Healthcare Regulatory Issues We Wish We d Never Heard of Robert G. Homchick, Davis Wright Tremaine, LLP William W. Horton, Johnston Barton Proctor & Rose LLP #1 Will Tuomey Happen to Me? The problem: We gotta keep the docs Wait a minute: That bona fide employee exception might work! And no one understands indirect comp anyway! And all we need is a legal opinion. And all the lawyers need is a fair market value opinion. After all, what s the worst that can happen? And remember, a lawyer may discuss the legal consequences of any proposed course of conduct with a client and may counsel or assist a client to make a good faith effort to determine the validity, scope, meaning or application of the law. 1
#2 Halifax s Folly Stark Statute focuses on Medicare Separate law denies state Medicaid programs federal financial participation if state Medicaid pays for services that would not be paid for by Medicare CMS states However, we do not believe that these rules and sanctions [Stark s referral and billing prohibitions] apply to physicians and providers when the referral involves Medicaid services. 63 Fed. Reg at 1704 Halifax case: When the Hospital billed Medicaid for services referred by tainted physician, the hospital caused the state to submit a false claim to the Federal government for federal financial participation dollars Aberration? Really? Other cases follow suit #3 QHP + CMS + AKS= WT_? Qualified Health Plans (QHPs) participate in the Insurance Exchanges QHPs are federally subsidized Open question whether QHPs were federal health care benefit programs and thus subject to AKS and other federal statutes Hospitals, drug companies and others interested in subsidizing premiums of QHP enrollees Secretary Sebelius Letter: QHPs not subject to AKS CMS Q&A: Hospitals and other Providers should not subsidize premiums Make up your mind... 2
#4 Two Midnight Tango Inpatient vs. Outpatient A longstanding controversy exacerbated by RACs Observation a source of nothing but confusion CMS Solution FY 2014 IPPS Qualify for Part A inpatient reimbursement if at the time of admission physician had expectation that patient s stay would cross two midnights or include services on the Inpatient Only list Intensity of services or severity of patient s condition not relevant Exception for unforeseen circumstances such as death? Only rare and unusual circumstances justify short inpatient stays #4 Two Midnight Tango Physician Order and Certification A physician order is required to initiate inpatient status But two midnight clock starts when patient starts receiving care. Physician certification authentication of the practitioner order (certifying that the hospital inpatient services were reasonable and necessary), the reason for inpatient services, and the estimated time the beneficiary is required to spend in the hospital The order for inpatient admission starts the certification, and must be documented in the medical record before the patient is discharged Stay less than 2 midnights billed under Part B as outpatient services Can change Part A inpatient claim to Outpatient claim but must make decision within one year of date of service Probe & Educate Period 3
#5 Too Much Swearing Certify, certify, certify SDP, SRDP, CIA, DPA, Sunshine Act, 855s, on and on False Claims Act false certification" cases express vs. implied condition of payment/material to getting claim paid How reliable is the pyramid of certifications? What certifications may a lawyer rely upon? #6 60 Ways to Count 60 Days ACA includes a provision which requires providers to disclose and repay overpayments within 60 days after the date on which the overpayment was identified Failure to report and return overpayment within the 60 day period triggers reverse false claims liability under the FCA When is an overpayment identified? Draft Regulations issued by CMS in February 2012 Wide range of opinions on when overpayment is identified 4
#7 I m High Value, Not Narrow Pressure under health care reform to reduce costs and improve quality Response: Development of High Value Networks Exchanges see narrow networks in Qualified Health Plans But then... United Healthcare Lawsuit, State AG objections, cries of desperation from some providers Payors start to offer in other contexts More to come? Will the political and public pressure deter High Value Networks? #8 Made Me Do It EPIC 2010: Government promotes Electronic Medical Records 2013 EHR Promotes Fraud Stark/AKS exception Meaningful use Total Investment of $17 Billion as of 2013 Statements of CMS and OIG OIG Report on Evils of EHR Technology The OIG Report identifies flaws in the oversight of the ambitious federal program aimed at converting patient records from paper to electronic. charges that the Federal government has failed to put safeguards in place to prevent [EHR] technology from being used for inflating costs and overbilling. criticizes the lack of guidelines around the widely used copy and paste function, also known as cloning, available in many of the largest electronic health record systems. 5
Electronic Health Records The OIG Report also focuses on the audit log 44% of hospitals surveyed allowed users to delete the audit log 35% of hospitals surveyed had disabled the audit log 11% of hospitals surveyed allow any user to freely edit the EMR Some language duplication is inevitable cut and paste can be fine It can also go too far... #9 Where the Sunshine Act Don t Shine ACA requires drug, device, biological and supply manufacturers to report on payments to / financial relationships with docs and teaching hospitals. All kinds of good data: For example, CMS explains when meals are subject to disclosure, who is included in the meal, and how to allocate the value of the meal among the appropriate individuals. Forbes, 2/11/13 Data to be reported and made public. But who will interpret it, how will it be used, and how will it be misused? I m just a doc whose intentions are good/oh Lord, please don t let me be misunderstood What are the implications for Hospitals? 6
#10 Miley Cyrus Can I unsee that? 7