civil…

Health Industry Washington Watch

Florida joins the ranks of states offering protections to businesses and health care providers from COVID-19 related lawsuits

By Jessica Christensen

April 5, 2021

During a press conference on Monday, March 29, 2021, Florida Governor Ron DeSantis signed Senate Bill 72, which grants civil immunity to corporations, hospitals, nursing homes, government entities, schools, and churches from COVID-19-related lawsuits, except in cases of gross negligence or intentional misconduct. Plaintiffs who file suit in Florida alleging coronavirus-related injuries will face robust legal hurdles. These plaintiffs must: Provide a physician’s affidavit stating with reasonable certainty that the injury or death from…

Health Industry Washington Watch

Congress considers the future of telehealth in the wake of COVID-19

By Alexandra Hussey

March 11, 2021

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to telehealth. However, it is unclear what role telehealth will play in the Medicare program after the pandemic. On March 2,…

Health Industry Washington Watch

New IRS rulemaking impacts FCA settlement payment deductibility

By Rick Robinson & James F. Hennessy

February 25, 2021

Effective January 14, 2021, the Internal Revenue Service (“IRS”) implemented a final rule (the “Final Rule”) concerning the tax deductibility of settlement payments made to the government. This rulemaking followed a legislative update to the Internal Revenue Code of 1986 (“IRC”), which was implemented as part of the 2017 federal tax overhaul and specifically included a prohibition against deducting certain settlement payments. Relative to the IRS proposed regulations released in May 2020 (the “Proposed Rule”),…

Health Industry Washington Watch

FDA and USDA battle over regulating genetically engineered animals

By Cori Annapolen Goldberg, Sung Park, Taber Rueter & Yuxin Jin

February 23, 2021

A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing comment period, which ends on February 26, 2021. The proposed rule strips FDA’s jurisdiction over food-bearing GE livestock and places it within USDA’s purview, thereby granting USDA jurisdiction over pre-market review and post-market safety monitoring of such products. This significant change would create a less burdensome pathway for the regulatory approval…

Health Industry Washington Watch

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

By Andrew Lu

February 10, 2021

With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic (or just looking to learn more), below is a brief primer on so-called “midnight regulations.” What exactly is a “midnight…

Health Industry Washington Watch

President Biden implements policies to expand access to health care and coverage

By Lauren Bentlage

February 8, 2021

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic. In addition to this Executive Order, the White House also announced President Biden’s Presidential Memorandum on Protecting Women’s Health at Home and Abroad (the “Presidential Memorandum”). The…

Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

Blog Authors

CMS finalizes rule to expand and modify Comprehensive Care for Joint Replacement Model

CMS acknowledges improvement in nursing home COVID-19 response, eliminates certain blanket waivers

Recent budget reforms to impact New York’s nursing homes

Plausibility Pleading in the Digital Age: Federal appellate courts take fresh look at Rule 8 in FCA context

Florida joins the ranks of states offering protections to businesses and health care providers from COVID-19 related lawsuits

Congress considers the future of telehealth in the wake of COVID-19

New IRS rulemaking impacts FCA settlement payment deductibility

FDA and USDA battle over regulating genetically engineered animals

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

President Biden implements policies to expand access to health care and coverage

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