Duane Morris Health Law

April 26, 2023April 26, 2023 by Duane Morris

CMS Rules for Coding Emergency Department Claims

By Gregory A. Brodek and Arti Fotedar

The Centers for Medicare and Medicaid Services (CMS) has consistently authorized hospitals to establish and utilize their own coding guidelines for emergency department facility claims. CMS makes clear that “[a]s long as the services furnished are documented and medically necessary and the facility is following its own system, which reasonably relates the intensity of hospital resources to the different levels of HCPCS codes, we will assume that it is in compliance with these reporting requirements as they relate to the clinic/ emergency department visit code reported on the bill.” 65 Fed. Reg. 18433, 18451 (Apr. 7, 2000). CMS also makes clear that “[t]he coding guidelines should be applied consistently across patients in the clinic or emergency department to which they apply” and should be verifiable by hospital staff and outside sources. 72 Fed. Reg. 66759, 66805 (Nov. 27, 2007). Continue reading “CMS Rules for Coding Emergency Department Claims”

February 8, 2023 by Duane Morris

FTC Wields Health Breach Notification Rule for First Time in Quest to Protect Consumer Health Information

By Samantha Dalmass and Melissa Sobel Snyder

The Federal Trade Commission (“FTC”) is seeking enforcement under the Health Breach Notification Rule for the first time since the rule was adopted in 2009. The Health Breach Notification Rule (16 C.F.R. Part 318) requires vendors of personal health records, PHR-related entities, and third party service providers that are not otherwise subject to the Health Insurance Portability and Accountability Act (“HIPAA”) to notify their customers and individuals whose personal health records are disclosed in the event of a breach or unauthorized disclosure. In its complaint filed against GoodRx on January 1, 2023, the FTC targets the digital health platform, alleging that it repeatedly violated the promises it has made to its customers regarding its protection of their personal health information, including that such information would be shared only with limited third parties and for limited purposes; that GoodRx would restrict such third parties’ use of customer information; and that it would never share personal health information with advertisers or other third parties. Continue reading “FTC Wields Health Breach Notification Rule for First Time in Quest to Protect Consumer Health Information”

January 18, 2023 by Duane Morris

340B Hospital Reimbursement Update: D.C. District Court Remands Underpayment Remedy to HHS

On Tuesday, January 10, 2023, the United States District Court for the District of Columbia issued an important ruling allowing the U.S. Department of Health and Human Services (HHS) to propose an appropriate retrospective remedy for underpayments made from 2018 through September 27, 2022, to hospitals participating in the 340B drug pricing program.

To read the full text of this Duane Morris Alert, please visit the firm website.

January 13, 2022 by Duane Morris

Revised Code of Pharmaceutical Research and Manufacturers of America Takes Effect

On January 1, 2022, the updated Code on Interactions with Health Care Professionals, published by the Pharmaceutical Research and Manufacturers of America (PhRMA), became effective. The updates reflect fraud and abuse concerns voiced by the Department of Health and Human Services’ Office of Inspector General in its November 2020 Special Fraud Alert. While it is not a legal document, companies that adopt the code’s rules are more likely to comply with federal fraud and abuse laws like the Anti-Kickback Statute.

To read the full text of this Duane Morris Alert, please visit the firm website.

December 2, 2021December 2, 2021 by Duane Morris

CMS Mandate Blocked Nationwide

By Erin M. Duffy and Samantha Dalmass

A federal judge in New Orleans blocked the Interim Final Rule with Comment requiring the vaccination of all staff of health care facilities subject to the health and safety standards under the Medicare Conditions of Participation (“CoPs”) issued by the Centers for Medicare and Medicaid Services (“CMS”) earlier this month. The nationwide block was issued on November 30, 2021, less than one week before the December 6, 2021 deadline for all staff of covered facilities to have received at least their first dose of a two-dose COVID-19 vaccine series, and only one day after a federal court in Missouri blocked the CMS vaccination requirement in Missouri, Arkansas, Alaska, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.

Notwithstanding the broad authority of CMS to regulate the health and safety of facilities subject to Medicare CoPs, the order issued by the U.S. District Court for the Western District of Louisiana blocking implementation of the CMS mandate set forth in 86 Fed. Reg. 61555-01 (November 5, 2021) will remain in effect pending final resolution of the case. The Biden Administration will likely appeal to the Supreme Court, but in the meantime facilities covered by the mandate should plan accordingly and ensure they are prepared to implement the required plans and processes for vaccinating staff, providing exemptions and accommodations for those who are exempt, and tracking and documenting staff vaccinations.

July 7, 2021July 7, 2021 by Duane Morris

New Reporting Requirements for Philadelphia Health Care Facilities

By Erin M. Duffy and Samantha Dalmass

On June 9, 2021 Mayor Jim Kenney signed municipal legislation amending the Philadelphia Health Code to add a section establishing reporting and employment requirements related to changes in ownership or of the license holder of long-term care facilities and hospitals. Proposed in April by the Committee on Public Health and Human Services, Bill No. 210331 (the “Ordinance”) was passed by the Philadelphia City Council on May 27, 2021. The Ordinance imposes certain notification requirements for hospitals and long-term care facilities pursuant to a 5% or more change in ownership of the owner or operator of such institutions. The City of Philadelphia Ordinance requires hospitals and long-term care facilities to provide notices to the City of Philadelphia, as well as to facility employees prior to the effective date of a sale or other change in ownership interest. The ordinance also requires that certain documentary evidence of the transaction be posted the institution’s website. Following the initial posting of such notices, there are ongoing requirements for the owner or operator of a facility to update the information made available to its employees and the public on a weekly basis as well as additional notice requirements upon the effective date of the change. Continue reading “New Reporting Requirements for Philadelphia Health Care Facilities”

June 16, 2021 by Duane Morris

Emergency Temporary Standard Issued for the Healthcare Industry by OSHA

On June 10, 2021, the U.S. Department of Labor’s Occupational Safety and Health Administration submitted for publication in the Federal Register its COVID-19 Emergency Temporary Standard (ETS), setting forth new mandatory safety requirements designed to protect workers from COVID-19. The much-anticipated ETS is generally applicable only to certain healthcare workplaces and imposes differing obligations with respect to vaccinated and unvaccinated employees in various contexts.

To read the full text of this Duane Morris Alert, please visit the firm website.

April 27, 2021 by Duane Morris

New National Standard for Barrier Face Coverings Approved by ASTM International

On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. Manufacturers should take full advantage of this new guidance as it implements a universal standard for the evaluation of barrier face coverings utilized by a majority of Americans every day.

To read the full text of this Duane Morris Alert, please visit the firm website.

April 22, 2021 by Duane Morris

Tale of Two Cases: Nursing Home COVID Immunity Battle Playing out in Court

A recent case decided Feb. 10 has the nursing home industry and plaintiﬀ malpractice attorneys clamoring over whether certain measures taken by nursing homes during the pandemic should be immune from plaintiﬀ negligence lawsuits against nursing homes.

To read the full text of this article by Duane Morris partner Neville M. Bilimoria, which was originally published in Chicago Lawyer, please visit the firm website.

April 8, 2021April 8, 2021 by Duane Morris

H.B. 3360 and S.B. 72: Assessing Prejudgment Interest to Personal Injury and Wrongful Death Verdicts in Illinois

By Nicholas J. Lynn

On March 25, 2021, Illinois Governor J. B. Pritzker vetoed a bill that would assess prejudgment interest to personal injury and wrongful death verdicts. The bill originally was reported as House Bill 3360 (“H.B. 3360”) and more recently passed the Legislature as a compromised plan, S.B. 72, which reduced the prejudgment rate from 9% to 6 %, allowing plaintiffs with personal injury or wrongful death verdicts to recover the interest on all damages except punitive damages, sanctions, statutory attorneys’ fees, and statutory costs. On January 13, 2021, H.B. 3360 passed the Democrat-controlled chambers of the General Assembly. H.B. 3360 provided 9% prejudgment interest to personal injury and wrongful death verdicts to be calculated annually from the time the defendant was placed on notice of the injury to the date of judgement. Illinois remains one of just four States not to have some form of prejudgment interest available for trial-winning plaintiffs.