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OBWC to Phase Out Coverage of OxyContin
Dinsmore & Shohl LLP, June 2019

The Ohio Bureau of Workers’ Compensation will no longer offer coverage for OxyContin by the end of 2019. The agency announced this change, given the drug’s potential for abuse, misuse, addiction, and dependence. The BWC will no longer pay for OxyContin or generic forms of the medication for workers who suffer an industrial injury on or after June 1, 2019. Injured workers who are currently on OxyContin will have until Dec...

'Modernizing Ignitable Liquids Determinations' Proposed Rule
Dinsmore & Shohl LLP, June 2019

On April 2, 2019, the United States Environmental Protection Agency (EPA) published its proposed “Modernizing Ignitable Liquids Determinations” rule in the Federal Register.[1]  Ostensibly, the rule is, as described in its title, an effort to “modernize” – i.e., update – certain aspects of the regulations relating to determining whether a waste is a hazardous waste based on the characteristic of ignitability, which are found in 40 C.F.R. 261...

U.S. Supreme Court Sides with Hospitals in Allina DSH Part C Days Decision
Verrill, June 2019

On June 3, 2019, the U.S. Supreme Court (“Court”) issued a 7-1 decision in Azar v. Allina Health Services, favoring hospitals that had sued the U.S. Department of Health and Human Services (“HHS”) over a Medicare payment policy change...

Op-ed: Blockchain Has the Power to Transform the Patient Experience
Schwabe, Williamson & Wyatt, June 2019

Brenna K. Legaard is a registered patent attorney with Schwabe, Williamson & Wyatt. Legaard wrote the following op-ed on the use of blockchain technology in health care.    When health care professionals and consumers think of blockchain, their minds very likely go to famous cryptocurrencies like Bitcoin. But blockchain technology can be applied to so much more, including to the field of health care...

HHS Proposes New Rule to Revise Section 1557 and Repeal Notice Requirements
Dinsmore & Shohl LLP, June 2019

On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications...

HHS Publishes New Fact Sheet on Business Associate Direct Liability
Dinsmore & Shohl LLP, June 2019

On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules)...

EPA Hazardous Waste Pharmaceuticals Rule Mandates Changes for Health Care Facilities 
Dinsmore & Shohl LLP, June 2019

Environmental Protection Agency (EPA) has issued a new rule that will impact the operations of a wide-range of health care facilities and the manner in which those facilities manage hazardous waste pharmaceuticals...

CMS Publishes Long-Awaited Final Rule Requiring Drug Pricing Transparency
Dinsmore & Shohl LLP, June 2019

On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) published its final rule, 42 CFR 403, requiring drug manufacturers to disclose the price of prescription drugs in direct to consumer (DTC) advertisements. Publication of the final rule was preceded by a lively comment period that commenced on October 18, 2018...

Summer is Here, But Will Your Medicare Outpatient Claims Get Paid?
Verrill, June 2019

CMS’ Exact Match Requirement for Addresses Your hospital may have some corrective work to do over the next few weeks if you want to avoid delays in receiving payment for your Medicare claims for services rendered at off-campus outpatient provider-based departments...

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...

Canadian Trademark Law is Changing This Year – What You Need to Know Now
Dinsmore & Shohl LLP, May 2019

Trademark law in Canada is undergoing a major change this year that will go into effect on June 17, 2019.  We have compiled the three things you need to know and important steps you may want to take before the June 17, 2019 date passes.  1...

Schedule A Regulations Streamline the Process for Acquiring Permanent Residency for Registered Nurses and Physical Therapists
Dinsmore & Shohl LLP, May 2019

Many employers currently have employees on staff on temporary work visas, and employers likely know that in order to continue to employ employees not born in the U.S., the employer must sponsor the employee for permanent residency in the U.S. (i.e,. a green card). The green card process has multiple steps, which, depending on a variety of factors, may take several years to complete...

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...

Health Data Confidentiality on a Rise in the UAE
Afridi & Angell, April 2019

Recent events, including the investigations into Facebook’s handling of its users’ personal data, have highlighted the realization that personal data is, in today’s world, one of the most valuable resources for any business and that businesses not only collect and store their customers’ personal data but also use and even sell it for profit...

Successor Employers Acquiring Unionized Workforces Benefit From NLRB Decision
Hanson Bridgett LLP, April 2019

In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce...

Possible Changes to the Legalization and Regulation of Hemp and CBD Oil
Dinsmore & Shohl LLP, April 2019

The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds...

OCR Publishes Recommendations to Prepare for Cybersecurity Threats
Dinsmore & Shohl LLP, April 2019

The Department of Health and Human Services Office of Civil Rights (OCR) Spring 2019 Cybersecurity Newsletter includes new recommendations regarding how HIPAA covered entities can prepare to defend against cybersecurity attacks such as advanced persistent threats (APTs) and zero-day vulnerabilities...

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...

Federal Court Grants Broad Access to Mental Health Facility's Residents, Records for Purposes of Investigation
Dinsmore & Shohl LLP, March 2019

A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities...

New OARRS Reporting Obligations Become Effective March 19, 2019
Dinsmore & Shohl LLP, March 2019

Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS)...

Tennessee Healthcare Providers Get a First Look at Gov Bill Lee's Priorities
Waller, March 2019

Earlier this week, Tennessee Governor Bill Lee delivered his first State of the State, which included a number of proposals that could impact healthcare in Tennessee: Healthcare Modernization Task Force–Gov...

Ohio Enacts New Cybersecurity Requirements for Insurers
Dinsmore & Shohl LLP, February 2019

Senate Bill 273 goes into effect on March 20, 2019, and creates new requirements for Ohio insurance companies, including health insurance plans, to develop and implement specific information security programs to safeguard nonpublic business and personal information. Senate Bill 273 is based upon the National Association of Insurance Commissioners’ Insurance Data Security Model Law (also referred to as "MDL-668")...

Medical Marijuana Rollout in Ohio
Dinsmore & Shohl LLP, February 2019

The Ohio medical marijuana market saw a robust start to sales on January 16, 2019.  First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales)...

Proposed Bill Would Increase Skilled Nursing and Intermediate Care Facility Citations and Penalties
Hanson Bridgett LLP, February 2019

On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts...

HHS Proposes Changes to Prescription Drug Rebates and Discounts Kickback Safe Harbors
Dinsmore & Shohl LLP, February 2019

On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts...

 

 

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