Recent News:
Chris Raphaely discusses a house-passed bill that may impact hospital decisions on mergers in Modern Healthcare.
More
Health care and life sciences is inarguably one of the largest, most heavily regulated, and fastest-growing industries in the U.S. economy. It is also utterly unique. Health care and life sciences companies do not function simply to maximize returns, and the standard economic forces of supply and demand do not apply. Ultimately, every player in this market—whether a hospital, biotechnology company, nursing home, or medical equipment manufacturer—is responsible for helping people lead longer and healthier lives.
To be effective, advocates for the health care and life sciences industry must integrate an awareness of and commitment to this underlying responsibility into every element of their work. The members of Cozen O’Connor’s health care and life sciences industry team understand this social mission as well as its legal, political, macroeconomic and business consequences for our clients. Attorneys at the firm have been providing excellent counsel to health care and life science companies for decades.
Our client base includes a diverse array of companies. In the health care sector, we serve leading pharmaceutical companies, hospitals, health care systems, medical equipment manufacturers and suppliers, assisted living facilities, academic institutions, insurers and physician groups. In the life sciences sector, we serve drug developers, biotechnology companies, medical device manufacturers and cutting-edge startups.
For health care and life sciences clients, it is essential that their attorneys have deep industry knowledge. Good commercial litigators or corporate lawyers can serve a chain of shoe stores just as capably as a chain of pizza parlors, but that does not mean they can serve a chain of hospitals. The health and life sciences field is so heavily regulated that all legal work in this arena must be grounded in a specific and sophisticated understanding of health laws. At Cozen O’Connor, we have litigators, transactional lawyers and corporate counselors who are both leaders in their legal disciplines and masters of this complex and ever-changing statutory regime.
SERVICE AREAS
Litigation
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Handle third-party payer litigation and reimbursement proceedings
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Represent clients in fraud, abuse, Stark Law and False Claims Act cases
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Conduct internal investigations and respond to enforcement acts by federal and state agencies
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Represent health care and life sciences companies in intellectual property, employment, antitrust and other commercial litigation
Transactional
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Arrange mergers, acquisitions, consolidations, divestitures, workouts and restructurings
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Negotiate joint ventures, alliances and co-management arrangements
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Resolve antitrust, tax and bankruptcy issues for health care and life sciences organizations
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Arrange financings through public offerings, bonds, loans and other investment vehicles
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Conduct major real estate deals for industry clients
Regulatory
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Advise on privacy, confidentiality, HIPAA compliance and safety laws
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Handle Medicare, Medicaid and other third-party reimbursement matters
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Develop and assess regulatory compliance programs for health care and life science clients
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Counsel clients on employee benefits, credentialing and executive compensation strategies
RELATED PRACTICES
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Health Law
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Labor & Employment
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Employee Benefits & Executive Compensation
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Antitrust
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Real Estate
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Public & Project Finance
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Intellectual Property
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Products Liability
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Cozen O’Connor Public Strategies, LLC
September 09, 2016
On September 8, 2016, CMS announced in its blog that it will allow physicians to select their level of participation for the first performance year of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) Quality Payment Program, which begins January 1, 2017. Importantly, during the... MORE
August 25, 2016
On July 29, 2016, the Federal Trade Commission (“FTC” or “Commission”) reversed an FTC administrative law judge’s (“ALJ”) opinion which had ruled against the FTC, finding that the Commission had failed to show that LabMD’s conduct caused harm to consumers to satisfy requirements under Section 5 of... MORE
August 22, 2016
On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana grower/processor permits that will become available under Pennsylvania’s Medical... MORE
July 13, 2016
In response to the increasing prevalence of ransomware cyber-attacks by hackers on electronic health information systems in hospitals and medical practices, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on Monday July 11, 2016 its publication of new HIPAA... MORE
June 16, 2016
The White House recently released a guidance document for those in the precision medicine community to help ensure that participants’ data and resources remain secure. The document, titled “Precision Medicine Initiative: Data Security Policy Principles and Framework,” is meant to offer “security... MORE
May 16, 2016
Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in the U.S. District Court for the District of Columbia. Nicopure seeks to... MORE
May 09, 2016
On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24th state (plus the District of Columbia) to legalize marijuana for medical use. The full text of the act is available here.
Physicians, not surprisingly, will play a vital role in making medical marijuana available... MORE
March 30, 2016
MedStar, a Washington, D.C.-area hospital chain, became the latest healthcare industry victim of a cyber-attack when hackers breached its systems with a crippling virus. MedStar operates 10 hospitals in the D.C./Baltimore region, employs 30,000 staff, has 6,000 affiliated physicians, and serviced... MORE
March 22, 2016
The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finally announced on March 21 that it is ready to begin Phase Two of its HIPAA audit program, which will include business associates. These audits, mandated by HITECH, will primarily be comprised of desk audits, scheduled... MORE
March 21, 2016
On consecutive days, the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) recently announced two large HIPAA breach settlements. On March 16, 2016, OCR announced that it entered into a Resolution Agreement with North Memorial Health Care of Minnesota for $1.55... MORE
March 14, 2016
House Bill 37 (“HB 37”), a bill intended to codify and regulate direct primary care in the State of Florida, which had sailed through the Florida House with virtually unanimous support, died in the Senate as the legislative clock ran out on it last week. When the Senate failed to take it up for vote... MORE
March 07, 2016
As part of admission into a nursing home, a facility typically requires prospective residents to agree to binding arbitration. Arbitrating disputes generally allows nursing facilities to handle disputes without incurring the onerous costs – both of time and money - associated with litigation.... MORE
April 01, 2016
Coryell Barlow discusses the most common legal issues that arise with teleradiology in the ALI CLE's The Practical Lawyer. MORE
March 10, 2016
Kenneth Schwarz of the Litigation Department discusses the liability of physicians to non-patient third-parties, as in the recent Court of Appeals decision Davis v. South Nassau Communities Hospital. MORE
November 03, 2015
Ryan P. Blaney discusses consent requirements when the TCPA and HIPAA intersect. MORE
July 07, 2015
Ahaviah Glaser discusses the history of disability rights law, the major employment barrier addressed by the Transition to Independence Act, what it might take for this bill to become law and what will be necessary to address problems the disabled face more broadly. MORE
March 16, 2015
While one part of the Affordable Care Act, exchange subsidies, hangs in the balance with the Supreme Court’s upcoming decision in King v Burwell, CMS is moving forward aggressively with the evolution of a less controversial ACA-created innovation, the Medicare ACO. MORE
March 03, 2015
On February 23, 2015, the District Court in Baney v. Fick held that a patient’s complications arising from elective surgery do not fall under the purview of the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, (EMTALA). See 2015 BL 45710, M.D. Pa., No. 4:14-cv-2393 (Feb. 23, 2015). Plaintiffs, a husband and wife, alleged that the medical team managing Brian Baney’s care at Mount Nittany Medical Center should have immediately arranged for his transport to another hospital when he received an esophageal injury following an elective neurosurgical procedure at Mount Nittany Medical Center, and that the team’s care of Baney amounted to a failure to properly stabilize and properly manage Baney’s injury as required under EMTALA. However, the Baney court (citing to Torretti v. Main Line Hospitals, Inc., 580 F.3d 168, 174-75, 177 (3d Cir. 2009), dismissed the plaintiffs’ EMTALA claim with prejudice because the claim “did not fit within EMTALA’s scope.” MORE
February 25, 2015
Today, in North Carolina State Board of Dental Examiners v. Federal Trade Commission, the Supreme Court held that a state dental board, created by the legislature, but comprised primarily of dentists elected by other dentists, did not qualify for immunity under the antitrust laws. This is the second time in two years that the Court has significantly limited the applicability of the state action exemption, under which states themselves are immune from the federal antitrust laws. Actions by private parties, including quasi-governmental entities, pursuant to a state regulatory regime may also be immune, but only under certain circumstances. Given the prevalence of state quasi-governmental bodies in regulating a broad range of industries such as energy, professional services, health care and transportation, these decisions will likely force states, and regulated industries, to reconsider their policy and legal strategies. MORE
December 31, 2014
Ryan Blaney, a member in the firm's Washington, D.C. office contributes to the OIG's summary of new and ongoing reviews and activities that OIG plans to pursue with respect to HHS programs during the current Fiscal Year and beyond. MORE
October 22, 2014
Ryan Blaney, a member of Cozen O’Connor’s Health Law practice group, was a contributor in the October edition of the ABA Health Care and Pharmaceuticals Committee Recent Developments. Recent Developments contains summaries of recent federal and state court cases, government enforcement actions, and other ‘’recent developments’’ involving antitrust and privacy issues in the health care and pharmaceutical industries. MORE
August 15, 2013
On July 29, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services released a memorandum report finding that Medicare paid more on average for short inpatient stays than for observation stays in 2012. The report, Hospitals' Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries, touches on the hot button issue of observation versus inpatient status, which has led to at least one class action lawsuit. MORE
July 03, 2013
On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted by federal law. This decision reversed the 1st Circuit’s affirmance of a jury verdict awarding Bartlett more than $21 million on her design-defect claim against Mutual Pharmaceutical under New Hampshire law. MORE
June 25, 2013
On June 17, 2013, the U.S. Supreme Court handed down a decision that addressed a “reverse payment” settlement agreement between a brand-name pharmaceutical company and multiple generic drug companies. The Supreme Court held that a settlement agreement in which a patentee pays an accused infringer not to enter the market – even if the agreement allows market entry before the patent term expires – is not presumptively lawful and is still subject to antitrust scrutiny. MORE
May 29, 2013
The jury determined that Tuomey violated the Stark Law by entering into improper compensation arrangements with specialist physicians and that the hospital violated the FCA by submitting 21,730 claims to the Medicare program (worth more than $39 million) that were tainted by improper provider referrals. MORE
May 07, 2013
The Internal Revenue Service issued proposed regulations addressing the requirement under Section 501(r)(3) of the Internal Revenue Code that tax-exempt hospitals conduct community health needs assessments. The proposed regulations also provide details on related reporting obligations and the consequences of noncompliance with CHNA. MORE
April 30, 2013
A variety of patent issues arise from the act’s Biologics Price Competition and Innovation Act. MORE
April 23, 2013
Two of Mercy Health System’s hospitals (Nazareth Hospital and the former St. Agnes Medical Center) successfully challenged, before Judge Ludwig of the U.S. District Court for the Eastern District of Pennsylvania, the Secretary of Health and Human Services’ exclusion of days of care provided to Pennsylvania’s General Assistance (GA) patients in fiscal year 2002 from the formula used to determine the hospitals’ Medicare disproportionate share hospital (DSH) payments (Nazareth Hosp. v. Sebelius, E.D. Pa. No. 2:10-cv-03513-EL, April 8, 2013). The exclusion resulted in lower Medicare DSH payments. MORE
March 07, 2013
On January 25, 2013, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) published the long-awaited omnibus final regulation governing health data privacy, security and enforcement (Omnibus Rule). The Omnibus Rule is a group of regulations that finalizes four sets of proposed or interim final rules, including changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act and proposed in 2010; changes to the interim final breach notification rule; modifications to the interim final enforcement rule; and implementation of changes to the Genetic Information Nondiscrimination Act of 2008 (GINA). The Omnibus Rule goes into effect on March 26, 2013, and compliance is required by September 23, 2013. As expected, the Omnibus Rule did not finalize the May 31, 2011 proposed regulation regarding accounting for disclosures. MORE
January 28, 2013
Under the Affordable Care Act, a number of significant tax increases go into effect in 2013 and other tax provisions will be implemented during the next several years. MORE
January 25, 2013
The countdown to the 2014 implementation of the Affordable Care Act (ACA) has begun. Each week, administrative decisions, guidance, rules and regulations are coming from the federal and state governments to make ACA a functioning health care system for the 21st century. MORE
October 24, 2012
Seventh Circuit Rules that Medical Necessity Trumps State-Imposed Cap on "Optional" Medicaid Coverage - Health Law Alert - In a class action lawsuit, the U.S. Court of Appeals for the 7th Circuit recently affirmed a lower court decision granting a preliminary injunction that prevented the state of Indiana from enforcing a $1,000 annual cap on Medicaid coverage for medically necessary dental services, and concluded the cap most likely violated rights granted to Medicaid beneficiaries under federal law. Bontrager v. Indiana Family and Social Services Administration, 2012 U.S. App. LEXIS 20157 (September 26, 2012). MORE
June 28, 2012
Supreme Court Rules on Affordable Health Care Act: Upholds Individual Mandate and Limits Scope of Medicaid Expansion - Health Law Alert - In a heavily anticipated landmark ruling, the Supreme Court has upheld the constitutionality of the so-called “individual mandate” of the Affordable Care Act – i.e., the requirement that those not insured privately, through their employer or through a governmental program, must either purchase minimum essential health insurance coverage or pay a “penalty” for failing to do so. MORE
June 26, 2012
Federal Court Sends Mixed Message on Hospital's Right to Payment for Out-of-Network Services - Health Law Alert - Hospitals seeking reimbursement from a Medicaid managed care organization (MCO) for non-contracted services, and without the benefit of a single case agreement, need a legal basis to compel payment by the MCO. MORE
February 21, 2012
CMS Issues Proposed Rule on Reporting and Returning Medicare Overpayments - Health Law Alert! - On February 16, 2012, the Centers for Medicare & Medicaid Services (CMS) issued a widely anticipated proposed rule (the proposed rule) implementing the statutory requirement of Section 6402(a) of the Affordable Care Act (the ACA) that providers and
suppliers report and return overpayments from Medicare and Medicaid. MORE
March 23, 2011
On First Anniversary, a Look at Challenges to Health Care - The Legal Intelligencer - On its one-year anniversary, the sweeping health care reform law — referred to as the "Affordable Care Act" (ACA) if you like it, and "Obamacare" if you don't — is embroiled in litigation. Its fate, like that of the 2000 presidential election, is likely to be determined by the Supreme Court. MORE
January 18, 2011
Adverse Incident Reports: How Many Is Too Many? - Life Sciences Alert - On January 10, 2011, the U.S. Supreme Court heard argument in the matter Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167 (9th Cir. 2009), and suggested that some major changes may be in store for pharmaceutical companies which could forever alter how they handle adverse reports. MORE
November 17, 2010
CMS Voluntary Self-Referral Disclosure Protocol: The Good, The Bad, and The Ugly - Health Law Alert! - On September 23, the Centers for Medicare & Medicaid Services (CMS) released the much anticipated Medicare self-referral disclosure protocol (SRDP). CMS was required to establish the SRDP by Section 6409 of the Affordable Care Act (ACA), which obligated the Secretary of Health and Human Services to inform providers and suppliers how to self-disclose actual or potential violations of the Stark law. MORE
November 16, 2010
CMS Delays Section 111 Reporting for Liability Insurers - Health Law Alert! - the Centers for Medicare & Medicaid Services (CMS) announced a one-year delay in the implementation of certain reporting obligations under Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 for claims involving liability insurers (including self-insured entities). Claims involving workers’ compensation and no-fault insurance, however, must be reported as scheduled in the first calendar quarter of 2011. The net result is a two-tiered implementation timeline. MORE
November 01, 2010
The Difficulty in Certifying a Class Action Against Drug Companies - Life Sciences Alert! - Three cases decided over the past few months demonstrate the difficulty with certifying class actions by third-party payors (TPPs) against drug companies. MORE
October 22, 2010
Investigational Devices and the Defenses that Protect Them - Cozen O'Connor Paper - MORE
September 09, 2010
Cozen O'Connor Webinar - Smoothing the Wrinkles of Off-Label Promotion: Allergan's Preemptive Strike Against the FDA - MORE
August 03, 2010
Proposed New Rules Implementing HITECH Amendments to HIPAA Make Significant Changes - Health Law Alert! - On July 14, 2010, the Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Regulations”) to modify certain regulations that implement the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Specifically, the Proposed Regulations implement statutory amendments to HIPAA’s Privacy, Security, and Enforcement Rules made by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), MORE
May 12, 2010
Stark Realities of Health Care Reform - Health Law Alert! - Our Health Law Alert of April 26, 2010 summarized recent amendments to the Anti-Kickback Statute (“AKS”) concerning “reverse” federal false claims act (“FCA”) and the implications of the requirement of Section 6402 of the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148 (the “PPACA”) to report and refund “overpayments” by Medicare and Medicaid within sixty (60) days of “identification.” An “overpayment” is defined to MORE
April 26, 2010
Providers Beware: Health Care Reforms Make Failing to Promptly Refund Overpayments—Including Those Attributable to Identified Stark Violations—Potential False Claims Act Violations - Health Law Alert! - By linking the retention of program overpayments and potential liability under the False Claims Act (FCA), the Patient Protection and Affordable Care Act of 2010 (PPACA) has dramatically expanded the scope of exposure for health care providers under the FCA. Potential overpayments to providers—including but not limited to such things as garden variety duplicate payments to discoveries of Medicare payments for designated health services (DHS) provided on referrals from MORE
April 19, 2010
Medicare Secondary Payer Update - CMS Delays Reporting Deadlines - Health Law Alert! - In December 2007, Congress amended the Medicare Secondary Payer law (MSP) through Section 111 of the Medicare, Medicaid and SCHIP Extension Act (MMSEA). The amendment imposes mandatory reporting obligations on Responsible Reporting Entities (RREs), including liability, self-insured, no-fault and workers’ compensation insurers (collectively referred to as “non-Group Health Plans” or “Non-GHPs”) regarding settlements with Medicare beneficiaries. MORE
March 23, 2010
Highmark, Inc. Challenges PA. Insurance Department Investigation - Health Law Alert! - Highmark, Inc. has filed a lawsuit in the Commonwealth Court of Pennsylvania challenging the legality of an ongoing Pennsylvania Insurance Department investigation involving potential anticompetitive conduct and/or unfair trade practices by Pennsylvania’s Blue Cross and Blue Shield companies. MORE
February 09, 2010
Under New Rules, Plans Offering Mental Health and Substance Use Disorder Benefits Must Ensure Parity in Member Costs and Access to Care - Health Law Alert! - On February 2, 2010, the Centers for Medicare &
Medicaid Services, the Internal Revenue Service,
and the Department of Labor’s Employee Benefits
Security Administration published long-awaited regulations implementing the Mental Health Parity and Addiction Equity Act of 2008 (the “MHPAEA”).1 The MHPAEA followed the Mental Health Parity Act of 1996, which had previously mandated parity in aggregate lifetime and annual dollar limits between mental health benefits and medical/surgical benefits. MORE
January 18, 2010
A New Era in HIPAA Enforcement: Connecticut Attorney General Files First HITECH Act Suit - Health Law Alert! - Connecticut Attorney General Richard Blumenthal has filed a lawsuit against Health Net of Connecticut, Inc. for violations of the Health Insurance Portability and Accountability Act (“HIPAA”) following Health Net’s loss of protected health information (“PHI”) and other personally identifiable information.
MORE
August 07, 2009
FTC Again Delays Enforcement of Red Flags Rule - Health Law Alert! - On July 29, 2009, just three days before the effective date of the "Red Flags Rule" (the "Rule"), the Federal Trade Commission ("FTC") announced that it would again delay enforcement of Rule from August 1, 2009 until November 1, 2009. The FTC delayed enforcement to allow it to further educate small business and health care providers about the Rule and what they need to do to comply with its requirements MORE
July 09, 2009
New Jersey Enforces Limits on Overpayment Recoveries - Health Law Alert! - The New Jersey Commissioner of Banking and Insurance
issues Enforcement Notice requiring Insurer to cease and
desist from attempting to recoup overpayments based on
improper extrapolations and to reimburse providers for
amounts improperly obtained. MORE
July 07, 2009
Recent Pennsylvania Decision Requires Disclosure of Medicaid Managed Care Rates - Health Law Alert! - Commonwealth Court holds that provider agreements with
Medicaid managed care plans, including the negotiated
payment rates contained in those agreements, are subject to
disclosure under the Pennsylvania Right to Know Law. MORE
May 08, 2009
Red Flags Rule Enforcement Delayed...Again - Health Law Alert! - On April 30, 2009, the eve of the effective date of the “Red Flags Rule,” the Federal Trade Commission (FTC) announced that it would again delay enforcement of the Rule until August 1, 2009 in order to allow organizations more time to develop and implement written identity theft
prevention programs. The FTC also announced plans to release a template to help entities that have a low risk of identity theft, such as businesses that know their customers personally, comply with the law MORE
April 28, 2009
New Medicare Secondary Payer Requirement: Mandatory Reporting for Liability, No-Fault and Workers Compensation Insurers - Health Law Alert! - The Medicare Secondary Payer law (“MSP”) is again “in the news” for liability (including self-insured), no-fault, and workers compensation insurers. In December 2007, Congress amended the MSP law through Section 111 of the Medicare, Medicaid, and SCHIP Extension Act to impose mandatory reporting requirements on liability, no-fault, and workers’ compensation insurers (collectively referred to as “non-Group
Health Plans” or “Non-GHPs”) MORE
March 20, 2009
The American Recovery and Reinvestment Act of 2009: New Markets Tax Credits Increased by $3 Billion - Health Law Alert! - The American Recovery and Reinvestment Act of 2009
increased the tax credits available under the New
Market Tax Credit program (the “Program”) by $3
billion. The Program provides tax credits to investors or lenders who provide funding to businesses that are primarily located in, derive their income from, and perform services within a low-income community.1 The tax credits allow an
investor or lender to get a 39% tax credit over the first 7 years of the investment, MORE
March 03, 2009
The American Recovery and Reinvestment Act of 2009: Sweeping Changes to HIPAA Put Business Associates in the Spotlight - Health Law Alert! - On February 17, 2009, President Obama signed into law the Health Information Technology for Economic and Clinical Health Act (“HITECH” or the “Act”), as part of the American Recovery and Reinvestment Act of 2009. The Act made
sweeping changes to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Privacy and Security Rules promulgated under HIPAA. This Alert focuses
primarily on Subtitle D of HITECH, which includes important MORE
February 27, 2009
New Codey Legislation to Provide Certainty After a Year of Limbo - Health Law Alert! - On February 5, 2009, the New Jersey legislature
adopted Assembly Bill No. A1933 (the “Bill”), which
amends the New Jersey Health Care Practitioner
Self-Referral Law (commonly referred to as the “Codey Law”).
The Senate adopted an identical bill (S. 787) on December 15,
2008. The Bill currently awaits Governor Corzine’s signature. MORE
October 27, 2008
FTC Delays Enforcement of Red Flags Rule - Health Law Alert! - MORE
October 01, 2008
HHS' First Resolution Agreement for Alleged HIPAA Violations and What it Means for You - Health Law Alert! - The Department of Health and Human Services
(“HHS”) has entered into its first resolution
agreement with a covered entity to settle alleged
violations of the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy and security rules.1 According to HHS, the resolution agreement with Providence Health & Services (“Providence”), a Seattle-based not-for-profit health system, addresses a series MORE
June 23, 2008
Supreme Court Weighs in on Scope of False Claims Act - Health Law Alert! - A recent, unanimous decision of the U.S. Supreme Court appears significantly to reduce the
potential liability under the False Claims Act for claims health care providers file with private Medicare and Medicaid managed care organizations, as opposed to with the Medicare and Medicaid fee-for-service programs. Allison Engine Co. v. United States ex rel. Sanders, 553 U.S.___ (No. 07-214, June 9, 2008). MORE
February 04, 2008
Update: Pennsylvania Hospitals to Pay For Medical Mistakes – Quality of Care At The Forefront - Health Law Alert! - Prevention of medical mistakes is a cause celebre, and states are beginning to jump
on the so-called “never event” bandwagon. Taking a highly proactive stance,
Governor Edward G. Rendell recently announced that Pennsylvania acute-care
general hospitals will not be reimbursed by the state Medicaid program for services
resulting from medical errors. On January 14, 2008, Pennsylvania became just the MORE
September 25, 2007
Pending Changes to the Stark Law Phase III - Health Law Alert - On September 5, 2007, the Centers for Medicare & Medicaid Services (CMS)
published its long-awaited Phase III regulations regarding the federal ban on
physician self-referrals, more commonly known as “Stark.” CMS claims that the
Phase III Stark regulations, effective on December 4, 2007, will reduce the
regulatory burden on the health care industry, “simplify” the rules and provide MORE
March 20, 2007
Medicare & Medicaid Issues - Leadership Health Care Spring 2007 Conference - MORE
March 20, 2007
Litigation - Leadership Health Care Spring 2007 Conference - MORE
March 20, 2007
SURVEY AND ENFORCEMENT IN LONG TERM CARE - Leadership Health Care Spring 2007 Conference - MORE
March 20, 2007
HIPAA – Current Issues & Implications for Nursing Homes - Leadership Health Care Spring 2007 Conference - MORE
March 20, 2007
Compliance Issues – Fraud and Fraud and Abuse - Leadership Health Care Spring 2007 Conference - MORE
January 01, 2007
Internet Prescribing: It’s Fast and Easy, But Is It Legal? - ANDREWS LITIGATION REPORTER - The Internet pharmacy industry is booming and apparently will only get bigger, unless, that is, the federal government decides that prescriptions written without a face-to-face meeting between the physician and patient are invalid. Given its recent enforcement efforts, the government may well be headed in that direction. MORE
September 01, 2006
Using Mental Health Records for Research - Compliance Today - The Health Insurance Portability and Accountability Act’s Privacy Rule (the “Privacy Rule”) strikes a balance between restricting the unauthorized disclosure of medical records and permitting health care providers to operate effectively, including participation in research studies. Specifically, the Privacy Rule takes into account that getting patient authorization for a disclosure can be problematic for researchers who do not interact directly with MORE
August 08, 2006
The Deficit Reduction Act of 2005 Imposes New Obligations On Medicaid Providers By January 1, 2007 - Health Law E-lert! - MORE
February 23, 2006
HIGHLIGHTS OF THE DEFICIT REDUCTION ACT OF 2005 - Health Law E-lert! - MORE
9/9/2016 3:21:25 PM
On September 8, 2016, CMS announced in its blog that it will allow physicians to select their level of participation for the first performance year of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) Quality Payment Program, which begins January 1, 2017. Importantly, during the... MORE
8/25/2016 12:16:35 PM
On July 29, 2016, the Federal Trade Commission (“FTC” or “Commission”) reversed an FTC administrative law judge’s (“ALJ”) opinion which had ruled against the FTC, finding that the Commission had failed to show that LabMD’s conduct caused harm to consumers to satisfy requirements under Section 5 of... MORE
8/22/2016 11:07:09 AM
On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana grower/processor permits that will become available under Pennsylvania’s Medical... MORE
7/13/2016 2:40:54 PM
In response to the increasing prevalence of ransomware cyber-attacks by hackers on electronic health information systems in hospitals and medical practices, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on Monday July 11, 2016 its publication of new HIPAA... MORE
6/16/2016 1:28:56 PM
The White House recently released a guidance document for those in the precision medicine community to help ensure that participants’ data and resources remain secure. The document, titled “Precision Medicine Initiative: Data Security Policy Principles and Framework,” is meant to offer “security... MORE
5/16/2016 12:09:37 PM
Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in the U.S. District Court for the District of Columbia. Nicopure seeks to... MORE
5/9/2016 12:02:38 PM
On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24th state (plus the District of Columbia) to legalize marijuana for medical use. The full text of the act is available here.
Physicians, not surprisingly, will play a vital role in making medical marijuana available... MORE
3/30/2016 10:04:52 AM
MedStar, a Washington, D.C.-area hospital chain, became the latest healthcare industry victim of a cyber-attack when hackers breached its systems with a crippling virus. MedStar operates 10 hospitals in the D.C./Baltimore region, employs 30,000 staff, has 6,000 affiliated physicians, and serviced... MORE
3/22/2016 4:30:52 PM
The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finally announced on March 21 that it is ready to begin Phase Two of its HIPAA audit program, which will include business associates. These audits, mandated by HITECH, will primarily be comprised of desk audits, scheduled... MORE
3/21/2016 2:43:32 PM
On consecutive days, the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) recently announced two large HIPAA breach settlements. On March 16, 2016, OCR announced that it entered into a Resolution Agreement with North Memorial Health Care of Minnesota for $1.55... MORE
3/14/2016 4:07:52 PM
House Bill 37 (“HB 37”), a bill intended to codify and regulate direct primary care in the State of Florida, which had sailed through the Florida House with virtually unanimous support, died in the Senate as the legislative clock ran out on it last week. When the Senate failed to take it up for vote... MORE
3/7/2016 1:04:25 PM
As part of admission into a nursing home, a facility typically requires prospective residents to agree to binding arbitration. Arbitrating disputes generally allows nursing facilities to handle disputes without incurring the onerous costs – both of time and money - associated with litigation.... MORE
9/15/2015 12:00:00 AM
Two Cozen O'Connor attorneys are among those recognized by The Legal Intelligencer as Lawyers on the Fast Track. MORE
4/21/2015 12:00:00 AM
Cozen O’Connor is pleased to announce that Marc H. Auerbach has joined the firm as a member of the Health Care Practice, resident in the Miami office. MORE
11/10/2014 12:00:00 AM
Cozen O’Connor is pleased to welcome James D. Schultz back to the firm as a member and chair of the newly formed Government Law and Regulatory Affairs Practice. Since 2011, Schultz has served in the Governor’s Office of General Counsel. He was appointed as First Executive Deputy General Counsel in 2011 and in 2012 was appointed by Governor Tom Corbett to head that office as General Counsel of the Commonwealth of Pennsylvania. MORE
10/7/2014 12:00:00 AM
Cozen O'Connor is pleased to announce that George Gowen, a former litigation member with experience in health care, securities, corporate governance and commercial transactions, is returning to the firm from food and facilities services multinational Aramark. Gowen rejoins the firm’s Commercial Litigation Department after more than four years at Aramark, where he served as vice president & associate general counsel and led the legal group for Aramark’s Healthcare and Business & Industry operating groups. MORE
7/9/2014 12:00:00 AM
Cozen O’Connor continues to strengthen its focus on health care with the recent hiring of R. Christopher Raphaely, who will serve as co-chair of the firm’s Health Care Practice Group. Previously deputy general counsel for the Jefferson Health System, and general counsel to the system’s accountable care organization and captive professional liability insurance companies, Raphaely will be resident in the Philadelphia office. MORE
9/9/2016 3:21:25 PM
On September 8, 2016, CMS announced in its blog that it will allow physicians to select their level of participation for the first performance year of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) Quality Payment Program, which begins January 1, 2017. Importantly, during the... MORE
8/25/2016 12:16:35 PM
On July 29, 2016, the Federal Trade Commission (“FTC” or “Commission”) reversed an FTC administrative law judge’s (“ALJ”) opinion which had ruled against the FTC, finding that the Commission had failed to show that LabMD’s conduct caused harm to consumers to satisfy requirements under Section 5 of... MORE
8/22/2016 11:07:09 AM
On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana grower/processor permits that will become available under Pennsylvania’s Medical... MORE
7/13/2016 2:40:54 PM
In response to the increasing prevalence of ransomware cyber-attacks by hackers on electronic health information systems in hospitals and medical practices, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on Monday July 11, 2016 its publication of new HIPAA... MORE
6/16/2016 1:28:56 PM
The White House recently released a guidance document for those in the precision medicine community to help ensure that participants’ data and resources remain secure. The document, titled “Precision Medicine Initiative: Data Security Policy Principles and Framework,” is meant to offer “security... MORE
5/16/2016 12:09:37 PM
Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in the U.S. District Court for the District of Columbia. Nicopure seeks to... MORE
5/9/2016 12:02:38 PM
On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24th state (plus the District of Columbia) to legalize marijuana for medical use. The full text of the act is available here.
Physicians, not surprisingly, will play a vital role in making medical marijuana available... MORE
3/30/2016 10:04:52 AM
MedStar, a Washington, D.C.-area hospital chain, became the latest healthcare industry victim of a cyber-attack when hackers breached its systems with a crippling virus. MedStar operates 10 hospitals in the D.C./Baltimore region, employs 30,000 staff, has 6,000 affiliated physicians, and serviced... MORE
3/22/2016 4:30:52 PM
The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finally announced on March 21 that it is ready to begin Phase Two of its HIPAA audit program, which will include business associates. These audits, mandated by HITECH, will primarily be comprised of desk audits, scheduled... MORE
3/21/2016 2:43:32 PM
On consecutive days, the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) recently announced two large HIPAA breach settlements. On March 16, 2016, OCR announced that it entered into a Resolution Agreement with North Memorial Health Care of Minnesota for $1.55... MORE
3/14/2016 4:07:52 PM
House Bill 37 (“HB 37”), a bill intended to codify and regulate direct primary care in the State of Florida, which had sailed through the Florida House with virtually unanimous support, died in the Senate as the legislative clock ran out on it last week. When the Senate failed to take it up for vote... MORE
3/7/2016 1:04:25 PM
As part of admission into a nursing home, a facility typically requires prospective residents to agree to binding arbitration. Arbitrating disputes generally allows nursing facilities to handle disputes without incurring the onerous costs – both of time and money - associated with litigation.... MORE
4/8/2016 12:00:00 AM
Chris Raphaely discusses a house-passed bill that may impact hospital decisions on mergers in Modern Healthcare. MORE
6/8/2015 12:00:00 AM
Christopher Raphaely discusses the challenges faced when moving from an in-house position to private practice with The Legal Intelligencer. MORE
4/14/2015 12:00:00 AM
Greg Fliszar, of the firm's health law practice, is quoted on the topic of breaches of medical data, and how the number of affected patients is on the rise. MORE
2/23/2015 12:00:00 AM
In early February, U.S. health insurer Anthem announced that it has been the victim of a huge hacking attack, with possibly millions of people’s personal information compromised. What lessons can health care risk managers take from this breach? HRMR investigates. MORE
1/20/2015 12:00:00 AM
In an article titled ''Why the Supreme Court's Medicaid Decision Matters,'' Mark Gallant, co-chair of the firm's Health Care Group, comments on Medicaid providers and how a recent Supreme Court hearing could affect issues at the state and federal level. MORE
8/25/2014 12:00:00 AM
Raphaely, co-chair of the firm's Health Law Practice, discussed the Affordable Care Act, ACOs and other issues facing in house counsel working in the health care industry. MORE
5/13/2014 12:00:00 AM
Mark Gallant, chair of the Health Care Group, was recently mentioned in a Law360 article about his victory on behalf of CardioNet and LifeWatch Services in the 3rd Circuit. MORE
1/24/2014 12:00:00 AM
In an article titled “Cigna Coverage Row Shouldn’t Be Arbitrated, 3rd Circ. Told,” Mark Gallant (Health Care, Philadelphia) discusses how a Pennsylvania federal judge wrongly forced two cardiac telemetry manufacturers to arbitrate their claims that Cigna Health Corp. violated federal pension laws and unfair competition laws when it decided to stop covering the devices. Mark, who’s representing CardioNet Inc. and LifeWatch Services Inc., told a three-judge panel that claims his clients brought against the insurer under the Employee Retirement Income Security Act and for trade disparagement did not fall under the terms of a provision in the contract the companies inked with Cigna requiring that the parties arbitrate any disputes over interpretations of the deal or any alleged breaches. MORE
1/24/2014 12:00:00 AM
Mark Gallant, Chair of the Health Care Practice Group, was mentioned in a Law360 article titled, "PA Charity Patients Can Be Nixed From DSH, 3rd. Circ. Told." The article explains how Mark is arguing on behalf of Nazareth Hospital and St. Agnes Medical Center. MORE
11/15/2013 12:00:00 AM
On November 14, President Obama announced that health insurers will be able to extend existing plans for individuals through 2014 that would have been otherwise cancelled due to changes under the Affordable Care Act. This proposed fix does not guarantee that extensions will be available, but rather allows insurers to offer the extension and for state regulators to approve it. MORE
5/31/2013 12:00:00 AM
In an article titled, "Hospitals Scramble As ACA Gives Patients Pricing Leverage", Mark Gallant of Health Care Group is quoted regarding the costs that uninsured patients may face as hospitals apply a form of "balance billing" to make up for lower reimbursements from insurers and government payors. Gallant was quoted as saying, "The charges are a problem, but they’re also a symptom of another problem, which is the unevenness of the payments and the need to rob Peter because you're not getting paid by Paul" MORE
4/17/2013 12:00:00 AM
Lauren Tulli, Jill Caughie and MaryTeresa Soltis secured a summary judgment from the District Court of the Western District of Kentucky in a factually complicated and contentious pain pump case that has been in active litigation for over four years. MORE
2/1/2013 12:00:00 AM
Mark Gallant, a member of the firm, and chair of the Health Law practice group, was quoted in Of Counsel: The Legal Practice and Management Report, in an article titled, “Affordable Care Act, Changing Demographic, Consolidation All Fueling Health Care Law.” MORE
3/29/2012 12:00:00 AM
Mark Gallant and Iden Martyn were featured in Bloomberg BNA's Health Care Daily Report article entitled ''Medicare: Court Finds Notice of Deadline Inadequate, Orders Payment of Medical Education Claims.'' MORE