202 General Compliance Hot Topics A Time to Reap and a Time to Sow

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1 202 General Compliance Hot Topics A Time to Reap and a Time to Sow Brian Flood, Partner Husch Blackwell LLP Regulators are being chided for their low return on investment and low collection of overpayments. What does this mean as they bring new enforcement and collection vendors online? Participation in incentive and pilot programs are being encouraged at the same time disincentives are being created in the system. How do you choose among the risks they create? Incentive programs like Meaningful Use, PQURI and electronic payment pilots are creating incentives to participate, but can also create overpayment and over promise issues. How do you update your program to keep up? 1

2 Regulatory Risks to Providers Challenging to provider stability and viability Increased risks of unexpected losses caused by regulatory actions Increased expenses to comply Failure to mitigate has more drastic consequences in the new regulatory scheme Providers have to understand and catch up with new theories 3 State Regulation & Enforcement HHS-Secretary Federal Regulation & Enforcement HHS OIG CMS Single State Agency: Program Integrity Unit State Pay and Chase Program (if separate from Single State Agency): NEW: Medicaid RACS AG Medicaid Fraud Control Units: funded by OIG Run by states Investigate and audit Federal Investigators/auditors/c ontractors PQRS, EPQRS, EHR, Meaningful USE and VBP CMS Integrity Group Medicaid Integrity Program (MIP) NEW: UPICs ZPICS & RACS State Auditor, Comptrol ler or IG 1A 1B 1C Medicaid & Medicare Providers Here is the Providers Future

3 Expected Outcomes CMS expects the UPIC initiative to generate an increased number of proactive, high quality, appropriate and timely administrative PI actions that are able to be sustained through any applicable administrative or legal review processes. CMS views such administrative actions, which stop inappropriate payments to providers and remove abusive or fraudulent providers from CMS programs, as a cornerstone of the agency s new PI strategy. 5 Duties Review of Providers The contractor shall use data-mining and analysis techniques to develop models that combines healthcare quality indicators, billing practices and Medicaid specific business rules to predict aberrant provider patterns to identify and rank by risk providers to be audited. The contractor will develop reporting tools that show ranked providers according to risk of fraud/overpayment problems with sufficient detail for auditors to begin their audits. 6 3

4 Audits: Audits of Providers, Fee for Service Providers, Managed Care Entities The Contractor shall plan individual audits of providers, including but not limited to fee for service providers, managed care entities, and individual providers and institutional providers of Medicaid services within the region. 7 Things to Think About Law360, New York (January 26, 2015, 6:11 PM ET) The U.S. Department of Health and Human Services on Monday announced a timeline for moving doctors and hospitals into new payment systems and tying Medicare reimbursement to quality of care, the first time regulators have laid out specific goals for such reforms HHS described its announcement as a historic development in the country s ongoing efforts to base payments on the efficiency with which health care providers operate and the extent to which they are successful in healing patients Under one element of Monday s announcement, HHS said it will try to link 85 percent of payments in Medicare Parts A and B to quality or value by 2016 and to link 90 percent of payments by 2018, compared with about 80 percent of payments that currently have some sort of link 4

5 Improper Payment Act Improper Payment Definition: (e) DEFINITIONS. Section 2 of the Improper Payments Information Act of 2002 (31 U.S.C note) as amended: (2) IMPROPER PAYMENT. The term improper payment (A) means any payment that should not have been made or that was made in an incorrect amount (including overpayments and underpayments) under statutory, contractual, administrative, or other legally applicable requirements; and (B) includes any payment to an ineligible recipient, any payment for an ineligible good or service, any duplicate payment, any payment for a good or service not received (except for such payments where authorized by law), and any payment that does not account for credit for applicable discounts. 9 Improper Payment Act (3) PAYMENT. The term payment means any transfer or commitment for future transfer of Federal funds such as cash, securities, loans, loan guarantees, and insurance subsidies to any non-federal person or entity, that is made by a Federal agency, a Federal contractor, a Federal grantee, or a governmental or other organization administering a Federal program or activity. (4) PAYMENT FOR AN INELIGIBLE GOOD OR SERVICE. The term payment for an ineligible good or service shall include a payment for any good or service that is rejected under any provision of any contract, grant, lease, cooperative agreement, or any other funding mechanism. 10 5

6 FERA-31 U.S.C The term "obligation" (to repay an overpayment) is defined as "an established duty, whether or not fixed " that arises from "a contractual, grantee, licensure or fee based relationship, from a statute or regulation, or from the retention of any overpayment." Under the FCA, "knowingly" is defined not only to comprise "actual knowledge" of a "falsity," but also includes "deliberate ignorance" or "reckless disregard" of the "truth or falsity" of a claim or statement. 31 U.S.C. 3729(b). 11 FERA-31 U.S.C FERA amends the "reverse false claims" provisions of the FCA to expand liability to "knowingly and improperly avoid[ing] or decreas[ing] an obligation to pay or transmit money or property to the government. In order to create a "reverse false claim" violation it is no longer required that the payor or provider be shown to have taken an "affirmative act": making a false statement or record. Instead, the mere ongoing possession of an overpayment, with an "obligation" to repay, can trigger an FCA violation and liability. 12 6

7 Summary - PPACA Section 6402 of the Act requires providers to report and return overpayments and to report in writing the reason that the overpayment occurred. The new law creates an affirmative and express obligation. Report of an overpayment must be made within 60 days after discovering the overpayment. The failure to report an overpayment could be deemed to be a false claim under the false claims act. Specific authorization to assess Civil Monetary Penalties is created for cases where a providers knows about an overpayment but does not report or return it. Section 6402 amends the Medicare Anti-Kickback Statute to clarify that claims for services resulting from a kickback constitute a false claim under the Federal False Claims Act. The element of intent under the Anti-kickback Statute is also statutorily modified to clarify that a specific intent to violate the anti-kickback statute is not required for a violation. 13 7

8 New Medicare Demands Spell Doom for Old Payment System Law360, New York (January 27, 2015, 6:08 PM ET) -- Medicare s newly announced plans to condition more payments on quality and value is another nail in the coffin of traditional reimbursement, What is virtually certain is that Medicare's move will spur similar changes in how private insurance plans structure their payments. According to the nonprofit Catalyst for Payment Reform, 40 percent of private insurance reimbursements last year were linked to quality, compared with about 10 percent the year prior, an increase that dovetails with Medicare's rising quality requirements. And CMS explicitly says it wants private plans to copy its approach. The agency on Monday announced it's creating a task force of sorts formally called the Health Care Payment Learning and Action Network to bring together government officials, private insurers, large employers, providers and other stakeholders to get in sync on quality-based payments. CMS Medicare Payment Reform 2015 Meaningful Use Using and EHR system PQRS and VBP 16 8

9 2014 Incentives 2016 Payment Adjustments PQRS Value Modifier EHR Incentive Program EPs 100+ EPs Incentive Pay Adj PQRS Reporting Non PQRS Reporting PQRS Reporting (Up or Neutral Adj) PQRS Reporting (Down Adj) Non PQRS Reporting Medicare Inc. Medicaid Inc. Medicare Pay Adj MD & DO DDM Oral Sur Pod. Opt. 0.5% of MPFS (1.0% with MOC) 2.0% of MPFS +2.0 (x), +1.0(x), or neutral 2.0% of MPFS +2.0 (x), +1.0(x), or neutral 1.0% or 2.0% of MPFS 2.0% of MPFS $4,000 $12,00 0 (based on when EP 1 st demo MU) $8,500 or $21,250 (based on when EP did A/I/U) $8,500 or $21,250 (based on when EP did A/I/U) N/A 2.0% of MPFS Chiro. 17 Mandatory Pay Reductions Federal Register / Vol. 78, No. 237 / Tuesday, December 10, 2013 / Rules and Regulations (e) Payment adjustments. For 2015 and subsequent years, with respect to covered professional services furnished by an eligible professional, if the eligible professional does not satisfactorily submit data on quality measures for covered professional services for the quality reporting period for the year (as determined under section 1848(m)(3)(A) of the Act), the fee schedule amount for such services furnished by such professional during the year (including the fee schedule amount for purposes for determining a payment based on such amount) must be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services under this paragraph (e). (1) The applicable percent is as follows: (i) For 2015, 98.5 percent. (ii) For 2016 and each subsequent year, 98 percent. (2) The Secretary must treat an individual eligible professional, as identified by a unique TIN/NPI combination, as satisfactorily submitting data on quality measures (as determined under paragraph (h) of this section), if the eligible professional is satisfactorily participating, in a qualified clinical data registry. 9

10 QRURs (Quality and Resource Use Reports) and the Value Modifier Medicare s version of physician profiling and P4P First QRURs went to large physician groups in 2012 Physicians in practices of 1-10 about to get first QRURs VM applies to entire Medicare revenue - 9% swing? 100 or more physicians - subject to the VM in 2015, based on CY 2013 performance. 10 or more physicians - subject to the VM in 2016, based on CY 2014 performance. VM does not apply to groups where any physician member in an ACO or CPPI in CY 2013 and All physicians in Fee-For-Service Medicare will be affected by the VM 19 starting in 2017, based on CY 2015 performance. Value Modifier: Quality composite and cost composite 10

11 CY 2017 Value-Based Payment Modifier Amounts Groups and solo practitioners eligible for an additional +1.0Å~ if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the top 25% of all beneficiary risk scores 21 What Information is Included on the Performance Highlights Page? 1. Your Quality Composite Score 2. Your Cost Composite Score 3. Your Beneficiaries Average Risk Score 4. Your Quality Tiering Performance Graph 5. Your Payment Adjustment Based on Quality Tiering (payment adjustments in example based on 2015 VM implementation) 22 11

12 Access to accurate, comprehensive data is increasingly key Only way to manage new payment models economic results depend on the variation between projected and actual experience, rather than on maximizing volume Only way to respond effectively to profiling to ensure publicly reported practice profiles are accurate, to use the data to improve practice quality and efficiency Only way to eliminate the currently inexplicable variation in treatment patterns 23 Former CFO indicted over fraudulent meaningful use claims - February 11, 2014 White faces up to seven years in prison. CFO of now closed Shelby Regional Medical Center in Texas, has been indicted for allegedly defrauding the federal government of nearly $800,000. Shelby was among thousands of providers that received payments through the government's meaningful use program. Under the program, health care providers who demonstrate meaningful use of certified electronic health record (EHR) systems can qualify for Medicaid and Medicare incentive payments. The indictment states that Shelby was granted $785,655 in January 2013 for successful demonstration of meaningful use during the 2012 full-year reporting period. In addition, the hospital had received $1.17 million in meaningful use payments from CMS in November He pled guilty November 12, 2014 The indictment alleges that he: Submitted the attestation while knowing the hospital did not meet the program's requirements and "only minimally used the EHR platform and continued to use paper records and charts as well as older, uncertified technology"; Directed the hospital's EHR vendor to input data into the system manually from paper records and other sources, even after the FY 2012 reporting period; and "[K]nowingly and willingly made materially false, fictitious and fraudulent statements and representations, and made and used false writings and documents" to defraud the EHR incentive program. 12

13 Question Number 1 What does it mean to possess EHR technology as mentioned in FAQ ? 13

14 ANSWER We consider possession of EHR technology certified to an edition of EHR certification criteria to be either the physical possession of the medium on which a certified Complete EHR, or certified EHR Module resides, or a legally enforceable right by an eligible health care provider to access and use, at its discretion, the capabilities of a certified Complete EHR or certified EHR Module. An eligible health care provider may determine the extent to which it will implement or use these capabilities, which will not affect the provider s possession of the certified Complete EHR or certified EHR Module. ANSWER An EP, EH, or CAH must possess all of a certified Complete EHR or certified EHR Module (i.e., the capabilities for which certification is required) in order to receive the benefit of such certification. An EP, EH, or CAH cannot purchase or possess only components of a certified Complete EHR or certified EHR Module for the purposes of meeting the CEHRT definition. That is, unless independently certified, those components could not be used to meet the CEHRT definition. 14

15 ANSWER We further explain this policy in FAQ 5 and in the 2014 Edition EHR certification criteria final rule (77 FR 54266). In the final rule, we also note that the possession policy does not apply to those capabilities that an EHR technology developer may include with those that constitute a certified Complete EHR or certified EHR Module but for which certification is not required. In those instances, because these other included capabilities are not required for certification, an EP, EH, or CAH, would not necessarily need to possess them if the EHR technology developer would separately sell them. Question Number 2 [EHR Incentive Programs] If data is captured using certified electronic health record (EHR) technology, can an eligible professional or eligible hospital use a different system to generate reports used to demonstrate meaningful use for the Medicare and Medicaid EHR Incentive Programs? 15

16 ANSWER By definition, certified EHR technology must include the capability to electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage for all percentage-based meaningful use measures (specified in the certification criterion adopted at 45 CFR (n)). However, the meaningful use measures do not specify that this capability must be used to calculate the numerators and denominators. Eligible professionals and eligible hospitals may use a separate, non-certified system to calculate numerators and denominators and to generate reports on the measures of the core and menu set meaningful use objectives. ANSWER Please note that eligible professionals and eligible hospitals cannot use a non-certified system to calculate the numerators, denominators, and exclusion information for clinical quality measures. Numerator, denominator, and exclusion information for clinical quality measures must be reported directly from certified EHR technology. For additional clarification about this, please refer to the following FAQ from the Office of the National Coordinator of Health Information Technology: onc_regulations_faqs/3163/faq_13/ For more information about the Medicare and Medicaid EHR Incentive Program, please visit 16

17 Question Number 3 [EHR Incentive Programs] Can an eligible professional (EP) use EHR technology certified for an inpatient setting to meet a meaningful use objective and measure? ANSWER Yes. For objectives and measures where the capabilities and standards of EHR technology designed and certified for an inpatient setting are equivalent to or require more information than EHR technology designed and certified for an ambulatory setting, an EP can use the EHR technology designed and certified for an inpatient setting to meet an objective and measure. 17

18 ANSWER [However,] There are some EP objectives, that have no corollary on the inpatient side. As a result, an EP must possess Certified EHR Technology designed for an ambulatory setting for such objectives. Please reference ONC FAQ and and CMS FAQ for discussions on what it means to possess Certified EHR Technology, ONC FAQ for a list of affected capabilities and standards, and how that relates to the exclusion and deferral options of meaningful use. To view the ONC FAQs, please visit: Question Number 4 [EHR Incentive Programs] To meet the meaningful use objective use computerized provider order entry (CPOE) for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, should eligible professionals (EPs) include hospital-based observation patients (billed under POS 22) whose records are maintained using the hospital's certified EHR system in the numerator and denominator calculation for this measure? 18

19 ANSWER If the patient has records that are maintained in both the hospital s certified EHR system and the EP s certified EHR system, the EP should include those patients seen in locations billed under POS 22 in the numerator and denominator calculation for this measure. If the patient s records are maintained only in a hospital certified EHR system, the EP does not need to include those patients in the numerator and denominator calculation to meet the measure of the use computerized provider order entry (CPOE) objective. For more information about the Medicare and Medicaid EHR Incentive Program, please visithttp:// Question Number 5 [EHR Incentive Programs] Does a provider have to record all clinical data in their certified EHR technology in order to accurately report complete clinical quality measure data for the Medicare and Medicaid EHR Incentive Programs? 19

20 ANSWER-Old Advice We recognize that providers are continuing to implement new workflow processes to accurately capture clinical data in their certified EHR technology, but many providers are not able to capture all data at this time. Although we encourage providers to capture complete clinical data in order to provide the best care possible for their patients, for the purpose of reporting clinical quality measure data, CMS does not require providers to record all clinical data in their certified EHR technology at this time. CMS recognizes that this may yield numerator, denominator, and exclusion values for clinical quality measures in the certified EHR technology that are not identical to the values generated from other methods (such as record extraction). However, at this time CMS requires providers to report the clinical quality measure data exactly as it is generated as output from the certified EHR technology in order to successfully demonstrate meaningful use. We will continue to collaborate with our partners in the Office of the National Coordinator for Health Information Technology and with industry stakeholders to make further headways in system interoperability, standards for EHR data, as well as certification of vendor products. For more information about the Medicare and Medicaid EHR Incentive Program, please visit Question Number 6 If a provider feeds data from certified electronic health record (EHR) technology to a data warehouse, can the provider report on Meaningful Use objectives and clinical quality measures from the data warehouse? 20

21 ANSWER To be a meaningful EHR user a provider must do three things: Have complete certified EHR technology for all meaningful use objectives either through a complete EHR or a combination of modules; and meet 20 measures (19 for eligible hospitals and CAHs), including all of the core and five (5) menu-set measures associated with the objectives (unless excluded). Core measures include reporting clinical quality measures. Use the capabilities and standards of certified EHR technology in meeting the measure of each objective. If the conditions above are met and data is transferred from the certified EHR technology to a data warehouse, the provider can use information from the data warehouse to report on Meaningful Use objectives and clinical quality measures. However, in order to report calculated clinical quality measures, the data warehouse may need to be certified. The Office of the National Coordinator of Health Information Technology has addressed the issue of certification of a data warehouse in the following Frequently Asked Question: For more information about certification, you can contact ONC directly at onc.certification@hhs.gov. For more information about the Medicare and Medicaid EHR Incentive Program, please visit Question Number 7 [EHR Incentive Programs] For the meaningful use objective of capability to exchange key clinical information for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, does exchange of electronic information using physical media, such as USB, CD-ROM, or other formats, meet the measure of this objective? 21

22 ANSWER No. The use of physical media such as a CD-ROM, a USB or hard drive, or other formats to exchange key clinical information would not utilize the certification capability of certified EHR technology to electronically transmit the information, and therefore would not meet the measure of this objective. For the purposes of the Stage 1 capability to exchange key clinical information measure, exchange is defined as electronic transmission and acceptance of key clinical information using the capabilities and standards of certified EHR technology (as specified at 45 CFR (i) for EPs and 45 CFR (f) for eligible hospitals and CAHs). We expect that this information would be exchanged in structured electronic format when available (e.g., drug or clinical lab data); however, where the information is available only in unstructured electronic formats (e.g., free text or scanned images), the exchange of unstructured information would satisfy this measure. For more information about electronic exchange of key clinical information, please refer to the following FAQ: ANSWER Please note that this objective is distinct from objectives such as provide a summary of care record for each transition of care, where electronic exchange of the summary of care record is not a requirement but an option. To satisfy the measure of the provide a summary of care record for each transition of care objective, a provider is permitted to send an electronic or paper copy of the summary care record directly to the next provider or can provide it to the patient to deliver. In this case, the use of physical media such as a CD-ROM, a USB or hard drive, or other formats could satisfy the measure of this objective. For more information about the Medicare and Medicaid EHR Incentive Program, please visit 22

23 Question Number 8 [EHR Incentive Programs] To meet the meaningful use objective capability to exchange key clinical information for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, can different providers of care (e.g., physicians, hospitals, etc.) share EHR technology and successfully meet this objective? ANSWER In order to meet this objective, clinical information must be sent between different legal entities with distinct certified EHR technology and not between organizations that share a certified EHR technology or organizations that are part of the same legal entity, since no actual exchange of clinical information would take place in these latter instances. Distinct certified EHR technologies are those that can achieve certification and operate independently of other certified EHR technologies. It is possible for different legal entities to meet this objective by using separate instances of the same certified EHR technology (e.g. both entities using separate license of the same program), subject to the following limitations: A different legal entity is an entity that has its own separate legal existence. Indications that two entities are legally separate would include (1) they are each separately incorporated; (2) they have separate Boards of Directors; and (3) neither entity is owned or controlled by the other. 23

24 ANSWER In order to be distinct certified EHR technology, each instance of certified EHR technology must be able to be certified and operate independently from all others. Separate instances of certified EHR technology that must link to a common database in order to gain certification would not be considered distinct. However, instances of certified EHR technology that link to a common, uncertified system or component would be considered distinct. Instances of certified EHR technology can be from the same vendor and still be considered distinct. The exchange of key clinical information requires that the eligible professional, eligible hospital, or critical access hospital (CAH) must use the standards of certified EHR technology as specified by the Office of the National Coordinator for Health IT, not the capabilities of uncertified or other vendor-specific alternative methods for exchanging clinical information. Question Number 9 [EHR Incentive Programs] To what attestation statements must an eligible professional (EP), eligible hospital, or critical access hospital (CAH) agree in order to submit an attestation, successfully demonstrate meaningful use, and receive an incentive payment under the Medicare Electronic Health Record (EHR) Incentive Program? 24

25 ANSWER Currently, the attestation process requires EPs, eligible hospitals, and CAHs to indicate that they agree with the following attestation statements: The information submitted for clinical quality measures (CQMs) was generated as output from an identified certified EHR technology. The information submitted is accurate to the knowledge and belief of the EP or the person submitting on behalf of the EP, eligible hospital, or CAH. The information submitted is accurate and complete for numerators, denominators, exclusions, and measures applicable to the EP, eligible hospital, or CAH. The information submitted includes information on all patients to whom the measure applies. For CQMs, a zero was reported in the denominator of a measure when an EP, eligible hospital or CAH did not care for any patients in the denominator population during the EHR Reporting Period. ANSWER CMS considers information to be accurate and complete for CQMs insofar as it is identical to the output that was generated from certified EHR technology. Numerator, denominator, and exclusion information for CQMs must be reported directly from information generated by certified EHR technology. By agreeing to the above statements, the EP, eligible hospital, or CAH is attesting that the information for CQMs entered into the Registration and Attestation System is identical to the information generated from certified EHR technology. CMS does not require EPs, eligible hospitals, or CAHs to provide any additional information beyond what is generated from certified EHR technology in order to satisfy the requirement for submitting CQM information. 25

26 ANSWER Please note that quality performance results for CQMs are not being assessed at this time under the EHR Incentive Programs. Complete and accurate information for the remaining meaningful use core and menu set measures does not necessarily have to be entered directly from information generated by certified EHR technology. By definition, for each meaningful use objective with a percentage-based measure, certified EHR technology must include the capability to electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage for these measures. However, with the exception of CQMs, meaningful use measures do not specify that this capability must be used to calculate the numerators and denominators. EPs, eligible hospitals, and CAHs can use a separate, uncertified system to calculate numerators and denominators and to generate reports on all measures of the core and menu set meaningful use objectives except CQMs. ANSWER In order to provide complete and accurate information for certain of these measures, they may also have to include information from paper-based patient records or from records maintained in uncertified EHR technology. By agreeing to the above statements, the EP, eligible hospital, or CAH is attesting to providing all of the information necessary from certified EHR technology, uncertified EHR technology, and/or paper-based records in order to render complete and accurate information for all meaningful use core and menu set measures except CQMs. For more information about the Medicare and Medicaid EHR Incentive Program, please visit 26

27 CMS intends to modify requirements for Meaningful Use - January 29, 2015 Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce our intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in These intended changes would help to reduce the reporting burden on providers, while supporting the long term goals of the program.expected this Spring Today s announcement that we intend to pursue the changes to meaningful use beginning in 2015 through rulemaking, is separate from the forthcoming Stage 3 proposed rule that is expected to be released by early March. CMS intends to limit the scope of the Stage 3 proposed rule to the requirements and criteria for meaningful use in 2017 and subsequent years. 27

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36 Brian Flood Partner Austin, Texas Thank You 36