Health Law Advisor

On May 17, 2024, Colorado Governor Jared Polis signed into law SB 24-205—concerning consumer protections in interactions with artificial intelligence systems—after the Senate passed the bill on May 3. The law adds a new part 17, “Artificial Intelligence,” to Article I, Title 6 of the Colorado Consumer Protection Act, to take effect on February 1, 2026. This makes Colorado “among the first in the country to attempt to regulate the burgeoning artificial intelligence industry on such a scale,” Polis said in a letter to the Colorado General Assembly.

The new law will ...

In this episode of the Diagnosing Health Care Podcast: What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders?

At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing telehealth policies, yet no two states are exactly alike in their approach to defining and regulating telehealth.

On this episode ...

In this episode of the Diagnosing Health Care Podcast:  A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?

In this episode of the Diagnosing Health Care Podcast:  When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it.

What unique challenges do direct access tests (DATs) pose when it comes to reimbursement and related compliance requirements?

In this episode of the Diagnosing Health Care Podcast:  What are the various factors impacting stakeholders in the direct access testing industry?

By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured.

In this episode of the Diagnosing Health Care Podcast:   The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.

How has this document caused confusion for industry? How can companies respond?

Featured on the Diagnosing Health Care Podcast:  How is openEHR transforming the way health data is managed and stored across Europe? Will it soon disrupt the U.S. marketplace?

In this episode of our special series on interoperability, hear from Alastair Allen, CTO of Better.

In this episode of the Diagnosing Health Care Podcast:  In the past decade, certified electronic health records (EHRs) have been instrumental in transforming medical records from paper to digital formats.

What obstacles are currently preventing providers from sharing patient data with each other or patients from sharing health information from their personal devices with their providers? In this episode of our special series on interoperability, hear from Tomaž Gornik, founder and CEO of Better.

In this episode of the Diagnosing Health Care Podcast:  What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry.

In this episode of the Diagnosing Health Care Podcast:  The interoperability and information-blocking rules have imposed new regulations and requirements on health information exchanges (HIEs). How are HIEs responding to these new regulations in a space they have been in for decades? In this episode of our special series on interoperability, hear from Dan Paoletti, CEO of the Ohio Health Information Partnership.

New from the Diagnosing Health Care Podcast:  One of the long-term goals of the interoperability and information-blocking rules is to give health care providers a much more comprehensive view of a patient’s entire continuum of care.

The application of artificial intelligence technologies to health care delivery, coding and population management may profoundly alter the manner in which clinicians and others interact with patients, and seek reimbursement. While on one hand, AI may promote better treatment decisions and streamline onerous coding and claims submission, there are risks associated with unintended bias that may be lurking in the algorithms. AI is trained on data. To the extent that data encodes historical bias, that bias may cause unintended errors when applied to new patients. This can result in ...

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and consolidation in 2020.  These predictions for 2020 are largely based on the increasing confluence of the following three key “drivers” of health industry transformation that is substantially underway:

1. The ongoing national imperative of reducing the cost of health care, via disease prevention and detection, and cost-effective, quality treatment, including more efficient care in ambulatory and retail settings;
2. Extraordinary advances in technologies which enhance disease prevention, detection and cost-effective treatment (e.g., artificial intelligence (AI)-driven diagnosis and treatment, virtual care, electronic medical record (EMR) systems, medical devices, gene therapy, and precision medicine); and
3. The aging baby-boomer population, with tens of millions of Americans entering into their 70s, 80s, and above.

One well-recognized way to protect patient privacy is to de-identify health data.  However, trends around increases in publicly-available personal data, data linking and aggregation, big data analytics, and computing power are challenging traditional de-identification models.  While traditional de-identification techniques may mitigate privacy risk, the possibility remains that such data may be coupled with other information to reveal the identity of the individual.

Last month, a JAMA article demonstrated that an artificial intelligence algorithm could re-identify ...

After July 1, 2017, optometrists and ophthalmologists ("Ophthalmic Providers") in Virginia will be able to practice through telehealth. Va. Code § 54.1-2400.01:2 permits Ophthalmic Providers to establish a bona fide provider-patient relationship "by an examination through face-to-face interactive, two-way, real-time communication" or through "store-and-forward technologies." Licensed Ophthalmic Providers may establish a provider-patient relationship so long as the provider conforms to the in-person standard of care.  To the extent that an Ophthalmic Provider ...

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called "superbugs," estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050.  By comparison, the ...

Epstein Becker Green has just released the 50-State Survey of Telemental/Telebehavioral Health (2016), a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia.

While other telehealth studies exist, this survey focuses solely on the remote delivery of behavioral health care.

Compiled by attorneys in Epstein Becker Green's Telehealth practice, the survey details the rapid growth of telemental health—mental health care delivered via interactive audio or video ...

By Arthur J. Fried.

In what is being called an historic announcement, Department of Health and Human Services Secretary Sylvia Mathews Burwell announced on Monday the setting of clear goals and timeframes for moving Medicare from volume to value payments.  The stated goals are to tie 30% of all Medicare provider payments to quality and cost of care by 2016, moving to 50% by 2018.   Nearly all fee-for-service payments will be aligned with quality and value – 85% by 2016 and 90% in 2018.  This transformation will be achieved by the expansion of mechanisms already in use – Accountable Care ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled The Impact of Value-Based Purchasing and Other Employee Initiatives on Population Health.  This session will discuss several approaches for population health managers to reduce costs and improve health care.

The webinar, scheduled for November 20, 2014, at 12:00 p.m. ET, will be led by Laurel Pickering, MPH, President & CEO of Northeast Business Group on Health, and David Lansky, PhD, President & CEO of Pacific Business Group on ...

Epstein Becker Green today announced that Lynn Shapiro Snyder and Tanya Cramer have written a newly released topical Portfolio for Bloomberg BNA on provider risk sharing arrangements entitled, "Accountable Care Organizations and Other Provider Risk Sharing Arrangements, 2nd edition." The Portfolio discusses the federal and state regulatory schemes for accountable care organizations (ACOs), integrated delivery systems, and other provider organizations that assume some or all of the financial risk for providing covered health care benefits to patients.  For ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar titled Moving to an Integrated Population Health Management Model. This session will highlight several approaches to help manage populations to promote better clinical outcomes, more cost savings and enhanced patient satisfaction.

The webinar, scheduled for October 30, 2014 at 12:00 p.m. ET, will be led by Sarika Aggarwal, MD, Senior Vice President and Chief Medical Officer of Fallon Community Health Plan, and Julie O'Brien, RN, BSN, MS ...

Epstein Becker Green and EBG Advisors, as part of the Thought Leaders in Population Health Speaker Series, will host a complimentary webinar on September 30, 2014 on emerging trends in value-based purchasing in health care. The next session will feature a former key official from the U.S. Department of Health and Human Services (HHS), Gary Cohen, JD, who played a central role in the implementation of the Affordable Care Act over the past several years and is moderated by Lynn Shapiro Snyder, Senior Member, Epstein Becker Green.  The session, The Impact of the Affordable Care Act on ...

Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their procompetitive vs. anticompetitive effects. With 65 organizations now participating in Medicare shared savings initiatives, including the 27 Medicare Shared Savings Program participants announced on April 10 ...

by René Y. Quashie and Lynn Shapiro Snyder

As the health care industry analyzes the recently released final rule and related guidance regarding the Medicare Shared Savings Program (“MSSP”) for accountable care organizations (“ACOs”), it is important for the industry to also pay attention to key deadlines related to initiatives being implemented by the Center for Medicare and Medicare Innovation (“CMMI” or “Innovation Center”) within the Centers for Medicare & Medicaid Services (“CMS”).

While the MSSP ACO initiative is a permanent Medicare program, CMMI ...

by Patricia M. Wagner and Ross K. Friedberg

Among the criteria that the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) uses to evaluate an accountable care organization’s (“ACO’s”) risk of an antitrust challenge is the ACO applicant’s “market share” within each of its service lines. The market share is a measure of the share of services an ACO participant provides in its Primary Service Area (“PSA”) relative to other ...

by Patricia M. Wagner and Ross K. Friedberg

On April 19, 2011, the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) was published in the Federal Register. As noted in the Proposed Statement, the antitrust enforcement agencies (the Department of Justice Antitrust Division and the Federal Trade Commission issued the Proposed Statement in response to a perceived preference by potential accountable care organization (“ACO”) participants to ...

by Shawn M. Gilman, Douglas A. Hastings, Mark E. Lutes, David E. Matyas, Lynn Shapiro Snyder, Carrie Valiant, Dale C. Van Demark, Patricia M. Wagner, and Lesley R. Yeung

On March 31, 2011, the Centers for Medicare & Medicaid Services ("CMS") released for public comment a much-anticipated Notice of Proposed Rulemaking implementing the voluntary Medicare Shared Savings Program ("Program") for accountable care organizations ("ACOs"). Also on March 31, the Office of Inspector General, along with CMS, released a Notice with Comment Period to solicit comments regarding proposed ...

by Douglas A. Hastings 

According to the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), Dr. Donald M. Berwick, the long-awaited proposed regulations implementing the Medicare Shared Savings Program should be out soon. Given the incredible proliferation of policy, business, and legal thinking about accountable care organizations (“ACOs”) that has taken place since the passage of the Affordable Care Act (“ACA”) less than a year ago, CMS’s initial effort to describe a program of payment and delivery reform built around the ACO “model” ...

As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:

1. Flexibility. 

 "Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande's advice and avoids being too proscriptive in launching the Share Savings Program. To me, the biggest risk to the program is being deemed a failure for having gone down too narrow a path that turns out to be unsuccessful.

Useful approaches have been suggested for ...

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let's look at the rollout of the accountable care provisions--i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in ...

In my most recent article in the series I have been writing for the BNA's Health Law Reporter on payment and delivery system reform, accountable care organizations and bundled payments, I comment on where things are now that federal reform has stalled. The article, titled "Payment and Delivery System Reform: It's Only a Matter of Time," argues that changes in payment and delivery are on the horizon regardless of the pace of federal reform and that providers (and payers as well) should continue their efforts toward accountable care to meet the cost and quality challenges that ...

Although there are some big issues that remain unresolved, such as the "public plan" component, it appears that we will see reform legislation pass in 2009. Drafts of the legislation are being prepared now by various members of Congress and their staffs.

The focus on medical homes, physician hospital organizations and accountable care organizations is very real, as is the focus on payment reform, including bundled payments and other forms of capitation-like reimbursement. A key element of the debate relates to "how integrated" a provider organization will need to be to qualify for ...

For health care facilities, and those who invest in them or lend to them, the President’s budget underscored the emerging “shape of things to come” in the delivery system. In short, the Administration intends to compel delivery system modifications through aggressive payment policy changes.

What industry segments are immediately concerned? -- home health agencies, skilled nursing facilities, IRFs, LTCHs, and rehab facilities. In the name of “efficiency and accountability” the President proposes to bleed (Bleeding Edge redux?) $950M over 5 years and $17.8B over ten ...