We have previously reported on the order that adopted the extraordinary measures under the COVID-19 health emergency declaration, published on March 31, 2020 (the “Order”), and the Technical Guidelines regarding certain essential activities described in Order, published on April 6, 2020 ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
Between September 2021 and May 2022, the words 'stress', 'mental health' and 'depression' appeared in more than 12,000 early conciliation or employment tribunal cases , demonstrating the prevalence of this subject matter in employment-related disputes. Today, more than ever, employers are expected to afford greater consideration to workplace conditions that do or could impact upon employees’ mental health ...
Membership substitution transactions are the most common form of business combination transaction in the nonprofit hospital industry. They are also widely misunderstood and the source of many mistakes. Many large 501(c)(3)s have become more acquisitive as a result of economic pressures of the ACA. Nonprofit health systems have been getting much better at participating in and winning competitive sale processes, resulting in an increased use of this business combination form. http://www ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
The impacts of COVID-19 appear set to permanently expand telehealth and fundamentally transform how and where providers practice. Shortly after the start of the pandemic, CMS made major temporary federal policy changes in response to the pandemic, including expanding access to telehealth services for people with Medicare, such as home health visits, and reimbursement for additional services when furnished via telehealth ...
The Centers for Medicare and Medicaid Services (CMS) has finalized its proposal to expand the experimental Home Health Value-Based Purchasing (HHVBP) Model to all 50 states and conclusively transition Medicare home health services to outcome-driven, value-based reimbursement beginning in calendar year (CY) 2023 ...
On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...
On Sept. 15, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was published on Jan. 14, 2021, and would be effective on Dec. 15, 2021. In June 2021, we reported on CMS’ decision to delay the MCIT Program Final Rule (The Rule) ...
On May 14, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Final Rule (the Final Rule) until no earlier than Dec. 15, 2021 ...
phttps://www.huntonak.com/en/insights/medical-timeshares-require-more-than-what-you-learned-in-kindergarten-american-health-law-association ...
On March 31, 2023, Governor Andy Beshear signed Senate Bill 47 making medical marijuana use and sale legal in Kentucky, effective January 1, 2025. [i] Kentucky now joins at least 37 other states that have legalized medical marijuana. The newest piece of legislation comes on the heels of Governor Beshear signing two executive orders related to cannabis in November of 2022 ...
The Ohio medical marijuana market saw a robust start to sales on January 16, 2019. First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales) ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
Below is a summary of key relief and operational measures implemented by the DIFC since 1 April 2020 and the time of this inBrief, 6:00 p.m. on Saturday, 11 April 2020. Dubai Financial Services Authority (DFSA) announces relief measures On Tuesday, 7 April 2020, the DFSA announced a number of relief measures to support their clients during this time of stress and uncertainty. These measures are aimed at both new firms setting up in the DIFC as well as existing authorised firms ...
The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19 The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygie
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...
Since the outbreak of the coronavirus (COVID-19), the Bank of Mauritius has been closely monitoring its economic impact on the banking sector and the Mauritian economy.On 10 March 2020, the Monetary Policy Committee of the Bank of Mauritius reduced the key repo rate by 50 basis points to 2.85% per annum and on 13 March 2020, the Bank of Mauritius introduced a Support Programme to further assist Mauritian Businesses across all economic sectors ...
The U.S. International Trade Commission (“ITC”) recently issued a Final Determination concluding that certain dental implants imported by Instradent USA, Inc. and by JJGC Industria e Comercio de Materiais Dentarios S/A of Brazil (“Respondents”) infringe U.S. Patent Numbers 8,714,977 and 8,764,443 and should be blocked from entry into the United States ...
For the past several years, the healthcare industry has been targeted by union organizers hoping to add nurses, physical therapists and others to their ranks. In the first half of 2015, there were more than 150 union elections in the healthcare industry, with unions winning more than three-quarters of these elections ...
On November 15, 2022, Governor Andy Beshear announced two executive orders related to cannabis in Kentucky. The first executive order allows certain individual Kentuckians and their caregivers to bring and use medical marijuana into the state without facing legal consequences beginning January 1, 2023, so long as they meet a set of three criteria ...
To the extent that there is such a thing as a “HIPAA Day,” it’s coming up soon. And, no, it’s not a HIPAA Holiday. Instead, March 1 is the deadline to report all HIPAA breaches of fewer than 500 affected individuals. HIPAA requires all breaches to be reported to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) ...
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
