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Topic: Regulatory

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U.S. House of Representatives passes the Veterans E-Health and Telemedicine Support Act of 2017

On November 8, 2017, the U.S. House of Representatives unanimously passed H.R. 2123, the Veterans E-Health and Telemedicine Support (“VETS”) Act of 2017. Under current regulations, VA health care providers in good standing may practice in another state if the provider is located in a facility owned by the Federal Government; however, this does not … Continue reading

Texas Medical Board proposes new telemedicine regulations

The Texas Medical Board (“TMB”) recently proposed new telemedicine regulations (the “Proposed Regulations”). Such regulations are necessary to revise current regulations of the TMB in light of Senate Bill 1107 (“SB 1107”), which recently passed the Texas Legislature. I. Prescriptions for Medications SB 1107 required that the TMB, the Texas Board of Nursing, the Texas … Continue reading

FDA releases new guidances on increasing generic drug competition

The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices.  Reducing drug prices was a stated objective of President Trump during his campaign and has also been a topic … Continue reading

Texas telemedicine stakeholder group recommends new rules to incorporate SB 1107

The Telemedicine Stakeholder Group met in late July 2017 and offered suggestions for revisions (“Suggested Revisions”) to the current Texas Medical Board (“TMB”) rules in light of the new SB 1107. As previously covered, SB 1107 greatly expanded the telemedicine services physicians can provide in Texas, including allowing the establishment of a physician-patient relationship in … Continue reading

US telemedicine industry players are pursuing opportunities abroad

Telemedicine has been rapidly expanding in the United States. Indeed, Texas recently passed legislation that gives Texas telemedicine providers more flexibility, including the ability to establish a physician-patient relationship in connection with telemedicine services without requiring an in-person visit. Business entrepreneurs are finding ways to expand telemedicine opportunities internationally as well. NBC News recently published … Continue reading

CMS extends deadline for health insurers to file 2018 rate requests; bipartisan group of experts advocates certain health reform initiatives

On August 11, the Centers for Medicare & Medicaid Services sent a memorandum to insurers announcing an extension of the deadline by almost three weeks until September 5 for insurers to file their 2018 rate requests.  Insurers are wrestling with whether to participate in the Affordable Care Act exchanges/marketplaces in 2018, and if so, the … Continue reading

SCOTUS applies ERISA exemption to plans established by church-affiliated hospitals

In an 8-0 decision, the Supreme Court unanimously held that ERISA’s exemption of “church plans” from its regulation of employee benefit plans extends to church-affiliated hospitals even if an actual church did not establish the plan. The Petitioners, Advocate Health Care Network, Saint Peter’s Healthcare System, and Dignity Health, are church-affiliated nonprofits that run hospitals … Continue reading

CMS proposes to remove a ban on pre-dispute arbitration agreements at long-term care facilities

On June 5, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to revise requirements established by the Reform of Requirements for Long-Term Care Facilities final rule (2016 Final Rule). Specifically, the proposed rule would remove regulations prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with residents or their … Continue reading

Impact of Brexit on marketing authorisation holders – new EMA and CMDh guidance

The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017. … Continue reading

FDA / EMA parallel scientific advice principles published

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products. The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational … Continue reading

European Union’s new medical device regulations come into force

Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical Devices Regulation (IVD MDR) which replaces the EU Directive on IVD medical devices. Now begins a … Continue reading

FDA and NIH finalize clinical trial protocol template

On May 2, 2017, the U.S. Food and Drug Administration (“FDA”) and The National Institutes of Health (“NIH”), through the NIH-FDA Joint Leadership Council, released the final version of a clinical trial protocol template in an effort to assist investigators conducting clinical trials and to create cost and time efficiencies in the medical product development … Continue reading

Texas Legislature moves to expand permissible telemedicine services in Texas

On May 11, 2017 the Texas House passed Senate Bill 1107 (“SB 1107”), which greatly expands the telemedicine services physicians can provide in Texas. SB 1107 passed the House with the support of substantially the entire House. Senate Bill 1107 was previously passed unanimously by the Texas Senate on March 29, 2017. SB 1107 must … Continue reading

Canada’s legalization of recreational cannabis – legislation introduced

In the 2015 Federal election, the Liberal Party of Canada ran on a platform that included the legalization of recreational cannabis. Following the election, a task force was created to report on legalization and regulation, and a report was delivered in November 2016. On April 13, 2017, Bill C-45, An Act respecting cannabis and to … Continue reading

CMS issues new Self-Referral Disclosure Protocol (SRDP)

CMS recently finalized a new Self-Referral Disclosure Protocol (SRDP) that includes forms for healthcare providers to use to disclose actual and potential violations of the federal physician self-referral statute (the “Stark Law”). Use of the new forms is mandatory starting June 1, 2017, but CMS encourages healthcare providers to start using the new forms immediately. … Continue reading

ONDCP addresses urgent public health threat posed by illicit fentanyl

On February 23, 2017, leaders of the Committee on Energy and Commerce, in a letter to the Office of Natural Drug Control Policy (“ONDCP”), urged ONDCP to address how it and other federal agencies intend to confront the immediate public health threat posed by illicit fentanyl.  The Committee correspondence also directed ONDCP to respond to … Continue reading

Federal district court endorses Stark liberalization of writing requirement

On March 15, a federal district court in the Western District of Pennsylvania endorsed CMS commentary from November 2015 that dramatically liberalized the “written agreement” requirement of core Stark exceptions, thus providing some new insights as to what may be the outer limits of CMS’s new approach. When ruling on cross motions for summary judgment … Continue reading

NICE to fast-track more medicine approvals but wider changes do not impress industry

The National Institute for Health and Care Excellence (NICE) produces guidance in a number of forms including technology appraisals. Technology appraisals are recommendations on the use of medicines and treatments within NHS England. The recommendations are based on a review of clinical and economic evidence. NHS England is legally obliged to fund medicines recommended by … Continue reading

European and US regulators’ agreement on mutual recognition of inspections of medicines manufacturers

In the European Union (EU), inspections of medicines manufacturing sites are carried out by national competent authorities from EU Member States. Each year, EU competent authorities and the US Food and Drug Administration inspect many manufacturing sites in the EU, US and elsewhere in the world, to ensure compliance with Good Manufacturing Practice (GMP). EU … Continue reading

Six legal and regulatory risks facing specialty pharmacies

“Specialty drugs” are a fast growing sector of the pharmaceutical industry and are predicated to represent 50 percent of drug expenditures in the United States by 2020.[1] Specialty drugs are typically dispensed by specialty pharmacies. Although there is no agreed-upon industry definition of “specialty pharmacy,” generally, these pharmacies focus on dispensing and distributing high cost … Continue reading

Joint Commission links safety culture to health care organization leadership

On March 1, 2017, the Joint Commission issued a Sentinel Event Alert warning of the link between inadequate safety cultures within health care organizations and a rise in the occurrence of adverse events, and further urging health care organization leadership to adopt a culture of safety through formal initiatives and a top-down model behavioral approach.  … Continue reading

CMS proposes rule to stabilize health insurance market

On February 15, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to stabilize the individual and small group health insurance market by increasing incentives for individuals to maintain enrollment in health plans, decreasing incentives to enroll in coverage only after healthcare services are needed, and reducing the regulatory burdens for … Continue reading
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