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.
I think of Bob Dylan’s raspy voice singing:
Then you better start swimmin’
Or you’ll sink like a stone
For the times they are a-changin’.
In 1933, Franklin D. Roosevelt took the presidency during a time of severe poverty. The Great Depression, which would last until the late 1930s or early 1940s, cast shadows and doubt over the future of America. People were starving. Unemployment and homelessness were at an all-time high.
FDR’s first 100 days in office were monumental. In fact, FDR’s first 100 days in office changed America forever. With bold legislation and a myriad of executive orders, he instituted the New Deal. The New Deal created government jobs for the homeless, banking reform, and emergency relief to states and cities. During those 100 days of lawmaking, Congress granted every major request Roosevelt asked. This is an example of what I call blending of the separation of powers. In a time of great national need, Congress took an expansive view of the president’s constitutional powers and cooperated with him to effect major change.
I am in no way comparing our General Assembly to Congress back in the 1930s nor am I comparing FDR to Gov. McCrory. In fact, there are vast differences. I am only making the point that rarely does the legislative body create such change.
But North Carolina’s current Senate Bill 744 may create this change. For example, if Senate Bill 744 passes the House, the Department of Health and Human Services (DHHS), Division of Medical Assistance (DMA) may no longer manage Medicaid. That’s right. A whole new state agency may manage Medicaid.
This past Friday, May 30, 2014, the state Senate passed a $21.2 billion budget, which is known as Senate Bill 744. On May 31, 2014, Senate Bill 744 passed its 3rd reading and will now go on to the House. So far, it has been revised 3 times, so we do not know whether the House will make substantial changes. But, as it stands today, it is shocking. Is it good? Bad? I don’t think we can know whether the changes are good or bad yet, and, quite honestly, I have not had time to digest all of the possible implications of Senate Bill 744. But, regardless, the changes are shocking.
Of the most shocking changes (should SB 744 get passed), consider the following:
1. DHHS must immediately cease all efforts to transition Medicaid to the affordable care organizations (ACOs) system that DHHS had touted would be in effect by July 2015;
2. DHHS’s DMA will no longer manage Medicaid. Instead, a new state entity will be formed to manage Medicaid. (A kind of…”scratch it all and start over” method);
3. All funds previously appropriated to DMA will be transferred to the Office of State Budget and Management (OSBM) and will be used for Medicaid reform and may not be used for any other purpose such as funding any shortfalls in the Medicaid program.
4. Categorical coverage for recipients of the optional state supplemental program State County Special Assistance is eliminated.
5. Coverage for the medically needy is eliminated, except those categories that the State is prohibited from eliminating by the “maintenance of effort” requirement of the Patient Protection and Affordable Care Act. Effective October 1, 2019, coverage for all medically needy categories is eliminated.
6. It is the intent of the General Assembly to reduce optional coverage for certain aged, blind, and disabled persons effective July 1, 2015, while meeting the State’s obligation under the Americans with Disabilities Act and the United States Supreme Court decision in Olmstead v. L.C. ex rel. Zimring, 527 U.S. 581 (1999).
7. Repeal the shared savings program and just reduce the reimbursement rates by 3%.
8. DHHS shall implement a Medicaid assessment program for local management entities/managed care organizations (LME/MCOs) at a rate of three and one-half percent (3.5%).
9. For additional notices as to State Plan Amendments (SPAs), DHHS must post the proposed SPAs on its website at least 10 days prior to submitting the SPAs to the federal Center for Medicare and Medicaid Services (CMS).
10. Reimbursement rate changes become effective when CMS approves the reimbursement rate changes.
11. The Department of Health and Human Services shall not enter into any contract involving the program integrity functions listed in subsection (a) of this section of SB 774 that would have a termination date after September 1, 2015.
12. The Medicaid PROVIDER will have the burden of proof in contested case actions against the Department.
13. The Department shall withhold payment to any Medicaid provider for whom the DMA, or its vendor, has identified an overpayment in a written notice to the provider. Withholding shall begin on the 75th day after the day the notice of overpayment is mailed and shall continue during the pendency of any appeal until the overpayment becomes a final overpayment (can we say injunction?).
Senate Bill 744 purports to make immense modifications to our Medicaid system. I wonder what Gov. McCrory and Secretary Wos think about Senate Bill 744. If SB 744 passes, McCrory and Wos can no longer continue down the ACO path. Does the General Assembly even have the authority to bind their hands from creating ACOs? It seems so.
As for the “new state agency” that will manage Medicaid, maybe the General Assembly is right and we do need to scratch out the current Medicaid management and start over…I doubt anyone would disagree that DHHS has had some “oops” moments in the past year or so. But (a) is this the way to start all over; and (b) does the General Assembly have the legal power to remove the management of Medicaid from Secretary Wos?
Going to the reduction of optional services for the “medically needy,” what services are considered optional? Here is a list of optional services, as defined by the Center of Medicare and Medicaid Services (CMS):
• Case Management
• Mental Health
• Intermediate Care Facilities (ICF-MR)
• Personal Care Services
• Respiratory Therapy
• Adult Dentures
• Prescription Drugs
• Community Alternative Programs (CAP)
• Private Duty Nursing
• Home Infusion Therapy
• Physical Therapy/Speech Therapy
I cannot comment on all the changes proposed by Senate Bill 744; I simply have not had enough time to review them in detail, because there are so many changes. I do not purport to know whether these modifications are ultimately for the good or for the bad.
All I know is that we better start swimming or we will sink like a stone, because the times they are a-changin’.