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Confluence:
                                     Health Reform or Not, Changes in
                                     Physician-Hospital Alignment Are Here
                                                                                                                 by Steven A. Eisenberg,
                                                                                                                    Susan Feigin Harris,
                                                                                                                    Emily E. Williams and
                                                                                                                    Susan Whittaker Hughes


       Whether one believes that elements of the           and promoted demonstration projects that            This article outlines the reimbursement trends
       health care industry required reform becomes        pay based upon performance and the term             driving the need to align, discusses the role
       irrelevant when events and environment              “performance” translates directly into quality.     of clinical integration in alignment strategies,
       catapult the industry towards major cultural        For instance, the CMS/Premier Hospital Qual-        and explores three innovative models for phy-
       change. When there is a confluence of events        ity Incentive Demonstration, which provides         sician-hospital alignment. There are nuances
       or circumstances, change is inevitable. The         financial incentives to hospitals demonstrating     to each model and each implicates traditional
       health care industry has experienced a conflu-      high quality in certain areas of acute care, re-    health care legal land mines (tax, fraud and
       ence of events which will arguably catapult the     sulted in hospitals raising their quality indices   abuse, reimbursement and antitrust).
       industry to shift in a way that focuses seriously   by over 17% over four years in certain care
       on creating innovative structures capable of        areas, resulting in bonus payments of almost        I. Reimbursement Trends Driving
       withstanding the new pressures caused by the        $30 million.2                                       Alignment
       confluence of circumstance.                                                                             Without question, healthcare expenses are
                                                           These alternatives are not sought solely in the     growing, and with them, federal healthcare
       Webster’s dictionary defines “confluence” as        public sector. In our own backyard, the Cleve-      program expenditures. The Kaiser Fam-
       “a coming or flowing together, meeting, or          land Clinic and Lowe’s Companies recently           ily Foundation estimates that Medicare alone,
       gathering at one point.”1 What are the events       announced an agreement where Lowe’s full-           currently 3.6% of the United States Gross
       that have caused this change? The Medicare          time employees and their covered dependents         Domestic Product (GDP), will grow to 4.2% of
       program is still projected to go bankrupt,          enrolled in the company’s self-funded medical       GDP by 2018 and to 6.4% of GDP by 2030.5
       especially without any legislation that would       plan may elect to schedule qualifying heart         At the current growth rate, the Medicare Part
       attempt to slow its growth. State budgets           surgery procedures at the Cleveland Clinic          A Hospital Insurance Trust Fund is projected
       continue to be strained or crippled by various      in Cleveland, Ohio at an enhanced benefits          to be insolvent by 2017.6 Simply put, without a
       state Medicaid programs, and states cannot          coverage level.3 In the press release announc-      reduction in costs or other reforms, Medicare
       pass legislation fast enough sufficient to draw     ing the agreement, Bob Ihrie, Lowe’s senior         may not survive another decade.
       down additional matching funds. Whether or          vice president of employee rewards and ser-
       not one advocates for a public option, there        vices, said “We believe that having the correct     This reality is reflected in reimbursement
       is almost universal agreement that fee-for-         diagnosis, combined with surgery by the un-         trends over the past few years, particularly for
       service payment makes little sense in today’s       disputed leaders in this field, will produce the    physicians. Medicare physician reimbursement
       environment, because it promotes quantity,          highest-quality outcomes for our employees.         has increased a mere 0%, 0.5% and 1.1% for
       not quality, health care. Employers are starting    By enabling access to top quality care, it is our   calendar years 2007, 2008 and 2009, respect-
       to demand that the delivery of health care be       hope that employees and their dependents will       fully.7 As small as these increases were, each
       based on quality metrics, not simply cost, be-      have an improved quality of life for many years     was a result of last-minute legislative interven-
       cause they know that keeping their employees        to come.”4 The focus was clearly on quality,        tion, without which the statutorily-calculated
       (and their dependents) healthy will lead to less    with higher quality and better outcomes both        adjustments would have been approximately
       absenteeism and, in turn, higher productivity.      lowering costs and getting employees back to        -5%, -11%, and -5%, respectfully.8 Even graver
                                                           work sooner.                                        is the 2010 Medicare Physician Fee Schedule
       The past several years have produced studies                                                            (MPFS) Final Rule, which calls for a 21% cut

12 |     Cleveland Metropolitan Bar Journal                                  MarCh 2010                                   www.CleMetroBar.org
in physician reimbursement effective Febru-         (FTC) with respect to clinical integration           in an effort to offer a competitive advantage
ary 28, 2010.9 While the national average for       began taking shape in 1999.16 In their State-        over other health plans.20 Pursuant to the
Medicaid physician reimbursement has faired         ments of Antitrust Enforcement Policy in             proposed arrangement, TriState would create
slightly better, with average yearly increases of   Health Care (1996 Statements), the DOJ and           clinical practice guidelines to improve clinical
approximately 2.5% for calendar years 2003          FTC indicated that joint contracting plans for       efficiency as well as a program to monitor the
through 2008, only primary care provider            non-financially integrated networks will pass        physicians’ adherence to those guidelines.21
reimbursement grew at the rate of inflation.10      antitrust muster if: (1) the clinical integration    Physicians would be required to refer their pa-
Even with a slightly higher yearly increase,        is likely to produce significant efficiencies that   tients to other member physicians (though the
average Medicaid fees across the United States      benefit consumers; and (2) any price agree-          patient still had the choice of which physician
remain only 69% of Medicare fees for the same       ments with payors are reasonably necessary           to select) and to grade their peers.22 TriState
services.11                                         to realize those efficiencies.17 Since the 1996      also proposed the implementation of a web-
                                                    Statements, guidelines, reports and speeches         based health information technology system
Hospitals have faired slightly better than          issued by the FTC have both reaffirmed the ac-       that will help identify high-risk and high-cost
physicians in recent years, but that is changing    ceptance of clinical integration and attempted       patients and facilitate the exchange of patients’
as well. For 2010, hospitals are facing a mere      to sharpen the characteristics of a clinical         treatment and medical management informa-
2.1% increase in OPPS payments and a nearly         integration program.                                 tion.23
zero, if not negative, adjustment in IPPS pay-
ments.12 Looking forward, if healthcare reform      The FTC has also approved several specific           The FTC, in part guided by the 1996 State-
legislation were to pass, it will likely result     clinical integration scenarios, the most recent      ments, determined that it would not challenge
in sustained, stagnant reimbursement for            being on behalf of Tri-State Health Partners in      TriState’s proposal due to three principal
hospitals. Both the House’s Affordable Health       2009.18 In its decisions, the FTC has found the      reasons:
Care for America Act of 2009 (H.R. 3962) and        following characteristics to be persuasive hall-
the Senate’s Patient Protection and Affordable      marks of clinical integration: (1) systems and         •   The program had the potential to lower
Care Act (H.R. 3590) call for reductions to the     programs to improve quality and efficiency,                healthcare costs and improve the quality
Medicare market basket updates to inpatient         including (a) clinical guidelines and practice             of care for patients;
hospital reimbursement, as well as cuts to          standards, (b) a web-based clinical-informa-           •   TriState’s collective negotiation of con-
Disproportionate Share Hospital payments.13         tion system, and (c) referral requirements                 tracts with payers, including the prices
Without health care reform legislation, there       and/or guidelines; (2) the network is selective            paid for participating physician services,
will be continued cuts, as outlined by President    in choosing participants, by (a) utilizing a               would be “subordinate and reason-
Obama’s budget. As these trends demonstrate,        participating provider contract and (b) limit-             ably related” to the overall proposal to
physicians and hospitals alike will be facing a     ing participation to fully committed providers             integrate healthcare for its members,
do-more-with-less scenario for the foreseeable      in a variety of specialties; (3) a significant             prompting application of the rule of
future, and one way to save cost is through the     investment of capital by participants, both (a)            reason; and
efficiencies inherent in alignment.                 monetary capital and (b) human capital; (4)            •   There would not be an increase in the
                                                    mechanisms for evaluating performance and                  market power of either TriState or the
II. The Role of Clinical Integration in             facilitating continuous progress, including (a)            physician members as a group because
Alignment Strategies                                the use of performance metrics, (b) identify-              all concerned were still free to contract
Despite the recent increase in physician            ing benchmarks for comparison, (c) using the               individually outside the proposed pro-
employment by hospitals and health systems,         system infrastructure to facilitate evaluation,            gram.24
healthcare remains very fragmented, making          and (d) having a follow-up action plan; (5) a
it difficult to achieve gains from treatment        pricing agreement that furthers the integration      Accordingly, the FTC determined that it would
efficiency, effectively manage care, avoid dupli-   of the network; (6) non-exclusivity, unless it is    not recommend the commencement of any
cation, and focus on quality. To achieve many       so small that an exclusive arrangement would         legal enforcement action against TriState or its
of the goals of health reform, entities that        not be anticompetitive; and (7) steps are taken      providers as long as the proposed plan was fol-
are otherwise competitors must collaborate.         to maintain the confidentiality of participating     lowed and no anti-competitive activities, like
The natural extension of this collaboration is      providers’ pricing information so that partici-      the exercise of market power, arose.
jointly negotiating with commercial payors          pants cannot enter into collateral agreements,
and employers to manage the delivery of             thus preventing “spillover effects” from affect-     Although no bright line test exists, the FTC is
healthcare. Ordinarily, this joint negotiation      ing the market.19                                    clearly comfortable with clinical integration
may be considered price-fixing, which is                                                                 models, which will facilitate new models of
generally a per se unlawful restraint on trade      TriState Health Partners, Inc., a physician-         alignment involving independent physicians,
under the Sherman Act,14 unless the potential       hospital organization located in Hagerstown,         health systems and their employed physicians.
pro-competitive efficiencies of the integrated      MD, sought FTC approval for an arrangement           The challenge for these parties is going the ex-
network outweigh the anticompetitive effects        aimed to: facilitate cooperation and collabora-      tra yard, to ensure that the clinical integration
of the price agreement. Any clinical integra-       tion among its member physicians; create a           is pure and not simply a facade for collabora-
tion model must pass this test, called the “rule    comprehensive program of care management             tion among competitors.25
of reason.”                                         by engaging everyone associated with TriState;
                                                    and offer a previously unavailable integrated        III. Three Innovative Models For Physician-
The position taken by the Department of             set of services desirable to self-insured em-        Hospital Alignment
Justice (DOJ) and Federal Trade Commission          ployers who want to lower healthcare costs           While the DOJ and FTC have become comfort-

           www.CleMetroBar.org                                        MarCh 2010                           Cleveland Metropolitan Bar Journal               | 13
able with clinical integration, both Congress       the groups to perform catherizations at the         A variety of alignment models are emerging
       and the Centers for Medicare and Medicaid           hospital.31 In approving this program, the OIG      to accommodate the integration of payment,
       Services (CMS) have advanced from comfort           cited a number of safeguards designed in the        quality and efficiency. One, which has been
       to active promotion of physician-hospital           program to prevent underutilization and over-       present for some time but whose importance
       alignment. A number of cost savings initia-         utilization and ensuring patient safety.32 Such     has increased, is clinical co-management.
       tives in today’s healthcare reform proposals        safeguards included the following:                  Clinical co-management is a relationship
       are targeted at improving efficiency through                                                            between a hospital or health system and either
       alignment. Following are three such models.           •   The parties agreed to use independent         a physician group or collection of physicians,
       The first two models, gainsharing and co-man-             third party to administrate the program,      that combines the clinical principles of pay-
       agement, have been used in limited form the               including developing the cost savings         for-performance and the market drivers of
       past several years, and its likely the confluence         metrics and measuring cost savings dur-       risk and reward. The hospital or health system
       of events will force their expansion. The final           ing the program;                              is able to use physician expertise to develop
       model, the Accountable Care Organization, is          •   Preferred products would be chosen            better care paths and better outcomes, and
       much more expansive in integration then gain-             first based on safety, then on cost;          physicians are able to become actively engaged
       sharing and co-management (although incor-            •   Quality would be continuously moni-           in managing a service line and receive com-
       porating elements of each). There is significant          tored, with a drop in quality indicators      pensation for their time and goal achievement.
       focus on the creation of the Accountable Care             resulting in termination of gainsharing
       Organization models and a great deal of inter-            payments;                                     There are a variety of legal structures, capital-
       est , as delivery models evolve.                      •   Physician productivity would be               ization models and committee models that can
                                                                 compared to historical data, preventing       be used, and it is really dependent upon the
   A. Gainsharing                                                overutilization;                              service line and the issues that co-management
   Gainsharing involves the payment of incen-                •   Cost savings would be measured on an          model will address. However, in developing a
   tive bonuses typically to physicians or other                 initiative-specific basis, preventing cost-   clinical co-management model, it is essential
   practitioners by hospitals, which payment                     shifting;                                     that the health system and physicians first
   represents a share of the savings incurred                •   Aggregate payments to physicians              focus on the outcomes and behaviors that
   directly as a result of collaborative efforts                 would be capped; and                          are desired, not the compensation that will
   between the hospital and the physician to                 •   The program would be disclosed to all         be paid. The parties need to develop measur-
   improve overall quality and efficiency.26 CMS                 affected patients.33                          able and actionable goals and objectives for a
   views permissible “gainsharing” as methodolo-                                                               service line, along with a committee structure
   gies and arrangements between hospitals and             Similar safeguards were present in the other        wherein both the physicians and hospital are
   physicians designed to govern the utilization           thirteen proposed gainsharing programs, and         actively managing a service line. The reim-
   of inpatient hospital resources and physician           the OIG advised each time that the program          bursement determination will follow, with the
   work to improve the quality and efficiency of           met muster under the CMP, AKS or Stark.34           physician entity being paid a base rate for the
   care provided to beneficiaries and to develop                                                               physician’s involvement. There will also likely
   improved operational and financial hospital             In 2005, Congress and CMS took this permis-         be an at-risk portion of compensation based
   performance with sharing of gains.27 Though             sive view of gainsharing one step further. Pur-     on overall qualitative performance in improv-
   such payments potentially implicate the                 suant to a mandate included in Section 5007 of      ing the service line.
   federal Civil Money Penalties Act (CMP),                the Deficit Reduction Act of 2005 (DRA), CMS
   the Anti-Kickback Statute (AKS) and the                 solicited up to six gainsharing demonstration       The standard caveats related to fraud and
   Physician Self-Referral Statute (Stark), the            projects, each consisting of one hospital.35        abuse and, if applicable, tax-exemption, apply
   Department of Health and Human Resources,               The solicitation asked hospitals to propose         to co-management models. However, the ar-
   Office of Inspector General (OIG) has issued            gainsharing programs CMS could follow and           rangement can be structured to comply with
   at least fourteen Advisory Opinions approving           evaluate to determine if gainsharing “aligns        safe harbors under both the Anti-Kickback
   gainsharing plans since 2001.28                         incentives between hospitals and physicians         Statute and Stark Law. Additionally, the Office
                                                           in order to improve the quality and efficiency      of the Inspector General, in Advisory Opinion
       These approved gainsharing plans largely            of care,” while improving hospital operational      08-16, approved an arrangement whereby a
       focused on standardization of devices, medi-        and financial performance.36 To date, two           hospital sought to share a portion of a quality-
       cations and supplies used for particular proce-     projects have been accepted into the program        based incentive received by a hospital from an
       dures.29 For example, the most recent opinion       – one at Beth Israel Medical Center in New          insurer with a group of physicians.
       outlines a program, involving a hospital, an        York and one at the Charleston Area Medical
       interventional radiology group and a vascular       Center in West Virginia. While the demonstra-       C. Accountable Care Organizations
       surgical group, designed to share the hospital’s    tion project is set to expire on December 31,       As healthcare reform continues to evolve,
       cost savings directly attributable to certain       2009, both H.R. 3962 and H.R. 3590 propose          another innovative alignment model likely
       changes in the groups’ cardiac catherization        to extend it through September 30, 2011.            will emerge: Accountable Care Organizations
       procedures.30 Specifically, these changes in-       Such commitment by Congress suggests that           (ACO). Experts define groups of providers
       volved standardization of the types of cardiac      gainsharing may prove to be an increasingly         (such as combinations of hospitals, physicians,
       catherization devices and supplies (stents, bal-    important cost-savings tool for physicians and      and other health care providers) that are jointly
       loons, interventional guidewires and catheters,     hospitals going forward.                            responsible, through shared penalties or bo-
       vascular closure devices, diagnostic devices,                                                           nuses, for the quality of the health care delivery
       pacemakers and defibrillators) employed by          B. Co-Management                                    for a specific population of beneficiaries, as an

14 |     Cleveland Metropolitan Bar Journal                                 MarCh 2010                                    www.CleMetroBar.org
accountable care organization. As referenced                          ogy systems. While ACOs could be integrated                        alignment to generate substantial cost savings.
more specifically below, Medicare has been                            delivery systems, they can also take advantage                     Through models such as gainsharing, co-man-
one of the proponents of this model and has                           of clinical integration and include independent                    agement and accountable care organizations,
funded demonstration projects, the Medicare                           physicians.                                                        hospitals and physicians may collaborate to
Physician Group Practice Demonstration                                                                                                   provide safe, quality care more efficiently.
to test the pay for performance incentives                            In its June, 2009 report to Congress, the
associated with this model. Results from the                          Medicare Payment Advisory Commission                               Moreover, the failure of Congress to pass
demonstration indicate that the model shows                           dedicated a chapter to the benefits of ACOs.41                     comprehensive health reform legislation will
promise for containing costs while simultane-                         Several prominent organizations, including                         not slow the need or the momentum that has
ously increasing patient outcomes.                                    the Dartmouth Institute for Health Policy and                      begun in the health care industry to move in a
                                                                      Clinical Practice and the Engelberg Center                         direction that more closely integrates care. The
An ACO could include a hospital, physicians,                          for Health Care Reform at Brookings Institu-                       health care industry recognizes that payment
both primary care physicians and specialists,                         tion, are instituting pilot programs to test                       reform and greater potential belt-tightening
and possibly other medical professionals.37                           the ACO concept.42 Additionally, a current                         require innovative thinking and realignment.
Services provided by these physicians would                           proposal suggests that Medicare may tie both                       •
be billed fee-for-service, but the participants in                    bonuses and penalties to and payments as a
the ACO would coordinate their care and have                          result of an ACO meeting or failing to meet
goals related to quality benchmarks.38 Examples                       the benchmarks.43 Congress is receptive to                                         Steven A. Eisenberg is a partner at
of such benchmarks may include low mortal-                            such a program because it would give Medi-                                         Baker Hostetler in the Cleveland
ity rates or reducing hospital readmissions.39                        care substantial leverage over providers to                                        office. He can be reached at seisen-
Members of an ACO would share in any cost                             improve quality. If enacted, H.R. 3962 would                                       berg@bakerlaw.com.
savings or Medicare incentive payments made                           direct Medicare to issue incentive payments to
as a result of meeting its benchmarks, as well as                     qualifying ACOs for meeting what it calls “per-                    Susan Feigin Harris is a partner
any Medicare penalties imposed as a result of                         formance targets.”44 H.R. 3590 also includes an                    in the Baker Hostetler Healthcare
failing to meet its benchmarks.40                                     ACO demonstration project, but it is targeted                      Practice Group in Houston. She
                                                                      to pediatric ACOs.45 Innovative health systems                     can be reached at sharris@baker-
The ACO structure will differ depending                               and physician groups likely will start planning                    law.com.
upon its goals and market and, to truly be                            now for ACOs.
maximized, will likely require changes to                                                                                                                Emily E. Williams is an associate
fraud and abuse laws and potentially more                             IV. Conclusion                                                                     at Baker Hostetler in the Cleveland
concrete antitrust guidelines. However, it will                       As reimbursement trends and increasing costs                                       office. She can be reached at eewil-
involve a single entity that will be owned by                         require physicians and hospitals to do more                                        liams@bakerlaw.com
healthcare providers. The single entity will en-                      with less, investigating alternative alignment
ter into participation agreements with payors                         models may offer a solution to this demand.                        Susan Whittaker Hughes is an
(including, potentially, governmental payors),                        Regulators, Congress and a growing number of                       associate at Baker Hostetler in
and have comprehensive clinical and quality                           physicians and hospitals are looking to the effi-                  the Cleveland Office. She can be
guidelines and robust information technol-                            ciencies inherent in greater hospital-physician                    reached at shughes@bakerlaw.com.


1
  Merriam-Websters Online Dictionary, available at: www.                 Care, DOJ and FTC (Aug. 1999), available at www. justice.       28
                                                                                                                                            See OIG Adv. Op. 01-1 (2001); OIG Adv. Op. 05-02 (2005);
  merriam-webster.com/dictionary/confluence.                             gov/atr/public/guidelines/0000.htm.                                OIG Adv. Op. 05-03 (2005); OIG Adv. Op. 05-04 (2005); OIG
2
  Premier website: http://www.premierinc.com/quality-safety/          17
                                                                         Id.                                                                Adv. Op. 05-05 (2005); OIG Adv. Op. 05-06 (2005); OIG Adv.
  tools-services/p4p/hqi/index.jsp                                    18
                                                                         See, e.g. TriState Health Partners, Inc., FTC Advi-                Op. 06-22 (2006); OIG Adv. Op. 07-21 (2007); OIG Adv. Op.
3
  See Lowe’s Companies press release dated February 16, 2010.            sory Op. (Apr. 13, 2009), available at www.ftc.gov/os/             07-22 (2007); OIG Adv. Op. 08-09 (2008); OIG Adv. Op. 08-
4
  Id.                                                                    closings/staff/090413tristateaoletter.pdf; Greater Rochester       15 (2008); OIG Adv. Op. 08-16 (2008); OIG Adv. Op. 08-21
5
  Medicare Spending and Financing Fact Sheet, Kaiser Family              Independent Practice Association, Inc., FTC Advisory               (2008); and OIG Adv. Op. 09-06 (2009).
  Foundation (May 2009), available at: www.kff.org.                      Op. (Sept. 17, 2007), available at www.ftc.gov/bc/adops/        29
                                                                                                                                            Id.
6
  Id.                                                                    gripa.pdf; MedSouth, Inc., FTC Advisory Op. (June 18, 2007),    30
                                                                                                                                            OIG Adv. Op. 09-06 (2009).
7
  See, 2010 Medicare Physician Fee Schedule Final Rule,                  available at www.ftc.gov/bc/adops/070618medsouth.pdf;           31
                                                                                                                                            Id.
  available at: www.federalregister.gove/OFRUpload/OFR-                  MedSouth, Inc., FTC Advisory Op. (Feb. 19, 2002), available     32
                                                                                                                                            See id.
  Data/2009-26502_PI.pdf; and Conversion Factor, CCH Med-                at www.ftc.gov/bc/adops/medsouth.shtm; Suburban Health          33
                                                                                                                                            See id.
  Guide ¶ 3410 (2009).                                                   Organization, Inc. (Mar. 28, 2006), available at www.ftc.gov/   34
                                                                                                                                            Id.
8
  See id.                                                                os/2006/03/SuburbanHealthOrganizationStaffAdvisoryOpin-         35
                                                                                                                                            See supra note 22.
9
  See id.                                                                ion03282006.pdf.                                                36
                                                                                                                                            Id.
10
   Karen E. Stockley, Aimee F. Williams & Stephen Zuckerman,          19
                                                                         See id.                                                         37
                                                                                                                                            Jane Cys, Accountable Care Organizations: A New Idea for
   Trends in Medicaid Physician Fees, 2003-2008, Health Tracking      20
                                                                         TriState Health Partners, Inc., FTC Advisory Op.                   Managing Medicare, American Medical News (Aug. 31, 2009).
   (April 28, 2009).                                                     (Apr. 13, 2009), available at www.ftc.gov/os/closings/          38
                                                                                                                                            Id.
11
   Id.                                                                   staff/090413tristateaoletter.pdf.                               39
                                                                                                                                            James Arvantes, MedPac Considers Accountable Care Organi-
12
   See, 2010 OPPS Final Rule, available at: www.federalregister.      21
                                                                         Id.                                                                zations as Possible Path to Health Care Reform, AAFP News
   gov/OFRUpload/OFRData/2009_26499_PI; 74 Fed. Reg.                  22
                                                                         Id.                                                                Now (April 20, 2009).
   43,754 (Aug. 27, 2009); and CCH Med-Guide No. 1559 (2009).         23
                                                                         Id.                                                             40
                                                                                                                                            See supra notes 33, 35.
13
   Affordable Health Care for America Act of 2009, H.R. 3962 §§       24
                                                                         Id.                                                             41
                                                                                                                                            See supra note 33.
   1103; 1112 and 1131; and Patient Protection and Affordanble        25
                                                                         Id.                                                             42
                                                                                                                                            Id.
   Care Act, H.R. 3590.                                               26
                                                                         DRA 5007 Medicare Hospital Gainsharing Demonstration            43
                                                                                                                                            See supra note 35.
14
   15 U.S.C. §§ 1, et seq.                                               Solicitation, CMS, available at www.cms.hhs.gov/DemoProj-       44
                                                                                                                                            H.R. 3962 § 1301.
15
   See, FTC v. Indiana Federation of Dentists, 476 U.S. 447 (1986).      ectsEvalRpts/downloads/DRA5007_Solicitation.pdf.                45
                                                                                                                                            See H.R. 3590 § 2706.
16
   See, Statements of Antitrust Enforcement Policy in Health          27
                                                                         Id.


              www.CleMetroBar.org                                                            MarCh 2010                                       Cleveland Metropolitan Bar Journal                     | 15

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Physician Alignment

  • 1. Confluence: Health Reform or Not, Changes in Physician-Hospital Alignment Are Here by Steven A. Eisenberg, Susan Feigin Harris, Emily E. Williams and Susan Whittaker Hughes Whether one believes that elements of the and promoted demonstration projects that This article outlines the reimbursement trends health care industry required reform becomes pay based upon performance and the term driving the need to align, discusses the role irrelevant when events and environment “performance” translates directly into quality. of clinical integration in alignment strategies, catapult the industry towards major cultural For instance, the CMS/Premier Hospital Qual- and explores three innovative models for phy- change. When there is a confluence of events ity Incentive Demonstration, which provides sician-hospital alignment. There are nuances or circumstances, change is inevitable. The financial incentives to hospitals demonstrating to each model and each implicates traditional health care industry has experienced a conflu- high quality in certain areas of acute care, re- health care legal land mines (tax, fraud and ence of events which will arguably catapult the sulted in hospitals raising their quality indices abuse, reimbursement and antitrust). industry to shift in a way that focuses seriously by over 17% over four years in certain care on creating innovative structures capable of areas, resulting in bonus payments of almost I. Reimbursement Trends Driving withstanding the new pressures caused by the $30 million.2 Alignment confluence of circumstance. Without question, healthcare expenses are These alternatives are not sought solely in the growing, and with them, federal healthcare Webster’s dictionary defines “confluence” as public sector. In our own backyard, the Cleve- program expenditures. The Kaiser Fam- “a coming or flowing together, meeting, or land Clinic and Lowe’s Companies recently ily Foundation estimates that Medicare alone, gathering at one point.”1 What are the events announced an agreement where Lowe’s full- currently 3.6% of the United States Gross that have caused this change? The Medicare time employees and their covered dependents Domestic Product (GDP), will grow to 4.2% of program is still projected to go bankrupt, enrolled in the company’s self-funded medical GDP by 2018 and to 6.4% of GDP by 2030.5 especially without any legislation that would plan may elect to schedule qualifying heart At the current growth rate, the Medicare Part attempt to slow its growth. State budgets surgery procedures at the Cleveland Clinic A Hospital Insurance Trust Fund is projected continue to be strained or crippled by various in Cleveland, Ohio at an enhanced benefits to be insolvent by 2017.6 Simply put, without a state Medicaid programs, and states cannot coverage level.3 In the press release announc- reduction in costs or other reforms, Medicare pass legislation fast enough sufficient to draw ing the agreement, Bob Ihrie, Lowe’s senior may not survive another decade. down additional matching funds. Whether or vice president of employee rewards and ser- not one advocates for a public option, there vices, said “We believe that having the correct This reality is reflected in reimbursement is almost universal agreement that fee-for- diagnosis, combined with surgery by the un- trends over the past few years, particularly for service payment makes little sense in today’s disputed leaders in this field, will produce the physicians. Medicare physician reimbursement environment, because it promotes quantity, highest-quality outcomes for our employees. has increased a mere 0%, 0.5% and 1.1% for not quality, health care. Employers are starting By enabling access to top quality care, it is our calendar years 2007, 2008 and 2009, respect- to demand that the delivery of health care be hope that employees and their dependents will fully.7 As small as these increases were, each based on quality metrics, not simply cost, be- have an improved quality of life for many years was a result of last-minute legislative interven- cause they know that keeping their employees to come.”4 The focus was clearly on quality, tion, without which the statutorily-calculated (and their dependents) healthy will lead to less with higher quality and better outcomes both adjustments would have been approximately absenteeism and, in turn, higher productivity. lowering costs and getting employees back to -5%, -11%, and -5%, respectfully.8 Even graver work sooner. is the 2010 Medicare Physician Fee Schedule The past several years have produced studies (MPFS) Final Rule, which calls for a 21% cut 12 | Cleveland Metropolitan Bar Journal MarCh 2010 www.CleMetroBar.org
  • 2. in physician reimbursement effective Febru- (FTC) with respect to clinical integration in an effort to offer a competitive advantage ary 28, 2010.9 While the national average for began taking shape in 1999.16 In their State- over other health plans.20 Pursuant to the Medicaid physician reimbursement has faired ments of Antitrust Enforcement Policy in proposed arrangement, TriState would create slightly better, with average yearly increases of Health Care (1996 Statements), the DOJ and clinical practice guidelines to improve clinical approximately 2.5% for calendar years 2003 FTC indicated that joint contracting plans for efficiency as well as a program to monitor the through 2008, only primary care provider non-financially integrated networks will pass physicians’ adherence to those guidelines.21 reimbursement grew at the rate of inflation.10 antitrust muster if: (1) the clinical integration Physicians would be required to refer their pa- Even with a slightly higher yearly increase, is likely to produce significant efficiencies that tients to other member physicians (though the average Medicaid fees across the United States benefit consumers; and (2) any price agree- patient still had the choice of which physician remain only 69% of Medicare fees for the same ments with payors are reasonably necessary to select) and to grade their peers.22 TriState services.11 to realize those efficiencies.17 Since the 1996 also proposed the implementation of a web- Statements, guidelines, reports and speeches based health information technology system Hospitals have faired slightly better than issued by the FTC have both reaffirmed the ac- that will help identify high-risk and high-cost physicians in recent years, but that is changing ceptance of clinical integration and attempted patients and facilitate the exchange of patients’ as well. For 2010, hospitals are facing a mere to sharpen the characteristics of a clinical treatment and medical management informa- 2.1% increase in OPPS payments and a nearly integration program. tion.23 zero, if not negative, adjustment in IPPS pay- ments.12 Looking forward, if healthcare reform The FTC has also approved several specific The FTC, in part guided by the 1996 State- legislation were to pass, it will likely result clinical integration scenarios, the most recent ments, determined that it would not challenge in sustained, stagnant reimbursement for being on behalf of Tri-State Health Partners in TriState’s proposal due to three principal hospitals. Both the House’s Affordable Health 2009.18 In its decisions, the FTC has found the reasons: Care for America Act of 2009 (H.R. 3962) and following characteristics to be persuasive hall- the Senate’s Patient Protection and Affordable marks of clinical integration: (1) systems and • The program had the potential to lower Care Act (H.R. 3590) call for reductions to the programs to improve quality and efficiency, healthcare costs and improve the quality Medicare market basket updates to inpatient including (a) clinical guidelines and practice of care for patients; hospital reimbursement, as well as cuts to standards, (b) a web-based clinical-informa- • TriState’s collective negotiation of con- Disproportionate Share Hospital payments.13 tion system, and (c) referral requirements tracts with payers, including the prices Without health care reform legislation, there and/or guidelines; (2) the network is selective paid for participating physician services, will be continued cuts, as outlined by President in choosing participants, by (a) utilizing a would be “subordinate and reason- Obama’s budget. As these trends demonstrate, participating provider contract and (b) limit- ably related” to the overall proposal to physicians and hospitals alike will be facing a ing participation to fully committed providers integrate healthcare for its members, do-more-with-less scenario for the foreseeable in a variety of specialties; (3) a significant prompting application of the rule of future, and one way to save cost is through the investment of capital by participants, both (a) reason; and efficiencies inherent in alignment. monetary capital and (b) human capital; (4) • There would not be an increase in the mechanisms for evaluating performance and market power of either TriState or the II. The Role of Clinical Integration in facilitating continuous progress, including (a) physician members as a group because Alignment Strategies the use of performance metrics, (b) identify- all concerned were still free to contract Despite the recent increase in physician ing benchmarks for comparison, (c) using the individually outside the proposed pro- employment by hospitals and health systems, system infrastructure to facilitate evaluation, gram.24 healthcare remains very fragmented, making and (d) having a follow-up action plan; (5) a it difficult to achieve gains from treatment pricing agreement that furthers the integration Accordingly, the FTC determined that it would efficiency, effectively manage care, avoid dupli- of the network; (6) non-exclusivity, unless it is not recommend the commencement of any cation, and focus on quality. To achieve many so small that an exclusive arrangement would legal enforcement action against TriState or its of the goals of health reform, entities that not be anticompetitive; and (7) steps are taken providers as long as the proposed plan was fol- are otherwise competitors must collaborate. to maintain the confidentiality of participating lowed and no anti-competitive activities, like The natural extension of this collaboration is providers’ pricing information so that partici- the exercise of market power, arose. jointly negotiating with commercial payors pants cannot enter into collateral agreements, and employers to manage the delivery of thus preventing “spillover effects” from affect- Although no bright line test exists, the FTC is healthcare. Ordinarily, this joint negotiation ing the market.19 clearly comfortable with clinical integration may be considered price-fixing, which is models, which will facilitate new models of generally a per se unlawful restraint on trade TriState Health Partners, Inc., a physician- alignment involving independent physicians, under the Sherman Act,14 unless the potential hospital organization located in Hagerstown, health systems and their employed physicians. pro-competitive efficiencies of the integrated MD, sought FTC approval for an arrangement The challenge for these parties is going the ex- network outweigh the anticompetitive effects aimed to: facilitate cooperation and collabora- tra yard, to ensure that the clinical integration of the price agreement. Any clinical integra- tion among its member physicians; create a is pure and not simply a facade for collabora- tion model must pass this test, called the “rule comprehensive program of care management tion among competitors.25 of reason.” by engaging everyone associated with TriState; and offer a previously unavailable integrated III. Three Innovative Models For Physician- The position taken by the Department of set of services desirable to self-insured em- Hospital Alignment Justice (DOJ) and Federal Trade Commission ployers who want to lower healthcare costs While the DOJ and FTC have become comfort- www.CleMetroBar.org MarCh 2010 Cleveland Metropolitan Bar Journal | 13
  • 3. able with clinical integration, both Congress the groups to perform catherizations at the A variety of alignment models are emerging and the Centers for Medicare and Medicaid hospital.31 In approving this program, the OIG to accommodate the integration of payment, Services (CMS) have advanced from comfort cited a number of safeguards designed in the quality and efficiency. One, which has been to active promotion of physician-hospital program to prevent underutilization and over- present for some time but whose importance alignment. A number of cost savings initia- utilization and ensuring patient safety.32 Such has increased, is clinical co-management. tives in today’s healthcare reform proposals safeguards included the following: Clinical co-management is a relationship are targeted at improving efficiency through between a hospital or health system and either alignment. Following are three such models. • The parties agreed to use independent a physician group or collection of physicians, The first two models, gainsharing and co-man- third party to administrate the program, that combines the clinical principles of pay- agement, have been used in limited form the including developing the cost savings for-performance and the market drivers of past several years, and its likely the confluence metrics and measuring cost savings dur- risk and reward. The hospital or health system of events will force their expansion. The final ing the program; is able to use physician expertise to develop model, the Accountable Care Organization, is • Preferred products would be chosen better care paths and better outcomes, and much more expansive in integration then gain- first based on safety, then on cost; physicians are able to become actively engaged sharing and co-management (although incor- • Quality would be continuously moni- in managing a service line and receive com- porating elements of each). There is significant tored, with a drop in quality indicators pensation for their time and goal achievement. focus on the creation of the Accountable Care resulting in termination of gainsharing Organization models and a great deal of inter- payments; There are a variety of legal structures, capital- est , as delivery models evolve. • Physician productivity would be ization models and committee models that can compared to historical data, preventing be used, and it is really dependent upon the A. Gainsharing overutilization; service line and the issues that co-management Gainsharing involves the payment of incen- • Cost savings would be measured on an model will address. However, in developing a tive bonuses typically to physicians or other initiative-specific basis, preventing cost- clinical co-management model, it is essential practitioners by hospitals, which payment shifting; that the health system and physicians first represents a share of the savings incurred • Aggregate payments to physicians focus on the outcomes and behaviors that directly as a result of collaborative efforts would be capped; and are desired, not the compensation that will between the hospital and the physician to • The program would be disclosed to all be paid. The parties need to develop measur- improve overall quality and efficiency.26 CMS affected patients.33 able and actionable goals and objectives for a views permissible “gainsharing” as methodolo- service line, along with a committee structure gies and arrangements between hospitals and Similar safeguards were present in the other wherein both the physicians and hospital are physicians designed to govern the utilization thirteen proposed gainsharing programs, and actively managing a service line. The reim- of inpatient hospital resources and physician the OIG advised each time that the program bursement determination will follow, with the work to improve the quality and efficiency of met muster under the CMP, AKS or Stark.34 physician entity being paid a base rate for the care provided to beneficiaries and to develop physician’s involvement. There will also likely improved operational and financial hospital In 2005, Congress and CMS took this permis- be an at-risk portion of compensation based performance with sharing of gains.27 Though sive view of gainsharing one step further. Pur- on overall qualitative performance in improv- such payments potentially implicate the suant to a mandate included in Section 5007 of ing the service line. federal Civil Money Penalties Act (CMP), the Deficit Reduction Act of 2005 (DRA), CMS the Anti-Kickback Statute (AKS) and the solicited up to six gainsharing demonstration The standard caveats related to fraud and Physician Self-Referral Statute (Stark), the projects, each consisting of one hospital.35 abuse and, if applicable, tax-exemption, apply Department of Health and Human Resources, The solicitation asked hospitals to propose to co-management models. However, the ar- Office of Inspector General (OIG) has issued gainsharing programs CMS could follow and rangement can be structured to comply with at least fourteen Advisory Opinions approving evaluate to determine if gainsharing “aligns safe harbors under both the Anti-Kickback gainsharing plans since 2001.28 incentives between hospitals and physicians Statute and Stark Law. Additionally, the Office in order to improve the quality and efficiency of the Inspector General, in Advisory Opinion These approved gainsharing plans largely of care,” while improving hospital operational 08-16, approved an arrangement whereby a focused on standardization of devices, medi- and financial performance.36 To date, two hospital sought to share a portion of a quality- cations and supplies used for particular proce- projects have been accepted into the program based incentive received by a hospital from an dures.29 For example, the most recent opinion – one at Beth Israel Medical Center in New insurer with a group of physicians. outlines a program, involving a hospital, an York and one at the Charleston Area Medical interventional radiology group and a vascular Center in West Virginia. While the demonstra- C. Accountable Care Organizations surgical group, designed to share the hospital’s tion project is set to expire on December 31, As healthcare reform continues to evolve, cost savings directly attributable to certain 2009, both H.R. 3962 and H.R. 3590 propose another innovative alignment model likely changes in the groups’ cardiac catherization to extend it through September 30, 2011. will emerge: Accountable Care Organizations procedures.30 Specifically, these changes in- Such commitment by Congress suggests that (ACO). Experts define groups of providers volved standardization of the types of cardiac gainsharing may prove to be an increasingly (such as combinations of hospitals, physicians, catherization devices and supplies (stents, bal- important cost-savings tool for physicians and and other health care providers) that are jointly loons, interventional guidewires and catheters, hospitals going forward. responsible, through shared penalties or bo- vascular closure devices, diagnostic devices, nuses, for the quality of the health care delivery pacemakers and defibrillators) employed by B. Co-Management for a specific population of beneficiaries, as an 14 | Cleveland Metropolitan Bar Journal MarCh 2010 www.CleMetroBar.org
  • 4. accountable care organization. As referenced ogy systems. While ACOs could be integrated alignment to generate substantial cost savings. more specifically below, Medicare has been delivery systems, they can also take advantage Through models such as gainsharing, co-man- one of the proponents of this model and has of clinical integration and include independent agement and accountable care organizations, funded demonstration projects, the Medicare physicians. hospitals and physicians may collaborate to Physician Group Practice Demonstration provide safe, quality care more efficiently. to test the pay for performance incentives In its June, 2009 report to Congress, the associated with this model. Results from the Medicare Payment Advisory Commission Moreover, the failure of Congress to pass demonstration indicate that the model shows dedicated a chapter to the benefits of ACOs.41 comprehensive health reform legislation will promise for containing costs while simultane- Several prominent organizations, including not slow the need or the momentum that has ously increasing patient outcomes. the Dartmouth Institute for Health Policy and begun in the health care industry to move in a Clinical Practice and the Engelberg Center direction that more closely integrates care. The An ACO could include a hospital, physicians, for Health Care Reform at Brookings Institu- health care industry recognizes that payment both primary care physicians and specialists, tion, are instituting pilot programs to test reform and greater potential belt-tightening and possibly other medical professionals.37 the ACO concept.42 Additionally, a current require innovative thinking and realignment. Services provided by these physicians would proposal suggests that Medicare may tie both • be billed fee-for-service, but the participants in bonuses and penalties to and payments as a the ACO would coordinate their care and have result of an ACO meeting or failing to meet goals related to quality benchmarks.38 Examples the benchmarks.43 Congress is receptive to Steven A. Eisenberg is a partner at of such benchmarks may include low mortal- such a program because it would give Medi- Baker Hostetler in the Cleveland ity rates or reducing hospital readmissions.39 care substantial leverage over providers to office. He can be reached at seisen- Members of an ACO would share in any cost improve quality. If enacted, H.R. 3962 would berg@bakerlaw.com. savings or Medicare incentive payments made direct Medicare to issue incentive payments to as a result of meeting its benchmarks, as well as qualifying ACOs for meeting what it calls “per- Susan Feigin Harris is a partner any Medicare penalties imposed as a result of formance targets.”44 H.R. 3590 also includes an in the Baker Hostetler Healthcare failing to meet its benchmarks.40 ACO demonstration project, but it is targeted Practice Group in Houston. She to pediatric ACOs.45 Innovative health systems can be reached at sharris@baker- The ACO structure will differ depending and physician groups likely will start planning law.com. upon its goals and market and, to truly be now for ACOs. maximized, will likely require changes to Emily E. Williams is an associate fraud and abuse laws and potentially more IV. Conclusion at Baker Hostetler in the Cleveland concrete antitrust guidelines. However, it will As reimbursement trends and increasing costs office. She can be reached at eewil- involve a single entity that will be owned by require physicians and hospitals to do more liams@bakerlaw.com healthcare providers. The single entity will en- with less, investigating alternative alignment ter into participation agreements with payors models may offer a solution to this demand. Susan Whittaker Hughes is an (including, potentially, governmental payors), Regulators, Congress and a growing number of associate at Baker Hostetler in and have comprehensive clinical and quality physicians and hospitals are looking to the effi- the Cleveland Office. She can be guidelines and robust information technol- ciencies inherent in greater hospital-physician reached at shughes@bakerlaw.com. 1 Merriam-Websters Online Dictionary, available at: www. Care, DOJ and FTC (Aug. 1999), available at www. justice. 28 See OIG Adv. Op. 01-1 (2001); OIG Adv. Op. 05-02 (2005); merriam-webster.com/dictionary/confluence. gov/atr/public/guidelines/0000.htm. OIG Adv. Op. 05-03 (2005); OIG Adv. Op. 05-04 (2005); OIG 2 Premier website: http://www.premierinc.com/quality-safety/ 17 Id. Adv. Op. 05-05 (2005); OIG Adv. Op. 05-06 (2005); OIG Adv. tools-services/p4p/hqi/index.jsp 18 See, e.g. TriState Health Partners, Inc., FTC Advi- Op. 06-22 (2006); OIG Adv. Op. 07-21 (2007); OIG Adv. Op. 3 See Lowe’s Companies press release dated February 16, 2010. sory Op. (Apr. 13, 2009), available at www.ftc.gov/os/ 07-22 (2007); OIG Adv. Op. 08-09 (2008); OIG Adv. Op. 08- 4 Id. closings/staff/090413tristateaoletter.pdf; Greater Rochester 15 (2008); OIG Adv. Op. 08-16 (2008); OIG Adv. Op. 08-21 5 Medicare Spending and Financing Fact Sheet, Kaiser Family Independent Practice Association, Inc., FTC Advisory (2008); and OIG Adv. Op. 09-06 (2009). Foundation (May 2009), available at: www.kff.org. Op. (Sept. 17, 2007), available at www.ftc.gov/bc/adops/ 29 Id. 6 Id. gripa.pdf; MedSouth, Inc., FTC Advisory Op. (June 18, 2007), 30 OIG Adv. Op. 09-06 (2009). 7 See, 2010 Medicare Physician Fee Schedule Final Rule, available at www.ftc.gov/bc/adops/070618medsouth.pdf; 31 Id. available at: www.federalregister.gove/OFRUpload/OFR- MedSouth, Inc., FTC Advisory Op. (Feb. 19, 2002), available 32 See id. Data/2009-26502_PI.pdf; and Conversion Factor, CCH Med- at www.ftc.gov/bc/adops/medsouth.shtm; Suburban Health 33 See id. Guide ¶ 3410 (2009). Organization, Inc. (Mar. 28, 2006), available at www.ftc.gov/ 34 Id. 8 See id. os/2006/03/SuburbanHealthOrganizationStaffAdvisoryOpin- 35 See supra note 22. 9 See id. ion03282006.pdf. 36 Id. 10 Karen E. Stockley, Aimee F. Williams & Stephen Zuckerman, 19 See id. 37 Jane Cys, Accountable Care Organizations: A New Idea for Trends in Medicaid Physician Fees, 2003-2008, Health Tracking 20 TriState Health Partners, Inc., FTC Advisory Op. Managing Medicare, American Medical News (Aug. 31, 2009). (April 28, 2009). (Apr. 13, 2009), available at www.ftc.gov/os/closings/ 38 Id. 11 Id. staff/090413tristateaoletter.pdf. 39 James Arvantes, MedPac Considers Accountable Care Organi- 12 See, 2010 OPPS Final Rule, available at: www.federalregister. 21 Id. zations as Possible Path to Health Care Reform, AAFP News gov/OFRUpload/OFRData/2009_26499_PI; 74 Fed. Reg. 22 Id. Now (April 20, 2009). 43,754 (Aug. 27, 2009); and CCH Med-Guide No. 1559 (2009). 23 Id. 40 See supra notes 33, 35. 13 Affordable Health Care for America Act of 2009, H.R. 3962 §§ 24 Id. 41 See supra note 33. 1103; 1112 and 1131; and Patient Protection and Affordanble 25 Id. 42 Id. Care Act, H.R. 3590. 26 DRA 5007 Medicare Hospital Gainsharing Demonstration 43 See supra note 35. 14 15 U.S.C. §§ 1, et seq. Solicitation, CMS, available at www.cms.hhs.gov/DemoProj- 44 H.R. 3962 § 1301. 15 See, FTC v. Indiana Federation of Dentists, 476 U.S. 447 (1986). ectsEvalRpts/downloads/DRA5007_Solicitation.pdf. 45 See H.R. 3590 § 2706. 16 See, Statements of Antitrust Enforcement Policy in Health 27 Id. www.CleMetroBar.org MarCh 2010 Cleveland Metropolitan Bar Journal | 15