Healthcare fundamentals.

SUPPLEMENT ARTICLE

Healthcare Fundamentals Justin Kauk, MD,* Austin D. Hill, MD, MPH,† and Peter L. Althausen, MD, MBA*

Summary: In order for a trauma surgeon to have an intelligent discussion with hospital administrators, healthcare plans, policymakers, or any other physicians, a basic understanding of the fundamentals of healthcare is paramount. It is truly shocking how many surgeons are unable to describe the difference between Medicare and Medicaid or describe how hospitals and physicians get paid. These topics may seem burdensome but they are vital to all business decision making in the healthcare field. The following chapter provides further insight about what we call “the basics” of providing medical care today. Most of the topics presented can be applied to all specialties of medicine. It is broken down into 5 sections. The first section is a brief overview of government programs, their influence on care delivery and reimbursement, and past and future legislation. Section 2 focuses on the compliance, care provision, and privacy statutes that regulate physicians who care for Medicare/Medicaid patient populations. With a better understanding of these obligations, section 3 discusses avenues by which physicians can stay informed of current and pending health policy and provides ways that they can become involved in shaping future legislation. The fourth section changes gears slightly by explaining how the concepts of trade restraint, libel, antitrust legislation, and indemnity relate to physician practice. The fifth, and final, section ties all of components together by describing how physician–hospital alignment can be mutually beneficial in providing patient care under current healthcare policy legislation. Key Words: government programs, legal issues, compliance (J Orthop Trauma 2014;28:S25–S41)

GOVERNMENT PROGRAMS

Medicare and Medicaid are 2 federally financed health insurance programs. It is important to understand which patients qualify for these plans as well as the implications of caring for patients supported by each. Patients covered under these plans are all protected by very strict regulations and failure to be in compliance can have financial and criminal implications. Further, physician reimbursement is linked closely to Medicare rates. This section discusses the difference between Medicare and Medicaid, who oversees these programs, and the role of government-sponsored health plans in hospital and physician bottom lines. It also discusses recent Accepted for publication April 9, 2014. From the *Reno Orthopaedic Clinic, Reno, NV; and †Austin Skeletal Trauma Specialists, Austin, TX. The authors report no conflict of interest. Reprints: Peter L. Althausen, MD, MBA, Reno Orthopaedic Clinic, 555 North Arlington Avenue, Reno, NV 89503-4724 (e-mail: palthausen@ sbcglobal.net). Copyright © 2014 by Lippincott Williams & Wilkins

J Orthop Trauma Volume 28, Number 7 Supplement, July 2014

legislative efforts of the Patient Protection and Affordable Care Act (PPACA) and Accountable Care Organizations (ACOs).

MEDICARE Medicare is a government-sponsored health insurance programs under the umbrella of the Centers for Medicare & Medicaid Services (CMS) operated within the Department of Health and Human Services (HHS).1 For more information, visit the CMS Web site at CMS.gov. Medicare was created in 1965 under the Title XVIII Amendment to 1933 Social Security Act. Medicare is a health insurance program for persons: • $ age 65. • , age 65 with certain disabilities. • All patients with end-stage renal disease (requiring dialysis or a kidney transplant). • Receiving disability payments from Social Security. State and local government employees not covered under Social Security. Medicare has 4 components2: • Part A—Hospital Insurance • Subsidized by payroll taxes • Inpatient care: critical access hospitals, skilled nursing facilities (not custodial or long-term care) • Hospice care • Some home healthcare • Part B—Medical Insurance • Subsidized by monthly premiums paid by patient • Premiums are income dependent • Reimburses providers 80% of the service’s allowable charge (patient is responsible for 20%) • Covers a portion of doctors’ services and outpatient care • Covers some medical services that Part A does not: • Physical, occupational, and speech therapy • Radiation therapy • Diagnostic tests • Home health • Durable medical equipment (DME) • Office administered medications (chemotherapy, hyaluronic acid) • Part C—Medicare+Choice, Medicare Advantage • Created under Balanced Budget Act of 1997 • Subsidizes health maintenance organizations (HMOs) with a predetermined per capita fee by allowing beneficiaries to select managed care providers (eg, Blue Cross Blue Shield may administrate and coordinate care for Medicare patients in some communities) • Part D—Prescription Drug Coverage • Subsidized by: • Monthly premium paid by patient www.jorthotrauma.com |

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• United States Treasury general fund • State governments • Insurance provided by private companies • Beneficiaries choose the drug plan and pay a monthly premium

MEDICARE AND REIMBURSEMENT Medicare initially reimbursed physicians using the customary, prevailing, and reasonable payment system.1 Physicians were incentivized to increase charges which led to increased payments. The Omnibus Budget Reconciliation Act of 1989 established the resource-based relative value unit (RVU) system and began the focus on budget neutral government spending. Today, reimbursement from Medicare is based on RVUs. Most private insurers have also adopted this model. Medicare was also the origin of the 90-day global period. RVU values are determined by physician surveys that ask about the time, malpractice expense, and resources utilized by a specific service. Only 30 survey responses are required to make policy changes, which is why physician participation is crucial. The American Medical Association (AMA) Specialty Relative Value Scale Update Committee (RUC) is responsible for conducting the annual surveys to develop and revise current procedural terminology (CPT) codes. Members of the RUC are appointed by medical specialty societies (eg, American College of Physicians, American Academy of Orthopaedic Surgeons [AAOS]). RVUs are broken down into 3 components: 1. Work RVUs (wRVU) represent 54% of the total RVUs 2. Practice expenses represent 41% 3. 5% covers liability insurance. Each RVU is also multiplied by a geographic practice cost index, accounting for cost of living disparities between regions. While Medicare expenditures have steadily increased, reimbursements from 1992 to 2007 have increased an average of 4%. However, when taking inflation into account, an average decline of 28% has occurred in the most frequently performed orthopaedic procedures. The Omnibus Act of 1989 also mandated that for Medicare Part B, which includes physicians’ fees, expenditures could not exceed $20 million. In practice, if reimbursement is increased for 1 CPT code, it is at the expense of another.

BUNDLED PAYMENTS FOR CARE IMPROVEMENT INITIATIVE In 2013, CMS announced the creation of a new program to incentivize alignment between physicians and hospitals. This is a payment model where hospitals and physicians enter into payment arrangements that include financial and performance accountability for care episodes. In the past, Medicare has made separate payments to providers and hospitals for individual services. Worry was expressed that this system rewards quantity not quality of care. The philosophy of this new initiative is that bundled payments will align incentives of physicians, hospitals, postacute care providers and other practitioners. This creates

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a gain sharing type model which hopefully will prove effective. There are 48 different episodes of care. Episodes pertinent to orthopaedic trauma include fractures of the hip/ pelvis, hip and femur procedures, lower extremity procedures, and removal of orthopaedic devices. The bundled payments for care improvement initiative has 4 models of care.

Model 1: Retrospective Acute Care Hospital Stay Only The episode of care is defined as the inpatient stay in the acute care hospital. Medicare will pay the hospital a discounted amount based on the payment rates established under the Inpatient Prospective Payment System used in the original Medicare program. Medicare will continue to pay physicians separately for their services under the Medicare Physician Fee Schedule. Under certain circumstances, hospitals and physicians will be permitted to share gains arising from the providers’ care redesign efforts.

Model 2: Retrospective Acute Care Hospital Stay plus Post-Acute Care The episode of care will include the inpatient stay in the acute care hospital and all related services during the episode. The episode will end either 30, 60, or 90 days after hospital discharge. Participants can select up to 48 different clinical condition episodes.

Model 3: Retrospective Post-Acute Care Only The episode of care will be triggered by an acute care hospital stay and will begin at initiation of post-acute care services with a participating skilled nursing facility, inpatient rehabilitation facility, long-term care hospital, or home health agency. The post-acute care services included in the episode must begin within 30 days of discharge from the inpatient stay and will end either a minimum of 30, 60, or 90 days after the initiation of the episode. Participants can select up to 48 different clinical condition episodes.

Model 4: Acute Care Hospital Stay Only CMS will make a single, prospectively determined bundled payment to the hospital that would encompass all services furnished during the inpatient stay by the hospital, physicians, and other practitioners. Physicians and other practitioners will submit “no-pay” claims to Medicare and will be paid by the hospital out of the bundled payment. Related readmissions for 30 days after hospital discharge will be included in the bundled payment amount. Participants can select up to 48 different clinical condition episodes.

SUSTAINED GROWTH FORMULA The Balanced Budget Act of 1997 introduced the sustained growth rate (SGR) formula, which set annual budget targets and altered the conversion factor applied to RVUs. The SGR is based on medical inflation, changes in fee-for-service enrollment, gross domestic product inflation, and changes in physician spending secondary to law and regulation. If the spending for a year exceeds that which is 2014 Lippincott Williams & Wilkins


budgeted, the following year’s reimbursement conversion factor is reduced (volume control mechanism) to make up the deficit. Four major flaws are present in the SGR formula: • The cost of providing services is not linked to payment • The volume control mechanism targets national goals without incentivizing individual physicians • Regional variations in volume are not considered • All volume increases are treated the same (whether beneficial or detrimental). Changes in the SGR only affect physician service reimbursement by Medicare. Thus, nonsurgeons, who receive reimbursement weighted heavily on evaluation and management (E&M) codes, are vested in targeting overvalued surgical procedures so that E&M codes could be more heavily weighted. From 2007 to 2015, the flawed SGR formula is scheduled to cut reimbursements by 37%; however, decreases have been consistently, but only temporarily, halted by Congress. Specialists, such as orthopaedists, are also being singled out as targets for larger cuts than primary care physicians. Pay-for-performance is the most recent iteration of Medicare reform. Basically, it reimburses physicians who provide and demonstrate high quality but economical care. Unfortunately, the outcome performance measures have not always been represented by evidenced-based medicine. In recent years, the AAOS has been actively involved in establishing guidelines to ensure the outcomes being monitored are created by orthopaedic surgeons and are “relevant, evidence-based, valid, practicable, not overly burdensome, pilot-tested, phased-in, and risk adjusted.3–5”

Medicaid Medicaid is the U.S. health program developed for low income individuals.6 It is an entitlement program created by the federal government but managed by individual states. • Legislated by the Affordable Care Act • State managed (but funded by state and federal government) • Requirements: • Individuals , age 65 • January 2014 requirements • Individuals with income below 133% of the federal poverty level (about $15,000) • Low-income adults without children guaranteed coverage in every state • Parents of children eligible at a uniform income level across all states In 2010, approximately 66 million individuals received medicaid coverage, for a total $383 billion. About 68% of this financial burden was born by the federal government with individual states making up the difference. See the Medicaid Web site (http://www.medicaid.gov/ Medicaid-CHIP-Program-Information/By-State/By-State. html) for state-by-state information. These individuals include 11 million nonelderly, lowincome parents, other caretaker relatives, pregnant women, and other nondisabled adults; 8.8 million nonelderly individuals with disabilities (3.7 million of which are also covered under Medicare); and 4.6 million low-income seniors also 2014 Lippincott Williams & Wilkins

Healthcare Fundamentals

received Medicaid assistance (in addition to Medicare). See the Medicaid Web site (http://www.medicaid.gov/MedicaidCHIP-Program-Information/By-Population/By-Population. html) for information per each population segment.

CHILDREN’S HEALTH INSURANCE PROGRAM This is a program administered by HHS to provide health insurance to families with children. It was designed to assist children of families unable to qualify for Medicaid.7–9 • Enacted in 1997. • State administered but funded by state and federal dollars. • Children’s Health Insurance Program (CHIP) is a capped program and each state is provided an annual CHIP allotment. • States can operate CHIP as a program separate from Medicaid, as an expansion of the Medicaid program, or as a combination. • Provides coverage to over 31 million children including half of all low-income children • Covers almost 8 million children in families with incomes too high to qualify for Medicaid, but who can’t afford private coverage.

HOSPITAL REIMBURSEMENT In training, physicians get little exposure, and often have little interest, in how hospitals get paid.10 Hospital reimbursement is dependent on several factors and the payer source plays a large role.

Medicare and Diagnostically Related Cases In 1983, Medicare established diagnostically related cases (DRGs) to compensate hospitals for care. These DRGs are updated annually and adjusted by the federal government, with the advice of Congress’ Medicare Payment Advisory Commission. Medicare pays hospitals a flat fee based on a patient’s diagnosis. For example, when a patient is admitted following a hip fracture, Medicare has a set fee schedule for all hip fractures and the hospital must accept that payment for the entire care of that patient (including prolonged length of stays, complications). The complexity of the patient’s medical history, based on the diagnostic efforts of the physician, is the significant modifier of fee schedules.

Medicaid Hospitals receive Medicaid reimbursement in 3 ways: 1. Case-based payments (DRGs) 2. Set amount of dollars per day of inpatient stay (per-diem payments) 3. Fees for individual services and supplies (fee-for-service or FFS payments); state governments set Medicaid pay schedules which are typically much lower than the cost of providing the services

Private Insurers Hospitals receive nongovernment subsidized reimbursement in 3 ways: www.jorthotrauma.com |

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1. Per-diems; negotiated annually between each hospital and each insurance carrier 2. Fee-for-service schedules 3. Other arrangements • Auto insurance • Workers’ compensation Typically, private insurer payments exceed hospital costs and subsidize the losses hospitals take on Medicare and Medicaid patients. These patients are billed the same charges as other private patients, but often only part of the bill is collected. Medicare reimbursement can range among institutions based on the charge schedule, but in some institutions it may only be 60% of cost. Medicaid pays even less. However, hospitals may have negotiated with private insurers to be reimbursed 130% of their charges to help account for this difference. (These numbers vary and are only provided as a reference. Individual hospitals set rates for what they will charge for a good or service.) In the past, the uninsured have been charged the highest prices, but more recently, hospitals have begun to offer discounted charges. Hospital-based clinics, lab and testing services, and radiology services can charge, and be paid more, than outside the hospital (eg, independent imaging center, physician’s office) as they have higher costs in overhead related to these services. However, this added expense often becomes the burden of the insured and not the insurer. In fact, in 2010, Medicare cut reimbursement rates for nonhospital-based cardiology services by 11% by 2014 (and the American College of Cardiology estimates the cuts to be closer to 10%–40%). These cuts drove many cardiologists to align themselves with hospitals (including becoming employees of the hospitals) with the goal of maintaining their prior level of reimbursement and standard of living.11

WHY ARE THESE REIMBURSEMENT CHANGES TO CARDIOLOGY IMPORTANT? Orthopaedists are also a group of subspecialists who also commonly offer outpatient services such as x-rays, magnetic resonance imaging, and DME and future cuts may affect orthopaedic surgeon reimbursement. Arthroscopists have already seen Medicare reimbursement adjustments and bundling of procedures. Medicare continues to refine the rules surrounding, and require specific language to obtain, full reimbursement. For example, while CMS espouses that it is not trying to dictate care delivery, it has assigned certain CPT codes as inpatient values while others fulfill outpatient criteria. If the improper admission status is assigned to an outpatient CPT code, Medicare will refuse full reimbursement for that episode without appeal. CMS continues to devise policies attempting to make Medicare budget neutral, and even financially rewards whistleblowers for discovering mistakes while financially penalizing physicians and hospitals. Such tactics support physician education of current policy.

ACCOUNTABLE CARE ORGANIZATIONS The concept of ACOs came to fruition under the PPACA.12,13 These are “fully integrated, continuum

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healthcare delivery models that provide for complete and coordinated patient care, including hospitalization and specialty services, with the goal of improving quality and health outcomes at a lower cost.” ACOs are mandated by PPACA of 2010 under Title XVIII of the Social Security Act (42 USC §1395 et seq.) Under this mandate, HHS was mandated to establish a shared savings program that promotes accountability for a defined patient population, coordinates items and services under Medicare Parts A and B, and encourages investments in infrastructure and redesigned care processes for high quality and efficient service delivery by January 1, 2012. The underlying goal is to contain healthcare costs to return solvency to the Medicare program. The downstream effect is that private insurers will be forced to offer lower cost policies, leading to lower reimbursement rates for hospitals and physicians. The consequence is that healthcare organizations and providers will need to provide more efficient and higher quality care. ACOs are dependent on primary care providers (PCPs) as coordinators of care, but these entities will also include specialists, hospitals, and ancillary services. All of these participants will be held responsible for the outcomes. Legal, administrative, and clinical structures and systems will promote evidence-based coordinated clinical practice and the development and implementation of quality and cost measures. ACOs are required to gather data, integrate it, and publicly report quality and cost outcomes. ACOs are differentiated from HMOs by the following characteristics: • Link quality and patient experience to financial rewards when providers meet quality and cost containment benchmarks. • ACO is accountable for meeting quality and cost containment targets. • Providers are incentivized ased on patient satisfaction and health. • Owned and operated by physicians and hospitals. • Provider-centric, recognizing and rewarding efficiency in the delivery of quality care. • Innovative providers can be rewarded for cost reduction for care delivery during episode treatment groups (ETGs) and/or uncomplicated treatment through referral patterns, data flow, and coordinated care team structures. ACOs must: • Provide care across a continuum of settings, including atminimum, ambulatory and inpatient settings, for a minimum of 5000 Medicare beneficiaries for at least 3 years. • PCPs would coordinate care. • Patients would have access to specialists who may or not be part of the ACO. • Have the capability to plan budgets and dedicate resources to participate in shared savings. • ACOs must have the structure to appropriately accept and distribute the shared savings component of income. • Shared savings, divided between CMS and the ACO, occur when the care costs are below established 2014 Lippincott Williams & Wilkins


benchmarks (based on historic healthcare spending for the population being managed). • Be of sufficient size to monitor and report on quality measurements. • Quality of care provided to the patient. • Defined by subjective, patient-centered criteria (eg, overall hospital experience and ability to return to work or sports). • Most current orthopaedic metrics employed by hospitals and payers are more objective and physiciandefined definitions (fracture alignment, joint range of motion, blood loss). • Reporting on metrics involving the system’s efficiency and effectiveness, including care transitions and readmissions. As mentioned, the incentives for cost savings as well as referrals within ACOs do risk scrutiny under antitrust, Stark, anti-kickback, and civil money penalties laws. As such, in considering participation in ACOs, one should seek legal counsel to avoid criminal or civil penalties. An ACO is not mandated to include all specialists, but it must still manage the cost and quality of providing specialty care. An orthopaedist’s practice may be affected by ACOs in the following ways: • Requirement of joining a multispecialty group to continue caring for patients within an ACO • Referral patterns may change as “preferred” specialists are identified • Improved communication between PCP and specialist to prevent duplication of services • Specialists not included in ACOs will likely not share in cost savings Other opportunities for orthopaedic surgeon alignment with ACOs include: • Participation in payment reform • Establish quality measures to ensure they are clinically relevant • Develop registries • Improve effectiveness and value of orthopaedic care • PCP education on appropriate referrals and conservative management • Evidence-based care • Contracting • Negotiate rates commensurate with current PPO/HMO reimbursement rates • Specify exclusions for services or procedures that risk greater declines in reimbursement under the ACO model (high risk procedures) • Focus on medical technology investments, efficiencies achieved through coordinated care, and frequent use of the office for minor surgical procedures • Development of a “super-multispecialty” group

HOSPITAL CONSUMER ASSESSMENT OF HEALTHCARE PROVIDERS AND SYSTEMS (HCAHPS)

HCAHPS (pronounced H-CAPS) is the “first national, standardized and publicly reported survey developed by CMS that queries patients about all aspects of their hospital care.14” 2014 Lippincott Williams & Wilkins


The survey was created in 2002, came into use in 2006, and results were first publicly reported in 2008. Under the Deficit Reduction Act of 2005 and starting in 2007, hospitals began receiving incentives to participate in HCAHPS surveys to receive full reimbursement under the Inpatient Prospective Payment System. Critical access hospitals were allowed to participate voluntarily. For other institutions, failure to participate can decrease hospital payments by up to 2%. The PPACA mandates that starting in October 2012, HCAHPS can be employed to determine value-based incentive payments in the Hospital Value-Based Purchasing Program (HVBP). The stated goals of the survey are: • Produce data about patients’ perspectives of care that allow objective and meaningful comparisons of hospitals on topics important to consumers. • Public reporting creates new incentives for hospitals to improve care quality. • Public reporting enhances accountability in healthcare by increasing transparency of the quality of hospital care provided in return for the public investment. Survey characteristics include: • Surveys random adult patients within 48 hours to 6 weeks post discharge • Administered by mail or telephone • Patients must be surveyed every month • Composed of 27 questions (expanded to 32 in July 2012) with 18 core focuses: • Communication with nurses and doctors • Responsiveness of hospital staff • Cleanliness and quietness of hospital environment • Pain management • Communication about medications, discharge information, self-responsibility for health maintenance • Assessing preferences about patients’ post discharge needs • Patients’ self-ratings of mental/emotional health • Overall rating of the hospital • Patient’s willingness to recommend hospital to others • Contains questions to help adjust for differences in a hospital’s patient population • Available in English, Spanish, Chinese, Russian, and Vietnamese The survey and its protocols are available on the official HCAHPS Web site (www.hcahpsonline.org).

HOSPITAL VALUE-BASED PURCHASING PROGRAM The HVBP is a program began in 2013.15 Per the CMS Web site, this program strives to promote quality care by “realigning hospital financial incentives.” In more direct language, hospitals can expect that they will receive full reimbursement for good care and be penalized by a 1% decrease in DRG reimbursement for care falling below benchmarks. Seventy percent of hospital scores will be based on clinical processes and 30% based on patient experiences. This will impact physician reimbursement as CMS considers lump sum (capitated) payments to hospitals for patient care. The hospital and physician must divide this amount between each other. www.jorthotrauma.com |

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As costs of care increase and payments decrease, physician reimbursement will decrease as a result. Additionally, private insurance carriers are likely to adopt similar surveys and base physician payments and insurance contract negotiations on results. While the above refers only to hospital reimbursements, starting in 2015, the PPACA mandates that physician Medicare fee schedules will be dependent on quality and resource utilization results. It is important to note that all of these initiatives relate only to hospitals and physicians who care for government subsidized patients and not privately insured patients. However, private insurers frequently adopt Medicare/Medicaid policy and reimbursement practices as their own, so one can expect these programs to affect reimbursement for all patient populations.

COMPLIANCE The practice of medicine has become more than just the scientific and practical knowledge required to actually treat the disease. With increasing frequency, physicians must also be aware of government regulations that not only affect how they provide care, but how they may be penalized if not followed. Physicians can be held accountable to these laws even if the act committed was not intentional. This section educates fellows on how to avoid Medicare and Medicaid fraud and abuse, and obligations under the Health Insurance Portability and Accountability Act (HIPAA) and Emergency Medical Treatment and Labor Act (EMTALA). Upon completion of this section, the fellow should be familiar with the following objectives. 1. In the context of this chapter, compliance refers to the federal laws that govern all physicians who care for patients enrolled in either Medicare or Medicaid. These regulations all serve the patients’ best interests by holding physicians accountable for fraud and abuse, provision of emergency care, and protection of patient confidentiality. 2. The information in the section was adapted from HHS’s Office of the Inspector General (OIG) handbook: A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse. It is available through the OIG’s Web site.16 3. Currently, the HHS OIG oversees the enforcement of the 5 most important fraud and abuse laws that apply to physicians. Each statute is listed here with a description and an example of misconduct.

FALSE CLAIMS ACT Civil [31 U.S.C. § 3729-3733]; Criminal [18 U.S.C. § 287] The U.S. government is protected under the False Claims Act (FCA) from being overcharged or sold inferior goods and services. Violations of the FCA can have both civil and criminal offenses. Civil offenses carry monetary penalties for violations, whereas criminal offenses can lead to criminal fines and prison time. In a healthcare setting, the FCA states that it is “illegal to submit claims for payment to Medicare or Medicaid that you know are should know are false or fraudulent.” The act does not distinguish between intentional and accidental violations. “Actual knowledge . . . as well as . . . instances of . . . deliberate ignorance or reckless disregard of the truth or falsity of the information” are

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included. Further, each instance of a violation counts as a separate act. Example: If a physician sees a new patient in clinic and codes them as an E&M level 4, but documentation only supports a level 3 charge, a violation of the FCA has occurred. If this same patient is billed for 2 knee immobilizers, when they received only 1, a second violation has occurred. As such, the physician can be penalized for 2 acts of impropriety. Violators of the FCA may also be held liable under the anti-kickback statute (AKS) and the Stark law. It is also important for physicians to know that the civil FCA created a “whistleblower provision that allows a private individual to file a lawsuit on behalf of the United States and entitles that whistleblower to a percentage of any recoveries.” Whistleblowers can be anyone including “current or ex-business partners, hospital or office staff, or competitors.”

ANTI-KICKBACK STATUTE [42 U.S.C. § 1320a-7b(b)] The AKS is a law that makes it a criminal offense for physicians to “knowingly and willingly give or receive inducements or rewards for patient referrals or the generation of business involving any item or service payable by the federal healthcare programs (eg, pharmaceuticals, supplies, services).” Inducements do not solely consist of money, but represent “anything of value (eg, free rent, vacations, meals, excessive compensation for medical directorships or consultancies).” Unlike the FCA, intent is a key element of liability. Penalties include fines, imprisonment, and exclusion from federal healthcare programs. Violations of the AKS may also be subject to the Civil Monetary Penalties Law (CMPL). Example 1: If an orthopaedist travels around to every PCP and offers them $1000/mo if all patients with orthopaedic issues are referred to their orthopaedic practice, that orthopaedist is in violation of the AKS (as is the PCP if the money is accepted). Example 2: If the ABC medical device company representative pays an orthopaedist an extra $500 for every ABC branded total hip prosthesis that is implanted, the AKS has been violated. Patients are not excluded from the AKS. Example 3: An orthopaedist that routinely waives Medicare/Medicaid copays is in violation of the AKS. Under the AKS, several safe harbors exist to protect “certain payment and business practices that could otherwise subject individuals to criminal and civil prosecution.” (Some safe harbors address personal services and rental agreements, investments in outpatient surgery centers, and payments to bona fide employees. However, these arrangements must meet all of the safe harbor requirements). For additional information on safe harbors, see “OIG’s Safe Harbor Regulations,” available at http://oig.hhs.gov/ fraud/safeharborregulations.asp.17

BENEFICIARY INDUCEMENT STATUE [42 U.S.C. § 1320a-7a(a)(5)] This is a law that imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. 2014 Lippincott Williams & Wilkins


Example: An orthopaedist routinely offers discounts on office visits to Medicare and Medicaid patients, but does not make these discounts available to patients with private insurance.

PHYSICIAN SELF-REFERRAL LAW (STARK LAW) [42 U.S.C. § 1395nn] The physician self-referral (Stark) law “prohibits physicians from referring patients to received “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship (with some exceptions)....It is a strict liability statute.18 Intent to violate the law is not required. It also prohibits the submission, or causing the submission, of claims in violation with the law’s restrictions on referrals. Penalties are monetary fines and exclusion from participation in the federal healthcare programs.” Financial relationships include: • Ownership and investment interests • Compensation arrangements. Designated health services include: • Clinical laboratory services • Physical therapy, occupational therapy, outpatient speech therapy • Radiology and certain other imaging services • Radiation therapy services and supplies • DME and supplies • Parenteral and enteral nutrients and supplies • Prosthetics, orthotics, and prosthetic devices, and supplies • Home health services • Outpatient prescription drugs • Inpatient and outpatient hospital services Example: Orthopaedists whose practices own physical therapy/magnetic resonance imaging services or DME must inform patients of financial benefit from utilization of these services as well as inform patients of their right to select where they would like to go for these services and supplies.

EXCLUSION STATUTE [42 U.S.C § 1320a-7] The exclusion statute legally requires the OIG to exclude individuals or entities convicted of the following offenses from federal healthcare program participation: • Medicare or Medicaid fraud • Patient abuse or neglect • Felony healthcare related fraud, theft, financial misconduct • Felony for unlawful manufacture distribution, prescription, or dispensing of controlled substances The OIG has the discretion to exclude individuals or entities with: • Misdemeanor convictions related to healthcare fraud outside of Medicare or Medicaid • Misdemeanor convictions for unlawful manufacture distribution, prescription, or dispensing of controlled • Suspension, revocation, or surrender of a license to provide healthcare for reasons related to: • Professional competence 2014 Lippincott Williams & Wilkins


• Professional performance • Financial integrity • Provision of unnecessary or substandard services • Submission of false or fraudulent claims to a federal healthcare program • Participation in unlawful kickback arrangements • Defaulting on health education loan or scholarship obligations Exclusion from federal healthcare programs means that providers will not receive reimbursement for items or services that are furnished, ordered, or prescribed to Medicare, Medicaid, TRICARE, and Veterans Health Administration (VHA) patients. Providers cannot bill directly (or indirectly through an employer or group practice) for care provided to these groups of patients. If services are provided to a patient on a private-pay basis, that patient cannot receive reimbursement for those goods or services from Medicare. Further, those who employ or contract with excluded individuals or entities, and payment is received from a federal healthcare program for that individual’s or entity’s services, may be subject to a civil monetary penalty.

CIVIL MONETARY PENALTIES LAW OIG may seek civil monetary penalties and exclusion of providers for misconduct. Penalties range from $10,000 to $50,000 per violation. Examples: • Presenting a false or fraudulent claim • Presenting a claim for an item/service for which payment may not be paid • Violating the AKS • Violating Medicare assignment provisions • Violating Medicare physician agreements • Providing false or misleading information expected to influence a decision to discharge a patient • Failing to provide an adequate medical screening examination for patients who present to a hospital emergency department (ED) with an emergency medical condition or are in labor (EMTALA violation) • Making false statements or misrepresentations on applications or contracts to participate in federal healthcare programs

PHYSICIAN–PAYER RELATIONSHIPS Our current healthcare system is composed of 3 parties. The first party is the patient, the second the provider, and the third party is composed of commercial insurers and state and federal governments. The financing of healthcare is dependent on third party payers. Federal fraud and abuse laws apply when the third party payer is the federal government (ie, Medicare, Medicaid, TRICARE, VHA). However, many states have enacted like legislation to protect state-sponsored health plans as well as private-pay patients.

CODING When a bill is submitted for a Medicare or Medicaid patient (beneficiary), the physician certifies that the services www.jorthotrauma.com |

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have been provided and the payment requested has been earned. Physicians can be held liable for false claims even if the error in the claim was unintentional. The provider “should have known” it was incorrect. Several examples of false claims are listed here. • Upcoding: use of a billing code that reflects a more severe illness than actually existed or a more expensive treatment than was provided (eg, coding a follow-up visit as a new patient visit; applying modifier 25 when the patient care rendered was not significant, not separately identifiable and not above and beyond the care usually associated with the procedure). • Billing for services that the physician did not actually render (eg, billing the full CPT code for a surgery and global follow-up care and not including the surgery-only modifier when the surgeon knows they will not be providing the follow-up care; or an emergency physician billing the global CPT code for closed treatment of a fracture but refers the patient to see an orthopaedist for follow-up care). • Billing for services that were not medically necessary. • Billing for services that were performed by an improperly supervised or unqualified employee (eg, those done by a resident, physician extender, or medical assistant). • Billing for services that were performed by an employee who has been excluded from federal healthcare program participation. • Billing for low quality (worthless) services. • Billing separately for services already included in a global fee (eg, billing for an E&M service on postop day 1).

DOCUMENTATION Good documentation ensures accurate and quality care and facilitates communication among providers. Additionally, all claims submitted for payment must be supported by sufficient documentation. If it wasn’t documented, it didn’t happen and the physician won’t be reimbursed for it.

DRUG ENFORCEMENT AGENCY/NATIONAL PROVIDER IDENTIFIER NUMBERS Physicians should only dispense prescription medication lawfully. A physician is responsible for the validity of any claim submitted under that physician’s National Provider Identifier number or prescription dispensed under their Drug Enforcement Agency number.

ASSIGNMENT ISSUES IN MEDICARE REIMBURSEMENT Most physicians bill Medicare as participating providers, which is referred to as “accepting assignment.” Medicare establishes an annual fee schedule that dictates the amount of reimbursement (based on multipliers of RVUs) for each physician service. Medicare beneficiaries are responsible for, and directly billed, 20% of the cost and the government is billed for the remaining 80%. When physicians accept assignment and agree to take care of Medicare patients, they agree to not collect more from the patient than the copayment

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or deductible required by Medicare. Physicians will accept the copay and Medicare’s reimbursement as the full payment for the physician’s services and will not seek any extra payment from the patient. Non-Medicare participating providers can bill the patient for the entire amount and the patient seeks reimbursement from Medicare. Nonparticipating providers are required to limit the amount of their charges to Medicare patients, which cannot exceed 15% of the Medicare fee schedule amount. Excluded providers may not receive Medicare payment either as participating or nonparticipating providers. If a physician has a boutique, concierge, or retainer practice, the physician may not double bill a patient for services already covered under Medicare. For example, an orthopaedist may not collect money (outside that required by a copayment or deductible) from a Medicare patient for visits during the global period. However, it is legal to charge for services uncovered by Medicare.

PHYSICIAN–FELLOW PROVIDER RELATIONSHIPS Fellow providers include, but are not limited to, other physicians, hospitals, nursing homes, laboratories, imaging centers, and DME suppliers. It is illegal for physicians to receive inducements in exchange for patient referrals.

Physician Investments in Healthcare Ventures Orthopaedists may have the opportunity to invest in imaging centers, ambulatory surgery centers, physical therapy, or DME. However, if a physician disproportionately steers patients toward these investments, they can be charged with violating AKS and Stark Law.

Physician Recruitment Recruitment incentives by hospitals can be violations of the AKS or Stark Law if they do not fit very specific criteria. The rationale behind the violation is that, by offering the physician an incentive, the physician may disproportionately refer patients to that institution. Such violations are particularly more likely in large communities with multiple institutions. However, in underserved areas, or under very specific conditions, hospitals may: • Provide relocation assistance • Provide practice support • Pay a fair market value salary as an employee • Pay a fair market value stipend for services rendered as an independent contractor. Hospitals may not do the following with the intent to influence referral patterns (incomplete list): • Offer money • Provide free or below-market rent for medical offices • Offer other benefits

Medical Directorships Physicians may accept the role of medical director (eg, Medical Director of Orthopaedic Trauma, Medical Director of Adult Reconstruction Service); however, directorship salaries 2014 Lippincott Williams & Wilkins


must be paid at fair-market value for demonstrated work done. If these criteria are not met, physicians may be violation of the AKS, FCA, and Stark Law. Broad goals of the medical director should include: • Active oversight of clinical care • Meet and exceed the standard of care • Ensure proper training, education, and oversight of physicians, nurses, and staff members • Identify and address quality problems

PHYSICIAN/VENDOR/INDUSTRY RELATIONSHIPS AND CONFLICTS OF INTEREST Orthopaedists interact with both pharmaceutical and implant vendors. Although surgeon interaction with pharmaceutical representatives is limited in comparison to implant representatives, it is important to know that it is illegal for physicians to sell, or bill Medicare for, free samples given to patients. Recently, the U.S. Department of Justice (DOJ) has been scrutinizing surgeon–vendor relationships. Spine and adult reconstruction surgeons have been the 2 orthopaedic subspecialists targeted the most. Financial relationships between industry and physicians typically take 1 of 2 forms: consulting agreements or other gifts/arrangements/inducements intended to increase surgeon use of that specific company’s implant. These relationships have shown to lead to increased used of those devices due to the financial reward, not necessarily because it is the best treatment. Orthopaedists must thoroughly evaluate consultation opportunities to ensure that misconduct is avoided. Physicians who have contractual or financial ties to a company or product should disclose these relationships to their patients, their colleagues, and during lectures or in research presentations. Under the PPACA of 2010, the DOJ and OIG also mandate transparency in these relationships and require drug, device, and biologic implant companies to publicly report nearly all gifts or payments made to physicians beginning in 2013. AAOS mandates this disclosure for all speakers and presenters. Individuals can declare their industry, or other potentially biasing ties, by going to the following Web site: http://www7.aaos.org/ education/disclosure/verifyUser.19 Many academic institutions also have restrictions on physician–vendor relationships and physicians should familiarize themselves with these policies. The OIG also provides guidelines for ethical and legitimate industry relationships. These guidelines may be reviewed by visiting the following Web site: http://oig.hhs.gov/compliance/compliance-guidance/index.asp.20 Additionally, the Pharmaceutical Research and Manufacturers of America (PhRMA, phrma.org) and the Advanced Medical Technology Association (AdvaMed, advamed.org), the industry societies for pharmaceuticals and medical devices, respectively, have also adopted codes of ethics for healthcare professional interactions. These position statements are available online through each organization’s Web site.

Continuing Medical Education Continuing Medical Education (CME) requirements may vary state to state but, in order to maintain licensure 2014 Lippincott Williams & Wilkins


and board certification, physicians must complete an annual or biennial number of credits. These credits can be offered by professional societies or be sponsored by drug and device manufacturers. Physicians must always be wary that CME offered by industry sponsors may be promotional in nature. If an industry-sponsored speaker describes off-label uses of drugs or medical devices, it is illegal for industry representatives to promote uses not approved by the U.S. Federal Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act.

COMPONENTS OF A PHYSICIAN COMPLIANCE PROGRAM Under the PPACA, physicians who care for federally funded patients will be required to establish a compliance program. Compliance measures help prevent fraudulent activities and the submission of false or inaccurate claims. A comprehensive compliance program will enable the physician to: 1. Conduct internal monitoring and auditing. 2. Implement compliance and practice standards. 3. Designate a compliance officer or contact. 4. Conduct appropriate training and education. 5. Respond appropriately to detected offenses and develop corrective action. 6. Develop open lines of communication with employees. 7. Enforce disciplinary standards through well-publicized guidelines. The OIG Web site has also published the “Compliance Program Guidelines for Individual and Small Group Physician Practices”.21 This document is available at: http://oig. hhs.gov/authorities/docs/physician.pdf.

OIG Self-disclosure Protocol This protocol allows physicians to voluntarily disclose self-discovered evidence of potential fraud to avoid the costs and practice disruptions associated with an investigation. The OIG’s self-disclosure protocol can be found at: http://oig.hhs. gov/compliance/self-disclosure-info/index.asp.22 Additional resources: • Healthcare lawyers • State/local medical societies • Specialty societies (eg, AAOS, Orthopaedic Trauma Association [OTA]) • CMS’s local contractor medical directors • CMS’s Medicare Physician Guide23 • OIG Web site (http://oig.hhs.gov)24 • OIG Compliance Program Guidance21 • OIG advisory opinions on the application of the AKS, CMPL, and exclusion authorities25 • CMS advisory opinions on the Stark Law18

EMERGENCY MEDICAL TREATMENT AND LABOR ACT [42 CFR § 489.24] EMTALA is a federal statute that became law in 1986 as part of the Consolidated Omnibus Reconciliation Act and www.jorthotrauma.com |

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was better defined and clarified by CMS in 2003. It is jointly enforced by CMS and the OIG. It is often referred to as the “antidumping” law. It is not exclusive to just Medicare or Medicaid patients and ensures that patients can receive emergency care regardless of their ability to pay. The following has been adapted from the EMTALA Training Handbook for Physicians and other ED Staff.26 Under EMTALA, Medicare-participating hospitals with emergency services must provide a “medical screening examination and stabilizing treatment for patients with an emergency medical condition (including active labor and certain psychiatric disturbances).” If a hospital is unable to stabilize a patient within its capability, or if the patient requests, a transfer can then be made. Hospitals and physicians cannot delay exam or treatment to inquire about method of payment or insurance status. An emergency medical condition is one that would be reasonably expected to cause harm if immediate medical care is not provided. • Harm is defined as acts that: • Place the health of the individual or unborn child at risk • Results in serious impairment to bodily functions • Results in serious dysfunction of bodily organs Patients who fulfill the following criteria are covered under EMTALA protection: • Patient who presents at a hospital’s dedicated ED requesting treatment for a medical condition • Dedicated ED is defined as: • Licensed by the state as an ED • Advertises emergency medical care on an urgent basis without an appointment • During the prior year, at least a third of all unscheduled visits provided treatment for emergency conditions • Individual who presents on the hospital campus (not the ED) and requests exam and treatment for an emergency medical condition • Includes: Main hospital campus: areas and structures within 250 yards of the main building (parking lot, sidewalk, driveway). • Excludes entities that have separate participations under Medicare. • Physician’s office • Physical/occupational/speech therapy • Rural health center • Skilled nursing facility • Restaurants, shops, nonmedical facilities • Outpatient clinics • Patients who request or appear to require emergency care even if they are in a nonemergency hospital departments. • Patients, whose appearance or behavior, but lacking an emergency medical condition or explicit request for treatment, deemed by a “prudent layperson observer” to need an exam or treatment for a medical condition. If an appropriate medical screening exam demonstrates that an individual does not have an emergency condition, the ED is not required to provide services. Triage protocols are not acceptable medical screening exams. Hospitals must have

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a policy in place to determine who can appropriately perform a medical screening exam. Examples: • Patient who presents to a hospital-based wound care clinic and requests nonemergent wound care is not protected by EMTALA. • Patient who presents at an ED requesting nonemergent wound care is protected by EMTALA. EMTALA does not apply to: • Outpatients already receiving outpatient services • Inpatients • Physician offices

Transfers Transfers may occur if: • Patients have been appropriately screened and their medical condition has been stabilized • Patient requests it (even if patient is unstable). • Unstable patients must be counseled about the risks and benefits of transfer. • Patient transfer requests must be made in writing. • Current hospital doesn’t have the capability to treat patient. • Receiving facility accepts the transfer and has the space, qualified personnel, and equipment necessary to care for the patient. • Patient is stable enough to endure transfer without “material deterioration.” • Physician has informed patient about the risks and benefits of transfer. Prior to transfer or discharge, the physician (or qualified physician extender) must document: • Benefits of transfer outweigh the risks. • Accepting facility has the ability and capacity to provide needed treatment and a physician willing to manage the patient. • Receiving hospitals must accept the transfer of an individual with an unstable medical condition (whether or not patient comes through the ED). The receiving facility must receive appropriate patient records upon transfer. • Medical history and exam findings • Preliminary diagnosis • Diagnostic study/test results • Description of prior treatment • Patient’s informed/written consent • Physician’s signed certification • Name/address of on-call physician who refused or failed to appear within a reasonable amount of time to provide necessary stabilizing treatment • Patient was stable when transferred or an unstable patient received appropriate care during the transfer • Patient transferred using appropriate transportation, equipment, personnel If a patient refuses transfer, the reason for refusal, the pros/cons of transfer, and what the transfer entailed should be documented. When patients refuse to be examined or treated EMTALA does not apply, however, hospital staff must document that they discussed the risks of refusing treatment 2014 Lippincott Williams & Wilkins


and benefits of accepting it after reiterating the importance of treatment to the patient. A hospital risks an EMTALA violation even if a patient leaves without being seen or notifying anyone that he/she is leaving.

Reverse Dumping Hospitals must accept patients when they possess the capacity, services, and physician specialists to do so. When EDs refuse appropriate transfers, it is called reverse dumping.

Call Coverage

EMTALA does not require a “hospital’s medical staff to provide constant on-call coverage but hospitals must maintain a list of physicians taking call who can provide the necessary treatment to stabilize an individual with an emergency medical condition.” Physicians can take call at more than one hospital at a time and can schedule elective cases and clinics while on call. The hospital is not required to have full on-call coverage if there are at least 3 physicians of that specialty on a medical staff. When call slots are unfilled or the on-call physician is unable to respond, hospitals must have a protocol in place so that patients can receive appropriate care. Additionally, if the on-call physician is in clinic, the hospital cannot send the patient to the outpatient clinic. The physician must see the patient at the hospital. If an on-call specialist disagrees with the request of an emergency physician to come in and see a patient covered under EMTALA, the healthcare provider who has performed the medical screening exam has the final say on whether that specialist must come to the ED. Nonemergent patients are covered by EMTALA if chronically long ED wait times delay treatment.

EMTALA Penalties Penalties for EMTALA violation can be substantial. They include: • Civil money penalties against the hospital and/or on-call physician • Termination of hospital’s Medicare provider agreement • Hospital fines from $25,000 to $50,000 per violation • Physician fines of $50,000 per violation (including on-call physicians who fail to respond or meet their on-call duties) • Exclusion of Medicare providers who are in “gross or flagrant” violation of the statute • Personal injury civil lawsuit brought by a patient • Suit brought by the receiving facility to recover any financial losses In 2002, the OTA held a symposium to establish a position on EMTALA. Among the discussion, the following recommendations were made27: • Rural hospitals with no orthopaedic surgeons on staff have full and easy access for transfer of all orthopaedic cases, including trauma patients. • Patients that fulfill prespecified trauma criteria are automatically transferred to the trauma center. • Transfer of isolated orthopaedic injuries that the referring institution cannot manage for whatever reason must be facilitated. 2014 Lippincott Williams & Wilkins


• The mechanism of transfer is a local issue and will be determined by the accepting hospital. • If the referring emergency physicians can manage emergency care of the injury, there is no need for an orthopaedic consultation as this will only delay the transfer and increase the cost of care. • A 24-hour voicemail number is provided in the orthopaedic trauma office specifically designed to report problems concerning transfers, or to report on requested referrals that are not accepted. Such an ongoing program is designed to collect data on transfer issues, as well as to develop an improved transfer program.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT HIPAA of 1996 was issued under the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) by HHS.28,29 HIPAA established standards for the use and disclosure of “protected health information” by organizations subject to the Privacy Rule. It was revised in 2000 and again in 2002.

Protected Health Information Information, including demographic data, that identifies an individual or could reasonably be used to identify an individual. It relates to: • Individual’s past, present, or future physical or mental health or condition • Provision of healthcare to the individual • Past, present, or future payment for the provision of healthcare to the individual (Examples of these identifiers include: name, address, birth date, Social Security number, etc.)

De-identified Health Information Information that neither identifies nor provides a reasonable basis to identify an individual. Information can be deidentified by a qualified statistician. The removal of specific identifiers of the individual and of the individual’s relatives, household members, and employers is required and is adequate only if the individual can no longer be identified. Organizations subject to the Privacy Rule include: • Health plans • Healthcare clearinghouses (eg, billing services) • Healthcare providers who transmit health information in electronic form • Business associates (eg, claims processors, data analyzers, utilization review, billers) • Exclusions: food stamp programs, community health centers, workers’ compensation, automobile insurance, property and casualty insurance HIPAA-covered entities must obtain individual consent for release of protected health information (PHI), and they may not withhold care based on refusal of consent. When coordinating or providing care, only the “minimum necessary” amount of information should be released. Covered entities are required to inform all individuals of privacy practices. www.jorthotrauma.com |

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HIPAA allows for the disclosure of information under the following conditions: • Individual provides written consent • It is allowed by the Privacy Rule 1. At individual’s request 2. Treatment, payment, healthcare operations 3. Opportunity to agree or object 4. Incident to an otherwise permitted use and disclosure 5. Limited data sets 6. Public interest and benefit activities • Public health activities • Victims of abuse, neglect, or domestic violence • Health oversight activities (audits) • Judicial or administrative proceedings • Covered entities may disclose PHI in a judicial or administrative proceeding if the request for the information is through an order from a court or administrative tribunal. Such information may also be disclosed in response to a subpoena or other lawful process if certain assurances regarding notice to the individual or a protective order are provided. 7. Law enforcement purposes: Covered entities may disclose PHI to law enforcement purposes under 6 circumstances. • Required by law (court orders, court-ordered warrants, subpoenas, administrative requests) • Identify or locate suspect, fugitive, material witness, missing person • In response to law enforcement official’s request for information about a victim or suspected victim of a crime • To alert law enforcement of a person’s death if caused by criminal activity • When PHI is evidence in a crime • By a covered healthcare provider in a medical emergency to inform law enforcement about the commission and nature of a crime, the location of the crime or crime victims, and the perpetrator of a crime Exceptions to the rule include issues of: • Decedents (funeral directors, coroners, medical examiners) • Research • Serious threat to health or safety • Essential government functions • Worker’s compensation Individual rights under HIPAA include the right to: • Review and obtain a copy of their PHI • Correct misinformation • Know to whom their information has been released • Restrict information release • Understand the method of information communication An individual may designate a “personal representative” and PHI may be released to that individual unless it could cause harm to the individual. Parental access to minor children’s records is allowed except as regulated by state and other laws. Those entities that fall under the guise of HIPAA must fulfill several requirements. HIPAA-covered entity requirements include:

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• • • • • • • •

Establishing written privacy policies and procedures Designating a privacy officer Educating its employees Mitigating any harmful consequences of information release Maintaining reasonable data safeguards Establishing procedures to handle complaints Not allowing retaliation against a person for exercising their rights Retaining records at least 6 years

HIPAA Violations • Civil money penalties are imposed at $100 per failure to comply. • Penalties may not exceed $25,000/y. • Intentional disclosure is penalized by a fine of $50,000 and up to 1 year of prison. • Intentional disclosure under false pretenses is penalized by a fine of $100,000 and up to 5 years of prison. • Intentional disclosure for the purposes of using information for commercial or individual gain or malicious harm can be fined $250,000 and 10 years of prison.

GOVERNMENT RELATIONS In order to stay informed of current and future legislation affecting care delivery, orthopaedists should be aware of the resources they have available to them through the academy and in their local, state, and national professional societies. Physicians should be involved in these societies, support them financially, and make an effort to meet and stay in contact with their legislators.

PPACA

PPACA is commonly referred to as “Obamacare.30–33” It will have significant implications on the provision of trauma care in the United States. The basic components are as follows: • Individual mandate. It requires most adults to purchase health insurance or pay a tax penalty. By 2016, the phased-in penalty will reach either $695 or 2.5% of yearly taxable income, whichever is greater. People with incomes below tax-filing thresholds will be exempt from the provision. Up to 16 million people are projected to join the rolls of the insured under the mandate. • Medicaid expansion. This would increase eligibility to all people under age 65 with annual incomes up to 133% of the federal poverty level—about $14,900 for a single adult and $23,550 for a family of 4 in 2014. Nondisabled adults under 65 without dependent children were previously ineligible. Another 16 million people are estimated to gain insurance under the expansion. • State-run insurance exchanges. They will be created to help small businesses and individuals purchase insurance through a more organized and competitive market.

PHYSICIAN ADVOCACY With the labile healthcare environment in today’s political arena it even more important for orthopaedists to stay abreast of the current legislative efforts and to stay in 2014 Lippincott Williams & Wilkins


communication with their state and federal representatives. Many avenues exist for education. These include: • American Medical Association • Young Physician’s Advocacy Section34 • General Advocacy Section35 • AAOS • AAOS Government Relations Office36 • AAOS Advocacy Now Newsletter • Subspecialty societies (eg, OTA, http://www.ota.org) • State and county medical societies • Local hospital’s government liaison • Political action committees Not only must orthopaedists seek education, they must also be financial supporters of medical societies. These groups advocate for legislative efforts favoring the public health and physician reimbursement. Fortunately, orthopaedists are well represented by the AAOS. According to the Center for Responsive Politics and based on Federal Election Commission data, the AAOS ranked third in contributions to federal candidates, political parties, and other outside groups among healthcare donors. Additional avenues for physician involvement include: • Writing letters to local and federal representatives • Signing petitions • Testifying in front of state and federal legislative sessions • Hosting fundraising events for political candidates • Running for political office

PHYSICIAN ACCOUNTABILITY, IMPLICATIONS OF ANTITRUST LAWS, AND PHYSICIAN INDEMNITY Physician Accountability Physicians are accountable to many different parties. Above all, physicians are primarily accountable to their patients. Although physician behaviors are gaining further scrutiny (primarily on the financial realm), our profession is one of the few that is allowed to police itself. State medical boards (composed of physician peers) are obligated to promote patient safety and must restrict unsafe or unethical physicians. Those to which the physician should be held accountable are listed here in no particular order. This list is by no means comprehensive. • Patient • Accurate and complete assessment (history/physical) • Unbiased care • Informed care • Care that meets or exceeds the community standard • Patient’s family • Communication of condition and treatment plan (with patient permission) • Self • Awareness of his/her limitations in knowledge and skill. Physicians must seek to either fill in these gaps, or assist the patient in finding another physician who can more appropriately assess and treat that patient’s illness. • Awareness, and efforts to seek help, when mental/ physical health or abuse of alcohol/other substances or other addictions threaten patient care. 2014 Lippincott Williams & Wilkins


• Community/society • Emergency room call coverage • Community stewardship (eg, volunteer, sponsor community events, charitable donations, cover local sports teams, support public health initiatives) • Partners/practice • Professionalism • Clinical practice and competence • Leadership, governance, collegiality • External and internal compliance • Cross-covering patients • Recognizing and addressing impairment • Support financial interests • Executive committee participation • Partnership meeting attendance • Colleagues/peers • Respond to consultation requests quickly and willingly • Maintain communication/correspondence with referring/consulting physicians • Quality assurance • Recognize and address impairment • Clinical staff (clinic and hospital) • Respect of staff • Professional interactions • Appropriate and constructive conflict resolution • Professional societies • Membership • Financial support • Committee involvement • Educational commitments (lectures, papers) • Hospital • Committee involvement • Public support • Participation in quality and cost-savings measures • Private insurance • Quality care of insured patients • Government • Accurate and honest billing practices • Compliance with civil and criminal regulations • State medical board

ANTITRUST LAWS Antitrust laws are designed to protect consumers by preventing boycotts, price-fixing, and monopolies. In healthcare, the consumers are the patients. However, when patients are insured, it is the insurance company who pays the bill that is considered the consumer. These laws do protect doctors, but only as consumers and not as service providers. Physicians must be familiar with antitrust regulation not only to avoid scrutiny, but also to help protect their patients, practice, and communities from dominant insurance companies or hospital organizations. Improper behavior alone can be interpreted as a violation of antitrust law. Even informal discussion with colleagues about insurance contract negotiation may be construed as misconduct. Since 2000, there have been 35 investigations by the Federal Trade Commission (FTC) and 3 by the DOJ against www.jorthotrauma.com |

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physicians—all but one focused on price-fixing. In 2008, a group of orthopaedic surgeons in Idaho were accused of violating antitrust laws by refusing to see workers’ compensation and other insured patients with the goal of obtaining higher reimbursement rates.37 They were investigated by the DOJ for undermining competition to set higher fees. This case was ultimately settled. In contrast, when collaboration occurs to improve the quality and cost of care, it does not represent collective bargaining and violation of antitrust legislation. Additionally, when multiple practices formally incorporate as a single organization, they are protected from antitrust legislation. Partial (ie, clinical or financial) integration may also serve as a safe harbor for physicians to employ collective price negotiations or group boycotts. These are evaluated and usually are protected under the “rule of reason” test by the DOJ and FTC. ACOs mays also fall under this test. However, when the legal criteria for clinical or financial integration is not satisfied, physicians are subject to the “per se” test, which almost always violates federal antitrust laws. Capitation, shared savings, and bundled payment arrangements will likely satisfy the DOJ’s and FTC’s financial integration requirements. It is worth noting that Vermont and Pennsylvania do not have state antitrust laws. However, residents of these states are still subject to federal antitrust legislation.

ADDITIONAL AMA RESOURCES Evaluating & Negotiating Emerging Payment Options: information regarding emerging payment arrangements that may also satisfy the DOJ’s and FTC’s financial integration requirements. Competing in the Marketplace: How Physicians Can Improve Quality and Increase Their Value in the Health Care Market Through Medical Practice Integration, second edition: in-depth information regarding federal antitrust laws, current DOJ and FTC antitrust enforcement perspectives, and how physicians may implement various physician practice integration strategies.

COLLECTIVE BARGAINING Collective bargaining refers to the negotiation of wages and other conditions of employment by an organized body of employees (eg, a union). In recent years, building frustrations with hospital and insurance organizations have led to increased attention to the concept of collective bargaining by physicians. It has even become a focus of the AMA. The AMA advocacy department addresses antitrust and collective bargaining concerns and has developed policies and lobbied for legislative change. In fact, the AMA formed the Physicians for Responsible Negotiation (PRN), the only national, independent labor organization created specifically for physicians. Since 2004, PRN has operated independently of the AMA. Its members agree not to strike or withhold essential medical services. In 2004, the AMA and PRN mutually agreed that PRN should operate as an entirely independent organization with no connection to the AMA. The stated mission of the organization is to: • Empower physicians in today’s healthcare arena

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• Protect medical ethics and professionalism • Maintain the integrity of the patient–physician relationship and quality of patient care • Reinforce the physician’s role as patient advocate • Make it economically viable for physicians to practice quality medicine • Provide physicians with the information, resources, and tools needed to stand up for their profession, for patients, and for quality healthcare

COLLECTIVE BARGAINING AND ANTITRUST RELIEF Situations when employed physicians have sought collective bargaining include38: • Employers set goals for increased productivity without physician input on repercussions on patient care quality • Employers alter care facilities, facility staffing, or administrative procedures used in the facilities without physician input • Employers reduce physician income • Employers break promises or force physicians to make concessions. Situations when self-employed physicians have sought collective bargaining include: • Inability to negotiate with managed care plans • Lack of involvement in key decisions that affect patient well-being or care quality in their professional practices

THE THIRD-PARTY MESSENGER The DOJ and the FTC allow restricted bargaining under the third-party messenger model.39 This model is described under the Statement of Antitrust Enforcement Policy in Health Care (1996). According to policy, third parties serve as channels of information and communications between insurers and individual physicians or physician group practices. However, a messenger may not negotiate on behalf of competing independent physicians or in any way enhance the bargaining leverage of such physicians. Criticisms of the third party messenger are that its execution is expensive and complex and still fails at protecting physicians. In many states, physicians have been issued subpoenas by the DOJ when attempting to use this model in insurance company negotiations. When physicians lose their negotiating power, they may be forced to sign less favorable insurance contracts that may lower reimbursement to the degree they can longer afford to practice.

ANTICOMPETITIVE BEHAVIOR Physicians should not only be aware of antitrust laws to avoid illegal activity.40,41 Familiarity with these regulations can also to protect them. Examples of potentially anticompetitive behavior include: • Hospital systems • A dominant hospital or merger of hospital systems that threatens individual physician practices or physicianowned facilities (surgery centers, imaging, etc.) 2014 Lippincott Williams & Wilkins


• Requires exclusive contracts with insurers • Bars physicians from taking an ownership interest in a competing facility • Requires economic credentialing • Employs referring physicians and limits the ability of employed physicians to make referrals outside of the employer hospital • Conditions privileges on the physician’s participation in noncompete agreements • Pressures health insurers to boycott physician-owned facilities • Pressures local bankers deny loans for physicianowned facilities • Insurance company monopsony (market situation in which there is only 1 buyer) • Health insurance company mergers that set reimbursement rates below market value • Insurance companies that insist on anticompetitive contract terms (eg, forcing physicians to accept the lowest rate accepted from other insurers) • Preventing other insurers (would-be competitors) from entering the market Under the McCarran-Ferguson Act, insurance companies are exempt from many antitrust regulations. However, if anticompetitive behavior is suspected, physicians can contact the AMA to facilitate investigation. Additional information on anticompetitive behaviors can be found on the AMA Web site.42

ACOS AND ANTITRUST CONSIDERATIONS The PPACA does not clearly delineate which insurance company negotiation practices are legal under the guise of an ACO.43,44 The DOJ has proposed approaches to antitrust enforcement policy as it applies to ACOs. To avoid antitrust scrutiny when ACOs are created, care providers must focus on quality, efficiency, and cost savings. Exclusive contracts between specialists and an ACO may be challenged if another ACO’s ability to compete is limited because it is unable to obtain specialist coverage. PCPs exclusive to ACOs also run the risk of attention if they limit referrals to specialists within their organization, limiting access to non-ACO specialists in the community. Due to antitrust legislation, several forms of conduct have been cited as “red flags.”45 These include: 1. Price fixing 2. Dividing markets by customers or territories 3. Limiting capacity through collusion 4. Agreements not to compete in sale or purchase 5. Group boycotts When interactions with competitors occur, discussions and emails can also be interpreted as anticompetitive. As a result, discussion should be avoided concerning: 1. Prices, pricing practices, and strategies 2. Patent viability 3. Confidential company plans 4. Ongoing litigation 5. Complaints about other practices/physicians 6. Business development 2014 Lippincott Williams & Wilkins


AAOS Position on Antitrust Laws • Laws should be changed to allow physicians to collectively negotiate with health plans and insurers without necessarily joining a labor union. • McCarran-Ferguson Act must be amended to change the anticompetitive practices of insurance companies and establish negotiating equity among health plans, insurers, and physicians. • AAOS also supports the AMA’s position on ACOs and the enactment and promulgation of regulations to ensure physicians’ continued ability to provide quality patient care.

PHYSICIAN INDEMNITY In this context, physician indemnity refers to legal protection of the orthopaedist under an institution’s liability policy for sanctions of peer physicians imposed during quality assurance proceedings. Morbidity and mortality or quality assurance committees serve 2 functions. 1. A learning tool. Orthopaedists can be exposed to complications of their peers with the goal of preventing themselves from making these same mistakes. 2. Peer review. Active processes to review the management and outcome of patient cases to ensure that the community standard of practice is being followed. Prior to the institution of quality assurance committees, specific policies for evaluation of work and formal penalties should be established and documented. Physicians who repeatedly demonstrate deficiencies in judgment, knowledge, and technical skill in caring for fracture patients should be evaluated to uphold the standard of care. At a community hospital, physicians of different practice affiliations should be involved in the assessment of these cases. Then, in a setting of a formal conference, and with orthopaedic medical staff and hospital support, these cases should be discussed with the physician and the appropriate action, as outlined by the bylaws, should be taken and enforced. Physicians coming under scrutiny under the peer review process may allege misconduct under antitrust legislation. Specifically, the Sherman Antitrust Act (15 U.S.C. §§ 1-7) provides federal protection of individuals from monopolization or conspiracy to restrain trade. On a state level, tortious interference with contractual relations or defamation can be alleged. The peer review process is protected by federal immunity under the Health Care Quality Improvement Act of 1986. A formal peer review process and indemnity policy protects physician peer reviewers against frivolous lawsuits. Judicial precedent has traditionally upheld hospital and peer review committee decisions. While this policy protects the peer reviewers, when true breach of the process occurs and antitrust laws are violated, courts have historically and infrequently supported the plaintiff.

ONLINE PHYSICIAN REVIEWS The Internet has afforded many benefits to medical education and communication of patient information between providers. Physicians and practices have been able to develop Web sites to educate patients and provide general information www.jorthotrauma.com |

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about staff and locations. Some physicians have begun blogs or engaged other types of social media to market their services and disseminate educational materials. Just as physicians have begun to use the Internet to provide care, in 2010, 59% of Americans sought health information online.46 Another use of the Internet of which physicians should become more aware are online reviews created by patients (eg, DrScore.com, RateMDs.com) or other sites based on government or public data (eg, HealthGrades. com). It is estimated that about 17% of physicians had at least 1 online review by the start of 2010 with OB/GYNs 2 times more likely to be rated than other specialties and surgeons representing about 20% of those rated.47 Other studies have found physician ratings prevalence at 86.4% to 91.2%.48,49 Rating sites may allow patients to evaluate their experience based on the following criteria: • Physician’s attitude and demeanor • Thoroughness • Time spent with the physician • Clarity and thoroughness of care instructions • Involvement in decision making • Communication of test results • Follow-up • Outcomes. Patients are also given the opportunity to rate their experience in the office: • Friendliness and courtesy of staff • Wait times • Parking and location • After-hours access • Referrals In January 2010, the average rating of physicians on RateMDs.com was overall favorable at 3.93 (on a scale of 1–5).47 However, physicians and their staff need to visit these sites frequently to ensure that information accurately represents the physician and to be aware of their reviews. eMerit. biz, a proprietary Web site created by a physician-lawyer, monitors several review sites for physicians so that they can keep on pulse on their online comments.50 Many sites allow an avenue for physicians to correct erroneous information. Physicians should be aware that many sites are updated infrequently and the information represented may be outdated. If a request to change the information is requested, several months may pass before the accurate data is reflected online. When patients or other individuals provide material that the physician finds offensive, very few legal ramifications exist due to freedom of speech. Over a dozen lawsuits, most settled or thrown out, have been filed by physicians and dentists against patients for online defamation since 2004.51 In the media, many examples of healthcare professionals seeking retribution for negative reviews have actually received even greater negative attention. Although specific sites should be monitored, physicians should also perform an Internet search using their names as the query. Patients and employers will use search engines, such as Google, to dig for information. Often, photographs or other information may be online that the physician would not like to be made public but come up under search parameters because they are available through Facebook or other social

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media sites. In a Google search of 250 internists, 92.8% had professional information listed on a Web site and 32.4% had personal information online (social networking, hobbies, charitable or political donations, family information).48 Another study of general surgery residence program directors found that 17% of them visited social networking sites to research residency candidates and 33.3% ranked applicants lower after review of these sites.52 It is also worth noting that physicians have been held liable for interactions with patients on social networking sites and physicians should be cautious in posting on forums or even professional networking sites.53 The Federation of State Medical Boards has developed guidelines for the use of social media and social networking in medical practices.54,55

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