The 340B drug program is a topic that needs daily updates. It seems that something is happening constantly. Like a prime time soap opera or The Bachelor, the 340B program is all the talk at the water cooler. From lawsuits to legislation to executive orders – there is no way of knowing the outcome, so we all wait with bated breath to watch who will hold the final rose.
On Tuesday, July 17, 2018, the metaphoric guillotine fell on the American Hospital Association (AHA) and on hospitals across the country. The Court of Appeals (COA) dismissed AHA’s lawsuit.
On November 1, 2017, the US Department of Health and Human Services released a Final Rule implementing a payment reduction for most covered outpatient drugs billed to Medicare by 340B-participating hospitals from the current Average Sales Price (ASP) plus 6% rate to ASP minus 22.5%, which represents a payment cut of almost 30%.
Effective January 1, 2018, the 30% slash in reimbursement rates became reality, but only for locations physically connected to participating hospitals. CMS is expected to broaden the 30% reduction to all 340B-participating entities in the near future.
What is the 340B drug program? The easiest explanation for the 340B program is that government insurance, Medicare and Medicaid, do not want to pay full price for medicine. In an effort to reduce costs of drugs for the government payors, the government requires that all drug companies enter into a rebate agreement with the Secretary of the Department of Health and Human Services (HHS) as a precondition for coverage of their drugs by Medicaid and Medicare Part B. If a drug manufacturer wants its drug to be prescribed to Medicare and Medicaid patients, then it must pay rebates.
The American Hospital Association (“AHA”) filed for an injunction last year requesting that the US District Court enjoin CMS from implementing the 340B payment reduction. On the merits, AHA argues that the HHS’s near-30% rate reduction constitutes an improper exercise of its statutory rate-setting authority.
The US District Court did not reach an opinion on the merits; it dismissed the case, issued December 29, 2017, based on lack of subject matter jurisdiction. The District Court found that: Whenever a provider challenges HHS, there is only one potential source of subject matter jurisdiction—42 U.S.C. § 405(g). The Medicare Act places strict limits on the jurisdiction of federal courts to decide ‘any claims arising under’ the Act.
The Supreme Court has defined two elements that a plaintiff must establish in order to satisfy § 405(g). First, there is a non-waivable, jurisdictional requirement that a claim for benefits shall have been “presented” to the Secretary. Without presentment, there is no jurisdiction.
The second element is a waivable requirement to exhaust administrative remedies. I call this legal doctrine the Monopoly requirement. Do not pass go. Go directly to jail. Do not collect $200. Unlike the first element, however, a plaintiff may be excused from this obligation when, for example, exhaustion would be futile. Together, § 405(g)’s two elements serve the practical purpose of preventing premature interference with agency processes, so that the agency may function efficiently and so that it may have an opportunity to correct its own errors, to afford the parties and the courts the benefit of its experience and expertise, and to compile a record which is adequate for judicial review. However, there are ways around these obsolete legal doctrines in order to hold a state agency liable for adverse decisions.
Following the Dec. 29, 2017, order by the District Court, which dismissed the lawsuit on jurisdictional grounds, the plaintiffs (AHA) appealed to the U.S. Court of Appeals (COA), which promptly granted AHA’s request for an expedited appeal schedule.
In their brief, AHA contends that the District Court erred in dismissing their action as premature and that their continued actual damages following the Jan. 1 payment reduction’s effective date weighs heavily in favor of preliminary injunctive relief. More specifically, AHA argues that 30% reduction is causing irreparable injury to the plaintiffs “by jeopardizing essential programs and services provided to their communities and the vulnerable, poor and other underserved populations, such as oncology, dialysis, and immediate stroke treatment services.”
By contrast, the government’s brief rests primarily on jurisdictional arguments, specifically that: (1) the Medicare Act precludes judicial review of rate-setting activities by HHS; and (2) the District Court was correct that no jurisdiction exists.
Oral arguments in this appeal were May 4, 2018.
AHA posted in its newsletter that the COA seemed most interested in whether Medicare law precludes judicial review of CMS’ rule implementing the cuts. AHA says it hopes a ruling will be reached in the case sometime this summer.
In a completely different case, the DC District Court is contemplating a request to toll the time to file a Section 340B appeal.
AHA v. Azar, a case about RAC audits and the Medicare appeal backlog. During a March 22, 2018, hearing, the COA asked AHA to submit specific proposals that AHA wishes the COA to impose and why current procedures are insufficient. It was filed June 22, 2018.
In it proposal, AHA pointed out that HHS is needlessly causing hospitals to file thousands of protective appeals by refusing to toll the time for hospitals to file appeals arising out of the reduction in reimbursement that certain 340B hospitals. In order to avoid potential arguments from the government that 340B hospitals that do not administratively appeal the legality of a reduced rate will be time barred from seeking recovery if the court holds that the reduction in payments is unlawful, AHA proposed that the Secretary agree to toll the deadline for such appeals until resolution of the 340B litigation—an arrangement that would preserve the 340B hospitals’ right to full reimbursement in the event the 340B litigation is not successful. HHS has refused to toll the time, meaning that Section 340B hospitals will have to protect their interests in the interim by filing thousands upon thousands of additional claim appeals, which will add thousands upon thousands of more appeals to the current ALJ-level backlog.
In a unanimous decision, three judges from the COA sided with HHS and ruled the hospitals’ suit was filed prematurely because hospitals had not formally filed claims with HHS because they were not yet experiencing cuts.
Basically, what the judges are saying is that you cannot ask for relief before the adverse action occurs. Even though the hospitals knew the 30% rate reduction would be implemented January 1, 2018, they had to wait until the pain was felt before they could ask for relief.
The lawsuit was not dismissed based on the doctrine of exhaustion of administrative remedies. The Decision noted that in some cases plaintiffs might be justified in seeking judicial review before they have exhausted their administrative remedies, but that wouldn’t be the solution here.
Hindsight is always 20-20. I read the 11 page decision. But I believe that AHA failed in two ways that may have changed the outcome: (1) Nowhere in the decision does it appear that the attorneys for AHA argued that the subject matter jurisdiction issue was collateral to the merits; and (2) The lawsuit was filed pre-January 1, 2018, but AHA could have amended its complaint after January 1, 2018, to show injury and argue that its comments were rejected (final decision) by the rule being implemented.
But, hey, we will never know.
In a January 11, 2018, opinion, a district court in Florida held that once the government learns of possible regulatory noncompliance or mistakes in billings Medicare or Medicaid, but continues to reimburse the provider for later claims – the fact that the government continues to reimburse the provider – can be evidence in court that the alleged documentation errors are minor and that, if the services are actually rendered, despite the minor mistakes, the provider should not be liable under the False Claims Act.
Here is an example: Provider Smith undergoes a post-payment review of claims from dates of service January 1, 2016 – January 1, 2017. It is February 1, 2018. Today, Smith is told by the RAC auditor that he owes $1 million. Smith appeals the adverse decision. However, despite the accusation of $1 million overpayment, Smith continues providing medically necessary services the exact same way, he did in 2016. Despite the supposed outcome of the post-payment review, Smith continues to bill Medicare and Medicaid for services rendered in the exact same way that he did in 2016.
At least, according to UNITED STATES OF AMERICA AND STATE OF FLORIDA v. SALUS REHABILITATION, LLC, if Smith continues to be reimbursed for services rendered, this continued reimbursement can be evidence in court that Smith is doing nothing wrong.
Many of my clients who are undergoing post-payment or prepayment reviews decrease or cease all together billing for future services rendered. First, and obviously, stopping or decreasing billings will adversely affect them. Many of those clients will be financially prohibited from defending the post or prepayment review audit because they won’t have enough funds to pay for an attorney. Secondly, and less obvious, at least according to the recent decision in Florida district court mentioned above, continuing to bill for and get reimbursed fo services rendered and billed to Medicare and/or Medicaid can be evidence in court that you are doing nothing wrong.
The facts of the Salus Rehabilitation case, are as follows:
A former employee of a health care system comprising of 53 specialized nursing facilities (“Salus”) filed a qui tam claim in federal court asserting that Salus billed the government for unnecessary, inadequate, or incompetent service.
Break from the facts of the case to explain qui tam actions: A former employee who brings a qui tam action is called the “relator.” In general, the reason that former employees bring qui tam cases is money. Relators get anywhere between 15 -30 % of the award of damages. Many qui tam actions result in multi million dollar awards in damages – meaning that a relator can get rich quickly by tattling on (or accusing) a former employer. Qui tam actions are jury trials (why this is important will be explained below).
Come and listen to a story ’bout a man named Jed
Poor mountaineer barely kept his family fed
Then one day he was shooting for some food,
And up through the ground come a bubbling crude
(Oil that is, black gold, Texas tea)
In the Salus case, the relator (Jed) asserted that Salus failured to maintain a “comprehensive care plan,” ostensibly required by a Medicaid regulation and that this failure rendered Salus’ Medicaid claims fraudulent. Also, Jed asserted that a handful of paperwork defects (for example, unsigned or undated documents) demonstrated that Salus never provided the therapy purported by the paperwork and billed to Medicare. Jed won almost $350 million based on the theory “that upcoding of RUG levels and failure to maintain care plans made [the defendants’] claims to Medicare and Medicaid false or fraudulent.” Oil, that is, black gold, Texas tea. You know Jed was celebrating like it was 1999.
Salus did not take it lying down.
The jury had awarded Jed $350 million. But in the legal world there is a legal tool if a losing party believes that the jury rendered an incorrect decision. It is called a Judgment as a Matter of Law. When a party files a Motion for Judgment as a Matter of Law, it is decided by the standard of whether a reasonable jury could find in favor of the party opposing the Motion, but it is decided by a judge.
In Salus, the Judge found that the verdict awarding Jed of $350 million could not be upheld. The Judge found that Jed’s burden was to show that the federal government and the state government did not know about the alleged record-keeping deficiencies but, had the governments known, the governments would have refused to pay Salus for services rendered, products delivered, and costs incurred. The Judge said that the record was deplete of any evidence that the governments would have refused to pay Salus. The Judge went so far to say that, theoretically, the governments could have implemented a less severe punishment, such as a warning or a plan or correction. Regardless, what the government MAY have done was not in the record. Specifically, the Judge held that “The resulting verdict (the $350 million to Jed), which perpetrates one of the forbidden “traps, zaps, and zingers” mentioned earlier, cannot stand. The judgment effects an unwarranted, unjustified, unconscionable, and probably unconstitutional forfeiture — times three — sufficient in proportion and irrationality to deter any prudent business from providing services and products to a government armed with the untethered and hair-trigger artillery of a False Claims Act invoked by a heavily invested relator.”
Wow. In other words, the Judge is saying that the verdict, which awarded Jed $350 million, will cause health care providers to NOT accept Medicare and Medicaid if the government is allowed to call every mistake in documentation “fraud,” or a violation of the False Claims Act. The Judge was not ok with this “slippery slope” result. Maybe he/she depends on Medicare…maybe he/she has a family member dependent on Medicaid…who knows? Regardless, this a WIN for providers!!
Legally, the Judge in Salus hung his hat on Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016), a Supreme Court case. In Escobar, the Supreme Court held that nit-picky documentation errors are not material and that materiality is required to condemn a provider under the False Claims Act. Escobar “necessarily means that if a service is non-compliant with a statute, a rule, or a contract; if the non-compliance is disclosed to, or discovered by, the United States; and if the United States pays notwithstanding the disclosed or discovered non-compliance, the False Claims Act provides a relator no claim for “implied false certification.”” (emphasis added). In other words, keep billing. If you are paid, then you can use that as evidence in court.
Escobar specifies that a “rigorous” and “demanding” standard for materiality and scienter precludes a False Claims Act claim based on a “minor or unsubstantial” or a “garden-variety” breach of contract or regulatory violation. Instead, Escobar assumes and enforces a course of dealing between the government and a supplier of goods or services that rests comfortably on proven and successful principles of exchange — fair value given for fair value received. Get it?? This is the first time that I have seen a judge be smart and intuitive enough to say – hey – providers are not perfect…and that’s ok. Providers may have insignificant documentation errors. But it is fundamentally unfair to prosecute a provider under the False Claims Act, which the Act is extraordinarily harsh and punitive, for minor, “garden variety” mistakes.
Granted, Salus was decided with a provider being prosecuted under the False Claims Act and not being accused of a pre or post-payment review finding of alleged overpayment.
But, isn’t it analogous?
A provider being accused that it owes $1 million because of minor documentation errors – but did actually provide the medically necessary services – should be afforded the same understanding that Salus was afforded. The mistakes need to be material. Minor mistakes should not be reasons for a 100% recoupment. Because there must be a course of dealing between the government and a supplier of goods or services that rests comfortably on proven and successful principles of exchange — fair value given for fair value received.
Oil has dried up, Jeb.