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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Hanson Bridgett LLP | January 2019

On January 28, 2019, the California Department of Social Services issued a letter informing all licensed Residential Care Facilities for the Elderly that Title 22, Section 87224 of the California Code of Regulations has been revised. Section 87224 previously provided for a 30-day eviction notice to residents upon the change of use of a facility. This notice period was inconsistent with the applicable statute, Health and Safety Code Section 1569.682(a)(2) ...

“I don’t want a British passport for myself but should I get one for my child?” This is a common immigration-related enquiry, and one my team and I have been asked about by EU nationals repeatedly since the June 2016 referendum vote ...

“I don’t want a British passport for myself but should I get one for my child?” This is a common immigration-related enquiry, and onemy team and Ihave been asked about by EU nationals repeatedly since the June 2016 referendum vote ...

Veirano Advogados | January 2019

The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication ...

Dinsmore & Shohl LLP | January 2019

The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...

ALRUD Law Firm | January 2019

During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines (“Guideline”) ...

ALRUD Law Firm | January 2019

On June 12, 2018, amendments to the Federal law No. 57-FZ, dated April 29, 2008 “On Foreign Investments into Business Entities of Strategic Importance for the Country’s Security, Protection and Defense Support” (“Strategic Investments Law”) came into force ...

An executive order to eliminate the income tax withholding for interest paid abroad on bonds listed in a stock exchange, as well as to grant tax incentives to taxpayers investing in a capital market in Mexico was published in the Federal Official Gazette on January 8, 2019. The following tax incentives were created for productive investment projects: Corporate Bonds ...

Dykema | January 2019

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 ...

Dykema | January 2019

A physician certification for Medicare coverage for ambulance services is not the final word. An ambulance service also must demonstrate the beneficiary’s condition and establish medical necessity when transporting the Medicare beneficiary ...

Dykema | January 2019

Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...

On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1]  The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...

Dinsmore & Shohl LLP | January 2019

In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...

Dinsmore & Shohl LLP | January 2019

Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...

Dykema | January 2019

On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...

Dykema | January 2019

The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...

Haynes and Boone, LLP | December 2018

Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...

Simonsen Vogt Wiig AS | December 2018

Despite a positive and active start in H12018 with high M&A activity in the Norwegian market, the total number of completed deals in Norway in 2018 will be significantly lower than in 2017. YTD it has been registered 248 completed deals in Norway compared to 346 in 2017 (full year) ...

Dinsmore & Shohl LLP | December 2018

On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...

Dykema | December 2018

The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...

Deacons | December 2018

On 26 October 2018, the Standing Committee of the National People's Congress approved a decision to revise the Company Law of the People’s Republic of China (Revision), with the aim of supplementing and improving the existing share repurchase regime. We have set out a brief introduction to this Revision below. Background It has only been five years since the last revision to the Company Law of the People’s Republic of China (Company Law) ...

Heuking | December 2018

Inland ports are of significant importance for handling of freight. Most inland ports are trimodal (road, railways and waterways) and have the necessary infrastructure to handle freight coming from all over the world. Recent State aid measures address the increasing importance of inland ports and allow subsidisation predominantly for constructing infrastructure ...

Heuking | December 2018

These days more and more use is being made of the Treaty rules on State aid. The European Commission is using the State aid rules in an innovative way to take over competence from the Member States in tax regulation by challenging the selectivity of national measures or rulings, which give preferable treatment to certain taxpayers ...

In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners.  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays).  And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc ...

Veirano Advogados | December 2018

The Brazilian Federal Government recently published Medida Provisória No. 863/2018 ("MP 863/18"), a new rule that amends Federal Law No. 7,565, of December 19, 1986 (Brazilian Aviation Code) and lifts the existing restrictions to foreign capital shareholding in Brazilian air transportation companies. As a result, foreign investors are from now on able to hold up to one hundred percent (100%) of the voting capital of Brazilian airlines ...

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