The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
The Affordable Care Act (ACA) has been one of the most sweeping, and most divisive, pieces of legislation related to healthcare in a generation. More ink has been spilled over enactment, constitutionality, and repeal than any other government healthcare program. With the election of Donald Trump, and a Republican-controlled Congress, the repeal of the ACA is all but assured ...
Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
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 ...
View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
External pressures, such as lower reimbursement rates and an overall shift in policy by the Centers for Medicare and Medicaid Services (CMS) and state Medicaid agencies have put significant financial and operational pressure on skilled nursing and other senior living operators in the United States ...
In one of the first concrete developments related to the Affordable Care Act (ACA) changes following Dr Thomas E Price’s approval as Secretary of the Department of Health and Human Services (HHS), a Notice of Proposed Rule making was recently released by HHS. The recent release by HHS stated a goal of helping to stabilize the individual and small group marketplaces established by the ACA ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
Industrial facility owners and operators in West Virginia should be aware of new reporting requirements that will soon go into effect. In addition to currently mandated notifications to federal, state, and local agencies after certain events occur, some facilities will soon be required to notify the state within 15 minutes of discovering specific types of emergency events or be subject to a fine of up to $100,000 ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
Resale price maintenance and price-fixing has been and still is under scrutiny by the Croatian Competition Agency (the "Agency"). Carrying on from a number of high-profile cases, in February 2017 the Agency fined Gorenje Zagreb, a subsidiary of Slovenia's premier manufacturer of household appliances for HRK 1,557,000 (approximately EUR 206,000) ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
The Oberlandesgericht Celle has recently adopted a decision that is likely to be of particular interest to hospitals which are not, in principle, public contracting authorities within the meaning of the law, but which are used by public authorities to pay more than 50 percent for the construction of hospitals pursuant to Section 99, 4 of the GWB (decision ref. 13 G 8/16). In the decided case, the client planned to modernize a hospital in three construction phases ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
The Chilean Economic Development Agency, Corfo, and the Foreign Investment Promotion Agency, InvestChile, have announced the opening of the first call for national and foreign companies, to express their interest in manufacturing lithium products, such as battery cathodes and electrolytes. Companies that are selected will be guaranteed 25 per cent of US producer Albemarle’s lithium production at the lowest cost available in the market ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
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 ...
In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017 ...
We previously reported that on March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain ...
Medical Cannabis approvals in the City have been the subject of intense negotiations, hearings, and appeals in the last two months. First, our law firm assisted the Apothecarium - Sunset (an additional location in the Sunset District for the medical cannabis dispensary called The Apothecarium currently near the Castro), in obtaining an approval at the Planning Commission ...
Few medical issues are as significant to an employee and an employer as major back surgery. The procedure incapacitates the injured worker for months and leaves the employer short staffed while the employee recovers. Additionally, these surgeries often do not result in the expected outcome, which leads to further impairment and expense ...
