Topic: Regulatory

HHS requests comments on healthcare innovation and investment workgroup

By Jeff Wurzburg (US) on June 11, 2018 Posted in Regulatory

A Request for Information (RFI) published in the June 7 Federal Register seeks comments on the structure of a workgroup to increase innovation and investment in the healthcare industry. The Immediate Office of the Secretary of HHS seeks comments on how to structure the workgroup in order to “spur investment, increase competition, accelerate innovation and … Continue reading

Joint Commission issues advisory on continuity of operations planning

By Jeff Wurzburg (US) and Yvonne Puig (US) on June 6, 2018 Posted in Regulatory

On May 22, 2018, the Joint Commission released an advisory addressing the importance of continuity of operations planning (COOP). When an emergency strikes, an ill-prepared health care organization can put patients at risk. The goal of an COOP is “to protect the organization’s physical plant, information technology systems, business and financial operations, and other infrastructure … Continue reading

OCR proposes to share HIPAA data breach settlements with victims

By Kim Gold (US) and Robert Kantrowitz (US) on May 22, 2018 Posted in Regulatory

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) plans to issue an advance notice of proposed rulemaking this November on potentially sharing HIPAA breach settlements with victims. The notice would solicit public opinion on creating a process for sharing a percentage of any penalty or settlement with those harmed … Continue reading

CMS FY 2019 IPPS and LTCH PPS proposed rule targets interoperability, transparency and burden reductions

By Wendy Wright (US) and Jeff Wurzburg (US) on April 27, 2018 Posted in Regulatory

On April 24, the Centers for Medicare & Medicaid Services (CMS) released its fiscal year (FY) 2019 inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) proposed rule. CMS proposes to reduce regulatory burdens for inpatient hospitals and increase price transparency and better data sharing between hospitals and other providers … Continue reading

NIST releases latest version of its Cybersecurity Framework

By Kim Gold (US) on April 19, 2018 Posted in Regulatory

On April 16, 2018, the National Institute of Standards and Technology (NIST) unveiled Version 1.1 of its widely known Cybersecurity Framework, which incorporates changes based on feedback collected through comments, questions, and workshops held in 2016 and 2017. The Cybersecurity Framework aims to focus on industries vital to national and economic security, including energy, banking, … Continue reading

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

By Robin Adelstein (US) and Krishna Kavi (US) on April 17, 2018 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

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

By Jeff Wurzburg (US) on April 16, 2018 Posted in Regulatory

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

By Jeff Wurzburg (US) on April 10, 2018 Posted in Regulatory

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

By Susan Ross (US) on March 19, 2018 Posted in Regulatory

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

By Kim Gold (US) on February 21, 2018 Posted in Regulatory

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

By Jeff Wurzburg (US) on February 21, 2018 Posted in Regulatory

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

By Thomas Dowdell (US) and Joseph Keillor (US) on February 20, 2018 Posted in News from DC, Regulatory

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

Connecticut case finds health care privacy cause of action

By Susan Ross (US) and Kim Gold (US) on February 15, 2018 Posted in Regulatory

On January 16, 2018, the Connecticut Supreme Court unilaterally created a new state law cause of action for violation of a patient’s health care privacy. (Byrne v. Avery Center for Obstetrics & Gynecology, P.C., 327 Conn. 540, __ A.3d __ (Jan. 16, 2018)). Particularly noteworthy is the new standard for a physician’s level of care: … Continue reading

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

By Jeff Wurzburg (US) on February 6, 2018 Posted in Regulatory

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

By Debbi Johnstone (US), Selina Coleman (US), Joseph Keillor (US) and Sarah Jean Kilker (US) on February 2, 2018 Posted in Regulatory

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

By Kim Gold (US) and Alexis Wilpon (US) on February 1, 2018 Posted in Regulatory

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

By Kim Gold (US) on January 29, 2018 Posted in Regulatory

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

By Jeff Wurzburg (US) on January 8, 2018 Posted in Regulatory

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

By Elise LeGros (US), Ashley Francois (US) and Lisa Genecov (US) on November 16, 2017 Posted in Regulatory

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

By Elise LeGros (US), Lisa Genecov (US) and Ashley Francois (US) on October 17, 2017 Posted in Regulatory

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

By Cori Goldberg (US) and Krishna Kavi (US) on October 12, 2017 Posted in Regulatory

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

By Elise LeGros (US) and Lisa Genecov (US) on August 15, 2017 Posted in Regulatory

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

By Elise LeGros (US) and Lisa Genecov (US) on August 15, 2017 Posted in International, Regulatory

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

By Thomas Dowdell (US) on August 14, 2017 Posted in Regulatory

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