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Topic: Regulatory

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Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading

CMS publishes annual exchange final rule for 2019

On April 9, 2018, the Centers for Medicare and Medicaid Services (CMS) published the Notice of Benefit and Payment Parameters for 2019 final rule (Payment Notice) and related guidance affecting the health insurance markets, including: key dates for calendar year 2018; the final 2019 Letter to Issuers in the Federally-facilitated Exchanges; guidance extending the transitional … Continue reading

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

On April 2, 2018, CMS released the 2019 Rate Announcement and Final Call Letter (Call Letter) and published an expansive final rule containing updates to policies for Medicare Advantage (MA) and the Medicare Part D Prescription Drug Program (Part D).  A Health Law Pulse summary of the proposed Annual Notice and Draft Call Letter may … Continue reading

Healthcare-related exception in FCC TCPA order upheld

On March 16, 2018, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision on the Federal Communications Commission (FCC) omnibus order of 2015, relating to challenges to the FCC’s determination on healthcare calls and three other rulings relating to cell phones. The appellate court upheld an exception for certain “emergency” … Continue reading

Amended Colorado bill aims to enhance data privacy laws

As Health Law Pulse posted on January 29, 2018, lawmakers in Colorado are considering legislation that, if enacted, would significantly strengthen Colorado’s data privacy protections. On Wednesday, February 14, 2018, an amended bill passed unanimously in Colorado’s House Committee on State, Veterans and Military Affairs. The proposed bill overlaps with the Health Insurance Portability and … Continue reading

The US Departments of HHS, Labor, and Treasury propose expanded access to short-term, limited duration insurance

On February 20, 2018, the Departments of Health and Human Services, Labor, and Treasury (the Departments) published a proposed rule to expand the availability of short-term, limited-duration insurance (STLDI) in order to “provide more affordable consumer choice for health coverage.”  The proposed rule follows President Trump’s October 12, 2017 Executive Order directing the Departments to … Continue reading

Budget Act codifies Stark liberalizations

As we previously reported, on February 9, the U.S. Senate and House of Representatives approved the Bipartisan Budget Act of 2018 (the “Act”) and President Trump subsequently signed the bill into law.  Section 50404 of the Act includes several amendments to the Stark Law.  Specifically, Section 50404 endorses recent liberalizations of the Stark Law requirements … Continue reading

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

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
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