On December 10, 2020, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) to modify the HIPAA Privacy Rule. HHS stated that the proposed modifications, which are being issued as part of HHS’s “Regulatory Sprint to Coordinated Care,” are aimed at removing barriers to coordinated care, strengthening individuals’ access to their own medical information, and reducing unnecessary administrative burdens. Proposed changes to the HIPAA Privacy Rule in the NPRM include: Continue reading “HHS Issues Proposed Changes to the HIPAA Privacy Rule”
Office of Inspector General Issues Special Fraud Alert on Speaker Programs
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert addressing speaker programs presented by pharmaceutical and medical device companies. Such programs, at which companies may pay physicians or other health care professionals (HCPs) for speeches or presentations about drugs and devices in addition to providing remuneration to attendees, are frequently sponsored by pharmaceutical and device companies seeking to provide education regarding their products. Highlighting what it called “inherent fraud and abuse risks,” OIG’s Special Fraud Alert expressed concerns surrounding the offer or payment of remuneration from pharmaceutical and device companies to physicians or other HCPs associated with such programs.
To read the full text of this Duane Morris Alert, please visit the firm website.
SCOTUS Strikes Down Texas Statute in Whole Woman’s Health v. Hellerstedt
In a 5-3 decision today, the Supreme Court of the United States in Whole Woman’s Health v. Hellerstedt, No. 15-275, slip op. (June 27, 2016) reversed a decision of the Fifth Circuit and overturned as unconstitutional a Texas law that (1) required abortion providers to have “active admitting privileges” at a hospital within 30 miles of the location at which they provide abortions and (2) required abortion facilities to meet standards adopted for ambulatory surgery centers. The Court wrote that each of the requirements “places a substantial obstacle in the path of women seeking a previability abortion, each constitutes an undue burden on abortion access, and each violates the Federal Constitution.” A team of Duane Morris attorneys, including Philip H. Lebowitz, Erin M. Duffy, Katharyn I. Christian McGee, Alison Taylor Rosenblum, and Erica Fruiterman, filed an amicus curiae brief on behalf of medical staff professionals in support of petitioners Whole Woman’s Health et al. In its decision, the Supreme Court cited Duane Morris’ amicus brief, noting, “Other amicus briefs filed here set forth without dispute other common prerequisites to obtaining admitting privileges that have nothing to do with ability to perform medical procedures.” The brief was one of only a handful of amici curiae briefs cited in the decision out of a total of 41 such briefs filed on behalf of petitioners.
Duane Morris Partner Patricia S. Hofstra to Speak on “Retail Clinics in Healthcare: Overcoming Complex Legal Challenges”
Duane Morris partner Patricia S. Hofstra will be speaking at the Strafford Live Webinar on “Retail Clinics in Healthcare: Overcoming Complex Legal Challenges” to be held on Thursday, March 10, 2016 from 1:00 p.m. to 2:30 p.m. (Eastern time). The webinar will address “Complying with Corporate Practice of Medicine, Licensure, and Scope of Practice Laws; Navigating Emerging Relationships with Physicians, Hospitals and Payers.”
For more information, please see the event page on the Duane Morris website.
SCOTUS Limits Claims Brought by Healthcare Providers’ for Denied Medicaid Reimbursement
In a recent 5-4 decision by the U.S. Supreme Court, Armstrong v. Exceptional Child Center, Inc., Slip. Op., 575 U.S. ____ (March 31, 2015), Justice Scalia, writing for the majority, took aim at health care providers seeking to enforce Medicaid rate-setting provisions against a state that refused to incorporate those provisions in the state’s Medicaid plan, and instead reimbursed providers for Medicaid services at lower rates.
In Armstrong, the plaintiffs, providers of habilitation services under Idaho’s Medicaid plan sought an injunction to prevent Idaho’s State Department of Health from violating Section 30(A) of Medicaid, 42 U.S.C. § 1396(a)(30)(A), which requires a state to “assure that payments are consistent with efficiency, economy, and quality of care,” while “safeguard[ing] against unnecessary utilization of. . . care and services.” The Court reversed the Ninth Circuit’s decision that the Supremacy Clause gave the providers an implied right of action to seek an injunction requiring Idaho to comply with Section 30(a). Continue reading “SCOTUS Limits Claims Brought by Healthcare Providers’ for Denied Medicaid Reimbursement”
Health System Integration and Antitrust Laws on Collision Course
Health systems attempting to fulfill the mandate of integrating hospitals and physicians may find themselves accused of going too far. Although the Affordable Care Act, shared savings, gainsharing and other alternative payment methodologies have made integration of physicians, hospitals and other providers an operational goal, success in reaching that goal may be challenged by private antitrust actions.
In a recent Florida federal court decision, the antitrust complaint of “several of Southern Brevard County’s physicians and physicians practice groups” was held to have stated a monopolization claim against Health First, Inc. and three of its wholly-owned subsidiaries — an insurer, a hospital and a physician practice group. Essentially, by fully integrating its business, and incentivizing in-network referrals and managed care pricing, Health First became vulnerable to claims of tying, exclusive dealing, price discrimination and monopolization.
Continue reading “Health System Integration and Antitrust Laws on Collision Course”
Mayo Lawsuit Against Former Exec Raises Numerous Health Care and Business Litigation Issues
A recent settlement between Mayo Collaborative Services d/b/a Mayo Medical Laboratories (“MML”) and Mayo Clinic (together with MML, “Mayo”) and a former Mayo executive, Dr. Franklin Cockerill, reveals the potential legal issues that may arise when health care executives seek new employment and the high stakes litigation that may ensue-regardless of which party may or may not be at fault.
As set forth in Mayo’s complaint, Dr. Cockerill was a former senior officer and director of MML and Chair of the Mayo Clinic Department of Laboratory Medicine and Pathology, where he managed several thousand medical professionals handling laboratory testing and intellectual property development for Mayo and MML. According to Mayo’s complaint, as a result of Dr. Cockerill’s various positions he had first-hand knowledge of confidential strategic, business, marketing, sales, pricing, and data management information from MML and Mayo. Eventually, Dr. Cockerill retired and obtained employment with a Mayo competitor.
Proposed Physician Payment Disclosure Rule Published
The Centers for Medicare and Medicaid Services (“CMS”) released its proposed rule regarding the required reporting of device, biologics and pharmaceutical manufacturer payments to physicians on December 14, 2011. The proposed rule includes templates for physicians and manufacturers to use when logging payments and gifts.
Continue reading “Proposed Physician Payment Disclosure Rule Published”
On-Call Issues Persist
I have been asked to speak at the Orthopaedic Trauma Association’s 2011 meeting in San Antonio on October 15. The Association recently polled its members asking them to identify a topic for the plenary session and orthopaedic on-call compensation emerged as a common concern. In preparing for the presentation, I came across the OTA On-Call Position Statement posed on OTA’s web site.
Expansion of CMS Never Events: They’re Not Just For Medicare Or Just For Hospitals Anymore
Expansion of CMS Never Events: They’re Not Just For Medicare Or Just For Hospitals Anymore
In 2005 when “Never Events” were proposed for hospitals through the Deficit Reduction Act, no one knew what the overall effect would be on hospitals or patient care. CMS later developed these and implemented these Never Events under the authority of the DRA to prevent Medicare payment to hospitals for certain “never events” or hospital acquired conditions (HACs) which were conditions that were high volume, involved higher payment, and which could be easily preventable. Now, hospitals and other health care providers have to worry about Never Events in the Medicaid space.