CMS Releases Final Stark Rules To Promote Value-Based Care [Health Law Informer Blog]

On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released final regulations to remove certain barriers to the implementation of physician compensation arrangements under value-based payment arrangements posed by the “Stark” Physician Self-Referral law. The...

Pennsylvania Act 80: Central Service Technician and Surgical Technologist Regulation Act [Health Law Informer Blog]

On October 29, 2020, Governor Wolf signed House Bill 81 into law, creating new minimum education and certification requirements for central service technicians and surgical technicians working in the Commonwealth, and regulating the practice of surgical technology. The Act will take effect on...

Trump vs. Biden: HEALTH CARE POLICY

Alex Campau, Mark Alderman, and Brett Banker discuss the similarities and differences between Trump and Biden's health care policies.

A Week After Pharma Price Disclosure Is Rule Struck Down, D.C. Judge Upholds Hospital Price Transparency Rule [Health Law Informer Blog]

As we indicated in last week’s blog post , the D.C. Circuit Court’s refusal to uphold HHS’ pharmaceutical price disclosure rule (“RX Rule”) was not a predictor of how the trial court might rule in the closely watched challenge to HHS’ hospital price transparency rule (“Hospital Rule”). In a June...

Pharma Price Disclosure Rule Struck Down: Will Hospital Price Transparency Rule Meet the Same Fate? [Health Law Informer Blog]

On June 16, the D.C. Circuit Court struck down the Centers for Medicare and Medicaid Services’ (“CMS”) rule issued in May 2019 requiring pharmaceutical companies to disclose the wholesale acquisition cost of drugs over $35 in their direct-to-consumer television advertisements (“RX Rule”). Similar...

Pennsylvania Attorney General Announces Nursing Home Criminal Investigations [Alert]

Danielle Sapega discusses the Pennsylvania attorney general's investigation into nursing homes, the Department of Health's guidance for nursing homes, and the governor's executive order granting immunity to health care workers.

COVID-Driven Commercial Litigation – What Businesses Can Expect

Adam Schlatner and Michael de Leeuw discuss potential COVID-19 related litigation, based on what is already happening and the legacy of other downturns.

CMS Issues Blanket Waivers for Long-Term Care Facilities, SNFs and NFs

J. Nicole Martin and Gregory M. Fliszar discuss CMS's blanket waivers for nursing facilities and skilled-nursing facilities effective through the end of the COVID-19-related emergency.

Pennsylvania Hospitals Can Now Resume Elective Surgeries and Procedures [Alert]

Gregory M. Fliszar discusses what measures Pennsylvania hospitals must take before resuming elective surgeries and procedures.

Additional Health Care Provider Relief Funds In April Stimulus Bill [Health Law Informer Blog]

On Friday, April 24th, President Trump signed the Paycheck Protection Program and Health Care Enhancement Act (“Act”) into law that will send an additional $75 billion to the Public Health Emergency and Social Services Fund (“Fund”) used to reimburse eligible health care providers for health care...

CMS Announces Enhanced Nursing Home Reporting Requirements

Danielle E. Sapega and Gregory M. Fliszar discuss CMS's new guidance for nursing homes when it comes to reporting confirmed or suspected cases of COVID-19.

CMS Issues Recommendations to Reopen Health Care Systems in Areas with Low Incidence of COVID-19 [Alert]

J. Nicole Martin and Gregory M. Fliszar discuss CMS's guidance for health care systems in areas with low COVID-19 infections to reopen nonessential care.

First $30 Billion to be Immediately Distributed to Hospitals, Other Health Care Providers

Gregory M. Fliszar discusses CMS's announcement that $30 billion will be distributed from the health care provider relief fund in the CARES Act.

HHS to Release Highly Anticipated Public Health and Social Services Emergency Fund Guidance Soon [Health Law Informer Blog]

The CARES Act (“Act”) appropriates $100 billion to create a Public Health Social Service Emergency Fund (“Fund”) to prevent, prepare for, and respond to coronavirus domestically and internationally for necessary expenses to reimburse, through grants or other mechanisms, eligible health...

Antitrust Agencies Offer COVID-19 Guidance and Warnings to Competitor Collaborations [Alert]

Robert K. Magovern and Matthew Howell discuss the DOJ's and FTC's joint statement pertaining to the enforcement of competition laws during the COVID-19 pandemic.

HIPAA and COVID-19: Balancing Public Health Concerns and Patient Privacy in the Midst of a Pandemic [Alert]

Gregory M. Fliszar and Danielle Sapega discuss the HIPAA Privacy and Novel Coronavirus bulletin and what providers and covered entities need to know during a public health emergency.

5th Circuit Holds Individual Mandate is Unconstitutional, but Remands to District Court to Decide Severability [Health Law Informer Blog]

In a 2-1 decision published on December 18, 2019, a 5th Circuit panel upheld the Texas District Court’s decision ruling that the ACA individual mandate tax which, since January 2019, has had no monetary consequence, is unconstitutional. Citing the Supreme Court’s 2012 NFIB v. Sebelius opinion, the...

Pennsylvania Act 112 of 2019: Opioid Treatment Agreements [Health Law Informer Blog]

As another mark of progress in the fight against opioid addiction, Governor Wolf signed Senate Bill 572 (the “Act”) into law on November 27, 2019, requiring prescribing providers (referred to as “Prescribers”) to take several additional steps before issuing a prescription for an opioid in...

Google Partners with Ascension To Store and Analyze Millions of Patient Health Records [Health Law Informer Blog]

Google has confirmed that it is working with Ascension, one of the nation’s largest health systems in a project that will involve the health data of millions of Americans.  Google and Ascension have partnered in a project to store and analyze patient data with the intended goal of using Google’s...

Hospital Price Transparency Requirements [Health Law Informer Blog]

CMS finalized the Outpatient Prospective Payment System hospital price transparency rules on November 15, 2019. As of January 1, 2021, hospitals will have to publicly post (and update annually) two sets of data: first, a comprehensive list of standard charges for items services offered by the...

Price Transparency Rules are Here [Health Law Informer Blog]

CMS today issued its Price Transparency Requirements for Hospitals Final Rule, which will go into effect on January 1, 2021. (CMS had initially proposed that it go into effect January 1, 2020, but agreed that that deadline was too “challenging”). Hospitals will be required to post on a public...

CMS Guidance on “Shared Space” – Comment Period Closing July 2, 2019 [Health Law Informer Blog]

CMS recently issued long-awaited draft guidance on hospital co-location with other hospitals or healthcare facilities, providing some potential insight on the otherwise ambiguous prohibition on “shared space.” This prohibition loosely stems from the requirement that a Medicare participating...

New Pennsylvania Laws: Is Your Organization Compliant? [Health Law Informer Blog]

In 2018, Governor Tom Wolf signed a multitude of bills into law that significantly impact Pennsylvania health care providers. Compliance deadlines for these new laws vary. Implementing any new policies or procedures often takes longer than anticipated, so we strongly recommend taking steps to...

HHS Publishes Conscientious Objector Rule for Health Care Entities: Litigation Follows [Alert]

Peter Ennis discusses HHS's new conscientious objector rule and what health care providers need to do in order to prepare for compliance.

Court Orders Stay of Order Declaring Individual Mandate Unconstitutional and Inseverable [Health Law Informer Blog]

We previously reported that District Court Judge Reed O’Connor of the Northern District of Texas declared on December 14, 2018 (1) that the Affordable Care Act’s (ACA) individual mandate is unconstitutional and (2) that the remaining provisions of the ACA are “inseverable” and therefore...

Federal Court Enjoins Medicare Recoupment [Health Law Informer Blog]

A Houston federal judge preliminarily enjoined the government from recouping alleged Medicare overpayments made to an ambulance service company facing bankruptcy.  See Adams EMS, Inc. v. Azar, No. H-18-1443, 2018 BL 391263 (S.D. Tex. 2018). As you may be aware, there is a massive backlog in the...

CMS Releases Final ACO Regulations [Health Law Informer Blog]

This morning CMS released a final rule regarding its most popular program for accountable care organizations (ACOs), the Medicare Shared Savings Programs. The final rule is based on the proposed rule for the program that was published in August.  The final rule adopts the major structural overhaul...

Third Circuit Provides Guidance on Handling of EMTALA Whistleblower Claims [Labor & Employment Alert]

Bobbi Britton Tucker discusses the court's decision in Marie Gillispie v. Regionalcare Hospital Partners, Inc., and how the court rules that the EMTALA’s whistleblower provision protects employees who inform personnel in a covered facility of an alleged EMTALA violation, even though the employee does not also inform any governmental or regulatory agency.

Next Generation ACOs: CMMI Doubles Down on the Two-Sided Risk ACO Model [Health Law Alert]

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.

Pennsylvania Federal Court Reiterates EMTALA’s Inapplicability to Transfers of “Admitted Patients”

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.”

Supreme Court Delivers another Blow to State Action Antitrust Immunity [Antitrust & Regulatory Alert]

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.

IRS Releases Guidance on Private Business Use, and ACOs and Management Contracts [Public Finance and Health Law Alert]

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company [Intellectual Property Alert]

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.

Supreme Court: Reverse Payment Settlements Subject to Antitrust Scrutiny [Intellectual Property Alert]

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.

IP: Obamacare’s Constitutional Impact on Patents [InsideCounsel]

A variety of patent issues arise from the act’s Biologics Price Competition and Innovation Act.

Hospitals Prevail in Effort to Include Pennsylvania GA Days in the Medicare DSH Calculation [Health Law Alert]

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.

Highlights of the Omnibus HIPAA/HITECH Final Rule [Cozen O'Connor Whitepaper]

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.

Implementing the Affordable Care Act: Countdown to 2014 (Tax Implications) [ACA Alert]

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.

Seventh Circuit Rules that Medical Necessity Trumps State-Imposed Cap on "Optional" Medicaid Coverage [Health Law Alert]

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).

Supreme Court Rules on Affordable Health Care Act: Upholds Individual Mandate and Limits Scope of Medicaid Expansion [Health Law Alert]

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.

Federal Court Sends Mixed Message on Hospital's Right to Payment for Out-of-Network Services [Health Law Alert]

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.

CMS Issues Proposed Rule on Reporting and Returning Medicare Overpayments [Health Law Alert!]

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.

On First Anniversary, a Look at Challenges to Health Care [The Legal Intelligencer]

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.

Adverse Incident Reports: How Many Is Too Many? [Life Sciences Alert]

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.

CMS Voluntary Self-Referral Disclosure Protocol: The Good, The Bad, and The Ugly [Health Law Alert!]

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.

CMS Delays Section 111 Reporting for Liability Insurers [Health Law Alert!]

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.

The Difficulty in Certifying a Class Action Against Drug Companies [Life Sciences Alert!]

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.

Investigational Devices and the Defenses that Protect Them [Cozen O'Connor Paper]

Investigational Devices and the Defenses that Protect Them - Cozen O'Connor Paper -

Stark Realities of Health Care Reform [Health Law Alert!]

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

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!]

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

Medicare Secondary Payer Update - CMS Delays Reporting Deadlines [Health Law Alert!]

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.

Highmark, Inc. Challenges PA. Insurance Department Investigation [Health Law Alert!]

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.

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!]

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.

A New Era in HIPAA Enforcement: Connecticut Attorney General Files First HITECH Act Suit [Health Law Alert!]

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.

New Jersey Enforces Limits on Overpayment Recoveries [Health Law Alert!]

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.

Recent Pennsylvania Decision Requires Disclosure of Medicaid Managed Care Rates [Health Law Alert!]

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.

New Medicare Secondary Payer Requirement: Mandatory Reporting for Liability, No-Fault and Workers Compensation Insurers [Health Law Alert!]

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”)

The American Recovery and Reinvestment Act of 2009: Sweeping Changes to HIPAA Put Business Associates in the Spotlight [Health Law Alert!]

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

New Codey Legislation to Provide Certainty After a Year of Limbo [Health Law Alert!]

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.

FTC Delays Enforcement of Red Flags Rule [Health Law Alert!]

FTC Delays Enforcement of Red Flags Rule - Health Law Alert! -

HHS' First Resolution Agreement for Alleged HIPAA Violations and What it Means for You [Health Law Alert!]

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

Supreme Court Weighs in on Scope of False Claims Act [Health Law Alert!]

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).

Update: Pennsylvania Hospitals to Pay For Medical Mistakes – Quality of Care At The Forefront [Health Law Alert!]

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

Pending Changes to the Stark Law Phase III [Health Law Alert]

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

Using Mental Health Records for Research [Compliance Today]

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

The Deficit Reduction Act of 2005 Imposes New Obligations On Medicaid Providers By January 1, 2007 [Health Law E-lert!]

The Deficit Reduction Act of 2005 Imposes New Obligations On Medicaid Providers By January 1, 2007 - Health Law E-lert! -

HIGHLIGHTS OF THE DEFICIT REDUCTION ACT OF 2005 [Health Law E-lert!]

HIGHLIGHTS OF THE DEFICIT REDUCTION ACT OF 2005 - Health Law E-lert! -

Cozen O’Connor Makes Strategic Move Adding John D. Shire to Washington, D.C. Health Care Practice

Shire brings a deep understanding of federal and state health care regulations and has been instrumental in several of the most well-known transactions in the health care space.

Fifty-Eight Cozen O'Connor Attorneys Named Pennsylvania Super Lawyers and Rising Stars

Super Lawyers has selected 58 Cozen O'Connor attorneys to the 2020 Pennsylvania Super Lawyers and Rising Stars lists.

Trump Administration Expands Pre-Tax Accounts for Health Insurance

Alex Campau discussed with The Wall Street Journal about how employees will now be able to use HRAs to buy individual coverage, with certain restrictions, starting January 2020.

FDA Alert on Hacking Vulnerability in Heart Defibrillators is Wake-Up Call: Lawyers

John Sullivan was quoted in Law360's recent article on the U.S. Food and Drug Administration's recent safety alert last week about the vulnerability to hacking of up to 750,000 implantable heart defibrillators.

Top 5 Health Policy Predictions for 2019

Alex Campau, Principal & Director of Health Policy, shares her predictions about the key health policy trends she anticipates taking center stage in 2019 with Morning Consult.

Cozen O'Connor Lands Ex-White House Health Care Pro

Alex Campau, a member of Cozen O'Connor's Public Strategies group, spoke with Law360 about her experience at the White House.

White House Special Assistant to the President for Health Policy Alexandra Campau Returns to Cozen O’Connor Public Strategies

Campau is a major add to the Firm’s Government Relations Practice in Washington, D.C.

International Life Sciences Attorney Joins IP Department

Former LeClairRyan attorney Jeffrey N. Townes brings substantial experience in international life sciences IP to the firm's Washington, D.C., office.

Hospital megamergers may lower overhead, but at what cost?

Jonathan Grossman, a member of the firm's Antitrust Practice, was quoted in Modern Healthcare's article, "Hospital megamergers may lower overhead, but at what cost?"

Cozen O’Connor’s Melinda Rudolph named a 2017 "Women of Distinction" by the Philadelphia Business Journal

Melinda Rudolph, a member of Cozen O’Connor’s Corporate Practice Group, has been selected as a 2017 Women of Distinction by the Philadelphia Business Journal.

Cozen O’Connor Strengthens Life Sciences Offerings with New Addition to Corporate Practice Group

Cozen O’Connor is pleased to welcome Melinda Rudolph to the firm as a member. Rudolph joins the firm’s Corporate Practice Group and is resident in the Philadelphia office.

Chris Raphaely Discusses SMARTER Act in Modern Healthcare

Chris Raphaely discusses a house-passed bill that may impact hospital decisions on mergers in Modern Healthcare.