MACRA Released

On Friday, CMS released the MACRA final rules, its innovative payment system for Medicare replacing the sustainable growth rate formula and the EHR Incentive Program for Medicare providers.

MACRA creates the framework for providers to participate in the CMS Quality Payment Program through either the Advanced Alternative Payment Models (Advanced APMS) or the Merit-based Incentive Payment System (MIPS). The goal of these models is to reward value and outcomes, specifically supporting CMS’ goal of paying for quality and value. The MIPS program importantly consolidates components of PQRS, the Physician Value-based Payment Modifier (“VM”), and the EHR Incentive Program (aka meaningful use).

“As prescribed by Congress, MIPS will focus on: quality – both a set of evidence-based, specialty-specific standards as well as practice-based improvement activities; cost; and use of certified electronic health record (EHR) technology (CEHRT) to support interoperability and advanced quality objectives in a single, cohesive program that avoids redundancies. Many features of MIPS are intended to simplify and integrate further during the second and third years.”

Though the new rule becomes effective on January 1st, 2017, clinicians will be given a transition period in which to prepare for MIPS, with negative payment adjustments not occurring until January 1, 2019. MACRA will sunset payment adjustments under the Medicare EHR Incentive Program, PQRS and VM after CY2018. For those clinicians not ready to start on January 1st, 2017 they have until October 2, 2017 to commence participation. Regardless of when a clinician starts he/she needs to submit performance data by March 31, 2018.

CMS’ Quality Payment Program has the following strategic objectives:

(1) to improve beneficiary outcomes and engage patients through patient-centered Advanced APM and MIPS policies;

(2) to enhance clinician experience through flexible and transparent program design and interactions with easy-to-use program tools;

(3) to increase the availability and adoption of robust Advanced APMs;

(4) to promote program understanding and maximize participation through customized communication, education, outreach and support that meet the needs of the diversity of physician practices and patients, especially the unique needs of small practices;

(5) to improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; and

(6) to ensure operational excellence in program implementation and ongoing development.

CMS also launched a new website with graphics to aid in understanding the MACRA regulations. The view the interactive website click here.

CMS has also provided a 24-page executive summary. Click here to view the executive summary.

If you have questions about MACRA please contact Elana Zana.

 

Overpayment Rule Sets 6 Year Lookback

Nearly 6 years after the passage of the Affordable Care Act, CMS published the final 60 day rule for Medicare Parts A and B overpayments. The rule requires a person who has received an overpayment to report and return the overpayment to HHS, the State, an intermediary, a carrier or a contractor within 60 days after the date the overpayment was identified or the due date of any corresponding cost report, as applicable. The final rule is codified at 42 CFR 401.301 – 305; 401.607. Failure to properly identify and return overpayments may lead to liability under the False Claims Act.

The Final Rule sets a 6 year lookback period and clarifies what it means to identify an Overpayment. Prior to publication of the Final Rule, CMS previously published final rules for Medicare Parts C and D. As we previously reported, the New York District Court considered the “identification issue” in Kane v. Healthfirst, Inc. Unlike the Final Rule, the Court in Kane did not allow for quantification of an overpayment prior to commencement of the 60 day clock.

A. Ten Year Lookback Burden ‘Reduced’ to Six Years.

As we described in a February 2012, blog post, CMS initially proposed a ten year lookback period. The final rule eases this burden and requires that an overpayment be reported and returned within six years of receipt of the overpayment. In CMS’s view, “[c]reating this limitation for how far back a provider or supplier must look when identifying an overpayment is necessary in order to avoid imposing unreasonable additional burden or cost on providers and suppliers. Yes, 6 years is better than 10, but CMS declined to adopt a 4 year lookback as contained in the current reopening rules at 42 CFR 405.980. In reaching the 6 year rule, it appears that CMS contemplated burden, statutes of limitation in enforcement statutes, and state law record retention rules that require providers to retain records for 6 or 7 years.

B. Clarification of Meaning of ‘Identification’ of An Overpayment.

When does the 60 day clock start? The ACA provides that an overpayment must be reported and returned by the later of (i) the date which is 60 days after the date on which the overpayment was identified; or (ii) the date any corresponding cost report is due, if applicable. The Final Rule clarifies that “a person has identified an overpayment when the person has, or should have through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount of the overpayment.” 81 Fed. Reg. 7654. Conversely, the Final Rule provides that “a person should have determined that the person received an overpayment and quantified the overpayment if the person fails to exercise reasonable diligence and the person in fact received an overpayment.” 81 Fed. Reg. 7661, 7683. Moreover, it identifies specific examples of where an overpayment may be identified. 81 Fed. Reg. 7659.

1. Reasonable Diligence in Quantifying an Overpayment – The commentary to the Final Rule provides guidance on what constitutes reasonable diligence. In terms of quantifying an overpayment, reasonable diligence is demonstrated “through the timely, good faith investigation of credible information, which is at most 6 months from receipt of the credible information, except in extraordinary circumstances.” Extraordinary circumstances are fact specific but may include unusually complex matters. Reasonable diligence in the Final Rule replaced the concept of “all deliberate speed” in the proposed rule.

2. Reasonable Diligence Through Compliance Activities – Under the Final Rule, reasonable diligence includes both proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments and investigations conducted in good faith in a timely manner by qualified individuals in response to obtaining credible information of a potential overpayment. The Final Rule admonishes the provider and supplier community to engage in meaningful compliance activities:

We believe that undertaking no or minimal compliance activities to monitor the accuracy and appropriateness of a provider or supplier’s Medicare claims would expose a provider or supplier to liability under the identified standard articulated in this rule based on the failure to exercise reasonable diligence if the provider or supplier received an overpayment.

81 Fed. Reg. 7661.

C. Reporting.

A person will satisfy the reporting obligations by making a disclosure under the OIG’s Self-Disclosure Protocol or the CMS Voluntary Self-Referral Disclosure Protocol. Otherwise, providers are required to use “an applicable claims adjustment, credit balance, self-reported refund, or other reporting process set forth by the Medicare contractor to report an overpayment.” Those SRDPs submitted prior to the effective date of the Final Rule will still be governed by the 4-year lookback period. Going forward the 6-year look back period will apply, though CMS still needs to modify this period with the OMB with regard to the financial analysis they are allowed to collect under the Paperwork Reduction Act. Therefore, at this point providers may voluntarily provide information for the 5th and 6th year. 81 Fed. Reg. 7673.

D. Conclusion.

In light of the Final Rule, providers should evaluate their compliance and auditing activities and evaluate the extent to which they could demonstrate “reasonable diligence.” In general, providers should work diligently to quantify and report overpayments by no later than 8 months (6 months to quantify, 2 months to report).

Adam Snyder is Chair of the Ogden Murphy Wallace Business Department and is a Part-time/Adjunct Faculty member of the University of Washington School of Law. For additional information regarding the Medicare 60 Day Overpayment Rule, Corporate Compliance, or internal investigations, please contact Adam Snyder.

Naughty or Nice – 60 Day Overpayment Reporting Rule

According to a recent New York District Court decision, whether providers are subjected to an enforcement action under the False Claims Act for failing to report and return an overpayment within the sixty-day window should turn on whether they have been naughty or nice after learning of the potential of an overpayment.  In this case, at least at the motion to dismiss stage, the court concluded that the providers had been naughty, which, based on the factual recitations seemed a pretty easy call.  Essentially, the providers were alerted to the potential of substantial overpayments by an employee tasked with examining an overpayment issue.  Four days after providing his employer with a spreadsheet detailing the overpayments, the employee was fired and his spreadsheet “filed”.  A couple months later, the employee filed his qui tam action in which the United States and the state of New York eventually intervened.

 

Naughty or nice became important because of the court’s analysis of what constitutes “identification” of an overpayment for purposes of triggering the 60 day report and return obligation.  In this regard, according to the decision, at least one thing is certain.  The answer is not when the amount of the overpayment is finally calculated with certainty.  In response to this argument by the defendants, the court observed this would create ” . . . a perverse incentive to delay learning the amount due . . . relegating the sixty-day period to merely the time within which they would have to cut the check.”

 

The Government took the position that an overpayment is identified when the recipient is put on notice that a certain claim may have been overpaid.  The court agreed that defining “identified”  ” . . . such that the sixty day clock begins ticking when a provider is put on notice of a potential overpayment , rather than when the overpayment is conclusively ascertained, is compatible with the legislative history of the FCA and the FERA highlighted by the Government.”

 

The court characterized the rule derived from a review of legislative history as “unforgiving”, noting that it provides no leeway for the recipient of an overpayment who ” . . . struggles to conduct an internal audit, and reports its efforts to the Government within the sixty-day window, but has yet to isolate and return all overpayments sixty-one days after being put on notice of potential overpayments.”  ”  . . .it nowhere requires the Government to grant more leeway or more time to a provider who fails timely to return an overpayment but acts with reasonable diligence in an attempt to do so.”  Any relief for the provider that is diligently attempting to determine whether the potential overpayment is factually and legally an actual overpayment and, if so, the amount of the overpayment to be returned rests with prosecutorial discretion, which according to the court, ” . . . would counsel against the institution of enforcement actions aimed at well-intentioned health care providers working with reasonable haste to address erroneous overpayments” because in such a  situation the provider would not have acted with reckless disregard, deliberate ignorance or actual knowledge of the overpayment, a requirement of a FCA claim.

 

In fact, in comments to the court in this case, the Government made clear that this was not a case of a provider working diligently on the claims and on the sixty-first day is still scrambling with its spreadsheets.  “You know, the Government wouldn’t be bringing that kind of claim.”

So the moral of the story is if a messenger notifies you of a potential overpayment, be nice, act with diligence to investigate and quantify any overpayment, and for goodness sake don’t shoot the messenger.

To learn more about refunding overpayments please contact Greg Montgomery or Adam Snyder.

 

ICD-10, Two-Midnight Rule, RAC Audits, SGR Delayed

The Senate passed this evening the “Protecting Access to Medicare Act of 2014“, which creates a 12 month delay for pending Medicare cuts pursuant to Medicare’s sustainable growth rate (SGR) payment formula. This bill avoids the 24% Medicare cuts physicians were facing starting on April 1st (this will be the 17th delay of the SGR).  Another significant component of the Act includes the delay in ICD-10 implementation, until at least October 1, 2015.

In addition to these significant postponements, the Act also delays until March 2015 the implementation of the “two-midnight” rule and the recovery audits of unnecessary claims.

Increased OIG Focus on Kwashiorkor Claims

In its recently released 2014 Work Plan, the OIG has announced that it will investigate hospital billing for Kwashiorkor.  Kwashiorkor is a form of severe protein malnutrition that generally affects children living in tropical and subtropical parts of the world during periods of famine or insufficient food supply. This syndrome is characterized by retarded growth, changes in skin and hair pigment, edema, and pathologic changes in the liver.

This extreme form of malnutrition, however, is very rare in the United States, which is why Kwashiorkor billing at hospitals is a target of the OIG. Because a diagnosis of Kwashiorkor on a claim also substantially increases a hospital’s reimbursement from Medicare, the OIG stated it would review Medicare payments based on Kwashiorkor claims to determine whether the diagnosis is adequately supported by documentation in the medical record.

Recently, for example, the OIG found that Wellspan York Hospital incorrectly billed Medicare inpatient claims with Kwashiorkor, resulting in overpayments of $204,000 over two years. The hospital attributed the errors to a misinterpretation of the coding guidelines for malnutrition because of a lack of clarity in the guidance.  Other hospitals, like Mercy Medical Center, have attributed Kwashiorkor errors to encoder software which incorrectly assign diagnoses of protein malnutrition to ICD-9-CM 260 (Kwashiorkor).

In light of the increased OIG focus on Kwashiorkor claims, hospitals should strengthen its controls to ensure that coding software and staff comply with Medicare billing requirements. Additionally, if there is in fact a Kwashiorkor diagnosis, hospitals should ensure that the medical record (e.g. discharge summary) substantiates the use of a Kwashiorkor diagnosis code.

For additional information regarding Kwashiorkor billing or the 2014 OIG Workplan please contact Adam Snyder or Jefferson Lin.

 

Want to Get Paid for Inpatient Admissions? Follow CMS Certification Requirements.

In its final regulations for the 2014 Inpatient Prospective Patient System, the Centers for Medicare and Medicaid Services emphasized the importance of physician certifications. Under the regulations, Medicare will only pay for an inpatient admission if a physician certifies the medical necessity for the stay. The first piece of such certification is for the physician to complete an inpatient order when he or she expects that the patient will require a stay that crosses at least two midnights.

In addition to the order, physician certification for the inpatient stay also must include the following information:

  • Certification that the inpatient services were ordered in accordance with the Medicare regulations governing the order;
  • The reasons for either: (1) hospitalization of the patient for inpatient medical treatment or medically required inpatient diagnostic study; or (2) special or unusual services for cost outlier cases under the inpatient prospective payment system;
  • The estimated time the beneficiary requires or required in the hospital;
  • The plans for post hospital care, if appropriate, and as provided in the Medicare regulations; and
  • For Critical Access Hospitals (CAHs), the physician must certify that the patient will reasonably be expected to be discharged or transferred to a hospital within 96 hours after admission to the CAH.

Physicians must complete all certification for the inpatient stay prior to patient discharge. In order to help ensure Medicare payment for inpatient admissions, hospitals should educate physicians on the importance of certifications, and provide assistance to physicians in gathering necessary documentation.

CMS has prepared a guidance document about hospital inpatient admission orders and certification. For more information about inpatient admission certification, please contact Casey Moriarty.

OIG Launches New Online Submission Process for the Self-Disclosure Protocol

On July 8th, the Office of Inspector General (OIG) launched a new online submission process for the Self-Disclosure Protocol (SDP).  The SDP allows health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving federal health care programs, including Medicare and Medicaid.   The OIG has stated that individuals and entities that utilize the SDP will pay a lower amount of damages for violations than would normally be required in resolving a government-initiated investigation.

You can access the online submission process here.

The OIG hopes that the online submission tool for the SDP will streamline the process for providers that want to resolve violations without the time and expense of a government-directed investigation.  With that said, we suggest that providers have an attorney analyze any potential SDP issues prior to completing the online form.  As always, the health law attorneys at OMW are happy to help.

For more information about the SDP online submission process please contact Casey Moriarty.

OIG ISSUES SPECIAL FRAUD ALERT ON PHYSICIAN-OWNED DISTRIBUTORSHIPS

On March 26, 2013, the Office of Inspector General (“OIG”) issued a Special Fraud Alert regarding physician-owned entities or distributorships (referred to as “PODs”) that generate revenue from the use of implantable medical devices ordered by their physician-owners for use in procedures performed by such physician-owners at hospitals or ambulatory surgery centers (“ASCs”).

While the Special Fraud Alert focuses on certain characteristics of PODs that create substantial risk of fraud and abuse and potential danger to patient safety, the OIG cited other prior pronouncements and guidance it issued over the past twenty-four years regarding its long-standing concern over physician investments in entities to which they refer.  Prior OIG guidance cited included the 1989 Special Fraud Alert on joint Venture Arrangements, published in 1994  and a letter dated October 6, 2006, regarding physician investments in the medical device industry.

It is clear that the OIG believes that significant risk of patient or program abuse, including but not limited to potential violations of the Federal Anti-Kickback statute, may flow from arrangements between and among physicians, device manufacturers and other device vendors.  The Anti-Kickback statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, referrals of items or services reimbursable by a Federal health care program.

In its current Special Fraud Alert regarding physician-owned entities, the OIG recounted its view of certain questionable features regarding selection and retention of investors, solicitation of capital contributions, and distribution of profits, all of which potentially raise four general concerns typically associated with kickback arrangements:

1.  Corruption of medical judgment;

2.  Over-utilization;

3.  Increased costs to the Federal health care programs and beneficiaries; and

4.  Unfair competition.

The OIG is particularly concerned in this arena because the physician may play a significant role in the selection of the type of device and which manufacturer to use.  The OIG cautions that disclosure of financial interest may not be sufficient to cure what would otherwise amount to fraud and abuse, and identifies the following specific characteristics of arrangements that would cause concern:

— The size of the investment offered varies with anticipated volume or value of devices used by the physician.

— Distributions are made on the basis of volume as opposed to ownership interest.

— Conditioning referrals based on the use of certain devices on entities to which physicians refer.

— Arrangements that incentivize a physician’s use of certain devices or penalizes the physician for the failure to use certain devices.

— PODs ability to buyout physicians interests on favorable terms based on physician’s failure to meet certain volume requirements.

— The POD is a shell entity that is not truly engaged in the business, or provides no oversight related to distribution functions.

— Physicians fail to identify conflicts of interest through their involvement with PODs related to Hospital or ASC conflict of interest processes.

This Special Fraud Alert reiterates the OIG’s longstanding position that a physician’s ability to profit from referrals may lead to violations of the Federal Anti-Kickback statute.  Finally, the OIG reminds concerned parties that the OIG Advisory Opinion process is available.   For more information about physician-owned entities, the applicability of the Anti-Kickback statute, and the OIG Advisory Opinion process, please contact Adam Snyder or Don Black at (206) 447-7000.

Assigning Patients to ACOs

A hotly contested area of the proposed ACO rules concerns the assignment of Medicare Fee-for-Service (“FFS”) beneficiaries to ACOs.  Once a Medicare beneficiary is assigned to an ACO, the ACO will then be held accountable “for the quality, cost and overall care” of that beneficiary.  The ACO may also qualify to receive a share of any savings that are realized in the care of these assigned beneficiaries due to appropriate efficiencies and quality improvements that the ACO may be able to implement.

As the final rule explains, assigning Medicare beneficiaries requires several elements:

  1. An operational definition of an ACO, as opposed to a formal definition of an ACO, so that ACOs can be efficiently identified, distinguished, and associated with the beneficiaries for whom they are providing services;
  2. A definition of primary care services for purposes of determining the appropriate assignment of beneficiaries;
  3. A determination concerning whether to assign beneficiaries to ACOs prospectively, at the beginning of a performance year on the basis of services rendered prior to the performance year, or retrospectively, on the basis of services actually rendered by the ACO during the performance year; and
  4. A determination concerning the proportion of primary care services that is necessary for a beneficiary to receive from an ACO in order to be assigned to that ACO, as compared to the proportion of primary care services from other ACOs or non-ACOs.