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Challenges facing independent integrated gastroenterology in 2017
The practice of gastroenterology is challenging for community physicians, those employed in multi-specialty clinics or large health care systems and those in academic health centers. Unique challenges confront independent GI practices, and there are mounting regulatory, financial, and operational barriers. Election results of 2016 have thrown us into an even more confusing future. In this month’s Road Ahead column, national GI leaders summarize the major challenges facing independent practices. Each leads (or has led) large GI practices and each has extensive experience with the policies, politics, payers, and pitfalls that impact our specialty. They have written a clear and helpful article for all physicians trying to maintain their independence and patient-focused practices. I have worked in many settings from the VA, to small and then large, independent practice, within a health system and in 2 academic medical centers. There is much to treasure in every type of practice and also many challenges. Physician leaders, both old and young, need to be informed and active in shaping medical policy.
John I. Allen, MD, MBA, AGAF, Editor in Chief
Physicians practicing in independent settings report greater satisfaction with their careers compared with those employed in hospital systems. In a recent survey,1 nearly two-thirds of independent practitioners strongly agreed with the statement, “I like being a physician,” compared with approximately half of those employed by hospital systems. The rapid pace of change in care delivery is forcing all caregivers to modify how they provide care. For physicians practicing in independent settings, understanding, reacting, and adapting to these changes is especially challenging.
It is particularly difficult for physicians and practices to remain abreast and cognizant of the ever-changing rules governing how we deliver care for our patients. The Digestive Health Physicians Association was formed 2 years ago to provide an active voice specifically for independent gastroenterology (GI) practices. The mission of the Digestive Health Physicians Association is to promote and protect the high-quality and cost-efficient care provided in the integrated GI practice model.
In the past decade, meeting the goal of the Triple Aim (improving population health, improving patient experience of care, and reducing the per-capita cost of health care) has become a central tenet of our national health policy strategy, especially since the enactment of the Affordable Care Act. Achieving the goals of the Triple Aim and complying with the changes and new requirements challenges all gastroenterologists, but particularly those working in the independent practice setting, and especially those in small group practices. The Centers for Medicare and Medicaid Services (CMS) recently estimated that under the Merit-Based Incentive Payment System, payment reductions resulting from the first year of reporting in 2017 will occur in 87% of solo practices, in 70% of groups with 2 to 9 physicians, and in 60% of groups with 10 to 24 physicians.2
Preparing yourself and your practice for the changes ahead will require an understanding of the rules, an assessment of your practice’s readiness, and the creation of a plan for compliance to ensure success.
The care model has undergone major changes in the past decade. The development of regional hospital systems has resulted in increasing numbers of employed physicians. Independent gastroenterology practices also have made changes in how they provide care. Vertical integration by independent practices has been a major, positive, and continuing development. As practices have grown more sophisticated with greater areas of specialization, they are increasingly capable of providing services directly to their patients rather than outsourcing them to external providers. Beginning first with endoscopic procedures and now extending to anesthesia, pathology, infusion, and other critical services, increased integration of services across the entire continuum of care has led to improved efficiency and care coordination, benefitting patients with improved outcomes as well as lower costs to our health care system.
The benefits and successes of practice integration, unfortunately, also have made vertically integrated practices a target for regulators and policy makers. Attacks on the integrated delivery model in gastroenterology have at times been supported, if not directly initiated, by our own colleagues in the house of medicine. In this article, we describe some of the threats and challenges confronting independent GI practice.
Anesthesia services
In April 2016, the Florida Society of Anesthesiologists (FSA) made headlines by drawing attention to its role as the relator in a qui tam (whistleblower) lawsuit that it had filed against more than 50 physicians, Ambulatory Surgery Centers, and anesthesia entities. This legal action — which the FSA filed in October 2013 but remained under seal until earlier this year — alleged that the defendants perpetrated Medicare and Medicaid fraud through violations of the federal Anti-Kickback Statute and the False Claims Act. In this lawsuit, the FSA specifically targeted the company model used to provide anesthesia services. Based on publicly available documents, the case currently is in its early stages, although the FSA has made it clear that it views the lawsuit as a blueprint for attacking integrated anesthesia services.
The FSA’s qui tam action in Florida is part of a broader agenda by those who seek to undermine the integrated care model that enables gastroenterologists and other physician specialists to integrate anesthesia services into lawful care models. A website describing the Florida qui tam action hailed the American Society of Anesthesiology for having “repeatedly petitioned the Office of the Inspector General, brought the issue up with Congressional leaders and executive branch regulators, and provided information and legal resources to its members.”3 These efforts to undermine integrated, coordinated care at the federal level also have extended to the state level, in which efforts have been made in front of licensing boards and state legislatures – albeit unsuccessfully – to restrict the integration of anesthesia services.
In-Office Ancillary Services Exception
The In-Office Ancillary Services Exception (IOASE) to the federal physician self-referral statute (the Stark Law), allows physician practices to provide certain services, including diagnostic imaging and anatomic pathology, in an integrated and coordinated fashion within their respective practices when strict criteria are met.
Not surprisingly, competing providers of these services have long fought for the elimination of the IOASE. In 2013, Representative Jackie Speier (D-CA) introduced the Promoting Integrity in Medicare Act. This bill sought to eliminate those legal protections for providing those integrated medical services under the IOASE. Vigorous support for the legislation was provided by a group called the Alliance for Integrity in Medicine, a coalition of organizations including the College of American Pathologists, the American Society for Clinical Pathology, the American Clinical Laboratory Association, and the American College of Radiology. Although that bill did not even receive a vote during the last Congress, Representative Speier has re-introduced it in this current session, and continues to lobby aggressively in support of this legislation. President Obama’s budget for 2016, as the President’s budget proposal had done for the past several years, also included elimination of the IOASE provision. Extensive advocacy efforts by a broad range of specialty organizations have been instrumental to date in defeating this proposal. A study commissioned by the Digestive Health Physicians Association,4 using Medicare data, showed that GI-related anatomic pathology services actually increased more slowly in professional settings (physician offices and laboratories), at an annual rate of 1.2% from 2009 to 2013, compared with the outpatient hospital setting of 3.5% during that same period. Efforts to restrict practice integration similarly are being made at the state level. In California, legislation to eliminate the IOASE under the State’s self-referral law was introduced in 2014. Coordinated efforts by California patient- and physician-interest groups were successful in educating legislators on the value of the integrated care mode and the bill was soundly defeated.
Medicare Part B Drug Benefit
In March 2016, a new threat to integrated care in GI surfaced when the CMS released a proposed rule that would test a new Medicare Part B payment model for infused drugs including infliximab and vedolizumab. Under the proposal, the CMS would reduce the current reimbursement of 6% above average sales price (ASP) to ASP plus 2.5%, plus a flat fee of $16.85 per infusion. CMS calculations in this proposal failed to include the mandatory 2% sequestration of Medicare payments under the Budget Control Act, which means that the actual reimbursement will be less than 1% over ASP. Because many practices are unable to negotiate discounts for these drugs, unintended consequences of this proposal may disrupt care coordination efforts, resulting in movement of infusions performed in the office setting into the more costly hospital setting. Perversely, although the stated intent of this proposal was to reduce incentives for prescribing more expensive drugs, infused biologic agents are actually treatments of last choice for many inflammatory bowel disease patients.
In the absence of less-expensive alternatives, this proposed change in reimbursement likely will reduce access to effective therapy for some of our sickest patients and will not reduce costs. It is hoped that the vigorous advocacy by a coalition of more than 300 medical societies and patient-interest groups along with a majority of members of Congress may result in modifications to this proposal when the final rule is released later this year.
Stark Law
The Stark Law, commonly known as the Physician Self-Referral Law, originally was passed by Congress in 1989 and was substantially amended last in 1993. The Stark Law was enacted to address concerns of potential overuse or inappropriate use of services in a fee-for-service payment system. Health care delivery has changed dramatically since the Stark law was passed 27 years ago, but this statute has not kept pace and is incompatible with new and innovative delivery models that now mandate a shift from fee-for-service payment models to value-based care and the development of risk-sharing arrangements and bundling of services. In 2011, the CMS created a set of waivers for Accountable Care Organizations in the Medicare Shared Savings Program, but these waivers do not apply to many of the alternative payment models under development by independent physicians.
In the past year, Congress repealed the Sustainable Growth Rate formula. Both the Affordable Care Act and the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015 were designed to move our health care system away from fee for service (volume) and toward payment for value. The current Stark Law was created to control arrangements in a fee-for-service system, but the Stark Law now obstructs the ability of physicians in independent practices to coordinate care and work as teams across specialties and with their colleagues who care for patients in other sites of service such as hospitals and academic medical centers.
Congress and CMS recently have heard from dozens of physician organizations, including all of the GI societies, about the need to modernize the Stark Law (by way of updates to the Stark statute and its corresponding regulations) to keep pace with the changes in health care delivery and to ensure successful implementation of the Medicare Access and Children’s Health Insurance Program Reauthorization Act. The changes sought include modifications to the definition of the term group practice to permit coordinated care across specialties and sites of service as well as to promote value-based compensation for all physicians.
Conclusions
To maximally amplify our voices as well our ability to effect positive change, gastroenterologists and other specialists should be actively engaged with the GI societies to help influence those changes proposed. Joining together will facilitate the adaptation by practices to change as it is mandated. The American Gastroenterological Association has long advocated for independent practices promoting optimal patient care delivery. Working cooperatively and collectively with colleagues in all GI professional organizations will enhance our ability to advance the best interests of our patients and our practices.
References
1. Great American Physician Survey 2013. Available from: Physicianspractice.com. Accessed: May 8, 2016.
2. Lowes, R. New Medicare penalty hits small groups, solo physicians hardest. Medscape Medical News. April 28, 2016;
3. The Anesthesia Company Model - FAQs. Available from: http://www.fsahq.org/anesthesia-company-model-faqs. Accessed: May 8, 2016.
4. Milliman White Paper, Medicare anatomic pathology utilization 2009-2013. Available: http://www.dhpassociation.org/wordpress/wp-content/uploads/2015/07/milliman-03-2009-2013-medicare-utilization-analysis.pdf. Accessed: May 8, 2016.
Dr. Rosenberg is a board-certified gastroenterologist who is currently the president of Illinois Gastroenterology Group, Highland Park, Ill; Dr Kim is a gastroenterologist at South Denver Gastroenterology, P.C., Lone Tree, Colo.; and Dr. Ketover is a gastroenterologist and is president and CEO of Minnesota Gastroenterology, P.A.; St. Paul. The authors disclose no conflicts.
The practice of gastroenterology is challenging for community physicians, those employed in multi-specialty clinics or large health care systems and those in academic health centers. Unique challenges confront independent GI practices, and there are mounting regulatory, financial, and operational barriers. Election results of 2016 have thrown us into an even more confusing future. In this month’s Road Ahead column, national GI leaders summarize the major challenges facing independent practices. Each leads (or has led) large GI practices and each has extensive experience with the policies, politics, payers, and pitfalls that impact our specialty. They have written a clear and helpful article for all physicians trying to maintain their independence and patient-focused practices. I have worked in many settings from the VA, to small and then large, independent practice, within a health system and in 2 academic medical centers. There is much to treasure in every type of practice and also many challenges. Physician leaders, both old and young, need to be informed and active in shaping medical policy.
John I. Allen, MD, MBA, AGAF, Editor in Chief
Physicians practicing in independent settings report greater satisfaction with their careers compared with those employed in hospital systems. In a recent survey,1 nearly two-thirds of independent practitioners strongly agreed with the statement, “I like being a physician,” compared with approximately half of those employed by hospital systems. The rapid pace of change in care delivery is forcing all caregivers to modify how they provide care. For physicians practicing in independent settings, understanding, reacting, and adapting to these changes is especially challenging.
It is particularly difficult for physicians and practices to remain abreast and cognizant of the ever-changing rules governing how we deliver care for our patients. The Digestive Health Physicians Association was formed 2 years ago to provide an active voice specifically for independent gastroenterology (GI) practices. The mission of the Digestive Health Physicians Association is to promote and protect the high-quality and cost-efficient care provided in the integrated GI practice model.
In the past decade, meeting the goal of the Triple Aim (improving population health, improving patient experience of care, and reducing the per-capita cost of health care) has become a central tenet of our national health policy strategy, especially since the enactment of the Affordable Care Act. Achieving the goals of the Triple Aim and complying with the changes and new requirements challenges all gastroenterologists, but particularly those working in the independent practice setting, and especially those in small group practices. The Centers for Medicare and Medicaid Services (CMS) recently estimated that under the Merit-Based Incentive Payment System, payment reductions resulting from the first year of reporting in 2017 will occur in 87% of solo practices, in 70% of groups with 2 to 9 physicians, and in 60% of groups with 10 to 24 physicians.2
Preparing yourself and your practice for the changes ahead will require an understanding of the rules, an assessment of your practice’s readiness, and the creation of a plan for compliance to ensure success.
The care model has undergone major changes in the past decade. The development of regional hospital systems has resulted in increasing numbers of employed physicians. Independent gastroenterology practices also have made changes in how they provide care. Vertical integration by independent practices has been a major, positive, and continuing development. As practices have grown more sophisticated with greater areas of specialization, they are increasingly capable of providing services directly to their patients rather than outsourcing them to external providers. Beginning first with endoscopic procedures and now extending to anesthesia, pathology, infusion, and other critical services, increased integration of services across the entire continuum of care has led to improved efficiency and care coordination, benefitting patients with improved outcomes as well as lower costs to our health care system.
The benefits and successes of practice integration, unfortunately, also have made vertically integrated practices a target for regulators and policy makers. Attacks on the integrated delivery model in gastroenterology have at times been supported, if not directly initiated, by our own colleagues in the house of medicine. In this article, we describe some of the threats and challenges confronting independent GI practice.
Anesthesia services
In April 2016, the Florida Society of Anesthesiologists (FSA) made headlines by drawing attention to its role as the relator in a qui tam (whistleblower) lawsuit that it had filed against more than 50 physicians, Ambulatory Surgery Centers, and anesthesia entities. This legal action — which the FSA filed in October 2013 but remained under seal until earlier this year — alleged that the defendants perpetrated Medicare and Medicaid fraud through violations of the federal Anti-Kickback Statute and the False Claims Act. In this lawsuit, the FSA specifically targeted the company model used to provide anesthesia services. Based on publicly available documents, the case currently is in its early stages, although the FSA has made it clear that it views the lawsuit as a blueprint for attacking integrated anesthesia services.
The FSA’s qui tam action in Florida is part of a broader agenda by those who seek to undermine the integrated care model that enables gastroenterologists and other physician specialists to integrate anesthesia services into lawful care models. A website describing the Florida qui tam action hailed the American Society of Anesthesiology for having “repeatedly petitioned the Office of the Inspector General, brought the issue up with Congressional leaders and executive branch regulators, and provided information and legal resources to its members.”3 These efforts to undermine integrated, coordinated care at the federal level also have extended to the state level, in which efforts have been made in front of licensing boards and state legislatures – albeit unsuccessfully – to restrict the integration of anesthesia services.
In-Office Ancillary Services Exception
The In-Office Ancillary Services Exception (IOASE) to the federal physician self-referral statute (the Stark Law), allows physician practices to provide certain services, including diagnostic imaging and anatomic pathology, in an integrated and coordinated fashion within their respective practices when strict criteria are met.
Not surprisingly, competing providers of these services have long fought for the elimination of the IOASE. In 2013, Representative Jackie Speier (D-CA) introduced the Promoting Integrity in Medicare Act. This bill sought to eliminate those legal protections for providing those integrated medical services under the IOASE. Vigorous support for the legislation was provided by a group called the Alliance for Integrity in Medicine, a coalition of organizations including the College of American Pathologists, the American Society for Clinical Pathology, the American Clinical Laboratory Association, and the American College of Radiology. Although that bill did not even receive a vote during the last Congress, Representative Speier has re-introduced it in this current session, and continues to lobby aggressively in support of this legislation. President Obama’s budget for 2016, as the President’s budget proposal had done for the past several years, also included elimination of the IOASE provision. Extensive advocacy efforts by a broad range of specialty organizations have been instrumental to date in defeating this proposal. A study commissioned by the Digestive Health Physicians Association,4 using Medicare data, showed that GI-related anatomic pathology services actually increased more slowly in professional settings (physician offices and laboratories), at an annual rate of 1.2% from 2009 to 2013, compared with the outpatient hospital setting of 3.5% during that same period. Efforts to restrict practice integration similarly are being made at the state level. In California, legislation to eliminate the IOASE under the State’s self-referral law was introduced in 2014. Coordinated efforts by California patient- and physician-interest groups were successful in educating legislators on the value of the integrated care mode and the bill was soundly defeated.
Medicare Part B Drug Benefit
In March 2016, a new threat to integrated care in GI surfaced when the CMS released a proposed rule that would test a new Medicare Part B payment model for infused drugs including infliximab and vedolizumab. Under the proposal, the CMS would reduce the current reimbursement of 6% above average sales price (ASP) to ASP plus 2.5%, plus a flat fee of $16.85 per infusion. CMS calculations in this proposal failed to include the mandatory 2% sequestration of Medicare payments under the Budget Control Act, which means that the actual reimbursement will be less than 1% over ASP. Because many practices are unable to negotiate discounts for these drugs, unintended consequences of this proposal may disrupt care coordination efforts, resulting in movement of infusions performed in the office setting into the more costly hospital setting. Perversely, although the stated intent of this proposal was to reduce incentives for prescribing more expensive drugs, infused biologic agents are actually treatments of last choice for many inflammatory bowel disease patients.
In the absence of less-expensive alternatives, this proposed change in reimbursement likely will reduce access to effective therapy for some of our sickest patients and will not reduce costs. It is hoped that the vigorous advocacy by a coalition of more than 300 medical societies and patient-interest groups along with a majority of members of Congress may result in modifications to this proposal when the final rule is released later this year.
Stark Law
The Stark Law, commonly known as the Physician Self-Referral Law, originally was passed by Congress in 1989 and was substantially amended last in 1993. The Stark Law was enacted to address concerns of potential overuse or inappropriate use of services in a fee-for-service payment system. Health care delivery has changed dramatically since the Stark law was passed 27 years ago, but this statute has not kept pace and is incompatible with new and innovative delivery models that now mandate a shift from fee-for-service payment models to value-based care and the development of risk-sharing arrangements and bundling of services. In 2011, the CMS created a set of waivers for Accountable Care Organizations in the Medicare Shared Savings Program, but these waivers do not apply to many of the alternative payment models under development by independent physicians.
In the past year, Congress repealed the Sustainable Growth Rate formula. Both the Affordable Care Act and the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015 were designed to move our health care system away from fee for service (volume) and toward payment for value. The current Stark Law was created to control arrangements in a fee-for-service system, but the Stark Law now obstructs the ability of physicians in independent practices to coordinate care and work as teams across specialties and with their colleagues who care for patients in other sites of service such as hospitals and academic medical centers.
Congress and CMS recently have heard from dozens of physician organizations, including all of the GI societies, about the need to modernize the Stark Law (by way of updates to the Stark statute and its corresponding regulations) to keep pace with the changes in health care delivery and to ensure successful implementation of the Medicare Access and Children’s Health Insurance Program Reauthorization Act. The changes sought include modifications to the definition of the term group practice to permit coordinated care across specialties and sites of service as well as to promote value-based compensation for all physicians.
Conclusions
To maximally amplify our voices as well our ability to effect positive change, gastroenterologists and other specialists should be actively engaged with the GI societies to help influence those changes proposed. Joining together will facilitate the adaptation by practices to change as it is mandated. The American Gastroenterological Association has long advocated for independent practices promoting optimal patient care delivery. Working cooperatively and collectively with colleagues in all GI professional organizations will enhance our ability to advance the best interests of our patients and our practices.
References
1. Great American Physician Survey 2013. Available from: Physicianspractice.com. Accessed: May 8, 2016.
2. Lowes, R. New Medicare penalty hits small groups, solo physicians hardest. Medscape Medical News. April 28, 2016;
3. The Anesthesia Company Model - FAQs. Available from: http://www.fsahq.org/anesthesia-company-model-faqs. Accessed: May 8, 2016.
4. Milliman White Paper, Medicare anatomic pathology utilization 2009-2013. Available: http://www.dhpassociation.org/wordpress/wp-content/uploads/2015/07/milliman-03-2009-2013-medicare-utilization-analysis.pdf. Accessed: May 8, 2016.
Dr. Rosenberg is a board-certified gastroenterologist who is currently the president of Illinois Gastroenterology Group, Highland Park, Ill; Dr Kim is a gastroenterologist at South Denver Gastroenterology, P.C., Lone Tree, Colo.; and Dr. Ketover is a gastroenterologist and is president and CEO of Minnesota Gastroenterology, P.A.; St. Paul. The authors disclose no conflicts.
The practice of gastroenterology is challenging for community physicians, those employed in multi-specialty clinics or large health care systems and those in academic health centers. Unique challenges confront independent GI practices, and there are mounting regulatory, financial, and operational barriers. Election results of 2016 have thrown us into an even more confusing future. In this month’s Road Ahead column, national GI leaders summarize the major challenges facing independent practices. Each leads (or has led) large GI practices and each has extensive experience with the policies, politics, payers, and pitfalls that impact our specialty. They have written a clear and helpful article for all physicians trying to maintain their independence and patient-focused practices. I have worked in many settings from the VA, to small and then large, independent practice, within a health system and in 2 academic medical centers. There is much to treasure in every type of practice and also many challenges. Physician leaders, both old and young, need to be informed and active in shaping medical policy.
John I. Allen, MD, MBA, AGAF, Editor in Chief
Physicians practicing in independent settings report greater satisfaction with their careers compared with those employed in hospital systems. In a recent survey,1 nearly two-thirds of independent practitioners strongly agreed with the statement, “I like being a physician,” compared with approximately half of those employed by hospital systems. The rapid pace of change in care delivery is forcing all caregivers to modify how they provide care. For physicians practicing in independent settings, understanding, reacting, and adapting to these changes is especially challenging.
It is particularly difficult for physicians and practices to remain abreast and cognizant of the ever-changing rules governing how we deliver care for our patients. The Digestive Health Physicians Association was formed 2 years ago to provide an active voice specifically for independent gastroenterology (GI) practices. The mission of the Digestive Health Physicians Association is to promote and protect the high-quality and cost-efficient care provided in the integrated GI practice model.
In the past decade, meeting the goal of the Triple Aim (improving population health, improving patient experience of care, and reducing the per-capita cost of health care) has become a central tenet of our national health policy strategy, especially since the enactment of the Affordable Care Act. Achieving the goals of the Triple Aim and complying with the changes and new requirements challenges all gastroenterologists, but particularly those working in the independent practice setting, and especially those in small group practices. The Centers for Medicare and Medicaid Services (CMS) recently estimated that under the Merit-Based Incentive Payment System, payment reductions resulting from the first year of reporting in 2017 will occur in 87% of solo practices, in 70% of groups with 2 to 9 physicians, and in 60% of groups with 10 to 24 physicians.2
Preparing yourself and your practice for the changes ahead will require an understanding of the rules, an assessment of your practice’s readiness, and the creation of a plan for compliance to ensure success.
The care model has undergone major changes in the past decade. The development of regional hospital systems has resulted in increasing numbers of employed physicians. Independent gastroenterology practices also have made changes in how they provide care. Vertical integration by independent practices has been a major, positive, and continuing development. As practices have grown more sophisticated with greater areas of specialization, they are increasingly capable of providing services directly to their patients rather than outsourcing them to external providers. Beginning first with endoscopic procedures and now extending to anesthesia, pathology, infusion, and other critical services, increased integration of services across the entire continuum of care has led to improved efficiency and care coordination, benefitting patients with improved outcomes as well as lower costs to our health care system.
The benefits and successes of practice integration, unfortunately, also have made vertically integrated practices a target for regulators and policy makers. Attacks on the integrated delivery model in gastroenterology have at times been supported, if not directly initiated, by our own colleagues in the house of medicine. In this article, we describe some of the threats and challenges confronting independent GI practice.
Anesthesia services
In April 2016, the Florida Society of Anesthesiologists (FSA) made headlines by drawing attention to its role as the relator in a qui tam (whistleblower) lawsuit that it had filed against more than 50 physicians, Ambulatory Surgery Centers, and anesthesia entities. This legal action — which the FSA filed in October 2013 but remained under seal until earlier this year — alleged that the defendants perpetrated Medicare and Medicaid fraud through violations of the federal Anti-Kickback Statute and the False Claims Act. In this lawsuit, the FSA specifically targeted the company model used to provide anesthesia services. Based on publicly available documents, the case currently is in its early stages, although the FSA has made it clear that it views the lawsuit as a blueprint for attacking integrated anesthesia services.
The FSA’s qui tam action in Florida is part of a broader agenda by those who seek to undermine the integrated care model that enables gastroenterologists and other physician specialists to integrate anesthesia services into lawful care models. A website describing the Florida qui tam action hailed the American Society of Anesthesiology for having “repeatedly petitioned the Office of the Inspector General, brought the issue up with Congressional leaders and executive branch regulators, and provided information and legal resources to its members.”3 These efforts to undermine integrated, coordinated care at the federal level also have extended to the state level, in which efforts have been made in front of licensing boards and state legislatures – albeit unsuccessfully – to restrict the integration of anesthesia services.
In-Office Ancillary Services Exception
The In-Office Ancillary Services Exception (IOASE) to the federal physician self-referral statute (the Stark Law), allows physician practices to provide certain services, including diagnostic imaging and anatomic pathology, in an integrated and coordinated fashion within their respective practices when strict criteria are met.
Not surprisingly, competing providers of these services have long fought for the elimination of the IOASE. In 2013, Representative Jackie Speier (D-CA) introduced the Promoting Integrity in Medicare Act. This bill sought to eliminate those legal protections for providing those integrated medical services under the IOASE. Vigorous support for the legislation was provided by a group called the Alliance for Integrity in Medicine, a coalition of organizations including the College of American Pathologists, the American Society for Clinical Pathology, the American Clinical Laboratory Association, and the American College of Radiology. Although that bill did not even receive a vote during the last Congress, Representative Speier has re-introduced it in this current session, and continues to lobby aggressively in support of this legislation. President Obama’s budget for 2016, as the President’s budget proposal had done for the past several years, also included elimination of the IOASE provision. Extensive advocacy efforts by a broad range of specialty organizations have been instrumental to date in defeating this proposal. A study commissioned by the Digestive Health Physicians Association,4 using Medicare data, showed that GI-related anatomic pathology services actually increased more slowly in professional settings (physician offices and laboratories), at an annual rate of 1.2% from 2009 to 2013, compared with the outpatient hospital setting of 3.5% during that same period. Efforts to restrict practice integration similarly are being made at the state level. In California, legislation to eliminate the IOASE under the State’s self-referral law was introduced in 2014. Coordinated efforts by California patient- and physician-interest groups were successful in educating legislators on the value of the integrated care mode and the bill was soundly defeated.
Medicare Part B Drug Benefit
In March 2016, a new threat to integrated care in GI surfaced when the CMS released a proposed rule that would test a new Medicare Part B payment model for infused drugs including infliximab and vedolizumab. Under the proposal, the CMS would reduce the current reimbursement of 6% above average sales price (ASP) to ASP plus 2.5%, plus a flat fee of $16.85 per infusion. CMS calculations in this proposal failed to include the mandatory 2% sequestration of Medicare payments under the Budget Control Act, which means that the actual reimbursement will be less than 1% over ASP. Because many practices are unable to negotiate discounts for these drugs, unintended consequences of this proposal may disrupt care coordination efforts, resulting in movement of infusions performed in the office setting into the more costly hospital setting. Perversely, although the stated intent of this proposal was to reduce incentives for prescribing more expensive drugs, infused biologic agents are actually treatments of last choice for many inflammatory bowel disease patients.
In the absence of less-expensive alternatives, this proposed change in reimbursement likely will reduce access to effective therapy for some of our sickest patients and will not reduce costs. It is hoped that the vigorous advocacy by a coalition of more than 300 medical societies and patient-interest groups along with a majority of members of Congress may result in modifications to this proposal when the final rule is released later this year.
Stark Law
The Stark Law, commonly known as the Physician Self-Referral Law, originally was passed by Congress in 1989 and was substantially amended last in 1993. The Stark Law was enacted to address concerns of potential overuse or inappropriate use of services in a fee-for-service payment system. Health care delivery has changed dramatically since the Stark law was passed 27 years ago, but this statute has not kept pace and is incompatible with new and innovative delivery models that now mandate a shift from fee-for-service payment models to value-based care and the development of risk-sharing arrangements and bundling of services. In 2011, the CMS created a set of waivers for Accountable Care Organizations in the Medicare Shared Savings Program, but these waivers do not apply to many of the alternative payment models under development by independent physicians.
In the past year, Congress repealed the Sustainable Growth Rate formula. Both the Affordable Care Act and the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015 were designed to move our health care system away from fee for service (volume) and toward payment for value. The current Stark Law was created to control arrangements in a fee-for-service system, but the Stark Law now obstructs the ability of physicians in independent practices to coordinate care and work as teams across specialties and with their colleagues who care for patients in other sites of service such as hospitals and academic medical centers.
Congress and CMS recently have heard from dozens of physician organizations, including all of the GI societies, about the need to modernize the Stark Law (by way of updates to the Stark statute and its corresponding regulations) to keep pace with the changes in health care delivery and to ensure successful implementation of the Medicare Access and Children’s Health Insurance Program Reauthorization Act. The changes sought include modifications to the definition of the term group practice to permit coordinated care across specialties and sites of service as well as to promote value-based compensation for all physicians.
Conclusions
To maximally amplify our voices as well our ability to effect positive change, gastroenterologists and other specialists should be actively engaged with the GI societies to help influence those changes proposed. Joining together will facilitate the adaptation by practices to change as it is mandated. The American Gastroenterological Association has long advocated for independent practices promoting optimal patient care delivery. Working cooperatively and collectively with colleagues in all GI professional organizations will enhance our ability to advance the best interests of our patients and our practices.
References
1. Great American Physician Survey 2013. Available from: Physicianspractice.com. Accessed: May 8, 2016.
2. Lowes, R. New Medicare penalty hits small groups, solo physicians hardest. Medscape Medical News. April 28, 2016;
3. The Anesthesia Company Model - FAQs. Available from: http://www.fsahq.org/anesthesia-company-model-faqs. Accessed: May 8, 2016.
4. Milliman White Paper, Medicare anatomic pathology utilization 2009-2013. Available: http://www.dhpassociation.org/wordpress/wp-content/uploads/2015/07/milliman-03-2009-2013-medicare-utilization-analysis.pdf. Accessed: May 8, 2016.
Dr. Rosenberg is a board-certified gastroenterologist who is currently the president of Illinois Gastroenterology Group, Highland Park, Ill; Dr Kim is a gastroenterologist at South Denver Gastroenterology, P.C., Lone Tree, Colo.; and Dr. Ketover is a gastroenterologist and is president and CEO of Minnesota Gastroenterology, P.A.; St. Paul. The authors disclose no conflicts.