States’ Debate on PPACA Implementation Puts Politics Above Practicality

The debate over Medicaid expansion and cooperation with the health insurance marketplaces continues. These two provisions are key to the successful implementation of health insurance reform under the  Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148) and the Health Care and Education Reconciliation Act (HCERA) (P.L. 111-152).  Although some Republican governors reluctantly decided that Medicaid expansion was in their states’ best interests, other members of their own party are determined to see PPACA fail regardless of cost.

Republican Arizona Governor Jan Brewer has campaigned for expansion for months with little success. As the legislature debated on May 16, 2013, two leaders from her party legislators brought up competing proposals. Senate President Andy Biggs’ bill would direct  the state’s Medicaid agency, the Arizona Health Care Cost Containment System (AHCCCS) to apply for an extension of its existing waiver, which provides coverage to a limited number of adults with incomes at or below the federal poverty level (FPL). It also would appropriate about $135 million for services to childless adults. If the waiver extension is not approved, Biggs suggests funding care for the existing number of childless adults, but not expanding it, and paying for it with the state’s rainy day fund. Brewer, on the other hand, says that fund should be saved for a rainy day.

House Speaker Andy Tobin would put the question to the voters. It is reported that his bill would require a constitutional amendment to implement Medicaid expansion and stop the expansion if either federal  funding or state revenue is insufficient. Yet another proposal would simply drop the existing benefits for childless adults, causing about 60,000 people to lose their coverage. Brewer calls that alternative “morally repugnant.” The debate is expected to be contentious. And Arizona can’t pass a budget until it is resolved.

The Florida legislature ended the session without passing any legislation on the Medicaid expansion. So the debate there is over for the year unless Governor Scott calls a special session. One interesting wrinkle in the argument might be worthy of attention. The House Republicans proposed, as an alternative to the Medicaid expansion, a bill that would have provided for a subsidy for the purchase of limited coverage from a state-operated marketplace for a premium of $25 per month. But the House members are eligible for comprehensive health insurance available to all state employees, for which they pay $8.34 per month for individual coverage, or $30 for family coverage. In 2012, they voted to keep this privilege.  It is reported that the Senate voluntarily gave  up the discount; now they pay the same premium as rank-and-file state employees: $50 per month for individual coverage or $180 per month for family coverage.

About half the states chose not to establish their own health insurance exchange, now called marketplace, under PPACA. A few have gone even farther down the road of resistance. In Missouri, voters passed a ballot measure that bars the establishment of a state exchange unless either the legislature or the voters have passed a law authorizing it. What’s more, no state employee may “provide resources or assistance of any kind” to the establishment of an exchange by the federal government without statutory authorization unless specifically required to do so under federal law. And any taxpayer has standing to sue to enforce the law.

Kusserow’s Corner: Medicaid Sanction Screening

“To obtain/maintain active enrollment status, providers may not employ or contract with individuals/entities excluded from participation in any federal health care program or debarred by the GSA from any other executive branch program or activity”.[1]

What all this means is that Medicare and Medicaid payments are prohibited for all items and services furnished by excluded persons and entities.  From CMS’ perspective, sanctions and exclusions do not only play a role in terms of payment, but also enrollment. In order for providers to enroll or maintain active enrollment status, they may not employ or contract with individuals/entities excluded from participation in any federal health care program or debarred by the Government Services Administration (GSA).  

When State Medicaid agencies take final actions against providers that affect their participation in the Medicaid program, they are supposed to promptly report those providers to Office of Inspector General (OIG).  The OIG then determines whether to exclude the provider based on federal criteria for exclusion and include the individual/entity on the OIG List of Excluded Individuals and Entities (LEIE).

It is a mistake to assume that all individuals excluded by States are also listed on the LEIE.  In fact, the LEIE cannot be relied upon to include Medicaid exclusions.  The OIG found in its own review of state reporting that many states were not sending their sanction information to the OIG.  It noted that two-thirds of providers with final actions imposed by state agencies were not included on the LEIE. The majority of states even had a match rate less than twenty-five percent.   Most states indicated that this is due to uncertainty among states about when they should notify the OIG of such final actions and what kind of information to provide. I believe this is just an excuse. 

Meanwhile, CMS has been taking action on ensuring providers and programs are screening for Medicaid exclusions.  Beginning in 2008, it has been sending letters to the State Medicaid Directors to give them guidance and inform them of CMS’ interpretation of the regulations as they relate to sanctioned and excluded individuals/entities.  First, CMS called for State Medicaid Directors to mandate checking their enrolled providers for exclusions on a monthly basis.  This was followed by another letter wherein CMS stated that states should remind providers of their obligation to screen all their employees and contractors against the OIG LEIE monthly.   It also stated that states should advise providers upon enrollment and re-enrollment of their obligation to screen all employees and contractors against the OIG LEIE monthly, and explicitly require providers to agree to comply with this obligation as a condition of enrollment.  While this letter is directed to State Medicaid Directors, it points to the direction CMS is taking: namely an obligation for providers to screen.  Furthermore, these letters formalize CMS’ position on the frequency (monthly) with which both the State Medicaid agency itself as well as providers should conduct screening.

At this urging by CMS, states are moving to develop and maintain their own Medicaid exclusion lists, followed by mandates for providers to screen against them on a monthly basis.  This movement has been slow and steady.  However, in response to this call, nearly half of the states have moved to develop their own statutes and regulations on sanctions for and exclusions of providers.  It is reasonable to assume that this trend will continue and that eventually all states will be doing this. A growing number of states have developed their own sanction and exclusion lists. In addition to the development of state Medicaid exclusion lists, more and more states are also following the CMS guidance that calls for monthly screening of the database. Most of those that have gone this route have published those lists on their websites, but not all.  As such, it may be necessary to contact the state Medicaid agency or health department directly in order to access the necessary information. The following are states have developed their own Medicaid sanction lists with many others having this under development:

Alabama, Arkansas, California, Connecticut, Florida, Hawaii, Idaho, Illinois, Kentucky, Maine, Maryland, Michigan, Mississippi, Nebraska, Nevada, New Jersey, New York, South Carolina, Texas, and West Virginia.

The following are suggestions and best practices for providers when it comes to meeting sanction screening obligations:

  1. It is mandatory to screen against the LEIE; therefore screen in advance of hiring or engaging any individual or entity, as well as granting staff privilege to physicians.  Thereafter it is advisable to screen all affected parties at least annually, but if possible, monthly.
  2. Check with the state jurisdictions where a provider does business for any Medicaid sanction screening mandates.  Note that states are moving to follow CMS guidance for monthly screening.
  3. If the state requires monthly screening, then it is advisable to consider screening against the LEIE as often. 
  4. The OIG notes the GSA debarment List, formerly called the Excluded Parties List System (EPLS), now System for Awards Management (SAM), is a resource that is available, but does not call for screening against it.  This was restated in its Special Advisory Opinion of May 8, 2013, wherein it also stated that it has no interest in and will take no action on any “hit” on the GSA debarment list.  However, CMS more directly says this should be done.  I strongly recommend screening against the GSA at the time of engagement of a vendor, contractor, physician, or employee and thereafter as infrequently as possible. In my opinion screening more often is unnecessary and a waste of time and resources.

[1] (42 CFR 424.516)

Richard P. Kusserow served 11 years as the DHHS Inspector General and currently is CEO of the Compliance Resource Center (CRC), including Sanction Screening Services (S³), which provides sanction screening tools and also provides full outsourcing of sanction screening. For more information, he can be contacted at rkusserow@strategicm.co.

Copyright © 2013 Strategic Management Services, LLC.  Published with permission.

Medtronic Petitions Supreme Court Concerning Preemption and Adverse Event Reports

Medtronic, Inc., has petitioned the U.S. Supreme Court to review a decision from the Ninth Circuit Court of Appeals concerning whether the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) preempt a state-law claim alleging that Medtronic violated a duty under federal law to report adverse-event information.

Background

In 2000, Richard Stengel had a SynchroMed EL Pump and Catheter, manufactured by Medtronic, surgically implanted into his abdomen to deliver pain relief medication directly into his spine. In 2005, after a hospitalization, he was diagnosed with ascending paralysis of his lower body, caused by the catheter, and a neurosurgeon removed the catheter. Stengel remained paralyzed after the surgery. In 2006, the FDA inspected a Medtronic facility and discovered that Medtronic was aware of the risks associated with the pump and catheter, and had known about them prior to Stengel’s paralysis. The FDA issued a warning letter to Medtronic, stating that Medtronic had misbranded the device by concealing known risks. Medtronic recalled the device in the spring of 2008, three years after Stengel’s paralysis.

The Stengels claimed that Medtronic was negligent under Arizona law because it allegedly failed to provide the FDA with information about adverse events involving the pump and catheter. The Ninth Circuit held that the state-law claim was not impliedly or expressly preempted by the MDA. Further, the court held that the general duty of care under Arizona common law incorporated a requirement to furnish adverse-event information to the FDA. (Stengel v Medtronic Incorporated, 704 F.3d 1224, January 10, 2013).

Petition for Certiorari

The Medtronic petition to the Supreme Court notes that courts of appeal have been divided regarding the applicability of both implied and express preemption under the MDA to state-law claims based on alleged violations of duties imposed by federal law. Regarding whether the MDA impliedly preempts state-law claims, the Ninth Circuit in this case and the Fifth Circuit in Hughes v Boston Scientific Corp., 632 F.3d 762 (2011) have said “no”; while the Sixth and Eighth Circuits have said “yes.” (See In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig (623 F.3d 1200, 1205-06 (8th Cir 2010); and Cupek v Medtronic, 405 F.3d 421, 423-24 (6th Cir. 2005)).

The circuit courts are also split on whether the MDA expressly preempts state-law claims alleging a violation of a generalized, rather than a device-specific, federal requirement. In Riegel v Medtronic, Inc. (552 U.S. 312 (2008)), the U.S. Supreme Court held that 21 U.S.C. sec. 360k expressly preempts state common-law claims regarding medical devices that have received premarket approval, unless those claims are based on state-law duties that are parallel to—and thus do not impose requirements different from, or in addition to—federal requirements. In the wake of Riegel, two circuits have held that this parallel duty exception is not applicable where a state-law duty is alleged to be parallel to a generalized federal duty that applies to all medical devices; four circuits have held the contrary position.

The petition further notes that the Ninth Circuit’s decision “would effectively eviscerate” the U.S. Supreme Court’s earlier decisions in Riegel and Buckman Co. v Plaintiffs’ Legal Comm. (531 U.S. 341 (2001)). “A claim concerning a device that has received pre-market approval can avoid preemption only if it is based on a state-law duty that is both (1) independent of (Buckman), and (2) parallel to (Riegel), a duty imposed by federal law,” according to the petition.

The petition concluded that this case is an “ideal vehicle for addressing a recurring question of exceptional importance to device manufacturers and the public health.”