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FDA Announces Revocation of Policy on Information Related to New Drug Applications
Dinsmore & Shohl LLP, May 2021

On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs...

Proposed Expansion to Ohio Laser Rule Advances to Public Rules Hearing
Dinsmore & Shohl LLP, May 2021

More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021...

Ohio Board of Pharmacy to Award Up to 73 New Medical Marijuana Dispensary Licenses
Dinsmore & Shohl LLP, May 2021

The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access...

HHS Advises on Fraudulent Postcard Disguised as Official OCR Communication
Dinsmore & Shohl LLP, May 2021

On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations.  The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org,  a non-governmental website marketing consulting service...

COVID-19 and the Impact on Disabled Employees in the Workplace
Shoosmiths LLP, May 2021

The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure...

CMS Proposes Increases to Hospital Reimbursement Rates and GME Residency Caps with a Focus on Rural Hospitals
Dinsmore & Shohl LLP, May 2021

As part of its 2022 Inpatient Prospective Payment System (IPPS) Proposed Rule for Acute Care Hospitals, the Centers for Medicare and Medicaid (CMS) is proposing an increase for Medicare fee-for-service payment rates to acute care hospitals by 2.8 percent, or $3.4 billion in Fiscal Year (FY) 2022.[[1]] Hospitals hoping to receive the payment increase must successfully participate in the Hospital Inpatient Quality Reporting Program and be meaningful electronic health record users...

Cambodia: Monthly Legal Update – April 2021
DFDL, April 2021

New Promulgated Law and Subsequent Regulations on Health, Administrative and Other Measures during Covid-19 Outbreak In response to the recent community outbreak of Covid-19 on 20 February 2021, the Royal Government of Cambodia (“RGC”) promulgated and issued a number of regulations, specifically: Law on Preventative Measures against the Spread of Covid-19 and other Highly Contagious Diseases dated 11 March 2021 (“Preventative Measures Law”); Sub-Decree 37 dated 12 Ma

COVID-19 Waivers Ending for Skilled Nursing Facilities
Dinsmore & Shohl LLP, April 2021

On April 8, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that some of the blanket waivers implemented during COVID-19 will expire on May 10, 2021.[1] The following waivers will expire: The emergency blanket waivers related to notification of resident room or roommate changes, and transfer and discharge notification requirements...

Initial Assessment of the Impact of Possible Legislative Changes in the Pharmaceutical Sector
PLMJ, April 2021

The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use...

Government Enforcement and Review of Managed Medicare Programs: A Glimpse of Historical Practice and Forthcoming Trends
Bradley Arant Boult Cummings LLP, April 2021

When President Biden announced in December 2020 that he intended to nominate California Attorney General Xavier Becerra to head the Department of Health and Human Services (HHS), the appointment raised eyebrows in certain policy circles. Becerra does not fit the typical administrative profile of past HHS heads. In fact, he has no actual experience in health care or public health policy. Rather, his background is primarily rooted in law enforcement...

Israel Reopens the Skies for Foreign Experts and Businessmen
Fischer, April 2021

Further to the decline of the Covid-19 spread in Israel after the successful vaccination rollout, Israel has announced changes in foreign entry policy into the country, which will allow, among others, the regular entry of foreign experts and businessmen. These reliefs come after several months in which the state borders were almost completely closed to foreigners...

IRS Guidance: COVID-19 PPE May be Eligible to be Reimbursed from Health FSAs, HRAs, and HSAs
Patterson Belknap Webb & Tyler LLP, April 2021

On March 26, 2021, the Internal Revenue Service (“IRS”) published Announcement 2021-7, which notifies taxpayers that certain amounts paid for personal protective equipment (such as masks, hand sanitizer, and sanitizing wipes) for the primary purpose of preventing the spread of COVID-19 (“COVID-19 PPE”) may be an eligible expense that can be reimbursed from certain health care account based plans...

China Introduces Pharma-Friendly Revisions to Patent Examination Guidelines
Deacons, April 2021

Did you know? The Chinese National Intellectual Property Administration (CNIPA) revised Patent Examination Guidelines came into force on 15 January 2021. The changes significantly relax the patentability requirements for inventions in the pharmaceutical, chemical and biotech field. Why does this matter to you? The revised guidelines focus on the examination criteria for novelty and inventive step in relation to the rapidly developing field of chemical and biotech inventions...

CMS Announces Proposed Rate Increases and Other Changes for Skilled Nursing Providers and Hospice Providers in Fiscal Year 2022
Dinsmore & Shohl LLP, April 2021

On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year.  This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184...

Legislative Proposal on Health Technology Assessment
PLMJ, April 2021

On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare...

Clinical Trials in Portugal
PLMJ, April 2021

Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether...

Chile Announces Stricter Quarantine Measures due to New Wave of Covid-19
Carey, April 2021

The Chilean Ministry of Health, through a press conference, announced on Thursday, April 1, that the following measures will be implemented as of Monday April 5. The country's borders will be closed during the month of April...

Real Estate IHL Series – HeartMath
Shoosmiths LLP, March 2021

Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours...

Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures
ENSafrica, March 2021

ENSafrica recently released Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures. This comprehensive report outlines the COVID-19 regulatory measures for each country across Sub-Sahara Africa, providing the sector, measure, effective date/status and key points and impact for each region. The information provided herein is intended to provide a general overview, and is not an exhaustive list of all legislatice developments across Sub-Sahara...

Bulletin Real Time: Latest News
Brigard Urrutia, March 2021

Beginning of Stage 2 of the National Vaccination Plan The Colombian Ministry of Health and Social Protection (Minsiterio de Salud y Protección Social) declared the initiation of stage 2 of the National Vaccination Plan against COVID-19 for the population between 60 and 79 years of age. This does not mean that vaccination for those over 80 years of age will be stopped; these people will continue to be vaccinated without any interruption...

Government Announces a Social Protection Network Strengthening
Carey, March 2021

On March 22, 2021, through a televised address, the President of the Republic announced the strengthening and extension of the Social Protection Network, destined to mitigate the adverse effects caused by the restrictions due to the COVID-19. These measures are based on 5 pillars: • Greater protection to the families’ incomes. • Strengthening of the middle-class support. • Greater job protection...

How Does The American Rescue Plan Affect Welfare Benefit Plans?
Dykema, March 2021

President Biden signed the American Rescue Plan Act of 2021 (the Act) on March 11, 2021. The Act provides COBRA premium subsidies, increases the tax-exclusion amount for employer-sponsored dependent care assistance programs and expands who may be eligible to receive premium tax credits for marketplace coverage. This alert explains how these provisions may impact your welfare benefit plans. Please contact your Dykema benefits attorney to explore the new provisions in greater depth...

Does Pandemic Fatigue Give Rise to a Duty to Accommodate?
Lawson Lundell LLP, March 2021

Now that we have persevered through one year of the COVID-19 pandemic, much has been written about pandemic fatigue and associated social isolation, mental stress, and anxiety. Employers may be seeing an increase in the incidence of mental illness claims in their workplaces...

2021 Open Payments (Sunshine Act) Reporting Window Closes March 31
Dinsmore & Shohl LLP, March 2021

As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020...

Health-Care Providers Still Stymied on Evidence Needed to Prove FCA Violation
Bradley Arant Boult Cummings LLP, March 2021

Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S...



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