The U.S. Food and Drug Administration (FDA) released a new set of guidelines on August 15, 2023, concerning informed consent (Final Guidance).

Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior update, the state had finalized regulations. Now, the state has licensed its first psilocybin service centers.

The U.S. Supreme Court has held—by a 5-4 margin—that it did not violate due process for a Pennsylvania court to exercise jurisdiction over an asbestos case with no connection to Pennsylvania because of a unique Pennsylvania foreign corporation registration statute that requires consent to general jurisdiction to do business in the state.

Washington state recently passed the My Health My Data Act, which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes.

This Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act. The original impetus for the Act was the protection of reproductive rights, and it was signed into law alongside several other pieces of legislation focused on providing abortion and gender-affirming protections. However, because of the broad and vague definition of “consumer health data” covered by the legislation and because it applies to a wide range of entities, the Act may reach much further than might be justified by its original purpose.

A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted false claims for payment in violation of the False Claims Act, the U.S. Supreme Court ruled on June 1, 2023.

As detailed in Part 1 of this ongoing series, Washington Governor Jay Inslee signed the state’s My Health My Data Act into law on April 27, 2023. In this installment, we provide an overview of the consumer rights bestowed by the Act and the obligations it imposes upon regulated entities and small businesses.

The U.S. Supreme Court has accepted review of a case taking direct aim at “overregulation” by federal administrative agencies. Any client that routinely deals with federal administrative agencies—especially those who have experienced administrative overreach—should pay attention and consider weighing in.

On April 27, 2023, Washington Governor Jay Inslee signed into law House Bill 1155, also known as the My Health, My Data Act. Its stated purpose is to protect “consumer health data” collected by entities not already subject to the federal Health Insurance Portability and Accountability Act, but one less obvious consequence of the Act is that it may make Washington state a new hot spot for class-action litigation involving biometric privacy.

The National Labor Relations Board recently ruled in McLaren Macomb that employee severance agreements with overly broad confidentiality and nondisparagement provisions violate the National Labor Relations Act. Recently, NLRB General Counsel Jennifer A. Abruzzo issued a memorandum to all regional directors, officers-in-charge, and resident officers to “assist Regions in responding to inquiries from workers, employers, labor organizations, and the public about implications stemming from the case.”

The Federal Trade Commision announced a proposed complaint and proposed consent order with BetterHelp, Inc., an online counseling platform that allegedly disclosed consumer health data to third-party advertising platforms.

In a recent ruling, the National Labor Relations Board found an employer violated the National Labor Relations Act when it offered furloughed employees a severance agreement that included overbroad nondisparagement and confidentiality provisions.

The Centers for Medicare and Medicaid Services has codified regulatory changes to its Medicare Advantage Risk Adjustment Data Validation audit program of risk adjustments submitted by Medicare Advantage Organizations. Most significantly, CMS will begin applying contract-level extrapolation to its RADV audit findings beginning with audits of calendar year 2018, which will significantly increase MAO exposure based upon alleged overpayment findings.

The U.S. Department of Justice obtained more than $2.2 billion in civil False Claims Act judgments and settlements in fiscal year 2022, the lowest such annual total since 2008 and a significant drop from a jump in FCA recoveries in the prior year. But the DOJ’s announcement of its FY 2022 FYA recoveries also discloses that the DOJ is increasingly bringing FCA cases on its own, and the total number of settlements and judgments in FCA matters increased to near-record highs in FY 2022, signaling a robust enforcement climate ahead.

The Federal Trade Commission announced its first enforcement of the Health Breach Notification Rule against a digital health company, a case it brought against a company that shared user health data with third-party advertising platforms without the authorization of the affected users. This case signals the importance for digital health companies, whether or not covered by the Health Insurance Portability Accountability Act, of treating personal health information as sensitive and regulated by the HBNR and other FTC-enforced laws.

The U.S. Department of Justice, Antitrust Division, recently withdrew three sets of healthcare policy guidelines. This Update discusses the DOJ's decision and its implications for the industry.

Oregon became the first state to offer controlled use of psilocybin to the public on January 1, 2023. This Update provides an overview of the new Oregon Health Authority regulations to implement the state’s first-in-the-nation psilocybin program.

A proposed healthcare acquisition was abandoned following the Federal Trade Commission’s unanimous vote to oppose the transaction.

National Security Presidential Memorandum-33 and implementation guidance from the National Science and Technology Council direct federal agencies to standardize and enhance disclosure and security requirements that apply to federally funded research and development.

The general counsel for the National Labor Relations Board, Jennifer Abruzzo, on April 11, 2022, filed a brief in a case pending before the NLRB asking the Board to overturn decades-old precedent and make several significant changes to employers’ rights during unionization campaigns.

Perkins Coie is pleased to announce the launch of our second annual report California Consumer Privacy Act Litigation Year in Review. The California Consumer Privacy Act (CCPA) became effective on January 1, 2020, and regulates any “business” that does business in California.

Perkins Coie is pleased to present the third edition of Labor Law Today —Year in Review, highlighting the past year’s most noteworthy developments.

The U.S. Department of Justice recovered more than $5.6 billion in civil False Claims Act judgments and settlements in fiscal year 2021, the second largest ever annual total in FCA recoveries and the largest since 2014, DOJ announced on February 1, 2022.

This update was also published on February 17, 2022, here on NASBP.

Further to New York City Mayor Bill DeBlasio’s December 6, 2021 announcement, the New York City Department of Health has now released detailed guidance regarding the vaccine mandate for private employers.

New York City Mayor Bill DeBlasio announced sweeping new vaccine requirements for NYC employers and residents, including a “first-in-the-nation” requirement that all private-sector employers mandate that their employees receive the COVID-19 vaccination, without a standard testing alternative.

The U.S. Department of Labor’s Occupational Safety and Health Administration issued its long-awaited emergency temporary standard requiring all employers with a total of 100 or more employees to mandate vaccination and/or weekly COVID-19 testing. OSHA also released a comprehensive FAQ to address questions.

On October 25, 2021, the U.S. Equal Employment Opportunity Commission (EEOC) updated its guidance related to the COVID-19 pandemic, adding a brand-new section addressing religious objections to COVID-19 vaccine mandates.

With the surge of COVID-19 cases due to the Delta variant, many employers are considering whether to require employees to be vaccinated, how to encourage employee vaccinations, and the implications of vaccine policies for their businesses.

The Occupational Safety and Health Administration (OSHA) issued the COVID-19 Healthcare Emergency Temporary Standards (ETS) on June 10, 2021. 

On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.”

The U.S. Department of Justice (DOJ) recovered more than $2.2 billion in settlements and judgments from civil cases under the False Claims Act (FCA) in the fiscal year ending September 30, 2020.

Perkins Coie is pleased to present the second edition of Labor Law Today —Year in Review, highlighting the past year’s most noteworthy developments.

More than thirty years ago, the Washington Supreme Court ruled defense counsel may not engage in ex parte communications with a plaintiff’s treating physician. Loudon v. Mhyre, 110 Wn.2d 675, 676 (1988).

The COVID-19 pandemic and the resulting need for patient access to remote healthcare, as well as the development of contact-tracing apps, have spotlighted the importance of health-focused mobile applications (mHealth apps).

In this AI Speaks podcast episode, Perkins Coie Senior Counsel James Ray sits down with Belinda Luu, Leader of Enterprise Data Management and Governance - Senior Counsel at Kaiser Permanente, to discuss the use AI in healthcare, including where AI has been beneficial and the challenges and ethical concerns with its use.

This article assesses the implications of that decision for the practice of healthcare law in the administrative law and regulatory areas.

In this white paper, the authors discuss the legal concerns arising from the potential bias manifestations in ML algorithms used in the healthcare context under U.S. law. They briefly describe the legal landscape governing algorithmic bias in the United States and offer some emerging tools that build on existing recommended best practices, such as adversarial debiasing and the use of synthetic data for detecting, avoiding, and mitigating algorithmic bias

As COVID-19 cases continue to rise locally and across the country, Illinois, Chicago, and Cook County continue to update their guidelines and recommendations for employers.

Hundreds of COVID-19-related class action claims have been filed in state and federal courts throughout the country.

In Proclamation 20-46.2 (July 29, 2020), Washington Governor Jay Inslee extended existing protections for “high-risk workers” for the duration of the current state of emergency.

COVID-19 has financially stressed the U.S. healthcare system in several ways.

The U.S. Department of Health and Human Services (HHS) recently announced two new targeted distributions from the CARES Act Provider Relief Fund (the Provider Relief Fund) to assist in the response to the medical and economic consequences of the COVID-19 pandemic

States across the country are beginning to reopen or considering reopening following shutdowns in response to the COVID-19 pandemic.

While some states (such as Georgia, South Carolina, Texas, Montana, and Oklahoma) have commenced, or will soon commence, phased or soft business reopenings, other jurisdictions (including the six San Francisco Bay Area counties in California, Connecticut, New York, and Rhode Island) have recently extended their “shelter-in-place” and eviction moratorium orders.

In recent days the federal government has taken two significant steps to increase healthcare funding to assist providers in responding to the medical and economic consequences of the novel coronavirus pandemic.

Following recent press and new guidance from the Small Business Administration (SBA), many nonprofit organizations are carefully considering whether borrowing funds under the Paycheck Protection Program (PPP loans) is “necessary” for their organization, a critical component of the loan application.

The Office of Management and Budget (OMB) and several federal agencies have issued guidance implementing a provision in the CARES Act that allows government contractors to be reimbursed for paid leave to employees and subcontractors unable to work during the COVID-19 crisis.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law on March 27, 2020, established the Paycheck Protection Program (PPP), a loan program that made $349 billion available to small businesses using the Small Business Administration’s (SBA) existing 7(a) loan program.

As Washington businesses continue to operate under Governor Jay Inslee’s “Stay Home, Stay Healthy” order in the wake of the global COVID-19 pandemic, workers’ compensation may not be of primary concern.

The U.S. Centers for Disease Control is now recommending that everyone consider wearing facemasks or other face coverings to help prevent the spread of COVID-19 in public settings where social distancing measures are difficult to maintain, which would include many workplaces.

No legal development over the past decades has had a greater impact on the free flow of information and technology than the rise of the open access and open source movements.

The CARES Act, which became law on March 27, 2020, appropriates $100 billion to the Public Health and Social Services Emergency Fund to reimburse providers for unreimbursed expenses and lost revenue attributable to the novel coronavirus pandemic.

In response to the ongoing public health emergency, the Federal Communications Commission released a Report and Order on April 2 establishing a COVID-19 Telehealth Program, along with a broader Connected Care Pilot Program, to support connected care services and devices.

The Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” became law on March 27, 2020. The CARES Act implements wide-ranging changes to law and funding designed to ameliorate the coronavirus pandemic’s impact on the American economy and its workers.

There are many ways that companies can cooperate with each other to combat COVID-19 without running afoul of antitrust laws. But companies considering cooperating with competitors should be aware of and assess potential antitrust risks before they do so.

Recently, the U.S. Department of Justice Antitrust Division and Federal Trade Commission issued a joint statement regarding COVID-19.

The federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to receive reimbursement for services to Medicare, Medicaid, and Children’s Hospital Insurance Program (CHIP) beneficiaries

By a vote of 363-40 the U.S. House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act, on March 14, 2020. The bill now proceeds to the U.S. Senate, and the White House has voiced its support for the legislation.

Due to rising concerns about the recent outbreak of the novel coronavirus, President Trump signed an executive order on March 18, 2020, invoking his authority under the Defense Production Act.

As federal and state governments respond to COVID-19, employers and plan fiduciaries must also address the evolving issues arising under employer-sponsored health plans.

The U.S. Department of Justice (DOJ) has reached a settlement with hospice company AseraCare, closing a 12-year-old saga that carries substantial implications for False Claims Act (FCA) enforcement in cases involving a clinician’s medical judgement.

Employers are rightfully concerned about what, if anything, they should be doing to respond to the continued spread of the coronavirus (COVID-19), with confirmed cases in dozens of countries, including the United States.

The Department of Justice (DOJ) recovered more than $3 billion in settlements and judgments from civil cases involving the False Claims Act (FCA) in the fiscal year ending September 30, 2019, according to statistics released by DOJ on January 9, 2020.

In an August 2019 case argued by Perkins Coie attorneys, the U.S. Bankruptcy Court for the District of Delaware ruled that the automatic stay under section 362(a) of the Bankruptcy Code bars the Centers for Medicare & Medicaid Services (CMS) from withholding Medicare payments to a healthcare provider in bankruptcy notwithstanding a pre-petition suspension due to credible allegations of fraud.

The wave of federal charges against some fifty individuals for college admissions fraud and testing bribery schemes caught numerous universities and much of the United States by surprise.

On November 30, 2018, the solicitor general filed an amicus brief in the U.S. Supreme Court supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the government’s brief disclosed for the first time that it would dismiss the relators’ qui tam complaint on remand, allegedly because discovery would interfere with federal agency responsibilities.

The U.S. Department of Justice (DOJ) and the Attorney General of North Carolina announced a settlement last week in their civil antitrust case against Atrium Health, the largest hospital system in the state of North Carolina.

The DOJ announced a “road map” for the healthcare industry last month to guide voluntary self-disclosures and cooperation with government investigations.

In recent guidance, we wrote about what companies should do to minimize the risk of federal criminal penalties when doing business with or investing in cannabis industry companies.

In recent guidance, we wrote about what companies should do to minimize the risk of federal criminal penalties when doing business with or investing in cannabis industry companies. 

What is the current state of federal enforcement as to cannabis? Are there ways that companies not directly involved in the cannabis industry may still do business with companies in the industry, while minimizing potential exposure to federal criminal penalties under the CSA?

A version of this article was originally published by Bloomberg BNA White Collar Crime Report on April 18, 2018.

Last Friday, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) issued its long-awaited decision in ACA International v. Federal Communications Commission, No. 15-1211 (D.C. Cir. Mar. 16, 2018).

The Federal Trade Commission announced on February 12, 2018, that it has filed an administrative complaint seeking injunctive relief against three large dental supply companies, alleging that they violated the antitrust laws by conspiring to refuse to provide discounts, and sometimes refusing to serve, buying groups representing dental practitioners.

Earlier in 2017, Judge Robert J. Conrad, of the U.S. District Court for the Western District of North Carolina, denied a motion to dismiss the antitrust case brought against the Carolinas HealthCare System (CHS) by the Department of Justice (DOJ) and the Attorney General of North Carolina. The CHS case is the first antitrust challenge of “anti-steering” contract clauses in the health-care industry.

On October 12, 2017, President Donald J. Trump signed an executive order designed to promote choice and competition in healthcare markets. The order was reported as a first step in the administration’s effort to undermine the Affordable Care Act.

The U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers for Medicaid beneficiaries.

As federal and state governments struggle to address future healthcare regulation, demand for healthcare that is cheaper, better and faster continues to surge.

On May 4, 2017, the U.S. House of Representatives approved the American Health Care Act (AHCA) by a vote of 217 to 213 (with 20 Republicans voting against the bill), sending the AHCA to the Senate.

The U.S. Department of Health and Human Services recently announced yet another HIPAA privacy and security settlement involving Protected Health Information on a stolen laptop.

Are you an Applicable Large Employer (ALE) that has received rejected Forms 1095-C from the IRS? If so, you are not alone.

This update was also published by Employee Benefit Advisor on 05.04.2017, "Views Assessing Employer Shared Responsibility Penalties," and by Society for Human Resource Management on 05.05.2017, "Employer Shared Responsibility: Have Penalties Been—or Will Penalties Ever Be—Assessed?"

As deliberations over a replacement of the Affordable Care Act (ACA) continue in the U.S. House of Representatives, the fate of the ACA’s Cost-Sharing Reduction subsidies may be at stake.

On the last day before the U.S. Congress began its spring recess, the U.S. House of Representatives amended the now consolidated bill H.R. 1628, known as the American Health Care Act.

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights of the U.S. Department of Health and Human Services is ongoing, with three settlements and one assessment of penalties already in 2017.

The much-anticipated vote by the U.S. House of Representatives on the “American Health Care Act,” also known as “AHCA” or the “Obamacare replacement bill,” was cancelled last week, leaving many to ask “what now?”

The U. S. House of Representatives (the House) proposed two bills to “repeal and replace Obamacare” this week, and while many popular consumer protections under the Patient Protection and Affordable Care Act (ACA) look to be preserved at this stage, some significant changes are included that could have an impact on employers and other plan sponsors if signed into law. We’ve highlighted a few of these potential changes below. 

With the filing of a class action complaint in late 2016 in the U.S. District Court for the Southern District of Florida, Wal-Mart Stores, Inc. became the latest large company accused of failing to provide adequate notices as required by COBRA.

During his campaign, President-elect Trump promised to make the repeal and replacement of the Affordable Care Act (ACA) a priority. Now that the election is over, what should employers expect?

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge.

The U.S. Supreme Court handed down an important decision on June 16, 2016 that expands the scope of liability under the False Claims Act, 31 U.S.C. §§ 3729-3733.

The U.S. Department of Health and Human Services Office for Civil Rights recently announced the long-awaited launch of Phase 2 of its HIPAA Audit Program.

The U.S. Supreme Court is poised to resolve a circuit split over the False Claims Act (FCA) that could have broad implications for those that do business with the federal government.

On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) published its long-anticipated Final Rule implementing Section 6402(a) of the Patient Protection and Affordable Care Act (ACA) (section 1128J(d) of the Social Security Act (Act)).

In what could be a major setback for the Federal Trade Commission (FTC) in the data security arena, an Administrative Law Judge (ALJ) has ruled that an unfairness claim brought by the FTC under Section 5 of the FTC Act requires a showing that substantial injury to consumers is probable, not merely possible, when there is no evidence of actual consumer injury.

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug, thereby helping to clarify lingering uncertainty over the scope of First Amendment protection afforded statements by drug representatives, at least in states located in the Second Circuit.

The Tax Court of New Jersey decided AHS Hospital Corp. v. Town of Morristown, a case of first impression with potentially serious consequences for nonprofit hospitals seeking to qualify under N.J.S.A. 54:4-3.6, a statutory property tax exemption applicable to “[a]ll buildings actually used for . . . hospital purposes.” 

The United States Supreme Court handed False Claims Act (FCA) defendants a mixed decision on May 26, 2015.  In a win for defendants, the Supreme Court held that the statute of limitations for False Claims Act lawsuits was not suspended for the duration of the Iraq and Afghanistan conflicts.

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in question were not federal healthcare program beneficiaries and the physician practices derived no direct financial benefit from the arrangement.

In a ruling with significant implications for state professional licensing boards and their members, on February 25, 2015, the United States Supreme Court found that practitioner-controlled state boards do not have inherent immunity from federal antitrust liability if they operate without active supervision by disinterested state actors. 

With major data breaches again making news, it is important for corporate policyholders to keep abreast of insurance developments in this emerging and fast-moving area. In this update, we provide some thoughts on cyber liability and reputational insurance trends to watch in the months ahead.

On May 30, 2014, the Departmental Appeals Board (DAB) issued a decision invalidating the long-standing National Coverage Determination (NCD) prohibiting Medicare payment for transsexual surgery (now known as gender reassignment surgery).

On April 22, the U.S. Department of Health and Human Services (HHS) announced settlements with both Concentra Health Services (Concentra) and QCA Health Plan, Inc. (QCA).  Through these latest settlements, HHS is reiterating its message to covered entities and business associates that laptops and similar devices containing electronic protected health information (ePHI) should be encrypted.

The Affordable Care Act added the so-called “Play-or-Pay” mandate or “Employer Shared Responsibility” provisions to the Internal Revenue Code (the Code).

On December 27, 2013, the Department of Health and Human Services published two final rules, one amending the Office of Inspector General’s (OIG) Anti-Kickback safe harbor related to electronic health records (EHR) items and services (42 C.F.R. § 1001.952(y)), and the other amending the Centers for Medicare & Medicaid Services’ (CMS) parallel Stark law exception.

On September 13, 2013 the U.S. Department of the Treasury (IRS), the U.S. Department of Health and Human Services (HHS), and the U.S. Department of Labor (DOL), collectively referred to herein as the Departments, coordinated the issuance of guidance regarding the application of certain provisions of the Affordable Care Act (ACA) to health reimbursement arrangements and other employer-sponsored healthcare arrangements.

The final regulations implementing the Health Information Technology for Economic and Clinical Health (HITECH) Act were issued in January and compliance is required by September 23, 2013.

The Department of Health and Human Services (HHS) announced a settlement on August 14, 2013, with Affinity Health Plan (Affinity), a not-for-profit managed care plan, which included a payment of $1,215,780, for a HIPAA security violation caused by Affinity’s failure to remove Electronic Protected Health Information (EPHI) from the hard drive of a leased photocopier that was returned to the leasing company.

As of August 1, 2013, pharmaceutical companies and medical device manufacturers are required to report to the federal government payments made to physicians under the Physician Payment Sunshine Act (PPSA).

On August 2, 2013, the Centers for Medicare and Medicaid Services (CMS) issued an advance copy of its final rulemaking that adopts a new approach to evaluating the medical necessity of inpatient hospital admissions.

The U.S. Department of the Treasury announced today that after hearing and considering the concerns of employers about the complexity of compliance with the Play-or-Pay requirements under the Affordable Care Act, it is postponing the mandatory employer and insurer reporting requirements until 2015.

Yesterday, the Supreme Court issued its highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc.  The Court unanimously held that isolated genomic DNA is a product of nature and therefore is not patent-eligible under 35 U.S.C. §101.  The Court also held that complementary DNA (cDNA) molecules excluding “intron” portions of the natural DNA sequence are patent eligible.

The Affordable Care Act (the ACA) established the Patient-Centered Outcomes Research Institute (the Institute) in order to provide comparative clinical effectiveness research data so that patients, health care providers, purchasers of health care and insurance products and policy-makers can make informed decisions.

Recently, we published a Client Updateexplaining how the Play-or-Pay mandate, or Employer Shared Responsibility provision, under the Affordable Care Act (ACA) generally works.

The Centers for Medicare & Medicaid Services (CMS) released a ruling and an interim rule that, effective immediately, will allow hospitals to rebill certain inpatient hospital services as outpatient services for one year after the date of service.

In a closely watched decision, a unanimous U.S. Supreme Court has reversed an 11th Circuit decision that invoked the state action doctrine to prevent the Federal Trade Commission (FTC) from challenging a state hospital authorities’ proposed acquisition of a competing hospital.

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug, medical device, biological and medical supply manufacturers to track and report, for publication by CMS, payments made to physicians and teaching hospitals.

As more countries join the Madrid Protocol System for the International Registration of Marks (Madrid System), trademark owners should be sure to take full advantage of this trademark registration option.  There are now 89 members of the Madrid System.  Significantly lower application and maintenance costs, as well as streamlined portfolio management options, are just a few of the reasons why the Madrid System is advantageous for trademark owners.

Final implementing regulations for many provisions of the HITECH Act (Health Insurance Technology for Economic and Clinical Health Act) were issued by the Department of Health and Human Services recently, and will appear in the Federal Register on January 25, 2013. Informally referred to as the Omnibus Rule, the regulations address a number of changes to the HIPAA Privacy Rule, HIPAA Security Rule, HIPAA breach notification rule, HIPAA privacy and security enforcement provisions, Business Associate definition and agreement requirements, and the interaction between HIPAA and the Genetic Information Nondiscrimination Act.

On January 22, 2013, the U.S. Supreme Court issued a unanimous decision in Sebelius v. Auburn Regional Medical Center, 568 U.S. _____ (2013), holding that hospitals cannot appeal Medicare inpatient reimbursement determinations to the Provider Reimbursement Review Board if it has been more than three years since the issuance of  a Notice of Program Reimbursement from a Medicare fiscal intermediary.

Prior to the termination of her employment, Sakile Chenzira worked for more than a decade as a customer service representative at the Cincinnati Children's Hospital Medical Center (the Hospital).  In December 2010, the Hospital fired Chenzira because she refused to be vaccinated against the flu.

The U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued much-anticipated final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any “taxable medical device” by a manufacturer, producer or importer (collectively referred to as “manufacturers”). The IRS simultaneously issued Notice 2012-77, providing interim guidance to manufacturers while it continues to study certain issues that are not addressed by the final regulations.

On November 29, 2012, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a report raising concerns about the Centers for Medicare and Medicaid Services’ (CMS) oversight of the Medicare electronic health record (EHR) incentive program.  The report was based on a review of healthcare professionals’ and hospitals’ meaningful use of certified EHR technology (i.e., the computerized systems that store health-related patient information) from May to December 2011.

On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of the federal Food, Drug and Cosmetic Act (FDCA). A majority of the court held on First Amendment grounds that the misbranding provisions of the FDCA do not “prohibit[] and criminaliz[e] the truthful off-label promotion of FDA-approved prescription drugs.”

On October 5, 2012, the Sixth Circuit reversed an $82.6 million award in a False Claims Act (FCA) lawsuit against Fresenius Medical Care Holdings (Fresenius) and granted partial summary judgment in favor of the defendants.

On July 2, 2012, the Department of Justice announced the largest health care fraud settlement in U.S. history: GlaxoSmithKline LLC (“GSK”) will pay $3 billion to resolve criminal and civil allegations of unlawfully promoting prescription drugs, failing to report safety data and engaging in allegedly false price reporting practices. This resolution includes a criminal fine and forfeiture totaling $1 billion and $2 billion in civil payments.

The U.S. Supreme Court's decision on the health care reform law has been subject to a lot of analysis already, but the bottom line is that all of the health care reform provisions that apply to group health plans and insurers that sell coverage to group health plans have been left standing and employers must make sure that their health plans comply.

In National Federation of Independent Business v. Sebelius, a divided U.S. Supreme Court upheld the vast bulk of the Patient Protection and Affordable Care Act (“ACA” or the “Act”) against a number of challenges.

On May 7, 2012, the Justice Department announced that Abbott Laboratories Inc. (“Abbott”) has agreed to pay $1.5 billion to resolve criminal and civil investigations into the company’s promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (“FDA”).  The resolution, which is the second-largest settlement ever for a drug company, includes a criminal fine and forfeiture totaling $700 million and civil payments with the federal government and states totaling $800 million.  Whistleblowers will receive $84 million from the federal share of the settlement amount.  With this settlement, the Justice Department has recovered over $10.2 billion in False Claims Act cases and has secured $3.9 billion in criminal fines, forfeitures, disgorgements and restitution relating to violations of the Food, Drug and Cosmetic Act (“FDCA”) since January 2009.

On May 4, 2012, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will not require applicable manufacturers and group purchasing organizations (“GPOs”) to begin collecting data on relevant payments under the Physician Payment Sunshine Act (“Act” or “Sunshine Act”) until January 1, 2013.  Under the Sunshine Act, data collection was set to begin January 1, 2012.

A small cardiac surgery practice (two owners; currently five physicians) is the latest covered entity to enter into a settlement agreement and Corrective Action Plan (CAP) with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), to resolve alleged violations of the HIPAA privacy and security regulations.  In announcing the $100,000 settlement OCR Director Leon Rodriguez stated, "OCR expects full compliance no matter the size of a covered entity."

In Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the Supreme Court has unanimously held that generic drug manufacturers may invoke the counterclaim provision of the Hatch-Waxman Act.

BlueCross BlueShield of Tennessee (BCBST) has agreed to pay $1.5 million to the U.S. Department of Health and Human Services (HHS) and enter into a Corrective Action Plan (CAP) to settle alleged violations of the HIPAA privacy and security regulations. The enforcement action arose from the theft of 57 hard drives that contained audio and video recordings of customer service calls and included electronic protected health information (ePHI) of over one million individuals. The settlement resolves HHS’s first enforcement action in connection with the Health Information Technology for Economic and Clinical Health (HITECH) Act Breach Notification Rule.  The CAP also provides insight into the kinds of security measures HHS expects companies in possession of ePHI to have in place.

In the final hours of its regular session, the Washington Legislature enacted the Washington Medicaid Fraud False Claims Act.

The U.S. Department of Justice announced on February 6, 2012 that medical device company Smith & Nephew Inc. has agreed to pay over $22 million to settle Foreign Corrupt Practices Act allegations that it paid government-employed doctors in Greece to use its products.

The Centers for Medicare and Medicaid Services published proposed regulations today under the Physician Payment Sunshine Act.

The Physician Payment Sunshine Act, enacted into law as part of the Health Care Reform package in 2010, will require the tracking and reporting to the government of payments made on or after January 1, 2012 by drug, medical device and medical supply manufacturers to physicians and teaching hospitals.

An overview of the government’s tools and authorities to combat fraud in COVID-19 relief spending and the anticipated areas of focus for the U.S. Department of Justice as well as other new and existing investigative entities.

As U.S. officials encourage Americans and American companies to prepare for, and as some companies are already dealing with significant disruptions to their daily routines, employers need to keep in mind the current state of applicable employment laws when implementing a response.

What you need to know now about your current coverage and what you need to know now to protect your company at renewal.