COMPLIANCE GOTCHAS AND EMERGING RISKS BROOKE BENNETT AZIERE & JUSTAN SHINKLE DIRECT SUPERVISION OF HOSPITAL OUTPATIENT THERAPEUTIC SERVICES Hospital outpatient therapeutic services generally require direct supervision by physician or midlevel Must be present on campus (or in off campus provider based department) where services are furnished Must be immediately available (i.e., interruptible) Enforcement moratorium for CAHs and small rural hospitals EXPIRED 12/31/2016 CMS contractors may enforce direct supervision requirement for 2017 2018 OPPS proposed rule: CMS proposes reinstating the nonenforcement of direct supervision enforcement instructions for outpatient therapeutic services for CAHs and small rural hospitals (100 beds or less) for CYs 2018 & 2019. Foulston Siefkin 2017 1
SECTION 1557 NON DISCRIMINATION RULES October 16, 2016 deadline Nondiscrimination Notice and Taglines Designation of an employee responsible for compliance (15 or more employees) Adoption of a grievance policy to promptly resolve complaints of discrimination OCR is investigating SECTION 1557 NON DISCRIMINATION RULES Case Example Patient makes frivolous complaint to Office for Civil Rights (OCR) that practice discriminated against him on the basis of race OCR launches investigation and requests: Nondiscrimination Notice Section 1557 Coordinator Grievance Policy Foulston Siefkin 2017 2
INCIDENT TO BILLING Direct supervision required to bill incident to services Present in office suite Immediately available (i.e., interruptible) Supervising physician does not need to be treating physician Only supervising physician may bill Medicare for incident to service If ordering, referring, or treating physician is not supervising physician, he/she may not bill Medicare for incident to services. Must track supervising physician Must ensure billing software adjusted accordingly Production credit to only the supervising/billing physician AUDIT FINDINGS AS CREDIBLE INFORMATION OF POTENTIAL OVERPAYMENT Letter from external auditor = credible information of an overpayment under the 60 Day Repayment Credible information is information that supports a reasonable belief that an overpayment may have been received Must do more than write a check Reasonable inquiry into the potential overpayment 6 year lookback If appeal, then 60 Day Rule says that it is reasonable for provider to assess that it is premature to initiate an investigation into nearly identical conduct in an additional time period until such appeal works through the administrative appeals process Foulston Siefkin 2017 3
SIMON S LAW Simon Crosier born with Trisomy 18 Parents learned after Simon s death that Doctor issued DNR Governor Brownback signed Senate Bill 85 (K.S.A. 38 150) on April 7, 2017 Effective July 1, 2017 First of its kind in United States No DNR of unemancipated minor unless One parent informed orally and in writing Attempt to notify other parent (if custodial or visitation rights) Document in medical record Both parents have veto power, unless court order Either parent may seek court resolution Healthcare facilities, nursing homes, and physicians must disclose, upon request, any policies relating to resuscitation and life sustaining measures Similar Missouri bill yet to receive hearing EHR RISKS Copy/Paste (or cloning) Physician signature short cuts Make me an Author tool Sharing log in credentials Lack of space for narratives No distinction between original and edited text Drop Down menus Foulston Siefkin 2017 4
MEANINGFUL USE AUDITS $14.6 billion paid to Medicare EH during 2011 2016 OIG claims EPs were overpaid by $729 million from 5/2011 to 6/2014 July 2017 OIG Work Plan included audits of EHR incentive payments Print/save all documentation supporting MU Audits performed for payment adjustments too OUTSOURCING RISKS What is an outsourced provider? A management company or third party provider that contracts to provide a particular health care service at your facility Examples: Skilled Nursing Rehabilitation Therapy Wound Care Physical, Occupational, Speech Therapy Behavioral Health Emergency Rooms Telehealth Foulston Siefkin 2017 5
OUTSOURCING RISKS Are we obligated to monitor these outsourced providers, after all, we are engaging them because of their experience? Yes Responsibilities include oversight of: Billing Documentation Medical Necessity Quality of Care Marketing OUTSOURCING RISKS So what should we doing? Consider how the relationship is structured? Joint venture versus management fee? Structure will not matter if patients are harmed Outsourced provider obligations: Are they required to routinely audit their documentation, billing, and quality of care? Are they required to cooperate with the facility s oversight? Are they required to follow the facility s policies and procedures related to documentation, billing, and quality of care? Are they required to train their employees? Does the outsourced provider indemnify the facility for fines and penalties? Overpayments? What happens if a compliance issue surfaces? Foulston Siefkin 2017 6
OUTSIDE AUDITORS Overpayment final rule requires proactive and reactive audits Government investigations seek auditor s findings EXHIBIT A Auditor communications not privileged unless attorney agent Primary purpose must be seeking legal advice Consider reason and consequence of internal/external audits Auditor motivation? Don t jump to conclusions Best practices vs. minimum necessary requirements HIPAA = HANDCUFFS??? Utah Hospital Nurse Alex Wubbels handcuffed and taken into custody after refusing to permit police to withdraw blood from unconscious patient Wubbels followed hospital policy and HIPAA regulations, which permitted policy blood draws under three circumstances: Patient s authorization/consent Patient under arrest Search warrant Hospital administration supported Wubbels Foulston Siefkin 2017 7
HIPAA = HANDCUFFS??? HIPAA Law Enforcement Exception (42 C.F.R. 164.512(f)) Limited exception Mandatory disclosures required by law (e.g., wounds) Court orders Identification and location purposes Victims of crime Decedents Crime on premises Reporting crime in emergencies (not on premises) MEDICARE ENROLLMENT CMS may revoke a currently enrolled provider/supplier for a variety of reasons including: Noncompliance with Medicare enrollment requirements Conviction of a felony by the provider/supplier, owner, or managing employee Certification by the provider/supplier of misleading or false enrollment information Failure to satisfy Medicare reporting requirements Foulston Siefkin 2017 8
MEDICARE ENROLLMENT Grounds have been exercised with varying degrees of enforcement, but recently CMS has stepped up its enforcement efforts Increased scrutiny = more revocations Increased use of site visits Increased enforcement of untimely reporting of changes Reenrollment bar (1 3 years) Billing problems MEDICARE ENROLLMENT Case examples HHA s enrollment revoked for failure to effectively change business office address NP s enrollment revoked for failure to demonstrate appropriate certification, even though enrolled in Medicare prior to implementation of certification requirement Physician s enrollment revoked for failure to report closure of practice location HHA s enrollment revoked for failing site visit based on failure to provide notification that it had move one of its locations 8 months prior Physician and his group s enrollment revoked for abuse of billing privileges, even though no evidence of intent to defraud Foulston Siefkin 2017 9
MEDICARE ENROLLMENT More on the horizon? March 1, 2016 CMS Proposed Rule Requires disclosure of affiliations with individuals or entities that have experienced adverse actions Affiliate is defined broadly 5% or greater direct or indirect ownership interest of an individual or entity in another organization An interest in which an individual or entity exercises operational or managerial control over or directly or indirectly conducts the day to day operations of another entity MEDICARE ENROLLMENT March 1, 2016 CMS Proposed Rule Greatly expands denial, revocation, and reenrollment bar authority (including for failure to fully disclose information regarding affiliates) Reenrollment bar Increases reenrollment bar from 3 to 10 years Gives CMS discretion to impose an additional 3 year bar Creates an enrollment bar of up to 20 years for repeat revocations Foulston Siefkin 2017 10
MEDICARE ENROLLMENT Denial and revocation Providing services at location provider or supplier knew or should have known did not comply with enrollment requirements Egregious pattern or practice of physician ordering or referring services or drugs that is abusive or medically unnecessary Revoking enrollment for existing debt referred by CMS for collection by the Department of Treasury Failure to timely report any change in Medicare enrollment MEDICARE ENROLLMENT Proposed Rule effective date January 1, 2018???? CMS accepted public comment through April 25, 2016, but has made no move to issue a Final Rule Trump s Executive Order limiting new agency regulation may thwart issuance of the Final Rule Foulston Siefkin 2017 11
WHISTLEBLOWERS ABOUNDING 600 FCA New Matters 1 500 FCA New Matters 400 300 200 100 0 Qui Tam New Matters Non Qui Tam New Matters 1 New matters refers to newly received referrals, investigations, and qui tam actions. WHISTLEBLOWERS ABOUNDING $3.5 $3.0 $2.5 2015: $1.97B Since 1987: $31.1B FCA Settlements and Judgments 1 5straight years at $2B or above Billions of Dollars $2.0 $1.5 $1.0 $0.5 $11.4M in 1987 $0.0 Qui Tam (U.S. Intervened or Pursued) Qui Tam (U.S. Declined) Non Qui Tam 1 Non qui tam settlements and judgments do not include matters delegated to United States Attorney s offices (the Civil Division maintains no data on such matters). Foulston Siefkin 2017 12
WHISTLEBLOWERS ABOUNDING The scorned lovers of the healthcare industry. They often fall into one of two categories: Providers left out of improper arrangement Employees who have been consistently ignored or rebuked by management All personnel should take seriously any complaints or allegations Any allegation of improper or illegal conduct should be reported to compliance officer and appropriate administrative personnel and promptly addressed COMPLIANCE GOTCHAS AND EMERGING RISKS BROOKE BENNETT AZIERE & JUSTAN SHINKLE Foulston Siefkin 2017 13