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 ...
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”) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
The recent decision in the Technology and Construction Court (“TCC”) in Toppan Holdings Limited and Abbey Healthcare (Mill Hill) Limited v Simply Construct (UK) LLP arguably does no more than follow precedent. But the outcome is significant for anyone taking a collateral warranty. The lesson is: get a warranty signed promptly, if you do not want to lose the right to adjudicate ...
The protracted legal battle between software giant Oracle America Inc. (“Oracle”) and technology behemoth Google LLC (“Google”) has truly been one for the ages. The Supreme Court of the United States of America (“SCOTUS”) on 05 April 2021 delivered its judgment in the writ of Certiorari filed by Google against Oracle ...
Cyber criminals have developed new ransomware techniques to improve the efficiency and profitability of their attacks. These include targeting large and high-value entities such as governments and the health care sector (also known as “big game hunting”), and the selling of user-friendly ransomware software kits (also known as ransomware as a service) ...
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 ...
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 ...
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 ...
California defamation law continues to evolve as the courts synthesize well-settled legal principles with ever-changing technological realities. On July 21, 2017, California’s First District Court of Appeal issued a published opinion in ZL Technologies v. Does 1-7 (July 21, 2017) 2017 DJ DAR 6999 ...
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 ...
Phase 1 of the ‘scaling-down’ process, third tranche of guarantees, extension of ERTE temporary layoffs, potential delay in the application of VAT directives and of DAC6, and measures to support the cultural sector For another week running, Garrigues summarizes the key issues that companies need to be aware of over the coming days ...
