As healthcare providers pursue transactions during and in the wake of COVID-19, both buyers and targets should prepare for heightened scrutiny during the due diligence process. Getting organized ahead of a sale can dramatically expedite timelines and reduce deal fatigue for all parties, particularly in light of the heavier-than-normal due diligence process as a result of the pandemic. Click here for a full PDF of this report ...
The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
On May 23, 2022, the Oregon Medical Board (OMB) is hosting a public hearing on rules that propose major changes to the way physician assistants (PAs) practice in Oregon. The rules were written in response to House Bill 3036, which supporters have dubbed the “Physician Assistant Modernization Bill.” More broadly, the rules were written in response to mounting concerns about health care access and equity, especially for rural and minority populations ...
On July 1, 2021, B.C. moved into Step 3 of its COVID-19 Restart Plan. As part of this phase, B.C. employers are no longer required to maintain a WorkSafeBC approved COVID-19 Safety Plan. Instead, they are required to transition to a Communicable Disease Prevention Plan. What is a Communicable Disease Prevention Plan? It is a plan that outlines the steps an employer is taking to reduce the risk to their workers from communicable diseases in their workplace ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
Last year, the European Commission initiated an inquiry into the pharmaceutical industry, claiming that there were indications that competition in the industry was not working as well as it should. Although responses to the preliminary report have been rather critical, from both the legal community and the industry itself, there are a few conclusions worth noting ...
In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
April 5, 2023 By: Nora Sheriff and Samir Hafez In their Wildfire Mitigation Plans (WMPs), Pacific Gas & Electric Company (PG&E) and Southern California Edison (SCE) indicate plans to spend roughly $18 billion and $5.8 billion respectively over the 2023-2025 WMP cycle. These total figures represent an approximately 26% increase over the utilities’ 2020-2022 WMP expenditures ...
Activists opposed to natural gas drilling are taking a unique approach in an attempt to ban hydraulic fracturing in Peters Township, which is located in Washington County, Pennsylvania. The Peters Township Marcellus Shale Awareness group is attempting to have township residents vote on a referendum that amends the home rule charter to ban hydraulic fracturing ...
On May 11, 2020, the Peruvian Government enacted Legislative Decree No. 1510 (“Legislative Decree”) which delays the entry into force of the new prior merger control regime approved by Urgent Decree Nº 013-2019 (“Urgent Decree”) until March 1, 2021 and the approval of the Urgent Decree’s regulations, originally expected by May, 2020, until November, 2020 ...
On November 15, 2012, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report titled “Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement,” which included a response from the Centers for Medicare and Medicaid Services (CMS) ...
Today, Governor Wolf signed an order to allow the administration to transfer supplies and information between medical facilities ...
As previously discussed in our January 5, 2023 legal alert, the Pennsylvania Department of Human Services (“Pennsylvania DHS”) issued a Medical Assistance Bulletin (the “Bulletin”) in late December, 2022 that had the potential to put 340B savings at risk in Pennsylvania ...
Beginning July 1, 2020, Pennsylvania’s Act 46 of 2019 (Act 46)[1] will require most Pennsylvania health insurers to cover medication synchronization services (MedSync) provided to patients taking two or more maintenance medications (i.e., medications for chronic long-term conditions, including diabetes, high blood pressure, and heart disease) ...
Pemex is considering offering to the private sector up to six of its refineries to obtain some liquidity for its financial restructuring. As announced by Pemex’s CEO, José Antonio González Anaya, estimated individual transaction values may range from US$500 million to US$1.5 billion per refinery. The six refineries are currently operating at a collective, estimated annual loss of MX$100 billion (approximately US$5.8 billion) ...
We would like to share with you the most recent updates regarding the draft Power Development Plan (“PDP”) VIII, a mechanism for wind, solar power projects in transition and future, and the police investigation into 62 wind power projects. PDP VIII UPDATE Following the report of the Ministry of Trade and Industry (“MOIT”) to the Prime Minister under official letter no ...
On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...
Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
The world is in an upheaval now with the pandemic raging for over a year. The discussions and decisions that probably would never have been made a few years ago are being made today in the interest of the greater good and the public at large. When Bill Gates expressed his reservations against lifting IP protection on vaccine patents, it left the world reeling and his comments understandably criticised by experts and laymen alike ...
