PACS ACO Compliance Training Program 12.01 · Ethics Training Physicians ... Any Policies or Procedures necessary to effect compliance with ... psychotherapy, physical and occupational

Medicare Shared Savings Program - ACO 2636

Compliance and Ethics Training

Physicians Accountable Care Solutions, LLC (PACS)

December 2, 2015

© Physicians Accountable Care Solutions, LLC (PACS)

Chief Compliance Officer: John D. Wood, JD

Anonymous 24-Hour ACO Compliance Hotline: 860-986-6606

Disclaimers

❖ This presentation does not constitute legal advice.

❖ This presentation does not create an attorney-client relationship.

❖ The content of this presentation is not exhaustive of all compliance responsibilities for ACO participants.

❖ Attendees should consult with their own legal counsel for specific legal opinions and advice.

© Physicians Accountable Care Solutions, LLC (PACS) 2

Overview

❖ Participating in PACS ACO

❖ Our Compliance Plan

❖ Remediable Actions

❖ Reporting a Compliance Breach

3© Physicians Accountable Care Solutions, LLC (PACS)

Participating in PACS ACO


The Program❖ Physicians Accountable Care Solutions, LLC (PACS) is a

Medicare Shared Savings Program (MSSP) Accountable Care Organization (ACO) under contract with the Centers for Medicare and Medicaid Services (CMS) to provide services to Medicare fee-for-service beneficiaries.

❖ PACS’ goals are to promote (1) better evidence-based medical care for individuals, (2) better health for populations assigned to the ACO, and (3) lower the unsustainable growth in health care expenditures.


Benefits of Participation❖ PACS offers its Network of participants a Financial Incentive

Plan as well as claims management technology in the form of CareScreen® platform to help coordinate efforts, align services to Medicare beneficiary patients assigned to the ACO, and internalize part of the shared savings.

❖ By participating, doctors are enabled and incentivized to help patients get the right care at the right time, avoid medical errors, and reduce wasteful duplication of services. By striving to go beyond mere compliance and enhance quality of care, all participants can be rewarded for “doing the right thing.”


Waivers❖ The various Fraud and Abuse laws reviewed in this training

program are waived with respect to the financial incentives provided to PACS participants through the shared savings program.

❖ Distributions of shared savings from participation in PACS, and financial arrangements made to successfully operate the ACO, are protected from liability from the Stark, Anti-Kickback, and Gainsharing laws under the Shared Savings Distribution waiver.

❖ This waiver does not otherwise reduce legal compliance or ethical responsibilities on the part of participants, suppliers, or providers affiliated with the ACO.


Shared Savings Distribution Waiver❖ The waiver applies if:

1. ACO is in good standing; 2. Shared savings earned pursuant to the law; 3. Shared savings earned during term of the Agreement, even if distribution occurs after; 4. Shared savings are: a. Distributed to the ACO participants, or b. Used for MSSP purposes such as paying suppliers for services; and 5. Payments are not made knowingly to induce a physician to reduce or limit medically necessary items or services to patients

❖ Other waivers apply but only one is needed. © Physicians Accountable Care Solutions, LLC (PACS)

8

Participation Ground-Rules❖ Participants are eligible for financial incentives only if they remain licensed;

maintain hospital privileges; remain in compliance with all applicable professional standards, federal regulations, and state laws; and accurately report quality measures to PACS.

❖ Participants must agree to report suspected violations of law to the Chief Compliance Officer of the ACO, to fully cooperate with any PACS’ compliance initiatives relating to auditing, oversight, looking into books and records for hierarchical condition category coding, or identifying instances or patterns of fraud, waste or abuse.

❖ Any Policies or Procedures necessary to effect compliance with laws do not require thirty (30) days prior notice and shall be effective as stated in such notice by the Chief Compliance Officer.


Screening for Excluded Providers

❖ Must maintain program integrity.

❖ If CMS discovers excluded providers who are participating in or affiliated with the ACO, the MSSP application could be denied, or additional program safeguards could be put into place.


Avoiding Improper Referrals❖ Must maintain beneficiary freedom of choice.

❖ ACOs are prohibited from requiring that Participants refer within the ACO for non-ACO patients.

❖ The Final Rule also prohibits ACOs from requiring that beneficiaries be referred within the ACO.

❖ Improper referrals can lead to over-utilization, increased costs, corruption of medical decision-making, patient steering, and unfair competition.


Ongoing Compliance Activities The ACO Compliance Officer shall ensure, through periodic monitoring procedures, that the ACO practices and participating providers:

❖ Meet the exclusion screening requirements of ACO Participation Agreements.

❖ Receive the training necessary to comply with MSSP regulations, and complete all attestations, affirming the ACO practice and participating providers comprehend the material (attached to this presentation).

❖ Adhere to all corrective action plans, remedial processes, and sanctions to improve compliance and performance.

❖ Comply with the ACO Compliance Plan to ensure that all probable violations of law are reported to law enforcement.

❖ Communicate routinely (monthly or sooner) with the ACO Board and participate in quality reporting.


Documentation and Coding❖ Providers must build a certification trail for every decision and billable service

rendered. Make specific notes in the EMR, coding the conditions. This is as important for compliance as it is for quality care.

❖ “The importance of consistent, service-appropriate documentation is relevant not only to the payer community. The relationship between documentation and coding is woven into the fabric of the health care system.”

❖ “Although the nexus between care and documentation may seem at times strained on an individual physician basis, its overall significance is broadly appreciated by the various health care stakeholders.” Expanding Physician Education in Health Care Fraud and Program Integrity, Agrawal, Shantanu MD, MPhil; Tarzy, Bruce MD; Hunt, Lauren MPH; Taitsman, Julie MD, JD; Budetti, Peter MD, JD, Academic Medicine: August 2013 - Volume 88 - Issue 8 - p 1081–1087.


Our Compliance Plan


Mandatory Compliance Plan Elements1. Written policies, procedures and standards of conduct 2. Compliance Officer and Compliance Committee 3. Effective training and education 4. Effective lines of communication 5. Well publicized disciplinary standards 6. System for auditing and monitoring compliance 7. Procedures for prompt response to identified issues

Link to PACS ACO Compliance Plan available here: http://www.pacsaco.com/physician-information/

Anonymous ACO Compliance Hotline: 860-986-6606


http://www.pacsaco.com/physician-information/

Compliance Reviews and AuditsAccuracy of data submissions. Annual certification that ACO is in compliance with all legal requirements and all data and information submitted is accurate and complete. Avoidance of at-risk beneficiaries (cherry picking). Beneficiary inducements. Compliance with Data Use Agreement (note: more stringent than HIPAA). Compliance with HIPAA. Documentation of OIG/GSA exclusion screening. Limitation on beneficiary freedom of choice (steering).


Monitoring and Enforcement

❖ The PACS Board of Managers and Medical Director will develop and set annual quality improvement initiatives and goals, and will monitor and report quality improvement initiative outcomes.

❖ Providers who continue to miss quality measures, reporting, or compliance performance standards will be referred to the Board of Managers for remedial action.


Investigating Misconduct❖ If I have reasonable grounds to believe that reported misconduct

constitutes a probable violation of criminal or civil law or administrative regulations relating to government contracts, particularly related to reporting data on payment and potential fraud, I will voluntarily report this conduct to CMS, and take corrective action.

❖ If I determine that a compliance-related vulnerability in the ACO’s operations exists, I will devise and recommend specific compliance-related education and mentoring for PACS practices, participating providers, PACS providers/suppliers, employees or contractors.


Disciplinary Standards

❖ Disciplinary or remedial measures may include, but are not limited to, the imposition of corrective action plans, the assessment of sanctions, the loss of the ability to receive shared savings, or expulsion from the ACO.

❖ Noncompliance will lead to an escalating disciplinary program beginning with a Warning, then Corrective action plan, then Special monitoring and/or Termination from PACS.

❖ Disciplinary or remedial measures will be imposed in accordance with PACS Board of Manager approval.


Remediable Actions


Recent Enforcement Activity❖ Sham consulting arrangements meant to disguise kickbacks.

❖ Illegal marketing and pricing practices, such as failure to redeem drug rebates.

❖ Switching drugs to get greater reimbursements.

❖ Kickbacks for durable medical equipment and supplies that were never delivered to beneficiaries.

❖ Medically unnecessary services (e.g., billing for inpatient when outpatient was sufficient, admitting to acute care when not needed).

❖ Arbitrarily upcoding bills.

❖ Outlier payments (unusually expensive episodes of care).


Fraud, Abuse, and PHI Laws

❖ Physician Self-Referral Law (42 U.S.C. § 1395nn)

❖ Anti-Kickback Statute (42 U.S.C. § 1320a–7b(b))

❖ False Claims Act (31 U.S.C. §§ 3729–3733)

❖ Civil Monetary Penalties Law (42 U.S.C. § 1320a–7a)

❖ HIPAA and HITECH regarding Protected Health Information


Cracking Down on Fraud❖ On June 18, 2015, Attorney General Loretta E. Lynch and Department of Health and Human

Services (HHS) Secretary Sylvia Mathews Burwell announced a nationwide sweep led by the Medicare Fraud Strike Force resulting in charges against 243 individuals, including 46 licensed medical professionals, for Medicare fraud schemes involving about $712 million in false billings for home health care, psychotherapy, physical and occupational therapy, durable medical equipment, and pharmacy fraud. A number of providers were suspended by CMS.

❖ In many cases, patient recruiters, Medicare beneficiaries and other co-conspirators allegedly were paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could then submit fraudulent bills to Medicare for services that were medically unnecessary or never performed.

❖ According to Attorney General Lynch, "The defendants … billed for equipment that wasn't provided, for care that wasn't needed, and for services that weren't rendered[.] Criminal activity drives up medical costs and jeopardizes a system that our citizens trust with their lives.”


Fraud, Part 2❖ The Medicare Fraud Strike Force team brings the investigative and

analytical resources of the FBI and HHS-OIG, the prosecutorial resources of the Criminal Division’s Fraud Section, and the United States Attorney’s Office (USAO), to analyze data obtained from CMS and bring cases in federal district court.

❖ In 2014 alone, the Strike Force filed charges against 353 defendants alleged to have collectively billed the Medicare program more than $830 million, negotiated 304 guilty pleas, litigated 38 jury trials, and obtained guilty verdicts following trial against 41 defendants.

❖ The Strike Force efforts in 2014 resulted in imprisonment for 248 defendants sentenced to an average of more than 50 months of incarceration each.


Fraud, Part 3❖ The Fraud Section of the U.S. Department of Justice addresses the following types of

health care fraud: 18 U.S.C. § 1343 (Wire Fraud) 8 U.S.C. § 1347 (Health Care Fraud) 18 U.S.C. § 1349 and 18 U.S.C. § 371 (Attempt or Conspiracy to Defraud) 18 U.S.C. §§ 1957-56 (Money Laundering) 42 U.S.C. § 1320a-7b(b) (Health Care Kickbacks) 18 U.S.C. §§ 1518, 1519 (Obstruction) 18 U.S.C. § 669 (Theft or Embezzlement in Connection with Health Care) 42 U.S.C. § 1320d-6 (Unlawful Use of Health Information) 18 U.S.C. § 1028A (Aggravated Identity Theft) 18 U.S.C. § 1028(a)(7) (Use of Identification Information) U.S.C. § 1035 (False Statements Relating to Health Care Matters)

❖ If it sounds fraudulent, abstain from the act and report it.


Fraud, Part 4❖ 18 U.S. Code 1347 - Health Care FraudWhoever knowingly and willfully executes, or attempts to execute a scheme or artifice to defraud any health care benefit program; or obtain under fraudulent pretenses, any of the money or property owned by, or under the custody or control of, any health care benefit program, in connection with the delivery of or payment for health care benefits, items, or services, shall be fined under this title or imprisoned not more than 10 years, or both. If the violation results in serious bodily injury (as defined in section 1365 of this title), such person shall be fined under this title or imprisoned not more than 20 years, or both; and if the violation results in death, such person shall be fined under this title, or imprisoned for any term of years or for life, or both. “A person need not have actual knowledge of this section or specific intent to commit a violation of this section.”


Self-Referral (Stark) Law

❖ Prohibits a physician from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship, unless an exception applies.

❖ Also prohibits the designated health services entity from submitting claims to Medicare for services resulting from a prohibited referral.

❖ Check if the physician or immediate family member has a relationship with the entity providing the designated health service. If there is a relationship, check with your local compliance officer if the financial relationship fits within an exception.

❖ No “intent” standard for overpayment—strict liability.

❖ Improper self-referral can lead to payment denial, monetary penalties up to three times the amount improperly claimed, or exclusion.


Avoidance of At-Risk Beneficiaries❖ CMS is required by statute to monitor ACOs for behavior that would indicate that the

ACO is avoiding “at risk beneficiaries.” Changes in beneficiary assignment may be audited for avoidance behavior. While the Affordable Care Act does not define the term “at risk beneficiary”, CMS defines it in the Final Rule:

❖ At-risk beneficiary means, but is not limited to, a beneficiary who— (1) Has a high risk score on the CMS–HCC risk adjustment model; (2) Is considered high cost due to having two or more hospitalizations or emergency room visits each year; (3) Is dually eligible for Medicare and Medicaid; (4) Has a high utilization pattern; (5) Has one or more chronic conditions; (6) Has had a recent diagnosis that is expected to result in increased cost; (7) Is entitled to Medicaid because of disability; or (8) Is diagnosed with a mental health or substance abuse disorder.

❖ If CMS determines that an ACO has been avoiding “at risk” beneficiaries, the ACO will be subject to sanctions, including possible termination from the MSSP. Providers should indicate to ACO when they terminate a physician-patient relationship.


Anti-Kickback Statute❖ Prohibits a provider from intentionally (knowing and

willfully) offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate reimbursable Federal health care program business.

❖ Only charge Fair Market Value for actual and necessary services.

❖ Civil assessments can be up to three times amount of the kickback.


False Claims Act❖ Prohibits the knowing submission of false or fraudulent claims to the

Government.

❖ “Knowing” = A person who has actual knowledge, or acts in deliberate ignorance of its truth or falsity, or acts in reckless disregard of truth or falsity of information submitted when making a claim. 31 U.S.C. § 3729(b)(1)(B).

❖ Resolve overpayments and billing errors as soon as possible to avoid potential liability under the False Claims Act.

❖ In June 2014, the U.S. Attorney’s Office in Manhattan filed a False Claims Act complaint against Beth Israel Medical Center, St. Luke’s-Roosevelt Hospital Center, and Continuum Health Partners, alleging that defendants had knowingly failed to return overpayments owed to Medicaid arising from a computer glitch.


Addressing Improper Payments❖ Payment errors (“improper payments”) can result from

a variety of circumstances, including billing for services with insufficient or lack of documentation, incorrectly coding claims, or providing services that were not “reasonable and necessary.”

❖ In addition to False Claims Act liability, improper payments can lead to failures of care delivery, lack of coordination, and spending on services that do not improve or preserve health.


Gainsharing CMP

❖ A hospital cannot induce a physician to reduce or limit “medically necessary” services provided to Medicare beneficiaries under the physician’s care.

❖ Any physician who knowingly accepts such a payment is also subject to the CMP.


Beneficiary Inducement CMP

❖ The law prohibits offering “remuneration” to a Medicare beneficiary if you know or should know doing so is likely to influence beneficiary selection of a particular provider or stay in the ACO.

❖ “Remuneration” is defined as the transfer of any item other than for fair market value. There are important exceptions to this rule, to balance the need for patient engagement.


Purpose of the Beneficiary Inducement CMP

❖ The Beneficiary Inducement Prohibitions are intended to prevent the following moral hazards:

❖ Overutilization which inappropriately increases federal and state health care program (collectively referred to as “Programs”) costs and potentially harms beneficiaries;

❖ Improperly influencing patient treatment decisions by offering items or services of value;

❖ Skewing patients’ selection of providers by shifting focus to the value of the inducement as opposed the value or quality of the health care services; and

❖ Creating a competitive disadvantage for providers who cannot afford or choose not to provide beneficiary incentives.


Access to Care Exception for Inducements

❖ Remunerations or inducements designed to promote access to care and which poses a low risk of harm to patients and federal health care programs does not constitute “remuneration” under the Beneficiary Inducement CMP. 42 USC § 1320a-7a(i)(6)(F).

❖ The Final Rule does provide exceptions for certain “in-kind” items or services provided to beneficiaries if they are reasonably connected to the beneficiaries care, are preventive care items or services, or advance a clinical goal for the beneficiary (such as adherence to a drug or treatment regime, a follow-up care plan or chronic disease management). Blood pressure monitor to patient with hypertension is classic example.

❖ Also, “nominal” value items worth no more than $10 each or $50 annually are not prohibited. 65 Fed. Reg. 24400, 24410-24411 (Apr. 26, 2000)

❖ Candidates for the Exception: Health and Wellness Fairs, Free Screenings, Items that Promote Adherence to a Treatment Regime, Properly Targeted to Patient Health and/or Population Needs, Advance Public Health and Safety.


Waiver for Patient Inventives❖ Waiver of Beneficiary Inducement law applies if:

1. ACO entered into a participation agreement and in good standing, 2. A reasonable connection between the items or services and the medical care of the beneficiary; 3. Items or services are “in-kind”; 4. The items or services a. Are “preventative care items or services”, or b. “Advance one or more of the following clinical goals”: i. “Adherence to a treatment regime”; ii. “Adherence to a drug regime”; iii. “Adherence to a follow-up care plan”; or iv. “Management of a chronic disease or condition.


HIPAA Compliance❖ Keep Protected Health Information private and secure, and take appropriate

steps in case of a breach.

❖ The Privacy Rules require covered entities to implement policies to ensure that the minimum amount necessary is used or disclosed for each permissible use of patient information. 45 C.F.R. § 164.502(b)

❖ The Security Rules require providers to establish appropriate administrative, technical, and physical safeguards to protect the privacy of health information. 45 C.F.R. § 164.530(c).

❖ Individual patients should control access of their health information, so there are limited circumstances in which use or disclosure is allowed, and then only under conditions of authorization, opportunity to object, or opt-out. If you have questions, contact your compliance officer.


HIPAA Compliance for Business Associates

❖ The HITECH Act rendered the HIPAA privacy rule and civil and criminal penalties directly applicable to Business Associates. Covered entities do not need to monitor business associates per se, but must take remedial action where needed.

❖ Business associates of covered entities, such as subcontractors that perform billing, collection, audit, or legal services requiring access to PHI, must also comply with HIPAA.


Antitrust, 1

❖ Federal Trade Commission (“FTC”) and Department of Justice (“DOJ”) issued a final Antitrust Enforcement Policy with regard to ACOs participating in the MSSP.

❖ Absent “extraordinary circumstances”, an ACO will fall within an antitrust enforcement “safety zone” if independent ACO participants that provide the same service have a share of 30 percent or less of the common service in each participant’s Primary Service Area (“PSA”).

❖ Antitrust is mainly a concern between competing hospitals, or scenarios where price fixing is possible. PACS uses claims data from CMS, and does not set prices, so the risk is low.


Antitrust, 2

❖ Antitrust enforcement is highly fact-specific. When the facts indicate financial risk sharing and clinical integration, the "rule of reason" applies. The rule of reason is more lenient than traditional antirust enforcement analysis, meaning that potential enforcement agencies would weigh any risk of anti-competitive effects against the gains in efficiency that result from the collaboration.


Antitrust, 3❖ All ACOs should avoid improper exchanges of prices or other competitively sensitive

information among competing participants and should implement appropriate firewalls or other safeguards to protect against collusion, price-fixing, or other anti-competitive practices.

❖ If ACO has high PSA share and indicia of market power, it should avoid these behaviors to lower audit risk:

❖ Preventing or discouraging private payers from directing patients to choose certain providers;

❖ Exclusive contracting with ACO physicians, hospitals, or other providers which would prevent or discourage those providers from contracting with private payers outside of the ACO;

❖ Any activity that is anti-competitive or not geared toward promoting efficient care.


Reporting A Compliance Breach


Duty to Report

❖ From PACS Participation Agreement, Article 2, Participant Representations and Obligations, Section 2.1 General:

❖ “The Participant must notify the ACO of any Disciplinary Actions within five (5) business days of receiving actual knowledge.”


Reporting and Retaliation

❖ According to a recent survey from the Ethics Resource Center, in the year prior to the survey, 52% of employees observed unethical behavior and 45% observed misconduct at work in the previous year, whereas only 65% reported this to management and only 55% of these employees felt comfortable doing so without fear of retaliation. Alarmingly, 22% of employees who reported violations experienced retaliation for doing so.


Non-Retaliation❖ PACS offers participants an environment free from reprisal, intimidation,

or retaliation of any kind for coming forward with a report or concern about ethical or legal violations.

❖ PACS strives for continuous improvement in every respect as an organization, including our ethical standing in society and our compliance regimen. PACS strives to go beyond mere compliance as an organization to benefit all stakeholders in the health care industry.

❖ I monitor the anonymous 24-7 Compliance Hotline and will follow up, investigate, and work with on-site compliance leaders to resolve issues. If you have a concern about compliance, please bring it to my attention. To maintain the highest ethical and professional standards we must work together.


Annual Certification of Compliance and Training

❖ All PACS ACO participants, providers, and suppliers must sign and return the two annual certifications (available on the PACS website).

❖ Compliance Certification: “By signing this form, the ACO practice, participating provider, or ACO supplier certifies that it has received, read, and understands the ACO Compliance Program Policies and Procedures; will use best efforts to monitor its processes to prevent and detect conduct that may violate federal and state law; and will report probable violations of law to the ACO’s Compliance Officer.”

❖ Training Certification: “By signing this form, the ACO participant certifies that, as part of its participation in the Physicians Accountable Care Solutions, LLC, Accountable Care Organization (the “ACO”), I have received the training required by the ACO Compliance Program and approved by the ACO’s Compliance Officer.”


Going Forward❖ Feel free to request training modules on emerging issues in compliance.

Proactive education should curb future compliance problems.

❖ I invite Human Resource Officers, Compliance Officers, and related professionals in the PACS network to contact me to discuss emerging issues they would like to address on a system-wide basis.

❖ I ask compliance officers at all participating organizations to furnish aggregated compliance logs. Unless otherwise required by law, the content of these reports will be kept confidential but will be used for benchmarking purposes. The purpose of collecting this data is to monitor progress toward continuous improvement and to enhance organizational learning.


Medicare Shared Savings Program - ACO 2636

Compliance and Ethics Training

Physicians Accountable Care Solutions, LLC (PACS)

Updated November 18, 2015

© Physicians Accountable Care Solutions, LLC (PACS)

Chief Compliance Officer: John D. Wood, JD

Anonymous 24-Hour ACO Compliance Hotline: 860-986-6606

48

Documents

PACS ACO Compliance Training Program 12.01 · Ethics Training Physicians ... Any Policies or Procedures necessary to effect compliance with ... psychotherapy, physical and occupational