Practice Areas & Industries: Duane Morris LLP


mHealth, Telemedicine and Health Information Technology Return to Practice Areas & Industries

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Practice/Industry Group Overview

Duane Morris healthcare clients continue to witness the increasing influence and complexity of information technology in the delivery of healthcare. The delivery of health care wirelessly impacts reimbursement, privacy, practice of medicine and regulatory legal issues among others. The use of application software (apps) on a portable phone or tablet or web-based software accessed through a traditional medical device fall under the new area of "mobile health" (mHealth). Other terms that are used to describe this new phenomenon include "telemedicine" and "health information technology" (HIT). Virtually any entity or individual who participates in the healthcare system is affected—healthcare providers such as hospitals, physicians, and nursing homes; health plans and payors including Medicare and Medicaid; provider and plan vendors such as entities that perform patient data analysis, support the development of health information exchanges/organizations (HIEs or HIOs) or provide data storage. Entrepreneurs and investors are leading the way in the development of these products and services.

To address this emerging area, Duane Morris has developed a multidisciplinary client team whose members are experienced in addressing the legal issues that clients must consider in developing, funding or deploying a product or service that could be considered mHealth or telemedicine, or relies on HIT. These legal issues include:

  • government and private payor reimbursement;
  • privacy and security requirements, including breach responses, under the Health Insurance Portability and Accountability Act (HIPAA) and state laws;
  • Food and Drug Administration (FDA) reviews for devices;
  • intellectual property (IP) issues;
  • practice of medicine concerns;
  • corporate formation, operation and governance;
  • fraud and abuse issues;
  • Federal Communication Commission (FCC) oversight; and
  • other issues.

Our attorneys are keeping pace with the key issues that drive further convergence of healthcare and technology. The firm's mHealth Newsletter discusses recent advances and report on new developments in this rapidly evolving sector of the healthcare industry.

Articles Authored by Lawyers at this office:

CMS Updates 5 Star Ratings System for Nursing Homes with New Measures
Ari J. Markenson, April 07, 2015
As of February 20, 2015, the Centers for Medicare & Medicaid Services (CMS) has revised its 5 Star Rating System for nursing homes. The changes to the system involve adding two new nursing home quality measures for antipsychotic use into the Quality Measure Rating, Increasing the number of...

Lawyer in Vietnam Oliver Massmann Pharmaceutical Market
Oliver Massmann, March 30, 2015
Vietnam’s healthcare system is currently in general on the move due to the economic growth and the rapid development.

OIG - Medicare Hospices Have Financial Incentives to Provide Care in Assisted Living Facilities
Ari J. Markenson, March 30, 2015
On January 14, 2015, the U.S. DHHS Inspector General’s Office (the “OIG”) released a report (OEI-02-14-00070) entitled “Medicare Hospices Have Financial Incentives to Provide Care in Assisted Living Facilities.”

CMS Advises That Payment Codes on Home Health Claims Will Be Matched Against OASIS
Ari J. Markenson, March 25, 2015
CMS recently issued Transmittal SE1504 entitled “Payment Codes on Home Health Claims Will Be Matched Against Patient Assessments”.

Civil RICO Actions on the Rise to Combat Healthcare Insurance Fraud
James J. Ferrelli, March 25, 2015
Over the past several years, insurance carriers have aggressively pursued civil suits against doctors and other medical providers in an effort to fight healthcare insurance fraud. Besides theories of liability based upon common law claims such as fraud and unjust enrichment, insurers have more...

Consultants’ Communications Privileged from Discovery
Philip H. Lebowitz, March 25, 2015
In healthcare, companies often hire consultants to review billing and coding, privacy and security and a host of other technical issues that regular staff does not have the time or expertise to pursue. A recent discovery ruling in federal court in the Eastern District of Pennsylvania holds that...

HHS Moves to Limit In-Office Ancillary Services Exception
Matthew C. Jones, March 19, 2015
The Department of Health and Human Services (“HHS”) is once again targeting the In-Office Ancillary Services Exception (“IOASE”) to the federal Stark Law, in an attempt to produce cost savings in the U.S. healthcare system. The IOASE provides a limited exception to the Stark...

Health System Integration and Antitrust Laws on Collision Course
Philip H. Lebowitz, March 18, 2015
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...

New Jersey State Bar Committee to Review RPC 1.2(d) and Issues Pertaining to Medical Marijuana
James J. Ferrelli, March 18, 2015
The New Jersey State Bar Association (“NJSBA”) has established an ad hoc committee to review the ethical issues raised under New Jersey Rule of Professional Conduct 1.2(d) (which prohibits a lawyer from counseling or assisting a client in conduct that the lawyer knows is illegal or...

Virtual Credit Card Payments
Patricia S. Hofstra, March 18, 2015
On January 30, 2015, several healthcare organizations sent a group letter to CMS protesting the use of virtual credit cards by health plans to pay providers. In a virtual credit card payment (a nonstandard type of electronic funds transfer EFT), a health plan or its payment vendor issues single-use...

ACOs are More Important Than Ever for LTC Facilities
Amy E. McCracken, March 13, 2015
On January 26, 2015, the United States Department of Health & Human Services (HHS) announced its timeline for shifting Medicare reimbursements from volume-based criteria to value-based criteria. HHS has adopted a framework that categorizes health care payments according to how providers receive...

Antipsychotic Drug Use Can Lower Nursing Home's Five-Star Rating
Amy E. McCracken, March 13, 2015
The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to reduce the national prevalence of antipsychotic drug use in long-stay nursing home residents. Its initial goal of a 15.1% reduction in antipsychotic drug use was met, so CMS now seeks to reduce antipsychotic drugs...

Fees and Costs Awarded to False Claims Act Defendant
Seth A. Goldberg, March 13, 2015
A recent decision in the U.S. District Court for the Southern District of New York provides fair warning to qui tam relators who assert erroneous claims under the False Claims Act ("FCA") that they could be hit with legal fees and expenses pursuant to 31 U.S.C. § 3730, which permits...

Health Care Workers May Think Twice Before Becoming a Relator
Amy E. McCracken, March 13, 2015
The Federal False Claims Act (and many similar state false claims acts) allow an individual-called a "relator"-to file a lawsuit on behalf of the United States Government. If successful, the relator stands to collect a portion of the amount collected. Since the False Claims Act provides...

Mayo Lawsuit Against Former Exec Raises Numerous Health Care and Business Litigation Issues
Elinor H. Murarova, March 13, 2015
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...

New CMS Payment Policy Will Negatively impact Healthcare Investors
C. Mitchell Goldman, March 13, 2015
I have been concerned about the difficulty of projecting revenue and determining valuations for new and existing healthcare companies based on risk based reimbursement models. My fears have not been allayed. Rather, they have been confirmed.

Real Estate Tax Exemption Issue Muddied Again
Philip H. Lebowitz, March 13, 2015
On December 23, 2014, the Commonwealth Court of Pennsylvania logged another frustrating mile down the confused and confusing road of property tax exemption for purely public charities. In Fayette Resources, Inc. v. Fayette County Board of Assessment Appeals, the Court overturned a lower court...

Top Three Problems with Text Messaging in Health Care Settings
Amy E. McCracken, March 13, 2015
1. Since most text messaging is not a secure form of communication, it raises HIPAA concerns if any protected health information is included in the text message. There is the possibility of a data breach in the transmission of the text message, as well as in the event of a lost or stolen phone.

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
, February 26, 2015
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

7th Circuit Clarifies FCA Fraud Standard
Philip H. Lebowitz, January 23, 2015
In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy. The principal claims in the case, nadyor v. Ukrainian Village Pharmacy,...

CMS Bringing Star Ratings to Home Health
Ari J. Markenson, January 23, 2015
The Centers for Medicare and Medicaid Services (“CMS”) issued a fact sheet on December 11th, 2014, discussing its intention to issue star ratings for Medicare certified home health agencies. The star ratings would be live in 2015.

Clinical Trial Sponsors Can Be Liable For Inadequate Consent Forms
Philip H. Lebowitz, January 23, 2015
Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal...

The IMPACT ACT of 2014 - New Enforcement and Oversight for Hospice Providers
Ari J. Markenson, January 23, 2015
The IMPACT Act of 2014 (“IMPACT”) was signed into law on October 6, 2014. It includes two significant enforcement and oversight changes for Medicare hospice providers among other post-acute care policy changes.

OIG 2015 Work Plan - Hospice
Ari J. Markenson, January 22, 2015
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

OIG 2015 Work Plan - Home Health
Ari J. Markenson, January 02, 2015
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

Responding to Subpoena for Medical Records May Create Liability for Healthcare Providers Under State Law Negligence Claims
Seth A. Goldberg,Philip H. Lebowitz, December 10, 2014
Healthcare providers receiving a subpoena for patient medical records may want to think twice before complying with the subpoena and producing the records. A recent Connecticut case, Byrne v. Avery Center for Obstetrics and Gynecology, P.C. ("Byrne"), arose when the defendant gynecology...

CMS Extends Period of Exemption for Hospices Affected by Nursing Shortage
Ari J. Markenson, November 17, 2014
On October 3, 2014, CMS issued S&C: 12-43-Hospice entitled “Impact of Nursing Shortage on Hospice Care”.

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA
Carolyn A. Alenci,Frederick R. Ball, November 17, 2014
The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE) exclusivity.

OIG 2015 Work Plan - Skilled Nursing Facilities
Ari J. Markenson, November 17, 2014
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...