Health Law – Page 10 – Duane Morris Health Law

June 27, 2016September 12, 2018 by Duane Morris

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.

March 29, 2016March 30, 2016 by Duane Morris

Hackers Unleash “Ransom” Attack on Health System, Forcing It to Shut Down Computer Systems

By Duane Morris partner Lisa W. Clark

On March 28 MedStar Health, the largest health system in the Washington, D.C. area, shut down its computer systems, including its electronic health records, on account of an apparent “ransom” attack in which the hackers infected its system with a virus. From media reports, it appears that the hackers demanded an unknown sum to stop the malware attack. The FBI is already involved. This incident, following February’s successful ransom attack on Hollywood Presbyterian Medical Center, reinforces the need for strong data security protection as well, as an incident response plan that includes law enforcement.

February 17, 2016 by Neville M. Bilimoria

ACOs Waking Up to the Value of Post-Acute Care Providers

Recently, the American Hospital Association published in its newletter Trendwatch a detailed 16 page article entitled “The Role of Post-Acute Care in New Care Delivery Models,” December 2015. The article discusses what we have been trying to tell our post-acute care, especially nursing home clients, for years: become a valued partner of an Accountable Care Organization (“ACO”) and be ready to show your value to those ACOs, or continue to operate as you historically have at your own peril.

When ACOs first started, there was virtually no room or focus on long-term care providers being involved in an ACO. Some hospitals talked initially about home health care, but very little discussion was geared towards long-term care providers being in an ACO network because hospitals did not understand the long-term care environment. Continue reading “ACOs Waking Up to the Value of Post-Acute Care Providers”

February 15, 2016February 15, 2016 by Gregory A. Brodek

TRICARE HPSA Bonus Payments

Many providers are unaware that they may be entitled to bonus payments of 10% when providing services to TRICARE beneficiaries. The process for determining eligibility is not simple, but the possible upside of eligibility is significant.

Continue reading “TRICARE HPSA Bonus Payments”

February 5, 2016February 5, 2016 by Duane Morris

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.

January 27, 2016January 27, 2016 by Duane Morris

Duane Morris’ Michael E. Clark Named a Recipient of the Corporate LiveWire Global Award 2016 in Healthcare Law – Texas

Duane Morris is pleased to announce that special counsel Michael E. Clark in the firm’s Houston office has been named a recipient of the Corporate LiveWire Global Award 2016 in Healthcare Law – Texas. The 2016 Corporate LiveWire Global Awards showcase the achievements of the most successful and ground-breaking individuals and companies of the last 12 months. As they have achieved something special in the fast-moving corporate finance arena, these recipients were selected due to their outstanding performances this past year.

December 9, 2015 by Amy E. McCracken

Supreme Court to Consider Implied Certification theory of FCA

The Supreme Court has agreed to hear a case involving the implied certification theory under the False Claims Act. Implied false certification occurs when an entity has previously undertaken to expressly comply with a law, rule, or regulation, and that obligation is implicated by submitting a claim for payment even though a certification of compliance is not required in the process of submitting the claim. Many relators have tried to use this theory to turn a regulatory violation into a false claim–with its concomitant treble damages and statutory damages.

There has long been a split in the circuits regarding the viability of the implied certification theory. As recently as June 2015, the Seventh Circuit rejected the theory, stating that the “FCA is simply not the proper mechanism for government to enforce violations of conditions of participation contained in—or incorporated by reference into—a PPA [Program Participation Agreement].” Rejection of this theory recognizes that there administrative procedures designed to address regulatory violations.

In contrast, the Ninth Circuit has embraced the implied certification theory, stating “”[i]t is the false certification of compliance which creates liability when certification is a prerequisite to obtaining a government benefit.” The problem in the health care arena is that facilities promise to comply with a myriad of regulations when entering into PPAs, and certify compliance when submitting bills. Thus, under this theory, every single regulatory violation can turn into a false claim.

The health care industry will be closely watching the Supreme Court’s ruling on this important issue.

December 3, 2015December 3, 2015 by Amy E. McCracken

CMS released its Focused Dementia Care Surveyor Worksheets

The Centers for Medicare and Medicaid Services (CMS) released its Focused Dementia Care Surveyor Worksheets on November 27, 2015. The Worksheets were developed for a pilot project in 2014 as part of CMS’ continuing effort to reduce the use of antipsychotic medication. The Worksheets are to be used by surveyors in reviewing dementia care at post-acute care facilities. The Worksheets were released so that facilities can use these tools to assess their own practices in providing resident care.

The Worksheets contain specific topics for review, and state that failure of the facility to perform certain practices will result in a deficiency of F309. F309 addresses quality of care, and requires that each resident receive (and the facility provide) the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

Facilities that serve individuals with dementia should have policies and procedures based upon nationally-recognized dementia care guidelines, such as CMS’ Hand in Hand series, the OASIS program, the University of Iowa program, the VA Program (STAR), Johns Hopkins’ DICE program, Alzheimer’s Association materials, NHQCC or other QIO guidelines, Advancing Excellence medication management tools, or the AHCA toolkit.

The Worksheets also evaluate supervision, staff training, and Quality Assessment and Assurance, as well as the care provided to specific residents. All facilities that serve individuals with dementia should obtain and use the Worksheets to evaluate their own practices.

December 2, 2015 by Amy E. McCracken

Final AKS and Stark Waivers in Connection With the Shared Savings Program

The Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) issued the final rule regarding waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the “Shared Savings Program”). For purposes of the Shared Savings Program, providers must integrate in ways that potentially implicate fraud and abuse laws addressing financial arrangements between sources of Federal health care program referrals and those seeking such referrals. The Shared Savings Program focuses on coordinating care between and among providers, including those who are potential referral sources for one another—potentially in violation of the fraud and abuse laws.

In order to provide flexibility for ACOs and their constituent parts, the following five waivers have been created:

ACO pre-participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to ACO-related start-up arrangements in anticipation of participating in the Shared Savings Program, subject to certain limitations, including limits on the duration of the waiver and the types of parties covered.
ACO participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies broadly to ACO-related arrangements during the term of the ACO’s participation agreement under the Shared Savings Program and for a specified time thereafter.
Shared savings distributions waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to distributions and uses of shared savings payments earned under the Shared Savings Program.
Compliance with the physician self-referral law waiver – waives the Federal anti-kickback statute for ACO arrangements that implicate the physician self-referral law and satisfy the requirements of an existing exception.
Patient incentive waiver – waives the Beneficiary Inducements CMP and the Federal anti-kickback statute for medically related incentives offered by ACOs, ACO participants, or ACO providers/suppliers under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes.

The waivers apply uniformly to each ACO, ACO participant, and ACO provider/supplier participating in the Shared Savings Program. The waivers are self-implementing; parties need not apply for a waiver. Rather, parties that meet the applicable waiver conditions are covered by the waiver.

December 2, 2015 by Susan V. Kayser

OIG Issues Annual Work Plan/Long-Term Care Provider Initiatives Included

The HHS Office of Inspector General (OIG) has published its annual Work Plan for Fiscal Year 2016. The Work Plan summarizes new and ongoing reviews and activities that OIG plans to pursue with respect to federal health care programs, including Medicare and Medicaid, during the current fiscal year and beyond. Work Plan agenda items for Nursing Homes, Home Health and Hospice are summarized below. Continue reading “OIG Issues Annual Work Plan/Long-Term Care Provider Initiatives Included”