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Topic: Regulatory

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Centers for Medicare & Medicaid Services proposes policies and updates to Medicare Advantage and Part D programs for 2019

On February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the Medicare Advantage and Part D programs through the Advance Notice and Draft Call Letter (Advance Notice) for calendar year 2019.  As required by section 1853(b) of the Social Security Act, CMS publishes annually the Advance Notice at least 60 … Continue reading

Deregulatory wave prompts renewed examination of Stark Law application

In another sign that the Trump administration’s penchant for regulatory flexibility may apply to the federal fraud-and-abuse regulatory regimes, CMS administrator Seema Verma announced during an AHA Town Hall webcast on January 17 that CMS is convening an interagency group to examine possible ways to minimize the regulatory barriers of fraud-and-abuse laws, including the Stark … Continue reading

HHS OCR issues cyber extortion newsletter

This week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a January 2018 newsletter focusing on “cyber extortion.” Cyber extortion often involves an attacker gaining access to an organization’s computer system, stealing sensitive information, and threatening to publish the information. Healthcare and public health organizations are often the … Continue reading

South Dakota and Colorado strengthen data breach protections

Last week, South Dakota moved closer to implementing a data breach notification law, while Colorado legislators introduced a new bill requiring “reasonable security procedures,” imposing data disposal rules and shortening the time frame in which to alert authorities regarding a breach.  South Dakota and Colorado are the latest states taking steps in cybersecurity lawmaking in … Continue reading

The US Department of Labor proposes expanded access to association health plans

Pursuant to President Donald J. Trump’s October 12, 2017 Executive Order instructing the U.S. Department of Labor (DOL) to consider expanding access to association health plans (AHP), the DOL published a proposed rule on January 5, 2018 that would modify ERISA regulations to increase the availability of AHPs.  Association health plans have been defined as … Continue reading

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

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
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