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Waller | September 2020

The Department of Health and Human Services (HHS) has implemented a new Medicare payment model, the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model. The ETC Model was developed to test whether the greater use of home dialysis and kidney transplantation for Medicare beneficiaries with ESRD will reduce Medicare expenditures, while also preserving or enhancing the quality of care furnished to beneficiaries with ESRD ...

Veirano Advogados | September 2020

Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located. Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located ...

Waller | September 2020

While the pandemic and subsequent economic downturn are creating unprecedented challenges for health systems across the country, opportunities for collaboration remain as strong as they had been pre-COVID, and large health systems are well positioned to take advantage of new opportunities. In light of this, Waller has partnered with Kaufman Hall to develop a guide for health system leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...

Waller | September 2020

Details regarding a new Medicare payment model for radiation oncology care have been released by the Department of Health and Human Services (HHS). The new Radiation Oncology Model (RO Model) qualifies as an Advanced Alternative Payment Model (APM) and a MIPS APM under the Quality Payment Program. According to this release from HHS, the RO Model aims to “promote quality and financial accountability for providers and suppliers of radiotherapy ...

Hanson Bridgett LLP | September 2020

Key Points Under Assembly Bill 685, Cal/OSHA can shut down a worksite if the worksite exposes employees to a COVID-19 related imminent hazard. AB 685 subjects employers to increased notification requirements that must be met within one business day of a potential exposure to COVID-19. Employers must notify local public health agencies of all workplace COVID-19 outbreaks amongst employees. Cal/OSHA can now issue serious citations more quickly. On Sept ...

Buchalter | September 2020

San Francisco’s Department of Public Health (“SFDPH”) issued yet-another update to its Shelter-in-Place Order, C19-07, on September 14, 2020 (now up to version “i”). This order has been frequently modified to reflect changes in other state and local directives, as more is learned about the disease and as more businesses are allowed to re-open ...

Dinsmore & Shohl LLP | September 2020

On Sept. 14, 2020, Ohio Governor Mike DeWine signed into law a bill, which provides significant protections against tort claims arising from COVID-19 to all entities, including individuals, businesses, health care providers, property owners, government entities, churches, and schools. Amended Sub ...

Waller | September 2020

The impact of COVID-19 and the economic downturn has pressured independent hospitals, rural hospitals and smaller health systems in particular. Despite the immense challenges, independent facilities and their Boards should take this time to best position for the near- and long-term. In light of this, Waller partnered with Kaufman Hall to develop a guide for healthcare leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...

Afridi & Angell | September 2020

On 12 September 2020, the UAE Ministry of Health and Prevention (MoHAP) reported 1007 new COVID-19 cases in the UAE. With the number of cases rising both within the UAE and in most other countries, the UAE government has reiterated the importance of adhering to preventive guidelines and has further placed safeguards, particularly in Abu Dhabi, to ensure that those traveling to the UAE are confined to prevent the transmission of the virus ...

PLMJ | September 2020

Presidential Decree no. 229/20 of 8 September 2020 has been published and its aim is to reassess the measures imposed by Presidential Decree no. 142/20, considering the evolution of the epidemiological situation. The new decree renews most of the measures already in force, although it also eases some restrictions ...

PLMJ | September 2020

Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...

Hanson Bridgett LLP | September 2020

Key Points On Aug. 25, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule with a comment period (IFC) establishing new Long-Term Care Facility COVID-19 Testing Requirements for Staff and Residents. CMS has added 42 CFR §483.80(h), which requires that the facility test all residents and staff for COVID-19. Noncompliance related to this new requirement will be cited at new tag F886 ...

Dinsmore & Shohl LLP | September 2020

The International Trade Commission (ITC) sits in a nondescript office building about a block farther south of the National Mall than tourists usually care to venture. Patent owners come from around the country to this tree-lined street in Washington, D.C., to seek a powerful remedy to protect their patented products: an exclusion order. An exclusion order directs U.S. Customs and Border Protection to block infringing imports at the United States border ...

Hanson Bridgett LLP | September 2020

Key Points HHS Provider Relief Fund payments are being extended to private pay assisted living facilities under Phase II. Relief will be equal to 2 percent of annual gross revenue from resident care. Interested providers must act swiftly: the deadline to submit basic information to HHS is Sept. 13 Provider relief funds need not be repaid if recipients comply with the program criteria. HHS Announcement: On Sept.1, the U.S ...

Waller | September 2020

Historically, telehealth services were limited both in reimbursement and location. Most encounters took place for purposes of rural health treatment and in underserved areas as a way to get specialized treatment to patients in geographic locations where they would not otherwise have treatment options. The use of telehealth services has increased in recent years ...

Hanson Bridgett LLP | August 2020

Key Points A new FDA rule clarifies when food manufacturers may label fermented or hydrolyzed foods as gluten-free. Manufacturers making gluten-free claims must maintain records showing that the foods or food ingredients used in the foods are gluten-free prior to fermentation or hydrolysis. A product marked as gluten-free may be deemed misbranded under the Food, Drug, and Cosmetics Act if its manufacturer does not maintain supporting documentation to the satisfaction of the FDA ...

PLMJ | August 2020

The world is desperately seeking a vaccine and treatments against COVID-19 and the answer will also be found in intellectual property. For this reason, PLMJ and Inventa International have joined forces toprepare a Digest on these issues that is continuously updated ...

Waller | August 2020

Executive summary The COVID-19 pandemic has created significant challenges for smaller hospitals and health systems. It has presented significant challenges to smaller, less capitalized and otherwise distressed healthcare providers. In terms of operating performance, half of our country’s hospitals reported negative margins as Q1 of 2020 ...

The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers ...

On August 25, 2020, Board Resolution No. 003-2020-EF/68.0 was published in the Official Gazette “El Peruano”, approving the “Guidelines for the State's response to the potential impacts of the COVID-19 pandemic on Public Private Partnership projects” (the “Guidelines”) ...

Heuking | August 2020

The Federal Ministry of Transport and Digital Infrastructure (BMVI) is providing EUR 50 million annually until 2023 to promote computer games in order to strengthen Germany as a location for developers. In the first phase,de minimis funding will be provided with grants of up to EUR 200,000. In a second phase larger-scale funding will also be possible ...

Waller | August 2020

Tennessee Governor Bill Lee has signed into law the Tennessee COVID-19 Recovery Act which provides liability protection from claims related to the COVID-19 pandemic. The Waller Government Relations team worked closely with the Tennessee Chamber of Commerce and Industry and various stakeholders in recent months to achieve passage of the Tennessee COVID-19 Recovery Act ...

Hanson Bridgett LLP | August 2020

In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19 ...

PLMJ | August 2020

The world is desperately seeking a vaccine and treatments against COVID-19 and the answer will also be found in intellectual property. For this reason, PLMJ and Inventa International have joined forces to prepare a Digest on these issues that is continuously updated ...

Buchalter | August 2020

On August 6, 2020, the U.S. Court of Appeals for the First Circuit affirmed the conviction of Massachusetts gynecologist Rita Luthra for criminal HIPAA violations and obstructing a health care investigation. Although such HIPAA prosecutions are uncommon, the case underscores the risks health care providers and others run when handling protected patient information and when speaking with government investigators ...

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