The American College of Emergency Physicians sent a comment letter to Dr. Donald Berwick, Administrator of the Centers for Medicare and Medicaid Services in response to the draft Accountable Care Organization regulations published Spring 2011.  The ACEP comment letter  lists a series of concerns regarding structure, governance, start-up costs and risk sharing that would make physician-based ACOs inaccessible except to large, well-capitalized multi-specialty practices.  Further, EM practices that cover large geographic areas could possibly trigger an expensive and resource consumptive Federal Trade Commission review as a result of the anti-trust requirements created by the new regulations.  If the final regulation is not changed significantly, the pool of applicants may be quite small.   

The letter in its entirety is posted below:

December 2, 2010

Donald M. Berwick, MD, MPP, FRCP 

Administrator, Centers for Medicare & Medicaid Services Department of Health and Human Services 445-G, Hubert H. Humphrey Building 200 Independence Avenue, 

SW Washington, DC 20201

Attention: CMS-1345-NC Re: Policies and Standards for ACOs Participating with the Medicare Program

Dear Dr. Berwick:

On behalf of the American College of Emergency Physicians’ (ACEP) more than 29,000 members and the Emergency Department Practice Management Association (EDPMA) and its 83 affiliated member organizations, we appreciate the opportunity to submit preliminary comments regarding aspects of policies and standards for Accountable Care Organization (ACO) design and development.

CMS has provided various background documents and public forums over the past few months in preparation for implementing Sec. 3021 and 3022 of PPACA. The vision for primary care physicians and/or hospital-based systems developing ACOs has been well-outlined. However, any description of expectations of the roles for emergency care physicians (and other hospital- based specialists) has not been addressed. We are concerned that once ACOs, medical homes, and expanded coverage are implemented, many policy makers expect emergency visits to all but disappear. While the health reform law will greatly expand insurance coverage starting in 2014, the volume of emergency visits is showing no signs of diminishing. In states like Massachusetts where 97 percent of the population has coverage, emergency department visits continue to grow.

According to the HHS’ Centers for Disease Control and Prevention, emergency visits in 2008 grew to 124 million, the highest level ever reported, and the number of uninsured recently reported by CDC has now reached 50 million, which will undoubtedly add to the volume of already crowded emergency departments. In addition, we predict that when the estimated 16 million individuals are added to Medicaid, the volume of emergency department visits will rise again as the supply and willingness of physicians in the community to add more low paying Medicaid patients to their practices falls short of demand.ACEP/EDPMA Response to ACO Questions December 2, 2010 Page 2

We believe there is a significant, and often overlooked, role for emergency physicians in new delivery system models that will greatly contribute to improvements in quality and coordination of patient care.

We have selected three of the seven questions posed in the November 17th Federal Register notice for response today. We will have more extensive reactions and recommendations when the draft regulation is released for comment.

• What policies or standards should we consider adopting to ensure that groups of solo and small practice providers have the opportunity to actively participate in the Medicare Shared Savings Program and the ACO models tested by CMMI?

We urge CMS, FTC, and OIG to strongly consider concerns on the structure and the need to remove certain legal barriers that have been articulated to CMS by the American Medical Association, American Hospital Association, the Federation, and other provider groups.

With regard to the question above, we believe that practice size is not the only factor that CMS needs to consider in planning shared savings models. Approximately one-third of emergency physicians are hospital employees while the majority are members of practice groups of varying sizes that contract with hospitals to provide 24/7 coverage of their emergency departments.

Fifty percent of Medicare admissions come through the emergency department and the majority of those have time-sensitive conditions. Our members play a critically important role coordinating care at the front end of an episode, i.e. they conduct a medical screening examination and assess the patient’s need to be either admitted, treated and discharged, or kept in observation for several hours before a final disposition decision is made. Approximately 25 percent of US hospitals have dedicated observation units and they are generally directed by emergency physicians. If the patient requires inpatient care, the emergency physician contacts the patient’s treating physician – primary care and/or specialty – who actually admits the patient. If the patient has no physician, the decision goes to the hospitalist or other hospital medical staff member. At the end of the inpatient stay, many patients are discharged into the community or to post acute care settings with little or no coordinated follow up. And, some of these individuals return to the emergency department when their conditions worsen and they don’t know where else to go.

This is an area where emergency physicians can improve transitions between sites of care, particularly when a patient comes back to the emergency department and is re-admitted within 30 days of discharge. As electronic health records continue to expand to link community-based physicians with the emergency department and other health care providers, emergency physicians will be able to play a more integral and expanded role in care coordination. Payment policies for specialty groups like emergency physicians who have little control over who comes to the emergency department should evolve over time as the ACO infrastructure improves and participating physicians can undertake joint risk sharing.

• The Affordable Care Act requires us to develop patient-centeredness criteria for assessment of ACOs participating in the Medicare Shared Savings Program. What aspects of patient-centeredness are particularly important for us to consider and how should we evaluate them?

ACEP/EDPMA Response to ACO Questions December 2, 2010 Page 3

We believe that collaborative patient education is the most effective tool to improving quality and patient satisfaction. ACEP has long provided public education regarding when an individual should come to the emergency department, based on the now universal ‘prudent lay person standard’ that is based on the individual’s belief that he/she may have a medical emergency. Appropriate use of the emergency department requires much more than communication between the emergency physician and the patient.

It starts with the patient’s primary care provider, who is often the one who tells the patient to go 

directly from home to the emergency department for tests, especially on nights and weekends.

The ACO should provide a framework to engage all the physicians in coordinating the patient’s care and keeping the patient informed about what types of services are actually needed at the most appropriate site for that care. We envision that inclusion of collaborative clinical decisions can reduce the number of diagnostic images and foster greater consideration of alternatives to inpatient care. Patient understanding and satisfaction should improve along with the quality, safety and efficiency. A team approach is especially important for Medicare patients with chronic conditions.

Again, real time exchange between providers will require extensive investments in health information technology (IT) infrastructure to facilitate coordination using EHRs and other technology. We urge CMS to reassess the EHR incentive program as policies and standards continue to be established and the current state of health IT adoption and functionality evolves. At the same time, HCAHPS and/or other instruments can be refined to measure patient understanding and satisfaction with their overall care.

We also note that emphasis on physicians providing more extensive education, coordination, and collaboration through participation in ACOs may result in higher costs for physician services, while reducing costs of inpatient and post acute care. The current payment silos must be adjusted to recognize overall system savings so physicians are not penalized.

• In order for an ACO to share in savings under the Medicare Shared Savings Program, it must meet a quality performance standard determined by the Secretary. What quality measures should the Secretary use to determine performance in the Shared Savings Program?

The most important aspect of performance measurement for nascent ACOs is to begin with existing measures endorsed by a consensus based entity (e.g., National Quality Forum) and work with consensus groups and private payers to further standardize measures and metrics. Most physicians and other providers are responding to myriad “quality” measures, and new, ACO-specific measures make no sense at this point.

The majority of physician groups are now participating in PQRI/PQRS including emergency physicians who were early adopters, so PQRI/PQRS measures are the best source of measures for the foreseeable future. As CMS and ACOs glean experience with these new delivery models, more outcome measures should be added, while some of the more process- oriented measures should be retired.

We also recommend that as the experience is gained, measures that reduce emergency department overcrowding be considered, as well as measures encouraging communication

ACEP/EDPMA Response to ACO Questions December 2, 2010 Page 4

between hospital physicians and primary care physicians and coordination of emergency department transitions so that a loop of continuous care is created to diminish morbidity and mortality at critical transition points.

We look forward to working with CMS and other physician and hospital groups to share research and clinical guidelines that can be integrated into larger bundles of care. If you have any questions about our comments, please contact Barbara Tomar, ACEP’s Federal Affairs Director at (202) 728-0610, ext. 3017.

Sincerely,

Sandra H. Schneider, MD, FACEP Randy Pilgrim, MD, FACEP President, ACEP Chairman, Board of Directors, EDPMA

Policies and Standards for ACOs Participating with the Medicare Program

In response to pre-ACO regulations, CMS posed questions to physicians concerning their possible participation in soon to be developed accountable care organizations. ACOs are a product of the new Patient Protection and Affordable Care Act (PPPAC) and will serve a minimum of 5000 Medicare beneficiaries.  It is assumed that most ACOs will enroll private patients as well as Medicare once they are up and running.  ACEP's comments to CMS Administrator Donald Berwick regarding aspects of policies and standards for ACOs' design and development include the need to recognize the potential role that emergency physicians can play in coordinating care across sites of service.


Below is the text of the letter sent to Dr. Berwick by ACEP President Dr. Sandra Schneider and EDPMA Board Chairman Dr. Randy Pilgrim.
                                       

December 2, 2010

Donald M. Berwick, MD, MPP, FRCP                                                                     

Administrator, Centers for Medicare & Medicaid Services                       

Department of Health and Human Services

445-G, Hubert H. Humphrey Building

200 Independence Avenue, SW

Washington, DC  20201

                                                                                            Attention:  CMS-1345-NC

Re: Policies and Standards for ACOs Participating with the Medicare Program

Dear Dr. Berwick:

On behalf of the American College of Emergency Physicians’ (ACEP) more than 29,000 members and the Emergency Department Practice Management Association (EDPMA) and its 83 affiliated member organizations, we appreciate the opportunity to submit preliminary comments regarding aspects of policies and standards for Accountable Care Organization (ACO) design and development. 

CMS has provided various background documents and public forums over the past few months in preparation for implementing Sec. 3021 and 3022 of PPACA.  The vision for primary care physicians and/or hospital-based systems developing ACOs has been well-outlined.  However, any description of expectations of the roles for emergency care physicians (and other hospital-based specialists) has not been addressed.  We are concerned that once ACOs, medical homes, and expanded coverage are implemented, many policy makers expect emergency visits to all but disappear.  While the health reform law will greatly expand insurance coverage starting in 2014, the volume of emergency visits is showing no signs of diminishing.  In states like Massachusetts where 97 percent of the population has coverage, emergency department visits continue to grow. 

According to the HHS’ Centers for Disease Control and Prevention, emergency visits in 2008 grew to 124 million, the highest level ever reported, and the number of uninsured recently reported by CDC has now reached 50 million, which will undoubtedly add to the volume of already crowded emergency departments.  In addition, we predict that when the estimated 16 million individuals are added to Medicaid, the volume of emergency department visits will rise again as the supply and willingness of physicians in the community to add more low paying Medicaid patients to their practices falls short of demand.  

We believe there is a significant, and often overlooked, role for emergency physicians in new delivery system models that will greatly contribute to improvements in quality and coordination of patient care. 

We have selected three of the seven questions posed in the November 17^th Federal Register notice for response today.  We will have more extensive reactions and recommendations when the draft regulation is released for comment.  

•       What policies or standards should we consider adopting to ensure that groups of solo and small practice providers have the opportunity to actively participate in the Medicare Shared Savings Program and the ACO models tested by CMMI?

We urge CMS, FTC, and OIG to strongly consider concerns on the structure and the need to remove certain legal barriers that have been articulated to CMS by the American Medical Association, American Hospital Association, the Federation, and other provider groups.

With regard to the question above, we believe that practice size is not the only factor that CMS needs to consider in planning shared savings models.  Approximately one-third of emergency physicians are hospital employees while the majority are members of practice groups of varying sizes that contract with hospitals to provide 24/7 coverage of their emergency departments.  

Fifty percent of Medicare admissions come through the emergency department and the majority of those have time-sensitive conditions.  Our members play a critically important role coordinating care at the front end of an episode, i.e.  they conduct a medical screening examination and assess the patient’s need to be either admitted, treated and discharged, or kept in observation for several hours before a final disposition decision is made.  Approximately 25 percent of US hospitals have dedicated observation units and they are generally directed by emergency physicians.   If the patient requires inpatient care, the emergency physician contacts the patient’s treating physician – primary care and/or specialty – who actually admits the patient.  If the patient has no physician, the decision goes to the hospitalist or other hospital medical staff member.  At the end of the inpatient stay, many patients are discharged into the community or to post acute care settings with little or no coordinated follow up.  And, some of these individuals return to the emergency department when their conditions worsen and they don’t know where else to go. 

This is an area where emergency physicians can improve transitions between sites of care, particularly when a patient comes back to the emergency department and is re-admitted within 30 days of discharge.  As electronic health records continue to expand to link community-based physicians with the emergency department and other health care providers, emergency physicians will be able to play a more  integral and expanded role in care coordination.  Payment policies for specialty groups like emergency physicians who have little control over who comes to the emergency department should evolve over time as the ACO infrastructure improves and  participating physicians can undertake joint risk sharing.   

•       The Affordable Care Act requires us to develop patient-centeredness criteria for assessment of ACOs participating in the Medicare Shared Savings Program. What aspects of patient-centeredness are particularly important for us to consider and how should we evaluate them?

We believe that collaborative patient education is the most effective tool to improving quality and patient satisfaction.  ACEP has long provided public education regarding when an individual should come to the emergency department, based on the now universal ‘prudent lay person standard’ that is based on the individual’s belief that he/she may have a medical emergency.  Appropriate use of the emergency department requires much more than communication between the emergency physician and the patient.   It starts with the patient’s primary care provider, who is often the one who tells the patient to go directly from home to the emergency department for tests, especially on nights and weekends. 

The ACO should provide a framework to engage all the physicians in coordinating the patient’s care and keeping the patient informed about what types of services are actually needed at the most appropriate site for that care.  We envision that inclusion of collaborative clinical decisions can reduce the number of diagnostic images and foster greater consideration of alternatives to inpatient care.  Patient understanding and satisfaction should improve along with the quality, safety and efficiency.  A team approach is especially important for Medicare patients with chronic conditions.

Again, real time exchange between providers will require extensive investments in health information technology (IT) infrastructure to facilitate coordination using EHRs and other technology. We urge CMS to reassess the EHR incentive program as policies and standards continue to be established and the current state of health IT adoption and functionality evolves.  At the same time, HCAHPS and/or other instruments can be refined to measure patient understanding and satisfaction with their overall care.

We also note that emphasis on physicians providing more extensive education, coordination, and collaboration through participation in ACOs may result in higher costs for physician services, while reducing costs of inpatient and post acute care.  The current payment silos must be adjusted to recognize overall system savings so physicians are not penalized. 

•       In order for an ACO to share in savings under the Medicare Shared Savings Program, it must meet a quality performance standard determined by the Secretary. What quality measures should the Secretary use to determine performance in the Shared Savings Program?

The most important aspect of performance measurement for nascent ACOs is to begin with existing measures endorsed by a consensus based entity (e.g., National Quality Forum) and work with consensus groups and private payers to further standardize measures and metrics.   Most physicians and other providers are responding to myriad “quality” measures, and new, ACO-specific measures make no sense at this point. 

The majority of physician groups are now participating in PQRI/PQRS including emergency physicians who were early adopters, so PQRI/PQRS measures are the best source of measures for the foreseeable future.  As CMS and ACOs glean experience with these new delivery models, more outcome measures should be added, while some of the more process-oriented measures should be retired.  

We also recommend that as the experience is gained, measures that reduce emergency department overcrowding be considered, as well as measures encouraging communication between hospital physicians and primary care physicians and coordination of emergency department transitions so that a loop of continuous care is created to diminish morbidity and mortality at critical transition points.

We look forward to working with CMS and other physician and hospital groups to share research and clinical guidelines that can be integrated into larger bundles of care. If you have any questions about our comments, please contact Barbara Tomar, ACEP’s Federal Affairs Director at (202) 728-0610, ext. 3017.

Sincerely,                                                                                                                                                          

Sandra H. Schneider, MD, FACEP                                     Randy Pilgrim, MD

President, ACEP                                                             Chairman, Board of Directors, EDPMA

ACEP sends letter to Dr. Berwick, CMS

ACEP sent a letter to newly appointed CMS administrator Dr. Donald Berwick this week.  The letter outlines emergency physician concerns with several health care reform law implementation issues and highlights specific provisions of the new law that affect the delivery of emergency care.  The letter is as presented here:

 July 19, 2010

Donald M. Berwick, MD, MPP, FRCP 

Administrator Centers for Medicare & Medicaid Services

200 Independence Avenue, SW 

Washington, DC 20201

Dear Dr. Berwick:

On behalf of the American College of Emergency Physicians (ACEP) and our 28,000 members, I want to congratulate you on your appointment as Administrator of the Centers for Medicare & Medicaid Services (CMS). We look forward to working with you and your staff during this critical time that the new health care reform law regulations are being promulgated and we believe your clinical and health care policy experience give you a unique perspective on how these rules may impact the delivery of health care in America.

As an elected member of the Institute of Medicine (IOM), we're sure you are familiar with the 2006 IOM reports on the "Future of Emergency Care in the United States Health System," which detailed the challenges and concerns this nation faces in maintaining access to emergency medical care. As articulated in the IOM reports, America's emergency medical system as a whole is overburdened, underfunded and highly fragmented. As a result, ambulances are diverted from emergency departments once every minute on average and patients in many areas may wait hours, or even days, for hospital beds causing admitted patients to be boarded in the emergency department and redirecting precious emergency care resources away from incoming patients.

Emergency departments in this country handle more than 120 million patient visits per year and utilization of our services continues to steadily increase. As we have learned from observing the evolution of the Massachusetts medical care system, and its near universal coverage, emergency department utilization has actually increased in that state, rather than decreased, as many projected. We believe this is the result of a number of factors, including the federal mandate applied by the Emergency Medical Treatment and Labor Act (EMTALA), the lack of internal medicine physicians and general practitioners in the state, injuries and illnesses that occur after normal physician office business hours, and the fact that emergency departments continue to be the sole source of access to the health care system for many in that state, despite their insurance status. The one true lesson from Massachusetts is that coverage does not equal access.

Frankly, we are concerned that the combination of health care law reforms and the general delay in producing more primary care physicians could potentially overwhelm America's emergency departments, many of which currently operate at or above capacity on a regular basis. In particular, we would like to focus your attention of the followingprovisions of the "Patient Protection and Affordable Care Act" and the "Health Care and Education Reconciliation Act:"

Patient Protections (§10101) - This measure extends the "prudent layperson standard" to group health plans, or issuers of group or individual health plans, which offer hospital emergency department services, as well as eliminates the need for prior authorization and provides parity in coverage and patient co-payments for in- and out-of-network providers. We urge you to consider expanding these important patient protections to grandfathered health plans as well.

Hospital Value-Based Purchasing Program (§3001) – As this program advances, we want to ensure measures that will improve emergency department efficiencies are considered an essential component of this plan.

Improvements to PQRI System (§3002) – Please assure emergency physician measures continue to be available in the PQRI program and that these measures promote integration of clinical reporting using electronic health records, as well as demonstrate both meaningful use of electronic health records and quality of care furnished to the patient.

Value-Based Payment Modifier (Physician Fee Schedule) (§3007) – As CMS develops its own transparent episode grouper software; it must account for the unique delivery aspects of emergency services. In addition, it is critical that future risk-based measures developed by HHS ensure emergency physician measures are applied only to services that are within the control of the physicians.

Medicare Shared Savings Program (§3022) and Payment Bundling (§3023) – We urge you to recognize the important role emergency physicians play in providing the full continuum of care to Medicare beneficiaries. There must be commensurate recognition of these distinctive services as an integral part of any Accountable Care Organization (ACO) and through the coordination of bundled payments for an episode of care.

Distribution of Additional Residency Positions (§5503) – Due to the statutory obligation to provide at least 75% of the redistributed residency positions to primary care or general surgery, it is even more imperative that CMS provide as many of the remaining slots to emergency medicine residency programs. The expected immediate increase in emergency department visits demands that we accelerate the availability of residency-trained emergency physicians in our communities.

National Health Care Workforce Commission (§5101) – The growing disparity between the increasing number of emergency department visits each year and the decreasing number of emergency departments is alarming and of great concern to us and our constituents. We strongly encourage you to highlight the education and training needs of emergency medicine as the commission proceeds.

Patient-Centered Outcomes Research (§6301) – Due to the integral role of emergency physicians in providing all types of care for elderly patients, we ask that the emergency medicine perspective be represented in the identification of research priorities and the establishment and implementation of the research project agenda.

Extension of Medical Malpractice Coverage (§10608) – The law extends Federal Tort Claims Act liability protections to an officer, governing board member, employee or contactor of a free clinic. This is an important recognition of the unique role of those individuals who provide medical services without requiring compensation from the patient. As you know, the federal mandate of the Emergency Medical Treatment and Labor Act (EMTALA) requires emergency department physicians and many on-call specialists to provide similar, and in fact more comprehensive, services as those provided at free clinics with a substantial burden of uncompensated care. We urge you to review the unique requirements on physicians who provide EMTALA- related services and consider how the Federal Tort Claims Act may be applied to ensure the availability of these emergency and on-call physicians.

In addition, we are writing to request your assistance with another matter of significant importance to the coordination and delivery of high-quality medical care in America's emergency departments. Senator Debbie Stabenow (D-MI) has requested a formal response from HHS on her proposal to create a CMS working group that would be responsible for reviewing issues affecting access to emergency care and for developing standards and measures to reduce emergency department boarding and crowding, as well as ambulance diversion. Both of these issues can have dire consequences for patient care and we urge you to develop your response to her request as soon as possible.

Thank you for your consideration of these important issues. As you know, enactment of health care reform was only the first step. We look forward to working with you to ensure the implementation of these laws help our patients receive the best medical care possible, including maintaining access to lifesaving emergency medical services that are so vital to our communities.

Sincerely,

Angela Gardner, MD, FACEP

President