The OIG published a notice today announcing that it is extending the public comment period on its July 11, 2014 notice soliciting recommendations for revising OIG's non-binding criteria for implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. The OIG notes that due to a technical problem, the public may have been unable to submit comments during the original comment period. The new comment deadline is December 29, 2014.
Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.
The Client Alert is available here.
OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy
Today the OIG and CMS published a joint notice continuing the effectiveness of fraud and abuse law waivers granted in 2011 in connection with the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs).
By way of background, in a November 2, 2011 joint OIG-CMS interim final rule with comment period, the agencies established waivers of the application of the federal physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law provisions to specified arrangements involving ACOs participating in the Shared Savings Program (the Waiver IFC). In 2011 Reed Smith prepared an in-depth analysis of the Medicare Shared Savings Program, including an analysis of the Waiver IFC. Because of a general 3-year deadline for publishing Medicare final rules after the publication of a proposed or interim final rule, the agencies are extending the timeline for publication of a final rule concerning Shared Savings Program waivers to avoid “creating legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupting ongoing business plans or operations of some ACOs.” The notice also states that CMS is developing a proposed rule to make certain modifications to the Shared Savings Program regulations; in order to ensure that the final waiver regulations align with the Shared Savings Program rules, the agencies believe “the prudent course of action at this time is to extend the effectiveness of the Waiver IFC.” Thus the Waiver IFC will remain in effect through November 2, 2015, unless a final waiver rule becomes effective on an earlier date.
In the notice, the agencies also suggest that they would benefit from additional stakeholder input to inform their understanding of:
- how and to what extent ACOs are using the waivers;
- whether the existing waivers serve the needs of ACOs and the Medicare program;
- whether the waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
- whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking.
No deadline is specified for providing feedback on these considerations.
OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing
The OIG has just released a major proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rule to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute. In particular, with regard to the AKS, the OIG proposes:
- a technical correction to the existing safe harbor for referral services;
- protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries, and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services;
- protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
- protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
- protection for free or discounted local transportation services that meet specified criteria.
The OIG also proposes to amend the definition of “remuneration” in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:
- copayment reductions for certain hospital outpatient department services;
- certain remuneration that poses a low risk of harm and promotes access to care;
- coupons, rebates, or other retailer reward programs that meet specified requirements;
- certain remuneration to financially needy individuals; and
- copayment waivers for the first fill of generic drugs.
The OIG also proposes to codify the gainsharing CMP rule set forth in section 1128A(b) of the Social Security Act. The official version will be published tomorrow; Reed Smith is preparing an analysis of this proposed rule.
In its September 19, 2014 Special Advisory Bulletin (SAB), the Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) noted the potential risks to federal health care programs presented by pharmaceutical manufacturers’ coupon programs designed to reduce or eliminate patient copayment requirements for brand-name drugs, and emphasized that coupon program sponsors and pharmacies are at risk of sanctions if they fail to take appropriate steps to carve out federal health care program beneficiaries from using the coupons. The OIG points out these coupon programs – which may take different forms, such as print coupons, electronic coupons, debit cards, and direct reimbursements – are remuneration offered to consumers to induce the purchase of specific items, and therefore implicate the criminal federal anti-kickback statute, 42 U.S.C § 1320a-7b(b). Where remuneration is knowingly and willfully paid with the intent to induce or reward referrals of items or services payable by a federal health care program, the anti-kickback statute is violated. The OIG goes on to observe that a claim that includes items or services resulting from a kickback violation would also constitute a false or fraudulent claim under the False Claims Act, 31 U.S.C. § 3729, and grounds for civil money penalties for beneficiary inducement if offer or acceptance of copayment coupons may induce a beneficiary to use a particular practitioner or pharmacy, 42 U.S.C § 1320a-7a(a)(5). While the SAB’s focus is on manufacturer coupon practices, in a footnote, the OIG states that pharmacies accepting coupons for Part D copayments may also be subject to these sanctions.
Notwithstanding the potential benefits of coupon programs to provide access to brand-name drugs and adherence to drug regimens, the OIG claims that such coupon programs may interfere with federal health care program cost-sharing requirements to promote prudent prescribing and purchasing choices by physicians and patients based on the “true costs” of drug and price competition in the market. As a result, the OIG writes, “[w]hile copayment coupons provide an immediate financial benefit to beneficiaries, they ultimately can harm both Federal health care programs and their beneficiaries.”
In the SAB, the OIG acknowledges that the pharmaceutical industry is aware of the potential anti-kickback concerns and generally has implemented a variety of controls to exclude federal health care program beneficiaries from these programs. The OIG’s concern seems to be that these controls don’t go far enough or don’t always work. In other words, the OIG sees the glass as “half empty.” The OIG does not seem to acknowledge that the glass may actually be half-full – i.e., the industry's attempt to have some controls (even if imperfect) evidences manufacturers’ intent to comply with the statute, making it difficult to show criminal liability.
In fact, the OIG’s report, “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” (OEI-05-12-00540) http://go.usa.gov/pdYQ, issued concurrently with the SAB, describes in detail mechanisms used by various manufacturers, most notably through claims processing and “switches,” to prevent use of the coupons for drugs paid for by Medicare Part D. The report identifies the principal shortcomings identified with these mechanisms as stemming from the fact that CMS does not permit manufacturers to submit Part D enrollment verification requests (“E1 transactions”) to the Part D Transaction Facilitator because of privacy concerns, so that manufacturers must use various “proxies” to attempt to determine whether the individual using the coupon is enrolled in a Part D plan. The report finds that these proxies, which may include elements as inexact as beneficiary age, may not be accurate enough to guarantee exclusion of Part D claims. Consequently, the OIG appears to be asserting that manufacturers may have liability for having imperfect controls, even though the current claims-processing system does not make a perfect solution available to them. The report did not identify any specific Part D claims for which coupons had in fact been used contrary to coupon terms and conditions.
The OIG recommends that CMS cooperate with industry stakeholders to improve the reliability of pharmacy claims edits, and make coupons transparent. CMS concurred with the recommendation.
OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing
The Office of Management and Budget (OMB) has cleared an HHS Office of Inspector General (OIG) proposed rule that would expand the OIG’s Medicare and state health care program fraud and abuse authorities. Specifically, on September 4, 2014, the OMB gave final regulatory clearance to an OIG proposed rule that would add new anti-kickback safe harbors to reflect statutory changes, codify the ACA’s definition of "remuneration," and add a gainsharing civil monetary penalty (CMP) regulation. The proposed rule should be published in the Federal Register in the near future.
The OIG published a notice July 11, 2014 announcing that it is considering revising its nonbinding criteria, established in 1997, outlining the circumstances under which the OIG may exercise its permissive authority under Section 1128(b)(7) of the Social Security Act to exclude an individual or entity from participation in the federal health care programs for engaging in conduct described in sections 1128A and 1128B of the Act (e.g., submitting or causing the submission of false or fraudulent claims or soliciting or paying kickbacks in violation of the Federal Anti-Kickback Statute). Since 1997, OIG has used these criteria in False Claims Act cases and administrative matters to evaluate whether to impose a permissive exclusion or release this authority in exchange for the defendant’s entering into a Corporate Integrity Agreement with OIG. The OIG suggests that “updated guidance could better reflect the state of the health care industry today, including the changes in legal requirements and the emergence of the health care compliance industry.” The OIG is particularly interested in input on: (1) whether there should be differences in the criteria for individuals and entities and (2) whether and how to consider a defendant's existing compliance program. The OIG will accept comments through September 9, 2014. After reviewing comments, the OIG will decide whether and how to revise its non-binding exclusion criteria.
On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG’s expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted.
Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG’s proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.
The Client Alert is available here.
On May 9, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a proposed rule that would significantly expand the exclusion regulations applicable to persons or entities that receive, directly or indirectly, funds from federal health care programs (the Proposed Rule). The Affordable Care Act (ACA) expanded the OIG’s authority for exclusion, and authorized the use of testimonial subpoenas in investigations of exclusion cases. In this Proposed Rule, the OIG incorporates these statutory changes, revises the definitions applicable to exclusions, proposes early reinstatement procedures, and offers a number of proposed policy changes as to when and how exclusions may take place.
Reed Smith has prepared a Client Alert that provides an overview of the Proposed Rule, including: proposed revisions to definitions; new grounds for exclusion; clarifications to existing regulations to add mitigating and aggravating factors; early reinstatement procedures; and proposed procedural changes in the OIG’s exclusion authorities. In particular, we discuss the OIG’s assertion that there should be no statute of limitations within which it would have to seek exclusion. This limitless look-back authority could place a tremendous burden on providers and suppliers, since their conduct and compliance efforts could be second-guessed many years into the future, when supporting documentation and witnesses may be long gone. We also discuss how these proposed changes to the OIG’s exclusion authorities could impact the debarment authority applicable to government contracts more generally.
The Client Alert is available here.
As previously reported, the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) published final rules in December amending Anti-Kickback Statute (AKS) and Stark Law regulations permitting certain arrangements involving the donation of interoperable electronic health record (EHR) software or information technology and training services. Reed Smith has prepared a summary of the final rules, including a side-by-side comparison of the EHR AKS Safe Harbor and the Stark Law’s EHR Exception that highlights the recent revisions.
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts. Comments will be accepted until February 25, 2014. For a status report on prior public safe harbor recommendations, see Appendix F of the OIG's Fall 2013 Semiannual Report to Congress.
On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements involving the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. The final rules:
- Extend the protections of the Stark law exception (42 C.F.R. § 411.357(w)) and the Anti-Kickback safe harbor (42 C.F.R. § 1001.952(y)) from December 31, 2013 to December 31, 2021 (the “sunset” provisions)
- Exclude laboratory companies from the types of entities that may donate EHR items and services
- Update the provisions under which an EHR donor or recipient can ascertain, with certainty, that EHR is interoperable pursuant to the exception and safe harbor (the “deeming” provisions)
- Remove the requirements that donated EHR include electronic prescribing capability
- Clarify the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services
With the exception of the amendments to the sunset provisions, which go into effect December 31, 2013, the amended regulations will be effective as of March 27, 2014.
Reed Smith will prepare a comprehensive Client Alert on the final rules, which will be published shortly.
Reed Smith lawyers have significant experience advising clients on EHR technology issues and will continue to monitor regulatory changes in this area. For more information regarding how we can assist you, please contact your principal Reed Smith lawyer or a lawyer listed in this publication.
A new OIG report estimates that Medicare could realize significant savings if drug manufacturers were required to pay rebates on Medicare Part B drugs, similar to rebates under the Medicaid program. Specifically, Medicare could have collected $3.1 billion in 2011 if manufacturers had been required to pay rebates based on average manufacturer price (AMP) for 60 high-expenditure Part B drugs, while rebates based on average sales price (ASP) for the same drugs could have generated $2.7 billion in payments. In the report, the OIG recommends that CMS examine establishing such a Part B drug rebate program and, if appropriate, seek legislative change. CMS rejected this suggestion, noting that developing such a plan – which would require new legislative authority -- would necessitate analysis of the effects of making fundamental changes to the Part B claims payment system, the impact on providers, and the impact on access to care. CMS maintains that it is “unable to devote significant administrative resources at this time to a proposal that is neither a provision of current law or actively under consideration.” (The Administration has, on the other hand, advocated rebates for Medicare Part D drugs furnished to low-income subsidy beneficiaries as part of its FY 2014 budget proposal.)
Almost two-thirds of critical access hospitals (CAHs) would not meet Medicare CAH location requirements if they were required to re-enroll today, according to the OIG. Many of these rural hospitals were permanently exempted from CAH distance requirements under previous authority of states to designate “necessary provider” (NP) CAHs. Medicare reimburses CAHs at 101% of their reasonable costs; if CMS had the authority to decertify CAHs that were 15 or fewer miles from their nearest hospitals in 2011, the OIG estimates that Medicare would have saved $449 million. The OIG recommends that CMS take several steps to “ensure that the only CAHs to remain certified would be those that serve beneficiaries who would otherwise be unable to reasonably access hospital services.” For instance, the OIG recommends that CMS seek legislative authority to remove NP CAHs’ permanent exemption from the distance requirement; CMS notes that the President’s proposed FY 2014 budget would decertify any CAHs located fewer than 10 miles from another hospital or CAH (and reduce payment to all remaining CAHs to 100% of reasonable cost). CMS also discusses steps it has already taken to implement OIG recommendations to periodically reassess CAHs for compliance with all location-related requirements and to ensure that CMS applies a uniform definition of “mountainous terrain” to all CAHs. CMS disagreed with an OIG recommendation to seek legislative authority to revise the CAH Conditions of Participation to include alternative location-related requirements.
A recent OIG report examines the extent of improper Medicare reimbursement for diabetes test strips (DTS), including the effect of mail-order DTS being subject to competitive bidding in nine geographic areas beginning in 2011 (CMS subsequently implemented a national competitive bidding program for mail-order DTS, effective July 1, 2013). According to the OIG, in 2011, Medicare inappropriately allowed $6 million for DTS claims billed for beneficiaries without a documented diagnosis code for diabetes, or that inappropriately overlapped with an inpatient hospital stay or an inpatient skilled nursing facility stay. Moreover, the OIG identified $425 million in Medicare-allowed DTS claims in 2011 that had characteristics of questionable billing, such as claims in excess of utilization guidelines, claims at perfectly regular intervals, or overlapping claims for the same beneficiary. The OIG observes that the Medicare competitive bidding program appears to have been successful in reducing questionable billing for mail-order DTS, since Medicare allowed claims for mail order DTS for suppliers exhibiting questionable billing in CBAs fell from $33.2 million to $4.3 million between 2010 and 2011. The OIG recommended that CMS take additional action to address inappropriate DTS claims, such as expanding supplier education, enforcing claims edits, and increasing monitoring of DTS suppliers’ billing. CMS also agreed to take appropriate action regarding inappropriate Medicare DTS claims and suppliers identified by the OIG, including referral of questionable claims to the Recovery Auditors and Medicare Administrative Contractors (MACs).
Two recent OIG reports point out the savings that state Medicaid programs could attain if they based reimbursement for DME, prosthetics, orthotics, and supplies (DMEPOS) on Medicare competitive bidding payment amounts – although at least one state is pushing back on this idea. In the first report, “Medicaid DMEPOS Costs May be Exceeding Medicare Costs in Competitive Bidding Areas,” the OIG calculated the potential savings Texas could have achieved in 2011 if it adopted Medicare DMEPOS bidding prices for selected items of DMEPOS. According to the OIG, Texas Medicaid fee-schedule could have saved approximately $2 million (state/federal shares combined) in the Dallas/Fort Worth area if it had based Medicaid rates on the Medicare DMEPOS competitive bidding amounts for 32 DMEPOS items covered under both programs. The OIG states that its report provides “a tangible example of potential State and Federal savings for Medicaid programs if the programs were to use the Medicare Competitive Bidding payment amounts for DMEPOS items.” This report did not include recommendations or state reaction.
In the second report, “New Jersey Medicaid Program Could Achieve Savings by Reducing Home Blood-Glucose Test Strip Prices,” the OIG estimates that the New Jersey Medicaid program could have saved approximately $1.8 million to $2.7 million in 2011 by reducing home blood-glucose test strip reimbursement rates to retail rates or by establishing a competitive bidding program for test strips. Such policy changes for test strips also could reduce Medicaid managed care organization reimbursement rates by up to 70%. However, the New Jersey Department of Human Services disagreed with the OIG’s recommendations to align state Medicaid reimbursement with average retail price or Medicare competitive bidding pricing, citing, among other things, doubts about the feasibility of attaining such savings and concerns about patient access and the impact on proper diabetes management.
The OIG has called on CMS to strengthen activities to prevent improper Medicare payments, including enhancements to the Recovery Audit Contractor (RAC) program. For instance, the OIG notes that RACs identified half of all claims they reviewed in FYs 2010 and 2011 as having resulted in improper payments totaling $1.3 billion. While CMS took corrective actions to address the majority of identified vulnerabilities, the agency did not evaluate the effectiveness of these actions, however, so high levels of improper payments may continue. The OIG also raised concerns about CMS failure to act on all referrals of potential fraud that it received from RACs, along with gaps in CMS evaluations of RAC performance on contract requirements. The OIG recommends that CMS: address identified vulnerabilities; ensure that RACs refer all appropriate cases of potential fraud; take appropriate action on RAC referrals of potential fraud; and enhance RAC performance evaluation. CMS generally concurred with the OIG recommendations. The report, “Medicare Recovery Audit Contractors and CMS’s Actions to Address Improper Payments, Referrals of Potential Fraud, and Performance,” is available here.
In a recent report, “Medicaid Drug Pricing in State Maximum Allowable Cost Programs,” the OIG examines options for controlling state Medicaid prescription drug costs, particularly given a surge in Medicaid enrollment expected in the coming years as a result of the ACA. The OIG highlights the value of state Maximum Allowable Cost (MAC) programs as an alternative to federal upper limit (FUL) pricing, especially since CMS is years behind in implementing AMP-based federal upper limit (FUL) amounts under the ACA. The OIG found that aggregate pre-ACA FUL amounts were on average nearly double state MAC prices in January 2012, although the post-ACA FUL amounts (which have not been implemented) were lower than MAC prices on average. The OIG also notes that states could achieve additional cost savings by using more aggressive MAC pricing formulas and inclusion criteria, particularly along the lines of Wyoming’s program, which sets MAC prices by considering (1) acquisition cost plus a markup, (2) wholesale acquisition cost (WAC) minus a percentage, (3) average wholesale price (AWP) minus a percentage, or (4) AMP plus a markup. According to the OIG, 39 states would have saved $483 million (excluding dispensing fees) in the first half of 2011 if they had used Wyoming’s MAC criteria. The OIG recommends that CMS complete implementation of the post-ACA FUL amounts; CMS concurred and said it plans to finalize these FULs in the near future. CMS also concurred with OIG's recommendation to encourage states to reevaluate their Medicaid programs to identify additional cost saving opportunities, and noted its plans to release a related informational bulletin to the states in the near future.
The HHS Office of the Inspector General (OIG) has issued a report entitled “Medicare Could Save Millions by Strengthening Billing Requirements for Canceled Elective Surgeries.” Based on a review of 100 claims, the OIG estimates that Medicare made $38.2 million in Part A inpatient hospital payments in calendar years 2009 and 2010 for short-stay, canceled elective surgery admissions that were not reasonable and necessary. Specifically, the OIG found that for 80 of the 100 sampled claims, Medicare made payments totaling $345,717 for hospital inpatient claims involving canceled elective surgeries when the condition of the patient was not severe enough to warrant an inpatient admission (i.e., a clinical condition did not exist on admission or a new condition did not emerge after admission that required inpatient care). The OIG recommends that CMS: (1) adjust sampled claims representing overpayments to the extent allowed under the law; (2) strengthen guidance to hospitals; (3) resolve remaining non-sampled claims and recover overpayments to the extent feasible and allowed under the law; and (4) instruct Medicare administrative contractors to emphasize to hospitals the need for stronger utilization review controls for claims that include admissions for elective surgeries that did not occur. CMS generally agreed with the OIG’s recommendations.
A recent OIG report examined “Hospitals’ Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries.” The report was conducted in response to concerns about hospitals’ use of observation stays, which may be resulting in Medicare beneficiaries paying more as outpatients than if they were admitted as inpatients, and which may prevent beneficiaries from qualifying under Medicare for SNF services following discharge from the hospital. In addition, CMS is concerned about improper payments for short inpatient stays when the beneficiaries should have been treated as outpatients. Based on a review of claims from 2012, the OIG found that Medicare beneficiaries had 1.5 million observation stays, commonly spending one night or more in the hospital. Beneficiaries had an additional 1.4 million long outpatient stays; some of these may have been observation stays. Beneficiaries also had 1.1 million short inpatient stays, which the OIG notes typically cost Medicare and beneficiaries more than observation stays. In addition, beneficiaries had more than 600,000 hospital stays that lasted 3 nights or more but did not qualify them for SNF services, while Medicare inappropriately paid $255 million for SNF services for which beneficiaries did not qualify (CMS will refer these SNFs to CMS so the agency can look into recoupment). The OIG points out that that the CMS proposed IPPS rule for FY 2014 (which subsequently was finalized, as discussed above) would substantially affect how hospitals bill for these stays. While the number of short inpatient stays would be significantly reduced under the proposed rule, the number of observation and long outpatient stays may not be reduced if outpatient nights are not counted towards the proposed two night presumption. The OIG suggests that CMS consider how to ensure that beneficiaries with similar post-hospital care needs have the same access to and cost sharing for SNF services. In a related matter, a nationwide class action lawsuit filed November 3, 2011 on behalf of 14 named seniors by the Center for Medicare Advocacy and the National Senior Citizens Law Center challenging CMS’s observation day policy and practice is still pending in federal district court. Bagnall v. Sebelius, No. 11-1703 (D. Conn. filed Nov. 3, 2011). The lawsuit alleges that the use of observation status violates the Medicare Act, the Freedom of Information Act, the Administrative Procedure Act, and the Due Process Clause of the Fifth Amendment to the Constitution.