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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 ...

Dinsmore & Shohl LLP | August 2022

On July 19, 2022, the Court of Claims ordered that the current Improved Workforce Opportunity Wage Act (minimum wage) and Michigan Paid Medical Leave Act (paid leave) are void and reinstated the original ballot initiatives. However, employers do not need to overhaul their policies just yet because the ruling is stayed until February 19, 2023. Pending the outcome of appeal, these changes may not go into effect at all ...

Waller | December 2015

Many healthcare boards believe that they have satisfied the 501(r) community health needs assessment (CHNA) requirements by completing their organization’s CHNA report and adopting an implementation strategy. After doing that, the board may feel ready to focus on other pressing issues until the next three-year CHNA deadline ...

Karanovic & Partners | June 2012

The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...

Karanovic & Partners | June 2012

New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...

Dinsmore & Shohl LLP | March 2021

On March 9, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public-comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on Dec. 10, 2020, and it was published in the Federal Register on Jan. 21, 2021 ...

ALRUD Law Firm | April 2016

On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...

Hanson Bridgett LLP | May 2020

Key Points Facilities will have until the week ending June 7, 2020 to report specific COVID-19 data to the CDC or face the assessment of deficiencies and CMPs. Facilities are now required to notify residents, their representatives, and families when the facility has a confirmed COVID-19 infection or 3 instances of new onset respiratory symptoms within 72 hours ...

The end of the COVID-19 public health emergency on May 11, 2023 has left many healthcare facilities confused about whether the vaccination mandate for Centers of Medicare and Medicaid Services (“CMS”) certified healthcare facilities still stands ...

On May 11, 2021, the Center for Medicare & Medicaid Services (CMS) announced a new rule that will require long-term care facilities and residential facilities serving clients with intellectual disabilities to educate and offer COVID-19 vaccines to residents, clients and staff. This new requirement will closely align with current requirements for influenza and pneumococcal vaccines in long-term care facilities ...

Hanson Bridgett LLP | February 2022

On November 5, 2021, CMS published an interim final rule regarding vaccination requirements for staff working for Medicare and/or Medicaid certified Skilled Nursing Facilities ("SNFs"). On December 28, 2021, CMS issued QSO 22-07-ALL covering the guidance and survey process related to these new regulatory requirements.  This QSO is specifically applicable to California ...

Dinsmore & Shohl LLP | April 2023

On March 22, 2023, the Centers for Medicare & Medicaid Services (“CMS”) updated its guidance and survey process for home dialysis services in nursing homes.[1] The updated guidance is based on comments, questions, and feedback received from state survey agencies, the dialysis community and other stakeholders since CMS initially issued guidance in 2018 ...

Waller | March 2020

Just 24 hours after the President signed the CARES Act into law, the Centers for Medicare & Medicaid Services (CMS) expanded the scope of its Accelerated and Advance Payment Program to include additional Part A providers and Part B suppliers. CMS outlined the program expansion in a fact sheet. The accelerated payments are intended to provide immediate cash flow relief to providers and suppliers focused on treating the flood of COVID patients ...

Waller | April 2020

The COVID-19 crisis has increased the need for behavioral services and has also led to some opportunities for providers ...

Hanson Bridgett LLP | June 2017

Long-term care (LTC) facilities received a boost last week when the Centers for Medicare and Medicaid Services (CMS) reversed its position regarding the use of arbitration agreements in this setting. On June 8, 2017, CMS published a proposed rule amending LTC facilities’ conditions of participation in the Medicare and Medicaid programs to remove prohibitions on binding pre-dispute arbitration agreements ...

Dinsmore & Shohl LLP | November 2021

On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022. The vaccine rule that was also released on Nov ...

Dinsmore & Shohl LLP | November 2021

In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...

Waller | April 2020

On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) published guidance (the “CMS Guidance”) for reopening facilities to provide elective procedures or “non-emergent, non-COVID-19 healthcare ...

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 ...

Waller | April 2020

The Centers for Medicare & Medicaid Services hasrecently announced an unprecedented “Hospitals Without Walls” program to aid in the fight against COVID-19. The goal of this program is to ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites including other, non-affiliated healthcare providers and even unlicensed locations such as community centers and schools ...

Dinsmore & Shohl LLP | August 2023

The Centers for Medicare & Medicaid Services (“CMS”) has announced its proposed rules for the Hospital Outpatient Prospective Payment (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment Systems, as well as its calendar year (CY) 2024 proposed Physician Fee Schedule (“PFS”), (collectively the “Proposed Rules”) ...

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 ...

Waller | February 2012

The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...

Haynes and Boone, LLP | February 2012

The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...

Waller | February 2012

Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...

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