Healthcare Law Blog

JANUARY 17, 2023

As 2023 begins, the nursing home industry faces unprecedented challenges on multiple fronts. While facilities struggle with a labor crisis, chronic underfunding, high inflation and a combined resurgence of COVID-19 and the flu, the government is ramping up efforts to hold them to even higher operational and regulatory standards.

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Hall Render

JANUARY 16, 2024

On December 21, 2023, the Departments of Health and Human Services, Labor and the Treasury (collectively, “the Departments”) released a final rule that sets the applicable fees for participating in the No Surprises Act’s (“NSA”) Independent Dispute Resolution (“IDR”) process.

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Bill of Health

NOVEMBER 15, 2023

drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). Code § 1701 et seq.

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Healthcare Law Blog

OCTOBER 2, 2023

The government buys billions of dollars in healthcare-related goods and services every year, and no government procurement is perfect. If the answer is “yes”—or even “maybe”—healthcare companies may file a bid protest at the Government Accountability Office (“GAO”) or the U.S. B-421325, 2023 CPD ¶ 74 (Mar.

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Bill of Health

JANUARY 18, 2024

While summarizing the entire content of the 13 blogs comprising this symposium in any depth is not possible here, this concluding post will attempt to synthesize some of the major inputs from the contributions. The South African Court ultimately ordered disclosure of such contracts despite the government’s reliance on confidentiality clauses.

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Hall Render

JUNE 16, 2023

On June 16, 2023, the U.S. The Court’s opinion settles two outstanding questions about the authority of the Government to dismiss FCA actions in which it first declines to intervene but that whistleblowers continue to pursue on the Government’s behalf. Supreme Court decided United States ex rel. Polansky v.

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Healthcare Blog

APRIL 13, 2023

As hospitals have become increasingly complex organizations, effective governance, risk, and compliance (GRC) strategies have become essential for ensuring patient safety and regulatory compliance. What are the Key Components of a Successful Governance, Risk, and Compliance (GRC) Strategy? What is patient safety culture? News Medical.

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Healthcare Law Blog

OCTOBER 18, 2023

At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our top 10 takeaways from what we heard, and did not hear, at HLTH 2023.

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Health Law Advisor

JANUARY 10, 2023

More than just New Year’s resolutions went into effect when the clock struck midnight on January 1, 2023. Have you created governance structures to monitor compliance and coordinate with other departments within your company? The CPRA does not expand the applicability of the CCPA, but does impose a number of new requirements.

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Healthcare Law Blog

DECEMBER 2, 2022

While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the privacy and security of protected health information generally, Part 2 specifically governs the medical records of federally assisted substance use treatment programs (“SUD Records”). Thereafter, we anticipate that HHS will issue a Final Rule in 2023.

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Provider Trust

FEBRUARY 3, 2023

In a recent webinar, ProviderTrust took a look at impactful healthcare trends to monitor in 2023 and beyond. According to a January 2023 Washington Post article , nurses across California, Oregon, Michigan, and Minnesota have also threatened to protest or have already gone on employment strike.

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Bill of Health

NOVEMBER 7, 2023

One of us (LG) was involved in the drafting of the Siracusa Principles, which have become the chief international instrument governing permissible human rights limitations during national emergencies. Governments should also reach into their diplomatic toolbox to encourage compliance. The HR Principles build on the Siracusa Principles.

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The Health Law Firm Blog

FEBRUARY 8, 2024

Board Certified by The Florida Bar in Health Law and Hartley Brooks, Law Clerk, The Health Law Firm On August 12, 2023, federal prosecutors recommended a life sentence for the Florida ex-CEO of a laboratory company who had been found guilty of fraudulently billing Medicare over one [.] By George F. Indest III, J.D.,

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The Health Law Firm Blog

JANUARY 18, 2024

Board Certified by The Florida Bar in Health Law and Hartley Brooks, Law Clerk, The Health Law Firm On August 12, 2023, federal prosecutors recommended a life sentence for the Florida ex-CEO of a laboratory company who had been found guilty of fraudulently billing Medicare over one [.] By George F. Indest III, J.D.,

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SQA

DECEMBER 21, 2023

2024 & Beyond Q4 and MICCS Success As we embark into Q4, we have just celebrated our most productive quarter in company history and , by serving more clients in more ways, we are on pace for 2023 to be our biggest year ever. We are excited to continue this trend into 2024 and beyond!

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The Health Law Firm Blog

DECEMBER 28, 2023

Board Certified by The Florida Bar in Health Law and Hartley Brooks, Law Clerk, The Health Law Firm On August 12, 2023, federal prosecutors recommended a life sentence for the Florida ex-CEO of a laboratory company who had been found guilty of fraudulently billing Medicare over one [.] By George F. Indest III, J.D.,

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Bill of Health

NOVEMBER 21, 2023

By Zione Ntaba Malawi is not a stranger to public health crises in the last number of years, having faced a severe HIV epidemic and several cholera outbreaks continuing into 2023. Additionally, the Government declared COVID-19 a “ formidable disease ” under the Public Health Act on April 1, 2020.

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SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products.

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YouCompli

JANUARY 18, 2023

The government is watching these adjustments to make sure they are appropriate for federally reimbursed services. Subscribe to the YouCompli blog for enforcement updates and real-world insight on compliance officer effectiveness, regulatory change management, and the value compliance brings to an organization.

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Bill of Health

DECEMBER 7, 2023

In June 2023, the Assembly adopted Resolution 2500 (2023) on “Public health emergency: the need for a holistic approach to multilateralism and health care.” The report supports the ongoing processes taking place at the international level to transform global health governance.

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Healthcare Law Blog

JANUARY 31, 2023

This blog is the second installment of our Digital Health Trends series. In November 2020, Oregon became the first state to legalize psilocybin-assisted therapy and began accepting applications for licensure on January 2, 2023. [v] Part 2, which governs the medical records of federally assisted substance use treatment programs.

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Bill of Health

JUNE 12, 2023

” In this blog post, I will summarize the main themes of the discussion paper, highlighting areas where FDA seems particularly concerned, and detailing how interested parties can engage with the agency on these issues. However, the paper goes on to explore the use cases of AI/ML in later stages of drug development as well.

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Provider Trust

AUGUST 9, 2023

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released its latest 2023 Spring Semiannual Report to Congress, providing a comprehensive overview of its activities from October 2022 to March 2023. Led by acting Inspector General Christi A.

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Hall Render

FEBRUARY 23, 2024

billion in False Claims Act (“FCA”) settlements and judgments during the 2023 federal fiscal year. In addition to the record-setting number of settlements and judgments, whistleblower activity continues to grow with over 712 qui tam lawsuits filed in 2023, averaging more than 13 new cases every week. billion of the $2.68

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MRO Compliance

MARCH 30, 2023

Interoperability Regulations and the Effects on Health Information Management In January 2023, the Health Data Management COVER story focused on the future of interoperability. As a follow up to this cover story, I wrote a guest article for them entitled 3 specific areas of data sharing to clarify and consider in 2023.

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SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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Hall Render

NOVEMBER 4, 2022

PWC and the Urban Land Institute published their Emerging Trends in Real Estate report for 2023. The report is extensive and wide-ranging in scope, but one interesting finding was a list of markets where the greatest overall real estate growth is expected in 2023. Additionally, more than three-quarters of U.S.

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Bill of Health

OCTOBER 24, 2023

Against the backdrop of this burgeoning collective amnesia, a project to articulate the human rights norms relevant to public health emergencies led to the development of the 2023 Principles and Guidelines on Human Rights and Public Health Emergencies (the Principles).

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Bill of Health

OCTOBER 26, 2023

Global solidarity requires cooperation between governments, while national solidarity involves cooperation within a state to address common challenges and achieve shared goals. Solidarity operates at two intersecting levels. That has created deep inequities in access to health products that can save lives.

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Healthcare Law Blog

MAY 17, 2022

On January 5, 2022, we discussed the Notice of Benefit and Payment Parameters for 2023 proposed rule released by the Centers for Medicare & Medicaid Services (CMS). On April 28, 2022, CMS issued the NBPP 2023 Final Rule. We previously noted that the 2023 NBPP proposed rule would have amended 45 C.F.R.

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Bill of Health

NOVEMBER 2, 2023

States maintain these obligations even when non-State actors are involved in health care financing, provision, and governance, albeit further normative development in this area is still urgently needed.

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Health Law Advisor

JULY 11, 2023

On June 16, 2023, Nevada enacted Senate Bill 370 (“ SB 370 ”), which imposes broad restrictions on the collection, use, and sale of consumer health data. This law is set to go into effect on March 31, 2024. Regulated entities are subject to the following provisions: SB 370 does not create a private right of action.

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Health Law RX

JUNE 27, 2023

Earlier, in the SuperValu decision (discussed in a recent Health Law Rx Blog ), the Court clarified that subjective intent is relevant in determining whether an objectively reasonable (but incorrect) interpretation of a rule or regulation could negate the FCA’s scienter element ( U.S. 21-1052, 2023 WL 4034314, at *2 (U.S. Polansky v.

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Bill of Health

DECEMBER 5, 2023

By Silvia Serrano Guzmán On July 4, 2023 the Constitutional Court of Colombia handed down a landmark decision on one of the most difficult dilemmas faced during the COVID-19 pandemic: the rationing of intensive care in situations of scarcity. The Colombian case reinforces that human rights and public health are not mutually exclusive.

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Hall Render

JANUARY 6, 2023

According to Senior Housing News, the senior living sector faces a potential disparity of outcomes for 2023 , with some operators building on 2022 success, while struggling operators may continue to flounder. Skilled Nursing News published its forecast of top skilled nursing trends for 2023. Anthony North Hospital in Westminster, CO.

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Natalia Mazina

JUNE 4, 2023

The DEA’s administrative action against Truepill is what first prompted me to write this blog post. Truepill is not the only one who became a target of government investigations due to improper online prescribing. As a result, they need to be ready for increased PBM audits and government investigations.

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Hall Render

JANUARY 4, 2024

Background The enactment of HB 4520 and HB 4521 represents the growing trend of the federal government and state governments protecting health care workers from workplace violence. Hall Render blog posts and articles are intended for informational purposes only.

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