log in
Submit an Article | Back

Member Articles

Healthcare & Pharmaceuticals - all

 

Sort By Title  |  Sort By Date

"A Cost-Effective Approach to Protecting Innovation in Healthcare" by Nate Bailey and Nicolo Davidson Executive Nashville
Waller, September 2016

With healthcare costs expected to soon exceed twenty percent of the United States economy, the healthcare industry represents fertile ground for innovation. From medical devices and pharmaceuticals to methods for managing patient data, new technologies continue to improve patient care and outcomes. Such innovation is vital for ensuring that the healthcare industry continues to meet the demands of aging populations in the 21st century.http://executivenashville...

"How to De-stress a Distressed Senior Living Company" Co-Authored by Jeffery D Parrish and John C Tishler
Waller, February 2017

External pressures, such as lower reimbursement rates and an overall shift in policy by the Centers for Medicare and Medicaid Services (CMS) and state Medicaid agencies have put significant financial and operational pressure on skilled nursing and other senior living operators in the United States...

"IRS Taking Harder Look at Non-Profit Hospitals" Don Stuart Quoted in FierceHealthcare
Waller, October 2016

The Internal Revenue Service (IRS) is ratcheting up surveillance of non-profit hospitals regarding their levels of community benefits and patient financial assistance. The IRS reviewed 692 hospitals in fiscal 2016, which ended late last month, Bloomberg BNA has reported. Of those, 166 were referred for a closer “field examination...

"QAPI Spells Success for SNFs" Jeff Parrish in McKnight's Long-Term Care News
Waller, August 2018

The skilled nursing sector has seen a significant number of facility divestitures and closures in the last few years. Quite frankly, this negative trend is due in part to a reluctance by some operators to implement clinical-based care standards and a lack of honest self-evaluation to improve the clinical care provided at skilled nursing facilities. Outdated operating models – solely meeting the basic needs of patients – does not bode well for SNF operators to survive...

"What Anesthesiologists Need to Know About Enforcement of Non-Compete Agreements" by Amanda K Jester and Ashleigh VanLandingham Anesthesia Communique
Waller, October 2016

On May 5, 2016, the White House issued a report citing a variety of issues with the use of non-compete agreements advocating for non-compete reform at the state and federal level.1 According to the White House report, with respect to healthcare services (i.e., physicians, nurses, psychologists, social workers and other medical professionals), noncompetes have the potential to interfere with the quality of care by restricting consumer choice...

"Will Growth Consolidation Lead Residential Addiction Treatment Industry to Police Itself in Terms of Ethics & Marketing" by Colbey Reagan Nashville Medical News
Waller, September 2017

At this year’s annual meeting of the National Association of Addiction Treatment Providers in Austin, there was a clear divide on display between the “old school” and the “new school” during a session on electronic marketing strategies. The number of residential addiction treatment providers operating in the United States has exploded since the passage of the Affordable Care Act in March 2010...

$39 Million Jury Verdict in False Claims Act Suit against Tuomey Healthcare
Haynes and Boone, LLP, May 2013

Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013)...

‘Human’ Influenza and Its Repercussions on the Mexican Industry
Moore Stephens Orozco Medina, S.C., May 2009

a) Influenza and the social impact it had on Mexico and the World Despite the fact that mankind, especially the scientific community, already expected an influenza pandemic, as the ones that are repeated every 20-40 years, this outbreak took by surprise both Mexicans and foreigners, creating fear among citizens...

10 things to know about pharmaceutical regulation in Ukraine
Asters, October 2016

1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2...

2013 Texas Legislative Session – Select Healthcare Issues
Waller, May 2013

The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4...

2019 West Virginia Legislative Highlights: Health Care
Dinsmore & Shohl LLP, June 2019

Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care...

21st Century Cures Act Holds Promise for Seniors and Senior Care Providers
Hanson Bridgett LLP, January 2017

As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform...

340B Drug Ceiling Prices Now Available
Dinsmore & Shohl LLP, April 2019

On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site).  Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa...

5 of the Biggest Myths About GDPR Data Protection - and Why You Shouldn't Believe Them
Waller, March 2018

You may have heard something about GDPR lately and thought "Why should I care? It probably won't affect me or my business.” In reality, the implications of GDPR are far-reaching. The European Union’s General Data Protection Regulation (GDPR) is a set of regulations strengthening data privacy and protection laws for residents of the EU. The regulations take effect in just two months: May 25, to be exact...

A Closer Look at the Final ACO Rule
Waller, October 2011

On October 20th, the federal government released a final rule and other companion releases relating to Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP), a key component of the Affordable Care Act enacted in March 2010. The proposed rule, issued in March 2011, generated extensive comment from the healthcare industry...

A Closer Look at the Two Midnight Rule as CMS Delays Enforcement Again Amid Legislative and Judicial Challenges
Waller, February 2014

CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014...

A Fly in the Water Bottle: The Supreme Court Defines Reasonable Foreseeability in Negligence Actions
Lavery Lawyers, December 2008

On May 22, 2008, the Supreme Court of Canada rendered its decision in a case involving the notion of reasonable foreseeability in negligence actions. This judgment, written by the Chief Justice, confirms that tort law must compensate harm done on the basis of reasonable foresight, and must not be considered as insurance...

A physician’s refusal to undergo refresher training is sufficient grounds for a health institution to deny the renewal of status and privileges
Lavery Lawyers, September 2015

On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago...

A Relationship Like No Other – IP & Pharmaceuticals
Karanovic & Partners, May 2016

As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way...

A Tale of Two Class Actions: U.S Supreme Court Ruling Allows State Litigation to Proceed Despite Federal Injunction
Haynes and Boone, LLP, June 2011

On June 16, 2011, the Supreme Court issued an opinion in Smith v. Bayer allowing a plaintiff to pursue class certification in a state court action after a federal court had denied certification in a substantially similar case. The Court held that it was improper for the federal court to enjoin the state proceeding under the “relitigation exception” of the Anti-Injunction Act because the issues were not identical and the state court plaintiff was not a party to the federal lawsuit...

ABA Section of Taxation Fall Meeting
Haynes and Boone, LLP, August 2002

HIPAA Privacy Primer for Group Health Plans The HIPAA Privacy regulations will apply to group health plans beginning on April 14, 2003. The HIPAA Privacy regulations require changes in group health plan contracts and operations and impact the entire organization sponsoring the group health plan...

Access to Medical Record - The Principle of Relevance and the Extent of Disclosure
Lavery Lawyers, June 2005

On May 20, 2005, the Supreme Court issued its judgment in the Smith & Nephew Inc. v. Louise Glegg and Christopher Carter and Gilles Dextradeur v. Louise Glegg cases1...

ACO Final Rules Released
Waller, October 2011

Today the federal government released final rules for the formation and operation of Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. The regulations initially proposed in March 2011 generated considerable attention and comment as ACOs represent a key component of the Affordable Care Act, the healthcare reform legislation enacted in 2010...

ACOs Face Large Start-Up Costs, Uncertain Savings and Possible Losses Under Proposed Rules from CMS
Haynes and Boone, LLP, April 2011

Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it...

ACOs: The Next Generation
Haynes and Boone, LLP, March 2015

On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care...

Actions of the Government Against ‘Miracle Products’
Basham, Ringe y Correa, S.C., February 2012

In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties...

Additional Information About Accountable Care Organizations
Waller, April 2011

As we stated in our bulletin last week, on March 31st, the federal government outlined proposed actions relating to Accountable Care Organizations (ACOs), a key component of the healthcare reform legislation (the Affordable Care Act, or ACA) enacted in March 2010. In this bulletin, we provide some additional information regarding each of the March 31st releases...

Advance Medical Directives (Part 1 of 2)
Lavery Lawyers, August 2016

Consent to End-of-Life Care Article 11 of the Civil Code of Québec1 states that no one can be made to undergo care without his consent. The Act respecting end-of-life care2 ("the Act"), passed by the National Assembly of Québec, came into force on December 15, 2015. Since that date, a person can give or refuse consent to specific forms of end-of-life care, provided he has given advance medical directives ("AMDs") for that purpose...

ALERT: IRS Publishes Final Intermediate Sanction Rule
Haynes and Boone, LLP, January 2002

On January 23, the Internal Revenue Service published its long-awaited final rule on intermediate sanctions in the Federal Register. Proposed regulations were published in 1998, followed by temporary and proposed regulations in January 2001. The rule implements the excise taxes on excess benefit transactions under Section 4958 of the Internal Revenue Code, which was enacted by the Taxpayer Bill of Rights...

Alex Mills Posts "Many Questions Left Unanswered in the Wake of Long-awaited CMS Proposed Rule Regarding Off-Campus Provider-Based Departments" on Waller Healthcare Blog
Waller, July 2016

Late last week, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting...

Alex Mills Posts "More Belt-Tightening for Home Health Providers as CMS Proposes Update to Prospective Payment System" on Waller Healthcare Blog
Waller, June 2016

The home health industry could see its profit margins shrink further as a result of proposed updates to the Home Health Prospective Payment System (HH PPS) released by the Centers for Medicare & Medicaid Services (CMS) earlier this week. This is the fourth and final year of payment reductions mandated by the Affordable Care Act in response to perceived Medicare overpayments to home health agencies. Profit margins are estimated to average 17.2% for the home health industry, and $17...

Amazon Sets Out to Tackle Healthcare Costs
Waller, February 2018

This week we learned that Amazon, Berkshire Hathaway and J.P. Morgan Chase have joined forces to tackle employee healthcare costs.  This announcement marks yet another chapter in some employers' frustration with our nation’s healthcare system.  Employees are equally tired of the increasing cost of healthcare eating away what should be their wage increases even as employers pay for ever increasing health insurance premiums...

Amendments to Health Law
Basham, Ringe y Correa, S.C., June 2005

On June 28, 2005, amendments to Articles 420 and 421 as well as the addition of a new Article 414bis of the Health Law were published in the Federal Official Gazette, entering into force the following day. Article 414bis provides that herbal products, food supplements, perfumes and beauty products may be seized, as a precautionary measure, when they have been improperly advertised by being held out as medicines or as having characteristics or therapeutic qualities which they do not have...

Amendments to the Patent Linkage Mechanism in the Latest “Measures for the Administration of Drug Registration (Revised Draft)”
Han Kun Law Offices, July 2016

On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...

An In-Depth Look at the Fraud Charges Against Vitas Hospice Services
Waller, May 2013

Earlier this month, the United States Department of Justice (“DOJ”) filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities (“Vitas”) alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill...

Anthem Breach a Sign of Increased Attacks on Health Care Institutions
Verrill Dana, LLP, March 2015

The attack on Anthem’s networks that exposed the Personally Identifiable Information (PII) of as many as 80 million Anthem health insurance customers brings home the importance of cyber hygiene at the individual as well as the corporate level. On February 5, 2015, Anthem reported that cyber criminals gained access to its customer databases through sophisticated hacking techniques that involved impersonating administrator logons to run database queries and extract troves of PII...

Antitrust Enforcement Update: FTC Agrees to Settlement with Renown Health Over Acquisitions of Cardiology Practices in Reno
Waller, August 2012

The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized.  While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets...

Appeals Court Overturns $44 Million Judgment Against Tuomey Hospital in Important Stark Law Case
Haynes and Boone, LLP, April 2012

The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception...

Are Ohio Prescribers and Pharmacies Prepared for the New Requirement to Include ICD-10 Diagnosis Codes on All Controlled Substance Prescriptions?
Dinsmore & Shohl LLP, August 2017

We previously reported that on March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain...

Are Stronger Dietary Supplement Regulations on the Horizon?
Dinsmore & Shohl LLP, April 2019

FDA Announces Public Meeting for Responsible Innovation in Dietary Supplements Industry Recently, the Federal Food and Drug Administration (FDA) announced it will hold a full-day public meeting to discuss strategies for responsible innovation in the dietary supplement industry.  The meeting will be held May 16, 2019, from 8:30 a.m. EST to 4 p.m. EST at the FDA Center for Food Safety and Applied Nutrition, Wiley Auditorium, located at 5001 Campus Dr., College Park, MD 20740...

Are you compliant with the Revised 42 CFR Part 2?
Dinsmore & Shohl LLP, July 2017

It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017...

Attorney General Announces Ninth Annual Fraud Takedown Targeting Opioid Epidemic
Dinsmore & Shohl LLP, July 2018

On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings...

Attorney’s Don Stuart and Kim Looney Author Chapters in “The ACO Handbook: A Guide to Accountable Care Organizations, Second Edition”
Waller, March 2015

Don Stuart, a partner in Waller’s Tax Practice Group and current Chair of the Tax and Finance Practice Group of the American Health Lawyers Association (AHLA), and Kim Looney, partner in the firm’s Healthcare Compliance and Operations group, are authors on two chapters in the AHLA’s new publication The ACO Handbook: A Guide to Accountable Care Organizations, Second Edition...

Authorization of Treatment and Placement: The Québec Court of Appeal Clarifies the Meaning of Article 393 C.C.P.
Lavery Lawyers, June 2016

On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital...

Best Practices For Sellers in The Evolving DSO Marketplace
Dykema, January 2019

The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices...

Beth Pitman Posts "HHS Issues Proposed Rule for MACRA Quality Payment Program" on Waller Healthcare Blog
Waller, May 2016

Following up on the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Department of Health and Human Services (HHS) recently issued a proposed rule to replace the Medicare sustainable growth rate (SGR) methodology which was repealed by MACRA. The proposed rule would implement the Merit-based Incentive Payment System (MIPS) to replace SGR and establish incentives for participation in Advanced Alternative Payment Models (Advanced APMs)...

Beth Vessel Ashleigh VanLandingham Posts "Flurry of Activity Signals FTCs Ongoing Interest in Healthcare Transactions" on Waller Healthcare Blog
Waller, April 2016

A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems...

Biobanks-is Lithuania ready for them?
Ellex Valiunas, September 2012

Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world...

Bio-Device Partnering – Legal Issues
Shepherd and Wedderburn LLP, July 2006

Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace...

Biotech Year in Review 2005 Supreme Court and Federal Circuit cases having an effect on chemical, pharmaceutical and biotech practice in 2005.
Hunton Andrews Kurth LLP, May 2006

Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas...

 

 

WSG's members are independent firms and are not affiliated in the joint practice of professional services. Each member exercises its own individual judgments on all client matters.

HOME | SITE MAP | GLANCE | PRIVACY POLICY | DISCLAIMER |  © World Services Group, 2019