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Price Transparency is Coming: Time to Get Ready
Dinsmore & Shohl LLP, January 2020

The Centers for Medicare & Medicaid Services (CMS) recently released a final rule, which will require hospitals to publicly disclose pricing information, effective January 1, 2021...

H-1B Visa Filing Season: New Registration Process Begins March 1
Dinsmore & Shohl LLP, January 2020

Why is H-1B Filing Season Important? This is the only time of year (with minor exceptions indicated below) U.S. Citizenship and Immigration Services (USCIS) accepts H-1B specialty worker petitions for the next fiscal year, which begins Oct. 1, 2020...

Pennsylvania Health Insurers Must Cover Medication Synchronization Services Beginning July 2020
Dinsmore & Shohl LLP, January 2020

Beginning July 1, 2020, Pennsylvania’s Act 46 of 2019 (Act 46)[1] will require most Pennsylvania health insurers to cover medication synchronization services (MedSync) provided to patients taking two or more maintenance medications (i.e., medications for chronic long-term conditions, including diabetes, high blood pressure, and heart disease)...

CMS Releases Bulletin Discussing Best Practices for Avoiding 340B Duplicate Discounts in Medicaid
Dinsmore & Shohl LLP, January 2020

On Jan. 8, 2020, the Centers for Medicare and Medicaid Services (CMS) published an informational bulletin titled “Best Practices for Avoiding 340B Duplicate Discounts in Medicaid.”[1] The bulletin outlines seven regulatory strategies State Medicaid agencies may consider when developing policies for preventing the occurrence of duplicate discounts in Medicaid Fee-for-Services (FFS) and Medicaid Managed Care Organization (MCO) programs...

OCR Announces Recent Enforcement Actions and Settlements for HIPAA Noncompliance
Dinsmore & Shohl LLP, January 2020

The Department of Health and Human Services (HHS), Office for Civil Rights (OCR) has announced several recent enforcement actions and settlements for violations of Health Insurance Portability and Accountability Act (HIPAA) rules. Ambulance Company Pays $65,000 to Settle Allegations of Long-Standing HIPAA Noncompliance On Dec. 30, 2019, West Georgia Ambulance, Inc...

"Sunshine Law Shining a Light on Governmental Hospital Transactions" Ken Marlow in The Governance Institute's Public Focus
Waller, December 2019

Governance and social factors play a significant role in determining a hospital’s openness to change and its ability to complete a business transaction, be that a merger, acquisition, or other strategic partnership. For government-owned hospitals, tension between the goals of government entities and the goals of a hospital’s board, in addition to added legal complexities, may result in failed or generally avoided transactions...

Under New California Law, Health Care Entities Must Promptly Report Allegations of Sexual Abuse or Sexual Misconduct to Licensing Boards
Hanson Bridgett LLP, December 2019

Under a new state law that takes effect January 1, 2020, California health care facilities and other entities must report any written allegations that a physician or other healing arts licensee has sexually abused or engaged in sexual misconduct with respect to a patient. Sexual misconduct is defined as "inappropriate contact or communication of a sexual nature." SB 425 (Hill) amends the Business and Professions Code to add a new provision, Section 805.8...

California Individual Mandate for Health Coverage Takes Effect in 2020
Hanson Bridgett LLP, December 2019

Starting next year, California residents who don’t have health care coverage could face a state tax penalty. Under the new Minimum Essential Coverage Individual Mandate, California residents who fail to maintain minimum essential coverage for themselves and their dependents could owe a state tax penalty, unless they qualify for an exemption...

Ohio Board of Pharmacy Issues Important Notice to all Licensees Regarding Extortion Scam
Dinsmore & Shohl LLP, December 2019

The Ohio Board of Pharmacy (“Board of Pharmacy”) recently issued a notice to all Board of Pharmacy licensees to be on alert for a scam being perpetrated against Ohio health care providers...

Avoid Rejection: Make Sure Your Medicare Cost Report is Properly Completed
Verrill, December 2019

As the calendar year draws to a close, hospitals with a 9/30 fiscal year end are working intensely on completing their FY 2019 Medicare cost reports. This seemed like a good time to remind everyone of some of CMS’s more recent stringent cost reporting requirements. In many cases, a MAC will reject a cost report for lack of supporting documentation, especially in the following areas, which CMS addressed in Medicare Learning Matters No. SE19015...

Court Annuls FOPH Order Limiting Medicinal Product Price Increase
Walder Wyss Ltd., December 2019

On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers...

Compliance Requirements Heightened Under New Pharmacy Board Rules
Dinsmore & Shohl LLP, November 2019

Beginning Dec. 1, 2019, pharmacists licensed by the State of Ohio Board of Pharmacy (“Board”) will have new reporting requirements. The Board enacted similar reporting requirements for pharmacy interns, pharmacy technician trainees, and registered and certified pharmacy technicians. These new reporting requirements add to existing compliance considerations and burdens for licensees, registrants, their employers, and owners and operators of retail and institutional pharmacies...

Emerging Concerns Regarding Silica Exposure in the Engineered Stone Industry
Dinsmore & Shohl LLP, November 2019

The dangers of workers developing silicosis amid the fabrication of engineered stone has become a topic heavily discussed in the news and elsewhere recently. Silicosis is a lung disease that develops from the exposure and inhalation of silica particles. On October 2, National Public Radio (“NPR”) aired a story entitled “Workers Are Falling Ill, Even Dying, After Making Kitchen Countertops...

"The Bridge to Blockchain in Health Care Guidance for Business Lawyers" Kristen Johns published in American Health Lawyers Association
Waller, November 2019

The application of distributed ledger, or blockchain, technology has permeated many industries. Since its debut through cryptocurrency, many companies have embraced its potential and many more are actively identifying and implementing novel use cases. The health care industry is no different, and blockchain technology is currently being used for physician and nurse credentialing, electronic medical records (EMRs), patient engagement, patient identity, and pharma supply chain management...

Up in Smoke: Lawsuits Pose Serious Threat to Vaping and Cannabis Industries
Bradley Arant Boult Cummings, LLP, November 2019

 This fall, an outbreak of lung illnesses allegedly related to vaping ignited public hysteria and legislative reactions in many states. The vaping and cannabis industries are already paying, and will continue to pay, high reputational and policy costs associated with these events, and the industries should also be aware that the widespread nature of reported injuries could lead to a substantial amount of costly mass tort litigation...

Keep Medicare Enrollment Information Correct and Current or Suffer Consequences
Verrill, October 2019

While most providers understand the need to bill Medicare correctly, many often fail to recognize the potentially disastrous results of not keeping Medicare informed of your correct and up-to-date practice information. A recent case highlights the dangers of a seemingly innocent error, which resulted in a physician’s Medicare billing privileges being revoked...

PTSD Compensation for First Responders without Associated Physical Injury Revisited by the Ohio Legislature in New House Bill
Dinsmore & Shohl LLP, October 2019

With the recent proliferation of mass shootings and other deadly incidents, several states have taken on the issue of allowing mental and/or emotional impairments caused by post-traumatic stress disorder (PTSD) to be a compensable workers’ compensation condition for first responders without the requirement of a physical injury. In June 2019, House Bill 80, the budget bill for the Ohio Bureau of Workers’ Compensation, included such a proposal...

Feinwachs Holds FCA Relator's Emails to Counsel, Even Though on Employer's Server, Protected as Work Product
Dinsmore & Shohl LLP, October 2019

In the False Claims Act (FCA) case of Feinwachs v. Minnesota Hospital Association, the district court recently upheld relator David Feinwachs’ claim of work-product privilege over emails sent to his work email account. No. 11-cv-0008, 2019 U.S. Dist. LEXIS 155027 (D. Minn. Sept. 11, 2019).  Feinwachs was formerly general counsel of the Minnesota Hospital Association (MHA), a trade association of Minnesota hospitals and health care systems...

FDA Warns Consumers to Stop Using THC Vaping Products Amid Ongoing Investigation into Lung Injuries
Dinsmore & Shohl LLP, October 2019

Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both...

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...

 

 

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