An $800 Head Cold? Time to Fight for Price Transparency in American Healthcare

Jay Singh had a nasty head cold. Not a “will-I-survive-this-plague” kind of infection, but also not one he thought, if left to its own devices, would blow over in a day or two. So he went to the primary care clinic near his exurban New York City home. The doctor spent ten minutes examining and talking to Singh (a pseudonym), a quick look at his throat, a cursory listen to his lungs. The doctor ordered a routine “respiratory viral panel” and prescribed a cough suppressant. Singh had already anted up a co-pay for the office visit, but a few weeks later he received a bill for the services rendered: $800 to cover his doctor’s time and the cost of the viral panel.

I spoke to Singh several months after his appointment, and he was still determined to leverage his experience into political action: he thinks it’s time for the state of New York, perhaps the whole U.S., to bring healthcare prices out of the dark so patients like him can make informed decisions about their medical care.

The full Forbes article can be viewed at this link.  

Billionaire Electronic Health Records Pioneer Judy Faulkner Warns Of Cambridge Analytica-Type Data Risk

Judy Faulkner, founder of Epic, one of the largest providers of electronic medical health records, warned that a proposed rule on information sharing could create a Cambridge Analytica-type situation, where the data of a patients’ friends and family is shared without their consent. 

A federal rule on digital health-sharing now under review “has good things to it but there are some bad things that have to be fixed, in my opinion,” Faulkner, 76, told NYU Langone Health CEO Robert Grossman at the Forbes Healthcare Summit in New York City on December 5. 

“It’s a bit like Facebook in that—the friends of the users who gave permission to Cambridge Analytica to use the system—the friends’ data got pulled out with the users who had authorized Cambridge Analytica,” she said.

The full Forbes article can be viewed at this link.  

Congress’s new plan to end surprise medical bills, explained

Just as the prospects of a congressional deal to stop surprise medical bills seemed to be dimming, lawmakers had a breakthrough. On Sunday evening, the leaders of several key health care committees announced they had come to an agreement.

Sen. Lamar Alexander, the top Republican on the Senate health committee, announced the news alongside Reps. Frank Pallone (D-NJ) and Greg Walden (R-OR), the top Democrat and Republican on an important House committee. (Sen. Patty Murray, the ranking Democrat on Alexander’s committee, did not join the trio; her spokesperson told Axios some Senate Democrats still have unspecified concerns but she still welcomed the development.)

”I do not think it is possible to write a bill that has broader agreement than this one does among Senate and House Democrats and Republicans on Americans’ number one financial concern: what they pay out of their own pockets for health care,” Alexander said on Sunday night.

They got there by compromising on what has been the most contentious issue in the surprise billing legislation: how much doctors will get paid when they provide emergency out-of-network care to patients.

The full Vox article can be viewed at this link.  

Here’s How Health Data Can Help Stem the Opioid Crisis

The number of people losing their lives each day to prescription or illicit opioid-related overdoses is staggering. According to the Centers for Disease Control and Prevention, more than 47,000 Americans died in 2017 — 130 fatalities each day — due to opioid overdoses, making it the deadliest year on record. 

You don’t have to be personally touched by the opioid crisis to understand the gravity of the statistics, let alone the immeasurable and lasting impact it is having on society. This can be addressed by better harnessing the power of data to stem this crisis. 

The full Morning Consult article can be viewed at this link.  

HEALTH RESEARCH AND DEVELOPMENT TO STEM THE OPIOID CRISIS: A NATIONAL ROADMAP

As the opioid crisis continues to devastate the United States (U.S.) and its communities, science and technology have been recognized as key components of a comprehensive approach to combat the crisis. Achieving scientific breakthroughs and advancements to help resolve the opioid crisis requires a Federal research portfolio that strategically supports basic, applied, and implementation science. In December 2017, the Office of Science and Technology Policy (OSTP) convened a Fast Track Action Committee (FTAC) on Health Science and Technology Response to the Opioid Crisis (Opioid FTAC) under the National Science and Technology Council (NSTC) Committee on Science. The Opioid FTAC was charged with creating a Roadmap for health research and development (R&D), and related science and technology (S&T), to support the President’s opioid response. This Roadmap achieves its purpose in the present report by identifying (1) R&D critical to addressing key gaps in knowledge and tools, and (2) opportunities to improve coordination of R&D essential to combating the opioid crisis.

To organize its efforts and the Roadmap, the Opioid FTAC identified seven areas of R&D: (1) the Biology and Chemistry of Pain and Opioid Addiction; (2) Non-Biological Contributors to Opioid Addiction; (3) Pain Management; (4) Prevention of Opioid Addiction;(5) Treatment of Opioid Addiction and Sustaining Recovery; (6) Overdose Prevention and Recovery; and (7) Community Consequences of Opioid Addiction. The research recommendations generated by the FTAC in each of these areas, as well as an eighth section that includes recommendations on ways to enhance coordination, are summarized below.

The full report can be downloaded below.  

Record-Breaking FDA Approvals Mean Hope for Patients but Challenges for Healthcare Access, Delivery and Affordability

Last year, the U.S. Food and Drug Administration (FDA) approved a record-breaking 59 new medicines that will advance healthcare for patients with chronic and rare diseases.

This is great news, because it shows that our scientific understanding of the mechanisms that change the course of disease is leading to pharmaceutical breakthroughs. And the evolution of regulatory requirements like Therapy Breakthrough designation is shortening approval times and getting new treatments to patients faster.

However, this same progress presents significant challenges for the healthcare industry. While recent and anticipated scientific innovation marks much-needed progress for patients, in many cases, the systems designed to promote patient access to these new treatments have not kept pace.

This disparity will undoubtedly impact many areas of healthcare. Payers, distributors and pharmacies will have to address the challenges that come with how a new generation of medicines is covered, reimbursed, distributed and dispensed—in addition to creating the need for effective care strategies that optimize outcomes.

The full Surescripts article can be viewed at this link.  

AI Policies Are Setting Stage To Transform Healthcare But More Is Needed

White House and federal leaders have been working behind the scenes to lay the groundwork to use technology for dramatic improvements in healthcare. Since the announcement of the Artificial Intelligence (AI) Initiative earlier this year there has been increased funding and agency proposals that will lead to more accurate diagnoses, earlier treatments and ultimately empower patients be in control of their own health. But even more attention is needed to keep America competitive on the global AI front. 

The full Forbes article can be found at this link.  

FDA Continues Implementation of 21st Century Cures Health IT Software Provisions

The U.S. Food and Drug Administration (FDA), on September 27, 2019, released final and draft guidance implementing provisions of the 2016 21^st Century Cures Act (Cures) that clarify the regulatory status of health IT software. These provisions, complementing a recent Cures-related proposed rule from the Office of the National Coordinator for Health IT (ONC), culminated years of efforts to resolve the regulatory status of electronic health records (EHRs) and other health IT software. Section 3060(a) of Cures amended Section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), removing some software functions from the definition of a device subject to FDA regulation.

The FDA’s first guidance, released in final form (subject to continued comment), updates a December 2017 draft guidance and provides the agency’s “current thinking” on the Cures device definition and its impact on existing FDA guidance on medical device software. The second guidance, a draft that updates a December 2017 draft (and FDA work that predates Cures), focuses on clinical decision support (CDS) provisions of Section 3060(a) of Cures. It defines which CDS will be subject to FDA regulation as a device and how FDA will approach such regulation. This new guidance is part of the FDA’s broader Digital Health strategy.

In general, software that is not a device would not be subject to FDA regulation. In some cases however, safety aspects of non-device health IT software would be regulated by ONC via the ONC certification process, for example for use of quality management programs and usability testing/safety-enhanced design. ONC also maintains a Health IT Feedback process to handle software complaints.

These new guidance documents have important implications for eHI members, including provider organizations, that develop health IT software. At a minimum, they will affect compliance plans, quality management, product development, and marketing

Guidance: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

The changes described in this final FDA guidance are also reflected in conforming revisions to:

• General Wellness: Policy for Low Risk Devices
• Mobile Medical Applications
• Off-The-Shelf Software Use in Medical Devices
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; and withdrawal of
• Guidance for the Submission of Premarket Notifications for Medical Image Management Devices

Section 520 of the FD&C Act states that “device” will not include a software function intended:

(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;

Note: FDA has generally not considered such functions to be a device and makes clarifying changes regarding aspects of Laboratory Information Systems.

(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

Note: FDA clarifies that the exclusion from the device definition applies only to software and not hardware and also does not apply where the function is related to “diagnosis, cure, mitigation, prevention, or treatment of a disease or condition,” with updated examples and pointers to updates in the General Wellness and Mobile Medical Application guidance.

(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as—

(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals;

(ii) such records are part of health information technology that is certified under section 3001(c)(5) of the Public Health Service Act; and

(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

Note: The definition of an “electronic patient record” is narrow, treating the EHR as an electronic version of a paper record.  It is unclear how far it extends to the full range of modern EHRs and likely does not apply to many CDS functions used in EHRs, which are addressed in the separate FDA guidance on 520(o)(1)(E). FDA also indicates that it will not enforce the Cures requirement that only certified functions are eligible for this exclusion. Important for EHRs and similar health IT, FDA also indicates that it will issue future guidance on software that combines device and non-device functions. FDA also provides examples that address apps and other tools that enable patients to interact with EHRs, consistent with the Administration focus on consumer-focused apps connected to EHRs via APIs.

(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or mother device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and finding . . .

Note: Medical Device Data Systems (MDDS), the subject of one of the FDA’s first forays into health IT software regulation in 2011, are now not FDA-regulated devices (software only) and FDA is revising existing MDDS and Mobile App guidance accordingly, including revised examples. FDA also states that, if a multiple function product contains MDDS hardware functions, FDA does not, at this time, intend to enforce FD&C Act requirements.

Draft Guidance: Clinical Decision Support Software

The second FDA guidance released on September 27 covers CDS. It updates the December 2017 draft Cures-related guidance based on comments, notably by (consistent with stakeholder recommendations)  implementing a risk model from the International Medical Device Regulators Forum (IMDRF). Comments are due December 26, 2019.

As amended by Cures, 520(o)(1)(E) of the FD&C Act states that certain CDS software functions are excluded from the definition of device, if they meet all the following four criteria:

1. Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;
2. Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);
3. Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and
4. Intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.

FDA uses the statutory CDS definition for this guidance and, based on its interpretation of Cures, identifies Non-Device CDS and Device CDS. Following Cures, the FDA’s primary determinants of whether CDS is a device are its use by a health care professional, the advisory nature of the CDS, and the ability of the professional to do independent review of input data, the basis for rules and algorithms, etc. Developers seeking to confirm or maintain non-device status will want to focus on the latter two criteria, especially for application of artificial intelligence and machine learning.

For Device CDS, FDA proposes a regulatory approach using the IMDRF risk model for Software as a Medical Device (SaMD). It asks if the condition being addressed is Critical, Serious, or Non-Serious (defined in the guidance) and whether the SaMD information Treats or Diagnoses, Drives Clinical Management, or Informs Clinical Management. (CDS that informs and also allows “independent review” is not a device.)

FDA proposes that, if the software goes beyond informing clinical management (i.e., driving clinical management or treating/diagnosing), it is not CDS per Cures and not subject to this guidance and its proposed regulatory flexibility. The FDA uses the IMDRF definition for driving clinical management: “the information . . . will be used to aid in treatment, aid in diagnoses, to triage or identify early signs of a disease or condition will be used to guide next diagnostics or next treatment interventions:

• To aid in treatment by providing enhanced support to safe and effective use of medicinal products or a medical device.
• To aid in diagnosis by analyzing relevant information to help predict risk of a disease or condition or as an aid to making a definitive diagnosis.
• To triage or identify early signs of a disease or condition.”

For Device CDS that informs, FDA focuses on the seriousness of the condition, proposing enforcement discretion for CDS for Non-Serious Conditions and oversight (i.e., regulatory focus) on health care professional-oriented CDS aimed at Serious or Critical conditions. Where the intended user is a patient or caregiver, FDA will apply oversight (regulation) to all scenarios except non-serious conditions where the user can independently verify the basis for the recommendation (subject to enforcement discretion).

FDA provides examples for each category of CDS (but not for CDS that is not defined as such in this guidance, for example, because it meets the “drive” criterion”).

Commentary on the CDS Guidance

• The FDA’s definitions of Inform and of Drive (especially with Drive including “guide) are not very different and do not seem to reflect the intent behind the concept “drive” or its plain meaning. It would be very easy for much CDS on the market today to meet the definition of “drive”. It is unclear whether the FDA will rely on the IMDRF “inform” definition in determining whether CDS is a device or only once that determination has been made.
• Many CDS software functions could apply across the full range of condition seriousness, notably those in an EHR or not disease specific, so the actual extent of enforcement discretion may be limited.
• Where it applies enforcement discretion, FDA could choose at a later time to require some device requirements, such as a quality system, while not requiring premarket clearance or approval. Notably, the FDA “encourages developers of CDS software functions that are not medical devices or are medical devices for which at this time FDA does not intend to enforce compliance . . . to implement a quality system consistent with IMDRF’s Software as a Medical Device (SaMD): Application of Quality Management System and to apply good cyber hygiene, such as through software design and cyber vigilance, consistent with applicable FDA guidance”.
• This guidance does not describe how the FDA will regulate CDS for which is applies oversight.

Implications for eHealth Initiative Members and Action Steps

Understanding these guidance documents is important for eHI members that develop health IT software. They finalize (for now) provisions of Cures that limit the extent of FDA regulation of EHRs and other health IT (other than CDS, which remains at a draft stage). They also highlight the limits of Cures-related regulatory relief, whether for EHRs, CDS beyond narrow confines, and certain patient/consumer-facing apps. They will affect how developers approach designing for and communicating the intended use of their products and, especially for CDS, how they enable healthcare professionals to independently review the basis for CDS recommendations.

Health IT software developers should review these new guidance documents, submit timely comments to FDA on the CDS draft guidance and on the finalized guidance documents if issues remain, and monitor how FDA will regulate health IT that it considers a device.

Mark Segal, PhD, FHIMSS, Principal, Digital Health Policy Advisors, LLC. Member and Past Chair of the eHI Policy Steering Committee. October 21, 2019. Twitter @msegal111

eHI thinks Mark Segal is a super cool guy and is providing his opinions for informational purposes only. The opinions presented, do not represent those of eHealth Initiative, our members or the Foundation.

Precision Medicine For Pediatric Patients Gets A Boost From Congress

Of the approximately 7,000 rare diseases 80% are genetic. And, more than half of rare diseases affect children.

For patients and their caregivers, one of the more frustrating aspects of rare diseases is the length of time from symptom onset to an accurate diagnosis, which averages 4.8 years.

Last month, together with several colleagues in the House, Representative Eric Swalwell of California reintroduced a bipartisan bill called Advancing Access to Precision Medicine Act. The legislation had originally been proposed in January 2018, and is aimed at promoting the use of genetic and genomic testing to improve healthcare delivery. Specifically, the bill is designed to improve patient access to genetic and genomic testing to help shorten the time to diagnosis, easing the diagnostic odyssey for pediatric patients suffering from rare diseases.

The full Forbes article can be viewed at this link.  

Don't Force Patients Off Opioids Abruptly, New Guidelines Say, Warning Of Severe Risks

There's no doubt that opioids have been massively overprescribed in U.S. In the haste to address the epidemic, there's been pressure on doctors to reduce prescriptions of these drugs — and in fact prescriptions are declining. But along the way, some chronic pain patients have been forced to rapidly taper or discontinue the drugs altogether.

Now, the U.S. Department of Health and Human Services has a new message for doctors: Abrupt changes to a patient's opioid prescription could harm them.

On Thursday, the agency issued new guidelines for physicians on how best to manage opioid prescriptions. They recommend a deliberate approach to lowering doses for chronic pain patients who have been on long-term opioid therapy.

"It must be done slowly and carefully," says Adm. Brett P. Giroir, MD, assistant secretary for health for HHS. "If opioids are going to be reduced in a chronic patient it really needs to be done in a patient-centered, compassionate, guided way."

The full NPR article can be viewed at this link.