Government and Regulations

In a letter addressed to VA Secretary Robert McDonald, the group—led by Senators Kirsten Gillibrand (D-NY) and Steve Daines (R-MT), as well as Representatives Earl Blumenauer (D-OR), Dina Titus (D-NV), and Dana Rohrabacher (R-CA)—asked for the VA to reform its stance on medical marijuana, noting that this policy limits physicians' ability to effectively treat their patients.

The law, VHA Directive 2011-004, expired on January 31. The law also discouraged veterans from having discussions on cannabis treatment with their physicians for fear of losing benefits.

“When veterans walk into a VA facility and talk with their doctor, they can’t discuss all of the options available to them that they could discuss at a non-VA facility next door,” Daines said in the letter. “Current VA policy is not only a clear violation of states’ 10th Amendment rights—it’s a violation of our veterans’ 1st Amendment rights to talk openly and freely with their doctors. Veterans shouldn’t be discriminated against just because they’re seeking the care they deserve at VA facilities.”

Twenty-one politicians signed the letter, which has also gained praise from the Marijuana Policy Project, a nonprofit organization committed to marijuana policy reform in the U.S., according to Yahoo News.

Attention was drawn to the issue by the recent story of Raymond Schwab, a Kansas veteran and VA employee, who has lost custody of 5 of his 6 children for alleged endangerment stemming from his prescription for cannabis from the neighboring state of Colorado. “There’s still a stigma against parents who use medical marijuana,” Jennifer Ani, a family law attorney, told The Guardian. “As much as marijuana is a moving target throughout the nation, with Child Protective Services it’s even more so.”

In a letter addressed to VA Secretary Robert McDonald, the group—led by Senators Kirsten Gillibrand (D-NY) and Steve Daines (R-MT), as well as Representatives Earl Blumenauer (D-OR), Dina Titus (D-NV), and Dana Rohrabacher (R-CA)—asked for the VA to reform its stance on medical marijuana, noting that this policy limits physicians' ability to effectively treat their patients.

The law, VHA Directive 2011-004, expired on January 31. The law also discouraged veterans from having discussions on cannabis treatment with their physicians for fear of losing benefits.

“When veterans walk into a VA facility and talk with their doctor, they can’t discuss all of the options available to them that they could discuss at a non-VA facility next door,” Daines said in the letter. “Current VA policy is not only a clear violation of states’ 10th Amendment rights—it’s a violation of our veterans’ 1st Amendment rights to talk openly and freely with their doctors. Veterans shouldn’t be discriminated against just because they’re seeking the care they deserve at VA facilities.”

Twenty-one politicians signed the letter, which has also gained praise from the Marijuana Policy Project, a nonprofit organization committed to marijuana policy reform in the U.S., according to Yahoo News.

Attention was drawn to the issue by the recent story of Raymond Schwab, a Kansas veteran and VA employee, who has lost custody of 5 of his 6 children for alleged endangerment stemming from his prescription for cannabis from the neighboring state of Colorado. “There’s still a stigma against parents who use medical marijuana,” Jennifer Ani, a family law attorney, told The Guardian. “As much as marijuana is a moving target throughout the nation, with Child Protective Services it’s even more so.”

In a letter addressed to VA Secretary Robert McDonald, the group—led by Senators Kirsten Gillibrand (D-NY) and Steve Daines (R-MT), as well as Representatives Earl Blumenauer (D-OR), Dina Titus (D-NV), and Dana Rohrabacher (R-CA)—asked for the VA to reform its stance on medical marijuana, noting that this policy limits physicians' ability to effectively treat their patients.

The law, VHA Directive 2011-004, expired on January 31. The law also discouraged veterans from having discussions on cannabis treatment with their physicians for fear of losing benefits.

“When veterans walk into a VA facility and talk with their doctor, they can’t discuss all of the options available to them that they could discuss at a non-VA facility next door,” Daines said in the letter. “Current VA policy is not only a clear violation of states’ 10th Amendment rights—it’s a violation of our veterans’ 1st Amendment rights to talk openly and freely with their doctors. Veterans shouldn’t be discriminated against just because they’re seeking the care they deserve at VA facilities.”

Twenty-one politicians signed the letter, which has also gained praise from the Marijuana Policy Project, a nonprofit organization committed to marijuana policy reform in the U.S., according to Yahoo News.

Attention was drawn to the issue by the recent story of Raymond Schwab, a Kansas veteran and VA employee, who has lost custody of 5 of his 6 children for alleged endangerment stemming from his prescription for cannabis from the neighboring state of Colorado. “There’s still a stigma against parents who use medical marijuana,” Jennifer Ani, a family law attorney, told The Guardian. “As much as marijuana is a moving target throughout the nation, with Child Protective Services it’s even more so.”

Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.

Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.

The Case for VA Leadership

A solution to these 2 central dilemmas will result in continued health care improvement and, arguably, meaningful cost reduction through elimination of inferior treatments and optimization of individual patient care strategies. Since the current research culture does not reward such accomplishments, the responsibility for moving forward is left squarely on the health care systems. Said differently, a health care research budget that is a small fraction (5%) of health care expenditures is undersized and too culturally foreign for the task.¹

A critical attribute that enables the VA to promote progress to the benefit of both veterans and taxpayers is an accountable care organization incentive to use a long horizon and invest in opportunities that reduce overall cost and improve outcomes for its beneficiariesover their entire lifespan. Although this feature is common to a handful of other large health care providers (Kaiser Permanente, Intermountain Healthcare, Mayo Clinic), those systems lack the assets fundamental to solution design that are broadly represented across VA medical centers: a staff, culture, and apparatus in support of research at most medical centers; an integrated electronic health record (EHR) for data access; and a patient population receptive to participating in activities that will aid fellow veterans.

Ongoing Programs

The VA is in an excellent position to create an efficient and scalable apparatus to perform comparative effectiveness studies.The Point-of-Care clinical trials program, proposed and championed by the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) and supported by the VA Cooperative Studies Program, embeds low-risk clinical trials directly into the clinical ecosystem with a resultant decreased cost and increased relevance owing to study designs driven by current patient care processes.

This methodology and program is applauded by the Institute of Medicine and the Society for Clinical Trials, and each has invited MAVERIC to present at national meetings and roundtable discussions.² Designation as a research “transformative initiative” by the VA Office of Research and Development (ORD) provided sufficient support to culminate in the imminent launch of the first national VA Point-of-Care Clinical Trial—the Diuretic Comparison Study. The VA is proceeding with this trial at 50 VA sites for a significantly lower cost.(VA Cooperative Studies Program study #597, methods manuscript in preparation). Results will inform the optimal initial treatment for hypertension and impact the care of millions of veterans and nonveterans.

Precision Oncology Program

The VA Precision Oncology Program (POP), initiated in VISN 1 and funded through a clinical care budget, goes a step further toward creating learning opportunities. The POP sequences the DNA of tumor tissue from veterans newly diagnosed with cancer to determine the DNA mutations responsible for the tumor development and behavior. Armed with this information, HCPs can optimize therapy based on mutation status by the delivery of drugs that are targeted against particular gene products.

Systematic implementation of the POP across all VAMCs will reduce disparities in cancer care induced by variation in medical center familiarity with treatment options. Features supported by the POP include enhanced enrollment of patients into clinical trials of novel targeted therapeutics and sharing of patient outcomes data to assist in decision support for future patients. In addition, this approach could facilitate the creation of a national VA database of cancer patient characteristics, tumor mutations, and cancer-related treatments and outcomes to accelerate the pace of discovery in VA cancer care.

Million Veteran Program

The Million Veteran Program (MVP) is a VA ORD initiative that asks veterans to share their medical data, lifestyle, and genetic data with researchers to allow for the discovery of correlations between their genetic profile and their health, disease and response totreatments. Currently more than 430,000 veterans have agreed to participate and have donated data and blood samples, and researchers are performing the first projects to use this resource.

Although the knowledge gained from these studies will be indirectly relevant to veterans in general the MVP presents an opportunity to present specific findings to individual participants that will directly affect their care. While reuse of the MVP resource for precision medicine is under consideration, there are important cultural and technical barriers that must be addressed. Like POP, integration of the MVP research program with clinical care should be carried out with consideration of a community of stakeholders and not driven exclusively by a research agenda.

Challenges in Moving Forward

Central to the implementation of a learning mechanism in health care systems is the recognition by administrators of the importance of the activity and appreciation of the business argument favoring the investment. This runs counter to the current notion of separate silos for health care and medical research whereby health care systems are liberated from the cost of investigation but then suffer from a dearth of knowledge relevant to their operation.

Additionally, research enterprises are not structured for such activities. Academic investigators are incentivized to create knowledge and generate publications and they understand best the currency of grant funding. Their world is not geared to reinvent or engineer solutions for health care systems. In light of these considerations, a decentralized approach that creates institutions for local learning needs to be developed and “owned” by individual and groups of medical centers with engagement of administration, patient, scientific, and community stakeholders. The Patient-Centered Outcome Research Institute (PCORI) and the consortia it has funded, PCOR-Net, have adopted this approach.³

Importantly, a new set of ethical and regulatory standards that distinguish it from traditional research must accompany progress in the creation of a learning health care system (LHS). Sharing of patient data to benefit fellow patients must come to be expected and without the formalized sharing agreements that are required in traditional research activities. Although the digitization of medical records makes most of what this article discusses possible, execution requires access to information technology resources and a talented staff.

More than a decade ago, the decision was made to dis-integrate the Office of Information Technology from VHA. This was executed with no provision to support the small army of VA clinician-informaticists who had done much in support of patient care, including the creation of the initial iteration of the VA EHR. Although the VA includes small pockets of this clinical informatics culture throughout its organization, the community has been largely silenced and taken refuge at academic affiliates. Access to VA information systems and funding opportunities for development and implementation of tools essential for learning will draw this intellectual capital back to the VA and allow for the VA to lead in this critical arena.

The VA Precision Oncology Program

Precision medicine is a medical model that incorporates the results of genetic diagnostic testing to customize or tailor medical decision making and treatment for the individual patient. Characteristics of the VA health care system that create a favored environment for introducing precision medicine include the single-payer model, where implementation decision and authority are centralized, a standardized EHR that enables informatics requirements, and a clinician and patient culture that supports innovation. To date, the benefits of precision medicine are most robust in cancer care. Under the leadership of Michael Mayo-Smith, MD, the VA New England Healthcare System has completed a regional pilot project in precision oncology that demonstrated feasibility of incorporating a precision medicine program in the clinical care environment.

For the majority of patients with lung cancer, DNA sequencing of tumor tissue identifies driver mutations—alterations believed responsible for tumor growth and behavior. The abundance of both driver and passenger mutations (those alterations whose significance is unknown) identified within an individual cancer specimen and the diversity of alterations found across the spectrum of all patients with cancer virtually assures the unique genetic profile (hence behavior) of any given patient’s tumor. The new generation of antineoplastic agents are targeted therapies that disrupt the downstream effects of these alterations and result in improved anticancer effects and reduced toxicity compared with conventional chemotherapy. The POP approach to cancer treatment determines the mutation profile of malignancies and identifies targeted therapies with the highest likelihood of treatment success. Although many driver mutation-targeted therapy combinations have been FDA approved, many more are in development and are available only as investigational agents.

Work Accomplished

Developed over the past 2 years in VISN 1, POP is a demonstration project that standardizes the processes necessary to deliver precision oncology care for veterans with lung cancer. With approval of the cancer care specialist, targeted sequencing of cancer genes (multiple biomarker panels) is performed on formalinfixed, paraffin-embedded tissue from newly diagnosed lung cancers as part of routine POP cancer care. Samples are shipped within 48 hours of diagnosis to Personal Genome Diagnostics (CancerSelect-88 targeted genome panel: PGD, Baltimore, MD) or Personalis (ACE Extended Cancer Panel: Menlo Park, CA). Following the sequencing of the targeted gene regions for mutations, a formal report of identified genomic aberrations is collated, annotated, and transmitted for inclusion in patient medical records. Both PGD and Personalis use N-of-One (Lexington, MA) to curate the medical literature and provide mutation annotations. The VA Computerized Patient Record System shares mutation results with the treating clinician, and a consultation service, offered through Specialty Care Access Network-Extension for Community technology, is available to help clinicians incorporate the test results into a treatment plan for the patient.

The POP is highly interdisciplinary: design and implementation required buy-in and coordinated efforts from the clinical medicine, laboratory medicine, pathology, pharmacy, radiology, and research services as well as from contracting, human resources, information technology, and procurement. With more than 150 specimens processed, procedures for tissue selection, processing, shipment, and tracking have been refined, and the informatics challenges met.

A Learning Health Care System Approach

Although the standard of care in oncology is evolving to include sequencing for all solid tumors and hematologic malignancies, the lack of correlated mutation status, patient outcomes data available for analysis, and difficulties in identifying subjects eligible for clinical trials of novel therapeutics combine to slow progress. The former problem arises from the effort required to aggregate EHR data from disparate systems as well as technical and cultural barriers to data sharing. The latter problem stems from the relative rarity of patients (and the difficulty identifying them) with a given mutation that determines eligibility for a clinical trial of a particular targeted therapy.

The POP attempts to overcome these limitations by embracing the principles of a LHS with clinical trials embedded to the extent possible in the clinical care ecosystem. The creation of a precision oncology data repository derived largely from the VA Corporate Data Warehouse makes correlated data available. This repository contains patient demographics and comorbidities, tumor features and mutation status, treatments, and outcomes. Data in the repository are used to both inform individual patient care (ie, what can we learn from past patients that would inform the care of the present patient?) and to allow for generalizable discovery and validation (ie, traditional data-mining research). Given a sufficiently large POP population, clinical trial-matching algorithms will identify patients available for any number of studies open for enrollment, thus reducing the existing bottleneck in clinical trial participation.

Rationale for a National Program

Numerous organizations, including the National Comprehensive Cancer Network, the American Society of Clinical Oncology Institute for Quality, and the Society for Gynecologic Oncology, already propose tumor sequencing as the standard of care for a variety of malignancies, and there is much to suggest that additional recommendations will be forthcoming.^4-6 Expanding the VISN 1 POP across the nation provides a mechanism to minimize disparities in the delivery of precision oncology across the VA. The POP will afford opportunities to create VA-centric expertise derived from the POP data repository and filtered through a national tumor board. The POP will also expand opportunities for patients to participate in clinical trials and receive state-of-the-art treatments beyond what can be offered regionally.

Both knowledge generation and the creation of a large-scale clinical trial operation require the numbers of patients that only a national POP can achieve. The economies of scale introduced by wide participation will also reduce the cost of tumor sequencing, therapeutics, and infrastructure development and will eliminate otherwise duplicate efforts that would be required to create a number of smaller regional activities. Importantly, a national POP with sufficient voice would be far more effective at moving forward the LHS agenda.

Research Activities

For the majority of POP participants, the best hope for improved quality and quantity of life lies with targeted therapeutics that are under development and available only through research protocols. The VISN 1 Clinical Trial Network (directed by Mary Brophy, MD) has developed an Oncology Consortium that includes facilities both within and outside of VISN 1. The consortium has partnered with the National Cancer Institute through a storefront mechanism with the Southwest Oncology Group to become the first national VA cancer consortium to participate in intergroup protocols. Novel therapeutics will be available to POP participants through this and other partnerships with a variety of industry sponsors.

Novel, efficient, and nationally scalable mechanisms have been proposed to facilitate clinician participation and patient enrollment in clinical trials. Additionally, MAVERIC is working with the VA Central Institutional Review Board to advance a distributed enrollment innovation, which brings the clinical trial to the patient rather than have patients travel to facilities where studies are open.

Conclusion

Unique features of the VHA enable a national rollout of the POP, which VISN 1 successfully piloted. The first of its kind effort for precision medicine within the VA holds the promise of delivering cutting-edge, life-enhancing therapy to cancer patients.

This interdisciplinary program incorporates LHS principles so that delivery of care is accompanied by analytics that can be applied to decision making for future patients. Participation in clinical trials, facilitated by the consortium model, is a cardinal feature of the POP. Opportunity exists to explore novel trial designs that meet the unique challenges presented in precision medicine, where therapeutics tailored to uncommon mutations limit patient availability.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.

Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.

The Case for VA Leadership

A solution to these 2 central dilemmas will result in continued health care improvement and, arguably, meaningful cost reduction through elimination of inferior treatments and optimization of individual patient care strategies. Since the current research culture does not reward such accomplishments, the responsibility for moving forward is left squarely on the health care systems. Said differently, a health care research budget that is a small fraction (5%) of health care expenditures is undersized and too culturally foreign for the task.¹

A critical attribute that enables the VA to promote progress to the benefit of both veterans and taxpayers is an accountable care organization incentive to use a long horizon and invest in opportunities that reduce overall cost and improve outcomes for its beneficiariesover their entire lifespan. Although this feature is common to a handful of other large health care providers (Kaiser Permanente, Intermountain Healthcare, Mayo Clinic), those systems lack the assets fundamental to solution design that are broadly represented across VA medical centers: a staff, culture, and apparatus in support of research at most medical centers; an integrated electronic health record (EHR) for data access; and a patient population receptive to participating in activities that will aid fellow veterans.

Ongoing Programs

The VA is in an excellent position to create an efficient and scalable apparatus to perform comparative effectiveness studies.The Point-of-Care clinical trials program, proposed and championed by the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) and supported by the VA Cooperative Studies Program, embeds low-risk clinical trials directly into the clinical ecosystem with a resultant decreased cost and increased relevance owing to study designs driven by current patient care processes.

This methodology and program is applauded by the Institute of Medicine and the Society for Clinical Trials, and each has invited MAVERIC to present at national meetings and roundtable discussions.² Designation as a research “transformative initiative” by the VA Office of Research and Development (ORD) provided sufficient support to culminate in the imminent launch of the first national VA Point-of-Care Clinical Trial—the Diuretic Comparison Study. The VA is proceeding with this trial at 50 VA sites for a significantly lower cost.(VA Cooperative Studies Program study #597, methods manuscript in preparation). Results will inform the optimal initial treatment for hypertension and impact the care of millions of veterans and nonveterans.

Precision Oncology Program

The VA Precision Oncology Program (POP), initiated in VISN 1 and funded through a clinical care budget, goes a step further toward creating learning opportunities. The POP sequences the DNA of tumor tissue from veterans newly diagnosed with cancer to determine the DNA mutations responsible for the tumor development and behavior. Armed with this information, HCPs can optimize therapy based on mutation status by the delivery of drugs that are targeted against particular gene products.

Systematic implementation of the POP across all VAMCs will reduce disparities in cancer care induced by variation in medical center familiarity with treatment options. Features supported by the POP include enhanced enrollment of patients into clinical trials of novel targeted therapeutics and sharing of patient outcomes data to assist in decision support for future patients. In addition, this approach could facilitate the creation of a national VA database of cancer patient characteristics, tumor mutations, and cancer-related treatments and outcomes to accelerate the pace of discovery in VA cancer care.

Million Veteran Program

The Million Veteran Program (MVP) is a VA ORD initiative that asks veterans to share their medical data, lifestyle, and genetic data with researchers to allow for the discovery of correlations between their genetic profile and their health, disease and response totreatments. Currently more than 430,000 veterans have agreed to participate and have donated data and blood samples, and researchers are performing the first projects to use this resource.

Although the knowledge gained from these studies will be indirectly relevant to veterans in general the MVP presents an opportunity to present specific findings to individual participants that will directly affect their care. While reuse of the MVP resource for precision medicine is under consideration, there are important cultural and technical barriers that must be addressed. Like POP, integration of the MVP research program with clinical care should be carried out with consideration of a community of stakeholders and not driven exclusively by a research agenda.

Challenges in Moving Forward

Central to the implementation of a learning mechanism in health care systems is the recognition by administrators of the importance of the activity and appreciation of the business argument favoring the investment. This runs counter to the current notion of separate silos for health care and medical research whereby health care systems are liberated from the cost of investigation but then suffer from a dearth of knowledge relevant to their operation.

Additionally, research enterprises are not structured for such activities. Academic investigators are incentivized to create knowledge and generate publications and they understand best the currency of grant funding. Their world is not geared to reinvent or engineer solutions for health care systems. In light of these considerations, a decentralized approach that creates institutions for local learning needs to be developed and “owned” by individual and groups of medical centers with engagement of administration, patient, scientific, and community stakeholders. The Patient-Centered Outcome Research Institute (PCORI) and the consortia it has funded, PCOR-Net, have adopted this approach.³

Importantly, a new set of ethical and regulatory standards that distinguish it from traditional research must accompany progress in the creation of a learning health care system (LHS). Sharing of patient data to benefit fellow patients must come to be expected and without the formalized sharing agreements that are required in traditional research activities. Although the digitization of medical records makes most of what this article discusses possible, execution requires access to information technology resources and a talented staff.

More than a decade ago, the decision was made to dis-integrate the Office of Information Technology from VHA. This was executed with no provision to support the small army of VA clinician-informaticists who had done much in support of patient care, including the creation of the initial iteration of the VA EHR. Although the VA includes small pockets of this clinical informatics culture throughout its organization, the community has been largely silenced and taken refuge at academic affiliates. Access to VA information systems and funding opportunities for development and implementation of tools essential for learning will draw this intellectual capital back to the VA and allow for the VA to lead in this critical arena.

The VA Precision Oncology Program

Precision medicine is a medical model that incorporates the results of genetic diagnostic testing to customize or tailor medical decision making and treatment for the individual patient. Characteristics of the VA health care system that create a favored environment for introducing precision medicine include the single-payer model, where implementation decision and authority are centralized, a standardized EHR that enables informatics requirements, and a clinician and patient culture that supports innovation. To date, the benefits of precision medicine are most robust in cancer care. Under the leadership of Michael Mayo-Smith, MD, the VA New England Healthcare System has completed a regional pilot project in precision oncology that demonstrated feasibility of incorporating a precision medicine program in the clinical care environment.

For the majority of patients with lung cancer, DNA sequencing of tumor tissue identifies driver mutations—alterations believed responsible for tumor growth and behavior. The abundance of both driver and passenger mutations (those alterations whose significance is unknown) identified within an individual cancer specimen and the diversity of alterations found across the spectrum of all patients with cancer virtually assures the unique genetic profile (hence behavior) of any given patient’s tumor. The new generation of antineoplastic agents are targeted therapies that disrupt the downstream effects of these alterations and result in improved anticancer effects and reduced toxicity compared with conventional chemotherapy. The POP approach to cancer treatment determines the mutation profile of malignancies and identifies targeted therapies with the highest likelihood of treatment success. Although many driver mutation-targeted therapy combinations have been FDA approved, many more are in development and are available only as investigational agents.

Work Accomplished

Developed over the past 2 years in VISN 1, POP is a demonstration project that standardizes the processes necessary to deliver precision oncology care for veterans with lung cancer. With approval of the cancer care specialist, targeted sequencing of cancer genes (multiple biomarker panels) is performed on formalinfixed, paraffin-embedded tissue from newly diagnosed lung cancers as part of routine POP cancer care. Samples are shipped within 48 hours of diagnosis to Personal Genome Diagnostics (CancerSelect-88 targeted genome panel: PGD, Baltimore, MD) or Personalis (ACE Extended Cancer Panel: Menlo Park, CA). Following the sequencing of the targeted gene regions for mutations, a formal report of identified genomic aberrations is collated, annotated, and transmitted for inclusion in patient medical records. Both PGD and Personalis use N-of-One (Lexington, MA) to curate the medical literature and provide mutation annotations. The VA Computerized Patient Record System shares mutation results with the treating clinician, and a consultation service, offered through Specialty Care Access Network-Extension for Community technology, is available to help clinicians incorporate the test results into a treatment plan for the patient.

The POP is highly interdisciplinary: design and implementation required buy-in and coordinated efforts from the clinical medicine, laboratory medicine, pathology, pharmacy, radiology, and research services as well as from contracting, human resources, information technology, and procurement. With more than 150 specimens processed, procedures for tissue selection, processing, shipment, and tracking have been refined, and the informatics challenges met.

A Learning Health Care System Approach

Although the standard of care in oncology is evolving to include sequencing for all solid tumors and hematologic malignancies, the lack of correlated mutation status, patient outcomes data available for analysis, and difficulties in identifying subjects eligible for clinical trials of novel therapeutics combine to slow progress. The former problem arises from the effort required to aggregate EHR data from disparate systems as well as technical and cultural barriers to data sharing. The latter problem stems from the relative rarity of patients (and the difficulty identifying them) with a given mutation that determines eligibility for a clinical trial of a particular targeted therapy.

The POP attempts to overcome these limitations by embracing the principles of a LHS with clinical trials embedded to the extent possible in the clinical care ecosystem. The creation of a precision oncology data repository derived largely from the VA Corporate Data Warehouse makes correlated data available. This repository contains patient demographics and comorbidities, tumor features and mutation status, treatments, and outcomes. Data in the repository are used to both inform individual patient care (ie, what can we learn from past patients that would inform the care of the present patient?) and to allow for generalizable discovery and validation (ie, traditional data-mining research). Given a sufficiently large POP population, clinical trial-matching algorithms will identify patients available for any number of studies open for enrollment, thus reducing the existing bottleneck in clinical trial participation.

Rationale for a National Program

Numerous organizations, including the National Comprehensive Cancer Network, the American Society of Clinical Oncology Institute for Quality, and the Society for Gynecologic Oncology, already propose tumor sequencing as the standard of care for a variety of malignancies, and there is much to suggest that additional recommendations will be forthcoming.^4-6 Expanding the VISN 1 POP across the nation provides a mechanism to minimize disparities in the delivery of precision oncology across the VA. The POP will afford opportunities to create VA-centric expertise derived from the POP data repository and filtered through a national tumor board. The POP will also expand opportunities for patients to participate in clinical trials and receive state-of-the-art treatments beyond what can be offered regionally.

Both knowledge generation and the creation of a large-scale clinical trial operation require the numbers of patients that only a national POP can achieve. The economies of scale introduced by wide participation will also reduce the cost of tumor sequencing, therapeutics, and infrastructure development and will eliminate otherwise duplicate efforts that would be required to create a number of smaller regional activities. Importantly, a national POP with sufficient voice would be far more effective at moving forward the LHS agenda.

Research Activities

For the majority of POP participants, the best hope for improved quality and quantity of life lies with targeted therapeutics that are under development and available only through research protocols. The VISN 1 Clinical Trial Network (directed by Mary Brophy, MD) has developed an Oncology Consortium that includes facilities both within and outside of VISN 1. The consortium has partnered with the National Cancer Institute through a storefront mechanism with the Southwest Oncology Group to become the first national VA cancer consortium to participate in intergroup protocols. Novel therapeutics will be available to POP participants through this and other partnerships with a variety of industry sponsors.

Novel, efficient, and nationally scalable mechanisms have been proposed to facilitate clinician participation and patient enrollment in clinical trials. Additionally, MAVERIC is working with the VA Central Institutional Review Board to advance a distributed enrollment innovation, which brings the clinical trial to the patient rather than have patients travel to facilities where studies are open.

Conclusion

Unique features of the VHA enable a national rollout of the POP, which VISN 1 successfully piloted. The first of its kind effort for precision medicine within the VA holds the promise of delivering cutting-edge, life-enhancing therapy to cancer patients.

This interdisciplinary program incorporates LHS principles so that delivery of care is accompanied by analytics that can be applied to decision making for future patients. Participation in clinical trials, facilitated by the consortium model, is a cardinal feature of the POP. Opportunity exists to explore novel trial designs that meet the unique challenges presented in precision medicine, where therapeutics tailored to uncommon mutations limit patient availability.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.

Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.

The Case for VA Leadership

A solution to these 2 central dilemmas will result in continued health care improvement and, arguably, meaningful cost reduction through elimination of inferior treatments and optimization of individual patient care strategies. Since the current research culture does not reward such accomplishments, the responsibility for moving forward is left squarely on the health care systems. Said differently, a health care research budget that is a small fraction (5%) of health care expenditures is undersized and too culturally foreign for the task.¹

A critical attribute that enables the VA to promote progress to the benefit of both veterans and taxpayers is an accountable care organization incentive to use a long horizon and invest in opportunities that reduce overall cost and improve outcomes for its beneficiariesover their entire lifespan. Although this feature is common to a handful of other large health care providers (Kaiser Permanente, Intermountain Healthcare, Mayo Clinic), those systems lack the assets fundamental to solution design that are broadly represented across VA medical centers: a staff, culture, and apparatus in support of research at most medical centers; an integrated electronic health record (EHR) for data access; and a patient population receptive to participating in activities that will aid fellow veterans.

Ongoing Programs

The VA is in an excellent position to create an efficient and scalable apparatus to perform comparative effectiveness studies.The Point-of-Care clinical trials program, proposed and championed by the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) and supported by the VA Cooperative Studies Program, embeds low-risk clinical trials directly into the clinical ecosystem with a resultant decreased cost and increased relevance owing to study designs driven by current patient care processes.

This methodology and program is applauded by the Institute of Medicine and the Society for Clinical Trials, and each has invited MAVERIC to present at national meetings and roundtable discussions.² Designation as a research “transformative initiative” by the VA Office of Research and Development (ORD) provided sufficient support to culminate in the imminent launch of the first national VA Point-of-Care Clinical Trial—the Diuretic Comparison Study. The VA is proceeding with this trial at 50 VA sites for a significantly lower cost.(VA Cooperative Studies Program study #597, methods manuscript in preparation). Results will inform the optimal initial treatment for hypertension and impact the care of millions of veterans and nonveterans.

Precision Oncology Program

The VA Precision Oncology Program (POP), initiated in VISN 1 and funded through a clinical care budget, goes a step further toward creating learning opportunities. The POP sequences the DNA of tumor tissue from veterans newly diagnosed with cancer to determine the DNA mutations responsible for the tumor development and behavior. Armed with this information, HCPs can optimize therapy based on mutation status by the delivery of drugs that are targeted against particular gene products.

Systematic implementation of the POP across all VAMCs will reduce disparities in cancer care induced by variation in medical center familiarity with treatment options. Features supported by the POP include enhanced enrollment of patients into clinical trials of novel targeted therapeutics and sharing of patient outcomes data to assist in decision support for future patients. In addition, this approach could facilitate the creation of a national VA database of cancer patient characteristics, tumor mutations, and cancer-related treatments and outcomes to accelerate the pace of discovery in VA cancer care.

Million Veteran Program

The Million Veteran Program (MVP) is a VA ORD initiative that asks veterans to share their medical data, lifestyle, and genetic data with researchers to allow for the discovery of correlations between their genetic profile and their health, disease and response totreatments. Currently more than 430,000 veterans have agreed to participate and have donated data and blood samples, and researchers are performing the first projects to use this resource.

Although the knowledge gained from these studies will be indirectly relevant to veterans in general the MVP presents an opportunity to present specific findings to individual participants that will directly affect their care. While reuse of the MVP resource for precision medicine is under consideration, there are important cultural and technical barriers that must be addressed. Like POP, integration of the MVP research program with clinical care should be carried out with consideration of a community of stakeholders and not driven exclusively by a research agenda.

Challenges in Moving Forward

Central to the implementation of a learning mechanism in health care systems is the recognition by administrators of the importance of the activity and appreciation of the business argument favoring the investment. This runs counter to the current notion of separate silos for health care and medical research whereby health care systems are liberated from the cost of investigation but then suffer from a dearth of knowledge relevant to their operation.

Additionally, research enterprises are not structured for such activities. Academic investigators are incentivized to create knowledge and generate publications and they understand best the currency of grant funding. Their world is not geared to reinvent or engineer solutions for health care systems. In light of these considerations, a decentralized approach that creates institutions for local learning needs to be developed and “owned” by individual and groups of medical centers with engagement of administration, patient, scientific, and community stakeholders. The Patient-Centered Outcome Research Institute (PCORI) and the consortia it has funded, PCOR-Net, have adopted this approach.³

Importantly, a new set of ethical and regulatory standards that distinguish it from traditional research must accompany progress in the creation of a learning health care system (LHS). Sharing of patient data to benefit fellow patients must come to be expected and without the formalized sharing agreements that are required in traditional research activities. Although the digitization of medical records makes most of what this article discusses possible, execution requires access to information technology resources and a talented staff.

More than a decade ago, the decision was made to dis-integrate the Office of Information Technology from VHA. This was executed with no provision to support the small army of VA clinician-informaticists who had done much in support of patient care, including the creation of the initial iteration of the VA EHR. Although the VA includes small pockets of this clinical informatics culture throughout its organization, the community has been largely silenced and taken refuge at academic affiliates. Access to VA information systems and funding opportunities for development and implementation of tools essential for learning will draw this intellectual capital back to the VA and allow for the VA to lead in this critical arena.

The VA Precision Oncology Program

Precision medicine is a medical model that incorporates the results of genetic diagnostic testing to customize or tailor medical decision making and treatment for the individual patient. Characteristics of the VA health care system that create a favored environment for introducing precision medicine include the single-payer model, where implementation decision and authority are centralized, a standardized EHR that enables informatics requirements, and a clinician and patient culture that supports innovation. To date, the benefits of precision medicine are most robust in cancer care. Under the leadership of Michael Mayo-Smith, MD, the VA New England Healthcare System has completed a regional pilot project in precision oncology that demonstrated feasibility of incorporating a precision medicine program in the clinical care environment.

For the majority of patients with lung cancer, DNA sequencing of tumor tissue identifies driver mutations—alterations believed responsible for tumor growth and behavior. The abundance of both driver and passenger mutations (those alterations whose significance is unknown) identified within an individual cancer specimen and the diversity of alterations found across the spectrum of all patients with cancer virtually assures the unique genetic profile (hence behavior) of any given patient’s tumor. The new generation of antineoplastic agents are targeted therapies that disrupt the downstream effects of these alterations and result in improved anticancer effects and reduced toxicity compared with conventional chemotherapy. The POP approach to cancer treatment determines the mutation profile of malignancies and identifies targeted therapies with the highest likelihood of treatment success. Although many driver mutation-targeted therapy combinations have been FDA approved, many more are in development and are available only as investigational agents.

Work Accomplished

Developed over the past 2 years in VISN 1, POP is a demonstration project that standardizes the processes necessary to deliver precision oncology care for veterans with lung cancer. With approval of the cancer care specialist, targeted sequencing of cancer genes (multiple biomarker panels) is performed on formalinfixed, paraffin-embedded tissue from newly diagnosed lung cancers as part of routine POP cancer care. Samples are shipped within 48 hours of diagnosis to Personal Genome Diagnostics (CancerSelect-88 targeted genome panel: PGD, Baltimore, MD) or Personalis (ACE Extended Cancer Panel: Menlo Park, CA). Following the sequencing of the targeted gene regions for mutations, a formal report of identified genomic aberrations is collated, annotated, and transmitted for inclusion in patient medical records. Both PGD and Personalis use N-of-One (Lexington, MA) to curate the medical literature and provide mutation annotations. The VA Computerized Patient Record System shares mutation results with the treating clinician, and a consultation service, offered through Specialty Care Access Network-Extension for Community technology, is available to help clinicians incorporate the test results into a treatment plan for the patient.

The POP is highly interdisciplinary: design and implementation required buy-in and coordinated efforts from the clinical medicine, laboratory medicine, pathology, pharmacy, radiology, and research services as well as from contracting, human resources, information technology, and procurement. With more than 150 specimens processed, procedures for tissue selection, processing, shipment, and tracking have been refined, and the informatics challenges met.

A Learning Health Care System Approach

Although the standard of care in oncology is evolving to include sequencing for all solid tumors and hematologic malignancies, the lack of correlated mutation status, patient outcomes data available for analysis, and difficulties in identifying subjects eligible for clinical trials of novel therapeutics combine to slow progress. The former problem arises from the effort required to aggregate EHR data from disparate systems as well as technical and cultural barriers to data sharing. The latter problem stems from the relative rarity of patients (and the difficulty identifying them) with a given mutation that determines eligibility for a clinical trial of a particular targeted therapy.

The POP attempts to overcome these limitations by embracing the principles of a LHS with clinical trials embedded to the extent possible in the clinical care ecosystem. The creation of a precision oncology data repository derived largely from the VA Corporate Data Warehouse makes correlated data available. This repository contains patient demographics and comorbidities, tumor features and mutation status, treatments, and outcomes. Data in the repository are used to both inform individual patient care (ie, what can we learn from past patients that would inform the care of the present patient?) and to allow for generalizable discovery and validation (ie, traditional data-mining research). Given a sufficiently large POP population, clinical trial-matching algorithms will identify patients available for any number of studies open for enrollment, thus reducing the existing bottleneck in clinical trial participation.

Rationale for a National Program

Numerous organizations, including the National Comprehensive Cancer Network, the American Society of Clinical Oncology Institute for Quality, and the Society for Gynecologic Oncology, already propose tumor sequencing as the standard of care for a variety of malignancies, and there is much to suggest that additional recommendations will be forthcoming.^4-6 Expanding the VISN 1 POP across the nation provides a mechanism to minimize disparities in the delivery of precision oncology across the VA. The POP will afford opportunities to create VA-centric expertise derived from the POP data repository and filtered through a national tumor board. The POP will also expand opportunities for patients to participate in clinical trials and receive state-of-the-art treatments beyond what can be offered regionally.

Both knowledge generation and the creation of a large-scale clinical trial operation require the numbers of patients that only a national POP can achieve. The economies of scale introduced by wide participation will also reduce the cost of tumor sequencing, therapeutics, and infrastructure development and will eliminate otherwise duplicate efforts that would be required to create a number of smaller regional activities. Importantly, a national POP with sufficient voice would be far more effective at moving forward the LHS agenda.

Research Activities

For the majority of POP participants, the best hope for improved quality and quantity of life lies with targeted therapeutics that are under development and available only through research protocols. The VISN 1 Clinical Trial Network (directed by Mary Brophy, MD) has developed an Oncology Consortium that includes facilities both within and outside of VISN 1. The consortium has partnered with the National Cancer Institute through a storefront mechanism with the Southwest Oncology Group to become the first national VA cancer consortium to participate in intergroup protocols. Novel therapeutics will be available to POP participants through this and other partnerships with a variety of industry sponsors.

Novel, efficient, and nationally scalable mechanisms have been proposed to facilitate clinician participation and patient enrollment in clinical trials. Additionally, MAVERIC is working with the VA Central Institutional Review Board to advance a distributed enrollment innovation, which brings the clinical trial to the patient rather than have patients travel to facilities where studies are open.

Conclusion

Unique features of the VHA enable a national rollout of the POP, which VISN 1 successfully piloted. The first of its kind effort for precision medicine within the VA holds the promise of delivering cutting-edge, life-enhancing therapy to cancer patients.

This interdisciplinary program incorporates LHS principles so that delivery of care is accompanied by analytics that can be applied to decision making for future patients. Participation in clinical trials, facilitated by the consortium model, is a cardinal feature of the POP. Opportunity exists to explore novel trial designs that meet the unique challenges presented in precision medicine, where therapeutics tailored to uncommon mutations limit patient availability.

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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According to the U.S. Army Institute of Surgical Research, 30% to 40% of civilian deaths from traumatic injury are due to hemorrhaging, and as many as half of patients die before reaching a hospital.

 

Recently, the FDA approved the use of XStat 30, a wound dressing used to control severe bleeding on the battlefield, for civilian emergencies and patients at high risk of life-threatening hemorrhagic shock.

The manufacturer calls it a first of its kind hemostatic device that comprises syringe-style applicators with 92 compressed cellulose sponges and an absorbent coating. Each sponge also contains an X-ray-detectable marker.   

The tiny sponges are dispensed directly into the wound where they expand within 20 seconds of contact with blood, blocking blood flow and providing hemostatic pressure for wounds in the groin or axilla when a tourniquet cannot be placed. Each applicator’s worth of sponges can absorb about a pint of blood and can be used for up to 4 hours, allowing time to get the patient to a hospital.

According to the U.S. Army Institute of Surgical Research, 30% to 40% of civilian deaths from traumatic injury are due to hemorrhaging, and as many as half of patients die before reaching a hospital.

 

Recently, the FDA approved the use of XStat 30, a wound dressing used to control severe bleeding on the battlefield, for civilian emergencies and patients at high risk of life-threatening hemorrhagic shock.

The manufacturer calls it a first of its kind hemostatic device that comprises syringe-style applicators with 92 compressed cellulose sponges and an absorbent coating. Each sponge also contains an X-ray-detectable marker.   

The tiny sponges are dispensed directly into the wound where they expand within 20 seconds of contact with blood, blocking blood flow and providing hemostatic pressure for wounds in the groin or axilla when a tourniquet cannot be placed. Each applicator’s worth of sponges can absorb about a pint of blood and can be used for up to 4 hours, allowing time to get the patient to a hospital.

According to the U.S. Army Institute of Surgical Research, 30% to 40% of civilian deaths from traumatic injury are due to hemorrhaging, and as many as half of patients die before reaching a hospital.

 

Recently, the FDA approved the use of XStat 30, a wound dressing used to control severe bleeding on the battlefield, for civilian emergencies and patients at high risk of life-threatening hemorrhagic shock.

The manufacturer calls it a first of its kind hemostatic device that comprises syringe-style applicators with 92 compressed cellulose sponges and an absorbent coating. Each sponge also contains an X-ray-detectable marker.   

The tiny sponges are dispensed directly into the wound where they expand within 20 seconds of contact with blood, blocking blood flow and providing hemostatic pressure for wounds in the groin or axilla when a tourniquet cannot be placed. Each applicator’s worth of sponges can absorb about a pint of blood and can be used for up to 4 hours, allowing time to get the patient to a hospital.

Physicians may soon be able to purchase reports that combine their Medicare and private payer claims data, according to the details of a new government proposal.

The proposed rule, released on Jan. 29, would enable entities approved by the government to share or sell Medicare and private claims information to health providers, suppliers, hospital associations, and medical societies. The new rule, as required by the Medicare Access and CHIP Reauthorization Act (MACRA), seeks to increase transparency about provider performance and generate data uses that improve care delivery, according to a statement from the Centers for Medicare & Medicaid Services.

“Increasing access to analyses and data that include Medicare data will make it easier for stakeholders throughout the healthcare system to make smarter and more informed healthcare decisions,” CMS Acting Administrator Andy Slavitt said in a statement.

Under the rule, qualified entities may provide or sell data or analyses of the data to providers and suppliers. CMS encourages the sharing of data analytics that would assist in quality and patient care improvement activities, including the development of new models of care.

Disclosure or use of data for marketing purposes would be barred.

The rule includes strict privacy and security requirements for all entities receiving Medicare analyses or data.

If finalized, the rule could help practices in their efforts to provide value-based care and perform population management, said Dr. Yul D. Ejnes, chair-emeritus of the American College of Physicians Board of Regents and an internist in private practice in Cranston, R.I.

“A barrier, especially for small groups, is access to all-payer data, since what is available now is often partitioned by payer and not easy to compile into practice-wide data covering all patients,” he said in an interview. “Clearly, there is also a need for analysis of the data that is beyond the reach of most practices and is best done by third parties with the resources and expertise, so making the CMS data available facilitates that.”

However, Dr. Ejnes questioned how much these analyses will cost practices, especially smaller practices.

“Another related issue, beyond CMS’ purview, is how affordable this type of data analysis would be for the small practice that might benefit the most from it, since larger organizations have resources that may make much of this available to its physicians at little or no cost,” he said.

Entities supplying the information to providers must be accepted into the qualified entity program. The program, authorized under the Affordable Care Act, allows organizations that meet certain criteria to access patient-protected Medicare data to produce public reports. Qualified entities must combine the Medicare data with other claims data to produce reports that are “representative of how providers and suppliers are performing across multiple payers.”

Thus far, 13 organizations have been accepted into the program. Of these organizations, 2 have completed public reporting, while the other 11 are preparing for public reporting, according to CMS.

Comments on the new rule are due by March 29.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Physicians may soon be able to purchase reports that combine their Medicare and private payer claims data, according to the details of a new government proposal.

The proposed rule, released on Jan. 29, would enable entities approved by the government to share or sell Medicare and private claims information to health providers, suppliers, hospital associations, and medical societies. The new rule, as required by the Medicare Access and CHIP Reauthorization Act (MACRA), seeks to increase transparency about provider performance and generate data uses that improve care delivery, according to a statement from the Centers for Medicare & Medicaid Services.

“Increasing access to analyses and data that include Medicare data will make it easier for stakeholders throughout the healthcare system to make smarter and more informed healthcare decisions,” CMS Acting Administrator Andy Slavitt said in a statement.

Under the rule, qualified entities may provide or sell data or analyses of the data to providers and suppliers. CMS encourages the sharing of data analytics that would assist in quality and patient care improvement activities, including the development of new models of care.

Disclosure or use of data for marketing purposes would be barred.

The rule includes strict privacy and security requirements for all entities receiving Medicare analyses or data.

If finalized, the rule could help practices in their efforts to provide value-based care and perform population management, said Dr. Yul D. Ejnes, chair-emeritus of the American College of Physicians Board of Regents and an internist in private practice in Cranston, R.I.

“A barrier, especially for small groups, is access to all-payer data, since what is available now is often partitioned by payer and not easy to compile into practice-wide data covering all patients,” he said in an interview. “Clearly, there is also a need for analysis of the data that is beyond the reach of most practices and is best done by third parties with the resources and expertise, so making the CMS data available facilitates that.”

However, Dr. Ejnes questioned how much these analyses will cost practices, especially smaller practices.

“Another related issue, beyond CMS’ purview, is how affordable this type of data analysis would be for the small practice that might benefit the most from it, since larger organizations have resources that may make much of this available to its physicians at little or no cost,” he said.

Entities supplying the information to providers must be accepted into the qualified entity program. The program, authorized under the Affordable Care Act, allows organizations that meet certain criteria to access patient-protected Medicare data to produce public reports. Qualified entities must combine the Medicare data with other claims data to produce reports that are “representative of how providers and suppliers are performing across multiple payers.”

Thus far, 13 organizations have been accepted into the program. Of these organizations, 2 have completed public reporting, while the other 11 are preparing for public reporting, according to CMS.

Comments on the new rule are due by March 29.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Physicians may soon be able to purchase reports that combine their Medicare and private payer claims data, according to the details of a new government proposal.

The proposed rule, released on Jan. 29, would enable entities approved by the government to share or sell Medicare and private claims information to health providers, suppliers, hospital associations, and medical societies. The new rule, as required by the Medicare Access and CHIP Reauthorization Act (MACRA), seeks to increase transparency about provider performance and generate data uses that improve care delivery, according to a statement from the Centers for Medicare & Medicaid Services.

“Increasing access to analyses and data that include Medicare data will make it easier for stakeholders throughout the healthcare system to make smarter and more informed healthcare decisions,” CMS Acting Administrator Andy Slavitt said in a statement.

Under the rule, qualified entities may provide or sell data or analyses of the data to providers and suppliers. CMS encourages the sharing of data analytics that would assist in quality and patient care improvement activities, including the development of new models of care.

Disclosure or use of data for marketing purposes would be barred.

The rule includes strict privacy and security requirements for all entities receiving Medicare analyses or data.

If finalized, the rule could help practices in their efforts to provide value-based care and perform population management, said Dr. Yul D. Ejnes, chair-emeritus of the American College of Physicians Board of Regents and an internist in private practice in Cranston, R.I.

“A barrier, especially for small groups, is access to all-payer data, since what is available now is often partitioned by payer and not easy to compile into practice-wide data covering all patients,” he said in an interview. “Clearly, there is also a need for analysis of the data that is beyond the reach of most practices and is best done by third parties with the resources and expertise, so making the CMS data available facilitates that.”

However, Dr. Ejnes questioned how much these analyses will cost practices, especially smaller practices.

“Another related issue, beyond CMS’ purview, is how affordable this type of data analysis would be for the small practice that might benefit the most from it, since larger organizations have resources that may make much of this available to its physicians at little or no cost,” he said.

Entities supplying the information to providers must be accepted into the qualified entity program. The program, authorized under the Affordable Care Act, allows organizations that meet certain criteria to access patient-protected Medicare data to produce public reports. Qualified entities must combine the Medicare data with other claims data to produce reports that are “representative of how providers and suppliers are performing across multiple payers.”

Thus far, 13 organizations have been accepted into the program. Of these organizations, 2 have completed public reporting, while the other 11 are preparing for public reporting, according to CMS.

Comments on the new rule are due by March 29.

agallegos@frontlinemedcom.com

On Twitter @legal_med

The CDC has released an updated version of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Atlas.

The Atlas is an online tool that allows a user to easily analyze, map, and create tables from more than 10 years’ of data reported to the CDC.

Easy-to-follow instructions guide users through the “basic query” function, allowing them to map diseases by year, geographical area, and population group and create bar graphs that display changes over time and patterns across the U.S. Users also can download and export data and graphics as PDFs. Footnote sections provide more information about the surveillance data for each disease.

The Advanced Query function allows for the creation of customized tables that provide flexibility when comparing diseases, areas, and populations. This functionality also allows users to compare 2 or more diseases, examine multiple areas (eg, by state), view 2 or more years of data (eg, 2008-2013), or drill down to subpopulations of interest (eg, race, age, or sex).

The CDC also offers ready-made slide sets that show examples of the analyses that can be performed with the Atlas. These slides address diagnoses, social determinants of health, and recommended queries for each disease. For example, the slide for new diagnoses breaks down the data for chlamydia, gonorrhea, syphilis, HIV, AIDS, hepatitis A, B, and C, and tuberculosis by race, sex, date, age, and U.S. county.

For more on the Atlas, visit www.cdc.gov/nchhstp/atlas/about-atlas.html. A webcast demonstrating functionality and Q&As are also available at www.cdc.gov/nchhstp/atlas/video.html

The CDC has released an updated version of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Atlas.

The Atlas is an online tool that allows a user to easily analyze, map, and create tables from more than 10 years’ of data reported to the CDC.

Easy-to-follow instructions guide users through the “basic query” function, allowing them to map diseases by year, geographical area, and population group and create bar graphs that display changes over time and patterns across the U.S. Users also can download and export data and graphics as PDFs. Footnote sections provide more information about the surveillance data for each disease.

The Advanced Query function allows for the creation of customized tables that provide flexibility when comparing diseases, areas, and populations. This functionality also allows users to compare 2 or more diseases, examine multiple areas (eg, by state), view 2 or more years of data (eg, 2008-2013), or drill down to subpopulations of interest (eg, race, age, or sex).

The CDC also offers ready-made slide sets that show examples of the analyses that can be performed with the Atlas. These slides address diagnoses, social determinants of health, and recommended queries for each disease. For example, the slide for new diagnoses breaks down the data for chlamydia, gonorrhea, syphilis, HIV, AIDS, hepatitis A, B, and C, and tuberculosis by race, sex, date, age, and U.S. county.

For more on the Atlas, visit www.cdc.gov/nchhstp/atlas/about-atlas.html. A webcast demonstrating functionality and Q&As are also available at www.cdc.gov/nchhstp/atlas/video.html

The CDC has released an updated version of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Atlas.

The Atlas is an online tool that allows a user to easily analyze, map, and create tables from more than 10 years’ of data reported to the CDC.

Easy-to-follow instructions guide users through the “basic query” function, allowing them to map diseases by year, geographical area, and population group and create bar graphs that display changes over time and patterns across the U.S. Users also can download and export data and graphics as PDFs. Footnote sections provide more information about the surveillance data for each disease.

The Advanced Query function allows for the creation of customized tables that provide flexibility when comparing diseases, areas, and populations. This functionality also allows users to compare 2 or more diseases, examine multiple areas (eg, by state), view 2 or more years of data (eg, 2008-2013), or drill down to subpopulations of interest (eg, race, age, or sex).

The CDC also offers ready-made slide sets that show examples of the analyses that can be performed with the Atlas. These slides address diagnoses, social determinants of health, and recommended queries for each disease. For example, the slide for new diagnoses breaks down the data for chlamydia, gonorrhea, syphilis, HIV, AIDS, hepatitis A, B, and C, and tuberculosis by race, sex, date, age, and U.S. county.

For more on the Atlas, visit www.cdc.gov/nchhstp/atlas/about-atlas.html. A webcast demonstrating functionality and Q&As are also available at www.cdc.gov/nchhstp/atlas/video.html

On January 21, VA Secretary Robert A. McDonald highlighted his goals for 2016, which focused on improving the patient and employee experience, before the Senate Committee on Veterans’ Affairs.

A majority of the priorities McDonald noted during his testimony were veteran touchpoints, including improved experience, increased access to health care, and a unified veteran's experience. Other priorities focused on enabling the VA to offer better services to veterans, such as transforming the agency’s dated infrastructure.

"Make no mistake, all 12 [goals] are designed to improve the delivery of timely care to and benefits to our veterans," McDonald noted during his testimony.

Committee members agreed that change was necessary. Republican Senator Johnny Isakson of Georgia noted that payment problems may cause private health care providers to withdraw from the Veterans Choice Program. "We have got to get a situation in the Veterans Administration where a physician can reasonably anticipate a prompt payment for services under the choice program—or Choice won't work," Isakson added during his opening remarks.

Ultimately, McDonald's plans are to transform the MyVA program to improve the veteran experience, employee experience, as well as the internal support services. "We must enable by bringing our infrastructure into the 21st  century. It's unacceptable, as it impedes our efforts to serve our veterans."

However, mutual concern was identified by committee members regarding how progress on these 12 goals will be tracked. "One thing we ought to talk about is, as you go forward, how members will have the ability to track progress on these initiatives," said Republican Senator Thom Tillis of North Carolina during open questioning. "They aren't just pretty on a PowerPoint; they have to map to initiatives."

Tillis added that this communication was necessary for overall success.

"Another thing going forward that's important is to make sure that when we make requests, in addition to what you have planned in this transformation, you need to make sure that you're very direct… and these things that we should be able to watch on your project dashboard," Tillis said.

Along with the discussion of upgraded technology infrastructure and enhanced employee experience, other topics included reducing the disability claims backlog, veterans' homelessness, and VA staff recruiting.

On January 21, VA Secretary Robert A. McDonald highlighted his goals for 2016, which focused on improving the patient and employee experience, before the Senate Committee on Veterans’ Affairs.

A majority of the priorities McDonald noted during his testimony were veteran touchpoints, including improved experience, increased access to health care, and a unified veteran's experience. Other priorities focused on enabling the VA to offer better services to veterans, such as transforming the agency’s dated infrastructure.

"Make no mistake, all 12 [goals] are designed to improve the delivery of timely care to and benefits to our veterans," McDonald noted during his testimony.

Committee members agreed that change was necessary. Republican Senator Johnny Isakson of Georgia noted that payment problems may cause private health care providers to withdraw from the Veterans Choice Program. "We have got to get a situation in the Veterans Administration where a physician can reasonably anticipate a prompt payment for services under the choice program—or Choice won't work," Isakson added during his opening remarks.

Ultimately, McDonald's plans are to transform the MyVA program to improve the veteran experience, employee experience, as well as the internal support services. "We must enable by bringing our infrastructure into the 21st  century. It's unacceptable, as it impedes our efforts to serve our veterans."

However, mutual concern was identified by committee members regarding how progress on these 12 goals will be tracked. "One thing we ought to talk about is, as you go forward, how members will have the ability to track progress on these initiatives," said Republican Senator Thom Tillis of North Carolina during open questioning. "They aren't just pretty on a PowerPoint; they have to map to initiatives."

Tillis added that this communication was necessary for overall success.

"Another thing going forward that's important is to make sure that when we make requests, in addition to what you have planned in this transformation, you need to make sure that you're very direct… and these things that we should be able to watch on your project dashboard," Tillis said.

Along with the discussion of upgraded technology infrastructure and enhanced employee experience, other topics included reducing the disability claims backlog, veterans' homelessness, and VA staff recruiting.

On January 21, VA Secretary Robert A. McDonald highlighted his goals for 2016, which focused on improving the patient and employee experience, before the Senate Committee on Veterans’ Affairs.

A majority of the priorities McDonald noted during his testimony were veteran touchpoints, including improved experience, increased access to health care, and a unified veteran's experience. Other priorities focused on enabling the VA to offer better services to veterans, such as transforming the agency’s dated infrastructure.

"Make no mistake, all 12 [goals] are designed to improve the delivery of timely care to and benefits to our veterans," McDonald noted during his testimony.

Committee members agreed that change was necessary. Republican Senator Johnny Isakson of Georgia noted that payment problems may cause private health care providers to withdraw from the Veterans Choice Program. "We have got to get a situation in the Veterans Administration where a physician can reasonably anticipate a prompt payment for services under the choice program—or Choice won't work," Isakson added during his opening remarks.

Ultimately, McDonald's plans are to transform the MyVA program to improve the veteran experience, employee experience, as well as the internal support services. "We must enable by bringing our infrastructure into the 21st  century. It's unacceptable, as it impedes our efforts to serve our veterans."

However, mutual concern was identified by committee members regarding how progress on these 12 goals will be tracked. "One thing we ought to talk about is, as you go forward, how members will have the ability to track progress on these initiatives," said Republican Senator Thom Tillis of North Carolina during open questioning. "They aren't just pretty on a PowerPoint; they have to map to initiatives."

Tillis added that this communication was necessary for overall success.

"Another thing going forward that's important is to make sure that when we make requests, in addition to what you have planned in this transformation, you need to make sure that you're very direct… and these things that we should be able to watch on your project dashboard," Tillis said.

Along with the discussion of upgraded technology infrastructure and enhanced employee experience, other topics included reducing the disability claims backlog, veterans' homelessness, and VA staff recruiting.

Opioid-related hospitalizations in rural areas are increasing nearly twice as fast as in urban areas (8.6% vs 4.9%).  But rural primary care comes with some barriers to effectively treat opioid abuse, including lack of access to specialty treatment centers, limited continuing training opportunities, and lack of social support services.

The Agency for Healthcare Research and Quality has called for research to expand access to evidence-based treatment for opioid abuse disorders in rural areas and is backing that call with up to $12 million to be awarded over the next 4 years. Specifically, the grants will fund as many as 4 research projects exploring ways to overcome barriers to the use of medication-assisted treatment (MAT) in underserved communities.

Researchers may examine online training for physicians, in-office practice coaching, and virtual counseling sessions; projects also can create training resources to expand patients’ access to MAT.

Grant applications are due March 4, 2016. For more information: http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-16-001.html.

Opioid-related hospitalizations in rural areas are increasing nearly twice as fast as in urban areas (8.6% vs 4.9%).  But rural primary care comes with some barriers to effectively treat opioid abuse, including lack of access to specialty treatment centers, limited continuing training opportunities, and lack of social support services.

The Agency for Healthcare Research and Quality has called for research to expand access to evidence-based treatment for opioid abuse disorders in rural areas and is backing that call with up to $12 million to be awarded over the next 4 years. Specifically, the grants will fund as many as 4 research projects exploring ways to overcome barriers to the use of medication-assisted treatment (MAT) in underserved communities.

Researchers may examine online training for physicians, in-office practice coaching, and virtual counseling sessions; projects also can create training resources to expand patients’ access to MAT.

Grant applications are due March 4, 2016. For more information: http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-16-001.html.

Opioid-related hospitalizations in rural areas are increasing nearly twice as fast as in urban areas (8.6% vs 4.9%).  But rural primary care comes with some barriers to effectively treat opioid abuse, including lack of access to specialty treatment centers, limited continuing training opportunities, and lack of social support services.

The Agency for Healthcare Research and Quality has called for research to expand access to evidence-based treatment for opioid abuse disorders in rural areas and is backing that call with up to $12 million to be awarded over the next 4 years. Specifically, the grants will fund as many as 4 research projects exploring ways to overcome barriers to the use of medication-assisted treatment (MAT) in underserved communities.

Researchers may examine online training for physicians, in-office practice coaching, and virtual counseling sessions; projects also can create training resources to expand patients’ access to MAT.

Grant applications are due March 4, 2016. For more information: http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-16-001.html.

Feedback from veterans has led to changes that will make participating in the Veterans Choice Program more convenient, especially for those who live far from a VA medical facility.

The Choice Program went into effect in 2014, and more than 400,000 medical appointments have been logged since then. Under the old policy, a veteran was eligible for the program if he or she had enrolled in VA health care by August 1, 2014, or was able to enroll as a combat veteran; experienced unusual or excessive burden, determined by geographical challenges, environmental factors, or medical condition affecting ability to travel; or lived more than 40 miles from the closest VA medical facility.

Under the updated requirements, a veteran is eligible if he or she has been waiting (or will have to wait) more than 30 days for VA medical care; lives more than 40 miles driving distance from the closest VA medical facility with a full-time primary care physician; needs to travel by air, boat, or ferry to the closest facility; faces an unusual or excessive burden in traveling; or lives in a state or territory without a full-service VA medical facility.

Care in the community is covered only by the VA for medical needs that have been approved by the veteran’s VA physician. The Choice Program does not affect the veteran’s existing VA health care or any other VA benefit.

For more details: www.va.gov/opa/choiceact.

Feedback from veterans has led to changes that will make participating in the Veterans Choice Program more convenient, especially for those who live far from a VA medical facility.

The Choice Program went into effect in 2014, and more than 400,000 medical appointments have been logged since then. Under the old policy, a veteran was eligible for the program if he or she had enrolled in VA health care by August 1, 2014, or was able to enroll as a combat veteran; experienced unusual or excessive burden, determined by geographical challenges, environmental factors, or medical condition affecting ability to travel; or lived more than 40 miles from the closest VA medical facility.

Under the updated requirements, a veteran is eligible if he or she has been waiting (or will have to wait) more than 30 days for VA medical care; lives more than 40 miles driving distance from the closest VA medical facility with a full-time primary care physician; needs to travel by air, boat, or ferry to the closest facility; faces an unusual or excessive burden in traveling; or lives in a state or territory without a full-service VA medical facility.

Care in the community is covered only by the VA for medical needs that have been approved by the veteran’s VA physician. The Choice Program does not affect the veteran’s existing VA health care or any other VA benefit.

For more details: www.va.gov/opa/choiceact.

Feedback from veterans has led to changes that will make participating in the Veterans Choice Program more convenient, especially for those who live far from a VA medical facility.

The Choice Program went into effect in 2014, and more than 400,000 medical appointments have been logged since then. Under the old policy, a veteran was eligible for the program if he or she had enrolled in VA health care by August 1, 2014, or was able to enroll as a combat veteran; experienced unusual or excessive burden, determined by geographical challenges, environmental factors, or medical condition affecting ability to travel; or lived more than 40 miles from the closest VA medical facility.

Under the updated requirements, a veteran is eligible if he or she has been waiting (or will have to wait) more than 30 days for VA medical care; lives more than 40 miles driving distance from the closest VA medical facility with a full-time primary care physician; needs to travel by air, boat, or ferry to the closest facility; faces an unusual or excessive burden in traveling; or lives in a state or territory without a full-service VA medical facility.

Care in the community is covered only by the VA for medical needs that have been approved by the veteran’s VA physician. The Choice Program does not affect the veteran’s existing VA health care or any other VA benefit.

For more details: www.va.gov/opa/choiceact.

Hospital-acquired catheter-associated urinary tract infections (CAUTIs) are largely preventable, yet they affect about 250,000 hospital patients each year at a cost of about $250 million.

About one-quarter of all patients have a urinary catheter placed during their hospital stay, which puts them at risk for infection. Preventing or stopping the infections would not only be better for patients, but would also reduce the chance of creating superbugs. To that end, the Agency for Healthcare Research and Quality (AHRQ) has released a new tool kit to help combat CAUTIs. The tool kit is the latest in a series of AHRQ tools and training materials that “help frontline providers go beyond the ‘what’ of improving care to actually show them ‘how’ to make changes in workflow processes to keep patients safer,” AHRQ says.

The tool kit is part of a 4-year project to promote the use of the Comprehensive Unit-Based Safety Program (CUSP),  a custom program that combines best practices with an increased focus on teamwork, AHRQ says. Based on the experiences of more than 1,200 hospitals that successfully reduced CAUTI while participating in AHRQ’s nationwide CUSP project, the tool kit includes checklists, modifiable teaching tools, and resources to help clinical teams decide when and how to safely use catheters.

Designed by Johns Hopkins researchers, it proved to significantly reduce central line-associated bloodstream infections in ICUS. Preliminary studies show CUSP reduces CAUTIs by about 15%.

Hospital-acquired catheter-associated urinary tract infections (CAUTIs) are largely preventable, yet they affect about 250,000 hospital patients each year at a cost of about $250 million.

About one-quarter of all patients have a urinary catheter placed during their hospital stay, which puts them at risk for infection. Preventing or stopping the infections would not only be better for patients, but would also reduce the chance of creating superbugs. To that end, the Agency for Healthcare Research and Quality (AHRQ) has released a new tool kit to help combat CAUTIs. The tool kit is the latest in a series of AHRQ tools and training materials that “help frontline providers go beyond the ‘what’ of improving care to actually show them ‘how’ to make changes in workflow processes to keep patients safer,” AHRQ says.

The tool kit is part of a 4-year project to promote the use of the Comprehensive Unit-Based Safety Program (CUSP),  a custom program that combines best practices with an increased focus on teamwork, AHRQ says. Based on the experiences of more than 1,200 hospitals that successfully reduced CAUTI while participating in AHRQ’s nationwide CUSP project, the tool kit includes checklists, modifiable teaching tools, and resources to help clinical teams decide when and how to safely use catheters.

Designed by Johns Hopkins researchers, it proved to significantly reduce central line-associated bloodstream infections in ICUS. Preliminary studies show CUSP reduces CAUTIs by about 15%.

Hospital-acquired catheter-associated urinary tract infections (CAUTIs) are largely preventable, yet they affect about 250,000 hospital patients each year at a cost of about $250 million.

About one-quarter of all patients have a urinary catheter placed during their hospital stay, which puts them at risk for infection. Preventing or stopping the infections would not only be better for patients, but would also reduce the chance of creating superbugs. To that end, the Agency for Healthcare Research and Quality (AHRQ) has released a new tool kit to help combat CAUTIs. The tool kit is the latest in a series of AHRQ tools and training materials that “help frontline providers go beyond the ‘what’ of improving care to actually show them ‘how’ to make changes in workflow processes to keep patients safer,” AHRQ says.

The tool kit is part of a 4-year project to promote the use of the Comprehensive Unit-Based Safety Program (CUSP),  a custom program that combines best practices with an increased focus on teamwork, AHRQ says. Based on the experiences of more than 1,200 hospitals that successfully reduced CAUTI while participating in AHRQ’s nationwide CUSP project, the tool kit includes checklists, modifiable teaching tools, and resources to help clinical teams decide when and how to safely use catheters.

Designed by Johns Hopkins researchers, it proved to significantly reduce central line-associated bloodstream infections in ICUS. Preliminary studies show CUSP reduces CAUTIs by about 15%.

The age of the information-empowered patient is upon us. Not only do patients bring the results of their Internet research when they come to the office, they also want to take a record of the clinical encounter with them when they leave.

New HIPAA guidance issued in January by the Health & Human Services Department’s Office of Civil Rights (OCR) aims to help clinicians know how to respond and with what information; it also addresses when patients can be charged for the information.

In the past, physicians and other providers had to “wing it” when it came to unclear rules about patient’s data requests, said Dianne J. Bourque, a Boston health law and HIPAA compliance attorney. “Prior to this, there may not have been readily available guidance that would drill down” to address specific concerns.

When it comes to systems security, physicians and other health providers do not have to put their health IT systems at risk in an effort to meet a request for patient records. For example, Mrs. Smith requests that her protected health information (PHI) be copied onto a thumb drive that she has provided.

In most cases, a covered entity must provide data access in the manner requested by the patient. But the updated guidance states that health providers are not expected to tolerate “unacceptable levels of risk to the security of the PHI on its systems” in responding to requests.

Unlike system security, patient security does not trump patient access. If Mr. Black requests that his records by emailed to him, but a connection cannot be made secure, physicians are still required to send the data.

While OCR requires HIPAA-covered entities to implement reasonable safeguards to protect PHI while in transit, patients have a right to receive a copy of records by unencrypted email if they so wish.

To comply with the new rules, be sure to warn patients of the risks, and confirm that they still want their PHI by unencrypted email. If confirmed, you must comply with the request. This clarification relieves doctors of potential breach notification and liability if the data is intercepted in transit.

The guidance also clarifies how to deliver patients’ data. If PHI is maintained electronically, physicians and other HIPAA-covered entities must be able provide it to patients electronically.

“Because you hold it electronically, you can’t say, ‘Forget it, you have to have paper,’” Ms. Bourque said. “You lose that option when you keep [data] electronically. Maybe you have to go buy a scanner and scan [the document] and email it, but you can’t charge [patients] for the scanner.”

The new guidance also allows patients to get results directly from a clinical laboratory; however, labs are not required to interpret test results. Rather, patients are encouraged to reach out to their physician for such insights.

Overall, the access guidelines appear reasonable and hopefully will relieve hassles for patients in obtaining their health information, said Dr. Sam Slishman, an emergency physician for Sierra Vista Hospital in San Luis Obispo, Calif., and co-founder of Pre-R, a service that provides in-home visits. Dr. Slishman does not foresee the guidance having much impact on his practices.

“It’s crazy to me that patients have to struggle to retrieve their records at all,” he said in an interview. “I routinely send my patients home with at least their lab tests and copies of their radiology reports so they have something to bring to their [primary care physicians]. If they want more, I hand it to them.”

Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., said that he has concerns about the guidelines. Specifically, that doctors may charge a fee to cover the cost of copying records, but that they cannot charge for the cost of searching and retrieving data, said Dr. Bilhartz, who is founder of ECGsource, an online cardiovascular medical education resource.

“Record requests can take significant time for staff to filter through and gather,” he said in an interview. “That time should be reimbursable ... If updated provisions prohibit charging for time spent compiling records, it seems those provisions are a bit out of touch with understanding what those of us on the ground floor must do when a request is received.”

But Dr. Bilhartz acknowledged that he would be unlikely to charge patients for “reasonable” data requests.

“I’m in private practice ... and because of that, I have more market-driven accountability to all my patients,” he said. “Why would I nickel and dime people who I would want to be satisfied patients? For reasonable requests, I would just provide records for free.”

Ms. Bourque notes that while the clarifications are primarily positive for health providers, they present a double-edged sword.

“The good side is that, it has all this detail and it’s really helpful and makes things easier when you have a tricky access request and don’t know what to do,” she said. “The flip side is that once it’s out there, they expect you to read it and pay attention. You start running out of excuses for why you didn’t comply with the access right or why you got it wrong.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

The age of the information-empowered patient is upon us. Not only do patients bring the results of their Internet research when they come to the office, they also want to take a record of the clinical encounter with them when they leave.

New HIPAA guidance issued in January by the Health & Human Services Department’s Office of Civil Rights (OCR) aims to help clinicians know how to respond and with what information; it also addresses when patients can be charged for the information.

In the past, physicians and other providers had to “wing it” when it came to unclear rules about patient’s data requests, said Dianne J. Bourque, a Boston health law and HIPAA compliance attorney. “Prior to this, there may not have been readily available guidance that would drill down” to address specific concerns.

When it comes to systems security, physicians and other health providers do not have to put their health IT systems at risk in an effort to meet a request for patient records. For example, Mrs. Smith requests that her protected health information (PHI) be copied onto a thumb drive that she has provided.

In most cases, a covered entity must provide data access in the manner requested by the patient. But the updated guidance states that health providers are not expected to tolerate “unacceptable levels of risk to the security of the PHI on its systems” in responding to requests.

Unlike system security, patient security does not trump patient access. If Mr. Black requests that his records by emailed to him, but a connection cannot be made secure, physicians are still required to send the data.

While OCR requires HIPAA-covered entities to implement reasonable safeguards to protect PHI while in transit, patients have a right to receive a copy of records by unencrypted email if they so wish.

To comply with the new rules, be sure to warn patients of the risks, and confirm that they still want their PHI by unencrypted email. If confirmed, you must comply with the request. This clarification relieves doctors of potential breach notification and liability if the data is intercepted in transit.

The guidance also clarifies how to deliver patients’ data. If PHI is maintained electronically, physicians and other HIPAA-covered entities must be able provide it to patients electronically.

“Because you hold it electronically, you can’t say, ‘Forget it, you have to have paper,’” Ms. Bourque said. “You lose that option when you keep [data] electronically. Maybe you have to go buy a scanner and scan [the document] and email it, but you can’t charge [patients] for the scanner.”

The new guidance also allows patients to get results directly from a clinical laboratory; however, labs are not required to interpret test results. Rather, patients are encouraged to reach out to their physician for such insights.

Overall, the access guidelines appear reasonable and hopefully will relieve hassles for patients in obtaining their health information, said Dr. Sam Slishman, an emergency physician for Sierra Vista Hospital in San Luis Obispo, Calif., and co-founder of Pre-R, a service that provides in-home visits. Dr. Slishman does not foresee the guidance having much impact on his practices.

“It’s crazy to me that patients have to struggle to retrieve their records at all,” he said in an interview. “I routinely send my patients home with at least their lab tests and copies of their radiology reports so they have something to bring to their [primary care physicians]. If they want more, I hand it to them.”

Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., said that he has concerns about the guidelines. Specifically, that doctors may charge a fee to cover the cost of copying records, but that they cannot charge for the cost of searching and retrieving data, said Dr. Bilhartz, who is founder of ECGsource, an online cardiovascular medical education resource.

“Record requests can take significant time for staff to filter through and gather,” he said in an interview. “That time should be reimbursable ... If updated provisions prohibit charging for time spent compiling records, it seems those provisions are a bit out of touch with understanding what those of us on the ground floor must do when a request is received.”

But Dr. Bilhartz acknowledged that he would be unlikely to charge patients for “reasonable” data requests.

“I’m in private practice ... and because of that, I have more market-driven accountability to all my patients,” he said. “Why would I nickel and dime people who I would want to be satisfied patients? For reasonable requests, I would just provide records for free.”

Ms. Bourque notes that while the clarifications are primarily positive for health providers, they present a double-edged sword.

“The good side is that, it has all this detail and it’s really helpful and makes things easier when you have a tricky access request and don’t know what to do,” she said. “The flip side is that once it’s out there, they expect you to read it and pay attention. You start running out of excuses for why you didn’t comply with the access right or why you got it wrong.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

The age of the information-empowered patient is upon us. Not only do patients bring the results of their Internet research when they come to the office, they also want to take a record of the clinical encounter with them when they leave.

New HIPAA guidance issued in January by the Health & Human Services Department’s Office of Civil Rights (OCR) aims to help clinicians know how to respond and with what information; it also addresses when patients can be charged for the information.

In the past, physicians and other providers had to “wing it” when it came to unclear rules about patient’s data requests, said Dianne J. Bourque, a Boston health law and HIPAA compliance attorney. “Prior to this, there may not have been readily available guidance that would drill down” to address specific concerns.

When it comes to systems security, physicians and other health providers do not have to put their health IT systems at risk in an effort to meet a request for patient records. For example, Mrs. Smith requests that her protected health information (PHI) be copied onto a thumb drive that she has provided.

In most cases, a covered entity must provide data access in the manner requested by the patient. But the updated guidance states that health providers are not expected to tolerate “unacceptable levels of risk to the security of the PHI on its systems” in responding to requests.

Unlike system security, patient security does not trump patient access. If Mr. Black requests that his records by emailed to him, but a connection cannot be made secure, physicians are still required to send the data.

While OCR requires HIPAA-covered entities to implement reasonable safeguards to protect PHI while in transit, patients have a right to receive a copy of records by unencrypted email if they so wish.

To comply with the new rules, be sure to warn patients of the risks, and confirm that they still want their PHI by unencrypted email. If confirmed, you must comply with the request. This clarification relieves doctors of potential breach notification and liability if the data is intercepted in transit.

The guidance also clarifies how to deliver patients’ data. If PHI is maintained electronically, physicians and other HIPAA-covered entities must be able provide it to patients electronically.

“Because you hold it electronically, you can’t say, ‘Forget it, you have to have paper,’” Ms. Bourque said. “You lose that option when you keep [data] electronically. Maybe you have to go buy a scanner and scan [the document] and email it, but you can’t charge [patients] for the scanner.”

The new guidance also allows patients to get results directly from a clinical laboratory; however, labs are not required to interpret test results. Rather, patients are encouraged to reach out to their physician for such insights.

Overall, the access guidelines appear reasonable and hopefully will relieve hassles for patients in obtaining their health information, said Dr. Sam Slishman, an emergency physician for Sierra Vista Hospital in San Luis Obispo, Calif., and co-founder of Pre-R, a service that provides in-home visits. Dr. Slishman does not foresee the guidance having much impact on his practices.

“It’s crazy to me that patients have to struggle to retrieve their records at all,” he said in an interview. “I routinely send my patients home with at least their lab tests and copies of their radiology reports so they have something to bring to their [primary care physicians]. If they want more, I hand it to them.”

Dr. Rocky D. Bilhartz, an interventional cardiologist in private practice in College Station, Tex., said that he has concerns about the guidelines. Specifically, that doctors may charge a fee to cover the cost of copying records, but that they cannot charge for the cost of searching and retrieving data, said Dr. Bilhartz, who is founder of ECGsource, an online cardiovascular medical education resource.

“Record requests can take significant time for staff to filter through and gather,” he said in an interview. “That time should be reimbursable ... If updated provisions prohibit charging for time spent compiling records, it seems those provisions are a bit out of touch with understanding what those of us on the ground floor must do when a request is received.”

But Dr. Bilhartz acknowledged that he would be unlikely to charge patients for “reasonable” data requests.

“I’m in private practice ... and because of that, I have more market-driven accountability to all my patients,” he said. “Why would I nickel and dime people who I would want to be satisfied patients? For reasonable requests, I would just provide records for free.”

Ms. Bourque notes that while the clarifications are primarily positive for health providers, they present a double-edged sword.

“The good side is that, it has all this detail and it’s really helpful and makes things easier when you have a tricky access request and don’t know what to do,” she said. “The flip side is that once it’s out there, they expect you to read it and pay attention. You start running out of excuses for why you didn’t comply with the access right or why you got it wrong.”

agallegos@frontlinemedcom.com

On Twitter @legal_med