Source: https://www.retinalphysician.com/issues/2016/june-2016/the-affordable-care-act-8217;s-next-step
Timestamp: 2019-04-22 05:59:51+00:00

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The Medicare 60-day overpayment rule is now final. What does it mean for retinal physicians?
Medicare requires physicians and other providers to report and return any Medicare overpayments within 60 days of identifying this overpayment.1 The government has finally issued what it considers the definitive guidance on exactly how retinal physicians are expected to comply with this requirement, which became effective on March 14, 2016.2 The purpose of this article is to provide background on how we got to where we are today, as well as specific steps you should be taking now to minimize liability under the law.
Dennis Hursh is managing partner of Hursh & Hursh, P.C., a Pennsylvania law firm that serves the needs of physicians and medical practices. He is a member of the American Health Lawyers Association, where he is involved in the Physician Organizations Practice Group. Mr. Hursh can be reached via the Hursh & Hursh Web site at www.PAHealthLaw.com.
The Proposed Rule also attempted to give some guidance as to when an overpayment was “identified.” Specifically, the Proposed Rule provided that “a person has identified an overpayment if the person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the overpayment.”12 Although this definition (and the numerous examples given in the Proposed Rule)13 helped somewhat, it obviously was not completely definitive.
Although the court recognized that “requiring the reporting and returning of overpayments within 60 days of such notice imposes an enormous burden on providers that may often be impossible to meet,”15 the only consolation offered to physicians by the court was its admonition that “prosecutorial discretion would counsel against the institution of enforcement actions aimed at well-intentioned healthcare providers working with reasonable haste to address erroneous overpayments.”16 In other words, although this may be an impossible obligation, physicians should hope for mercy on the part of governmental regulators. This court case was hardly a prescription for a good night’s sleep for those of us tasked with advising physicians!
This is the point where you are no doubt expecting me to lay out the final, definitive, clear, and unambiguous guidance provided by CMS. Unfortunately, although the final rule clarifies many issues regarding the 60-day rule, there are still some gray areas.
With these two concepts, it is possible to develop a timeline for when an overpayment needs to be reported, and the steps a retinal physician should be taking to assure compliance with the 60-day rule.
• Medicare payments for noncovered services.
• Medicare payments in excess of the allowable amount for an identified covered service.
• Errors and nonreimbursable expenditures in cost reports.
• Receipt of Medicare payment when another payor had the primary responsibility for payment.
WHEN IS AN OVERPAYMENT “IDENTIFIED”?
One of the biggest questions concerning the 60-day rule has been exactly when an overpayment is “identified,” which starts the 60-day clock ticking. The statute does not give any guidance in this regard.21 The final rule attempts to answer this question as follows.
That sounds scary, doesn’t it? In fact, though, if you parse through the legalese, there are a few rays of sunshine in this pronouncement. Since the New York Federal District Court had previously held that the clock starts running as soon as you have notice of a potential overpayment,23 this regulation actually provides significant relief. The new regulation makes it clear that you are given time to analyze a suspected overpayment, investigate the background of the overpayment, and quantify that overpayment. Only then does the 60-day clock started ticking.
False claim liability can be asserted by a private person (eg, the billing person you fired for gross incompetence).29 This means that you must assume that the “walls have eyes” in your practice.
Moreover, as I have previously written,30 the ACA’s “Sunshine Act”31 has led to massive scrutiny of retinal physicians, since the amount of money you are reported as receiving from Medicare includes drug reimbursement, even though 94% of that reimbursement was paid to the drug company.32 Because of the extraordinarily expensive drugs utilized by retinal physicians, such as ranibizumab (Lucentis, Genentech, South San Francisco, CA), ophthalmology has been identified in the work plan of the Health and Human Services Office of the Inspector General since 2013.33 The work plan lists the office’s targets for fraud investigations in the coming fiscal year, and once a specialty is on the work plan, it will probably stay on the work plan.34 This means that retinal physicians are likely to stay in the crosshairs of governmental investigators for the foreseeable future.
An appropriate compliance plan is now more critical than ever. CMS has made it clear that you must exercise “reasonable diligence” in determining overpayments.”38 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 and in a timely manner by qualified individuals in response to obtaining credible information of a potential overpayment.”39 In other words, you cannot just sit back and wait for evidence of a potential overpayment to present itself — you must have a reasonable compliance plan in place to proactively search for potential problems.
• Enforcing disciplinary standards through well-publicized guidelines.
1. 42 U.S.C. § 1320a-7k(d).
2. The rule was promulgated in the Federal Register on February 12, 2016. 81zFR 7653.
6. 42 U.S.C. § 1320a-7k(d).
21. 42 U.S.C. § 1320a-7k(d).
22. 42 CFR § 401.305(a)(2).
23. See Kane, supra, note xiv.
26. 42 U.S.C. § 1320a-7k(d)(3).
27. 31 U.S.C. § 3729.
28. 31 U.S.C. § 3729(a)(1)(G).
29. 31 U.S.C. § 3730(b).
30. Hursh J. The Affordable Care Act and retina. Retin Phys. 2015:12(6):44-46.
31. Enacted as §6002 of the ACA.
33. Page L. 8 ways the ACA could affect your ophthalmology practice. Medscape Web site. Available at: http://www.medscape.com/viewarticle/810516. Accessed May 1, 2016.
38. 42 CFR § 401.305(a)(1)(2).
41. See the OIG guidance for small physician practices, at http://oig.hhs.gov/authorities/docs/physician.pdf.

References: § 1320
 § 1320
 § 1320
 § 401
 § 1320
 § 3729
 § 3729
 § 3730
 §6002
 § 401