log in
Submit an Article | Back

Member Articles

Healthcare & Pharmaceuticals - all

 

Sort By Title  |  Sort By Date

IRS Issues Proposed Regulations Regarding Individual Coverage HRAs
Dinsmore & Shohl LLP, October 2019

On Sept. 30, 2019, the IRS issued proposed regulations regarding how the employer-shared-responsibility provisions of the Affordable Care Act (ACA) and certain nondiscrimination rules under the Internal Revenue Code (Code) will apply to individual coverage health reimbursement accounts (HRAs). The proposed regulations aim to facilitate the adoption of individual coverage HRAs by employers on or after Jan. 1, 2020.   Background On Oct...

Kentucky Proposed 340B Policy and Procedures Manual
Dinsmore & Shohl LLP, October 2019

The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers...

Changes to Definition of Ambulatory Surgical Facilities to Impact Hospitals
Dinsmore & Shohl LLP, October 2019

Effective Oct. 17, 2019, hospital outpatient departments (HOPDs) and other facilities which previously were exempt from the Ambulatory Surgical Facility (ASF) licensure requirement may now meet the criteria of an ASF. Governor Mike DeWine’s budget bill contained provisions which modified the definition of an ASF and will expand the number of facilities subject to regulation under Ohio law as an ASF...

Dental Practice Pays $10,000 in HIPAA Settlements for Disclosing Personal Health Information on Social Media
Dinsmore & Shohl LLP, October 2019

Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry...

FDA to Convene Metal-Containing Implants and Dental Amalgams Panel, Nov. 13-14, 2019
Dinsmore & Shohl LLP, October 2019

FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams...

Recent California Court of Appeal Decisions Highlight Importance of Process and Need for Signature of Authorized Individual to Secure Binding Arbitration Agreement
Hanson Bridgett LLP, September 2019

Two recent opinions of the California Court of Appeal address the enforcement of arbitration agreements in the senior care setting when executed by someone other than the resident. The Court of Appeal's decisions in Valentine v. Plum Healthcare Group, LLC (2019) 37 Cal.App.5th 1076 (Valentine) and Lopez v. Bartlett Care Center LLC (2019) ____ Cal.App...

CMS Cracking Down on Health Care Fraud and Abuse
Verrill, September 2019

To increase provider and supplier transparency and accountability, the Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule (“Final Rule”) with comment period that allows CMS greater ability to prevent fraud and abuse by providers and suppliers enrolled in federal health care programs such as Medicare, Medicaid, and the Children’s Health Insurance Programs (“CHIP”)...

Update on Epple: California's "New" Procedure for Providing Medical Interventions Requiring Informed Consent to SNF Residents Who Lack Both Capacity and a Legal Representative
Hanson Bridgett LLP, September 2019

California Health and Safety Code section 1418.8 outlines the requirements a skilled nursing facility (SNF) must follow when a physician prescribes a medical intervention that requires informed consent for an "unfriended" resident, meaning an individual who lacks capacity and does not have a person with legal authority to make health care decisions on their behalf. Section 1418...

Eleventh Circuit Rejects Expert Challenge to Clinical Judgment Decision in Hospice False Claims Act Litigation
Dykema, September 2019

On September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision for health care providers, especially those in the hospice industry. In U.S. v. AseraCare, Inc.,No.16-13004, Slip. Op. (11thCir. September 9, 2019), the Court held that a “reasonable disagreement between medical experts” about prognosis for a terminally ill patient, without more, cannot establish falsity. Slip. Op. at 3...

BORIM Issues Guidance on Recent Changes to Practice of Medicine Regulations
Verrill, September 2019

The Massachusetts Board of Registration in Medicine (“BORIM”) recently finalized revisions to 243 CMR 2.00 (Licensure and the Practice of Medicine). These changes took effect on August 9, 2019. Because of the uncertainty resulting from certain of those changes, on September 6, 2019, BORIM issued guidance in the form of responses to “Frequently Asked Questions” (“FAQs”)...

New Regulations for Binding Pre-Dispute Arbitration Agreements with Long-Term Care Residents
Hanson Bridgett LLP, August 2019

In 2016, the Centers for Medicare and Medicaid Services (CMS) issued regulations that prohibited long-term care facilities from entering into pre-dispute arbitration agreements with residents and their families. Shortly thereafter, those regulations were successfully challenged in federal court, and CMS has not attempted to enforce them. On July 18, 2019, CMS issued a final rule that will formally rescind the ban on pre-dispute arbitration agreements with long-term care residents...

Massachusetts Final Budget: How the Act will Affect Pharmaceutical Companies
Verrill, August 2019

On July 31, 2019, Governor Charlie Baker signed a $43.3 billion fiscal year 2020 budget (“General Appropriations Act”). Originating from the Conference Committee’s budget, the General Appropriations Act accounts for any vetoes by the Governor and any overrides by the Massachusetts House of Representatives (“House”) and Senate. The House and Senate voted in favor of the Conference Committee’s budget, H. 4000, on July 22, 2019, almost unanimously...

Massachusetts Budget Update: Commonwealth Now Waiting on Governor Baker
Verrill, July 2019

On July 22, 2019, the Massachusetts House of Representatives (“House”) and Senate Conference Committee (“Conference Committee”) released the Commonwealth’s $43.1 billion fiscal year 2020 budget bill (“H. 4000”). It passed the House unanimously and the Senate by 39-1. H. 4000 now heads to Governor Charlie Baker...

Ohio Lawmakers Decriminalize Hemp, Hemp Products
Dinsmore & Shohl LLP, July 2019

Legislation Aligns State and Federal Laws On July 17, 2019, Ohio lawmakers passed Senate Bill (S.B.) No. 57, which decriminalizes hemp and creates licensure programs for those wanting to cultivate or process hemp and hemp byproducts.  Ohio was one of the few states that did not update its statutes to align with federal regulations following the passage of the 2018 Farm Bill, which removed hemp as a controlled substance at the federal level...

Ohio Department of Commerce to Conduct Public Hearing on Proposed Amendments to Medical Marijuana Rules
Dinsmore & Shohl LLP, July 2019

On July 23, 2019, the Ohio Department of Commerce will conduct a public hearing regarding proposed amendments to several Medical Marijuana Control Program rules. The Medical Marijuana Control Program allows individuals with specified medical conditions, upon the recommendation of an Ohio-licensed physician, to purchase and use medical marijuana. The rules govern the activities of medical marijuana cultivators, processors, and testing laboratories...

Health Care Fraud and Abuse Enforcement Overview 2018
Waller, July 2019

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released the Health Care Fraud and Abuse Control Program Annual Report. The 2018 Report highlighted key enforcement areas and policy considerations. The Health Insurance Portability and Accountability Act of 1996 established a national Health Care Fraud and Abuse Control Program (the Program) under the direction of the Attorney General and the Secretary of HHS...

PA Board of Pharmacy Issues Compounding Regulations
Dinsmore & Shohl LLP, July 2019

After nine years of deliberation, the Pennsylvania Board of Pharmacy (Board) issued final regulations (effective June 22, 2019) setting new standards for pharmacist compounding of drug products.  While the final regulations are substantially less onerous than as originally proposed, the regulations represent the Board’s commitment to ensuring compounding is performed in a safe and reliable manner in Pennsylvania...

Skilled Nursing Facilities No Longer Permitted to Bill for Room and Board for Residents Receiving Hospice Care
Dinsmore & Shohl LLP, June 2019

Beginning July 1, 2019, the Ohio Department of Medicaid (ODM) is requiring all Ohio managed care plans to make room and board payments directly to hospice providers when hospice services are provided to individuals residing at skilled nursing facilities (SNF)...

How Operators Can Maximize the Benefits of MSHA’s New and Improved Mine Data Retrieval System
Dinsmore & Shohl LLP, June 2019

On June 13, 2019, the Mine Safety and Health Administration (MSHA) announced it had completed its upgrade of its Mine Data Retrieval System (MDRS). Under the new system, mine operators will have new tools to help review compliance with MSHA regulations as well as assessing employment and production records. The upgraded system will also enable mine operators to track accidents, inspections, violation history, and health sampling data...

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)...

 

 

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