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Following on the heels of its plans to review Medicare payments for telehealth services, the federal Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) just announced a new project to review state Medicaid payments for telemedicine and other remote services. Accordingly, providers who bill state Medicaid programs for telemedicine, telehealth, or remote patient monitoring services may expect to have those claims reviewed to confirm payment was correctly made in accordance with the conditions for coverage. The project will be added to the OIG’s 2017 Work Plan.
How Does OIG Define Projects Contained on their Work Plan
Historically, at the beginning of each new fiscal year, the OIG issued its Work Plan, setting forth the compliance and enforcement projects and priorities OIG intends to pursue in the coming year. Beginning this past June, OIG began updating the annual Work Plan on a monthly basis. The Work Plan contains dozens of projects affecting Medicare and Medicaid providers, suppliers and payors, as well as public health reviews and Department-specific reviews.
The Work Plan reflects (in large part) two aspects of the work of OIG:
- Projects originating within the Office of Audit Services (OAS), which conducts financial, billing, and performance audits of HHS programs; and
- Projects originating within the Office of Evaluations and Inspections (OEI), which provides management reviews and evaluations of HHS program operations.
Except by providing general statistics, the Work Plan itself does not detail the work of the Office of Investigations or the Office of Counsel to the Inspector General in investigating and enforcing matters involving specific individual providers and suppliers. The new Medicaid telemedicine project will be run by the OAS.
Review of Medicaid Services Delivered Using Telecommunication Systems
OIG describes its new telemedicine review project as follows:
“Medicaid pays for telemedicine, telehealth, and telemonitoring services delivered through a range of interactive video, audio or data transmission (telecommunications). Medicaid programs are seeing a significant increase in claims for these services and expect this trend to continue. We will determine whether selected States’ Medicaid payments for services delivered using telecommunication systems were allowable in accord with Medicaid requirements.”
The expected issue date of the OIG report is 2019, and this is understandable given the sweeping scope of the project and the significant variances in coverage rules across different state Medicaid programs.
As with the OIG’s Medicare review, telemedicine providers ought not fear the new OIG project, or see it as a reason not to offer telehealth services to their patients. Indeed, the project and its eventual report can help shed light on those areas of compliance which the OIG believes important. In the interim, providers should continue to ensure their telehealth programs and claims comply with state Medicaid requirements, including coverage, coding, and documentation rules.
For more information on telemedicine, telehealth, and virtual care innovations, including the team, publications, and other materials, visit Foley’s Telemedicine Practice.
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Congress is now back in session and, once again, focus has turned to health care. With all eyes on returning health care reform to the forefront, a flurry of activity has sparked new legislative efforts including the introduction of the Graham-Cassidy legislation, Medicare for All, and a Senate Finance Committee agreement to a five year reauthorization of the Children’s Health Insurance Program (CHIP). Here’s a summary of the efforts currently underway for Graham-Cassidy as well as a review of what is included in the bill. Subsequent posts will cover other congressional developments.
The Unveiling of the Graham-Cassidy Legislation
Legislation by Senators Lindsey Graham (R-LA) and Bill Cassidy (R-LA) was formally unveiled on September 13, 2017. A summary of the bill follows, but in its current form, Graham-Cassidy would block grant the funding in the Affordable Care Act (ACA) to states, make significant changes to the reforms in the ACA, and change the traditional Medicaid program into a per capita cap or block grant program.
The Graham-Cassidy legislation appears to be shy of the 50 votes required to pass the Senate, but its supporters are working hard to convince their colleagues to get behind what could be the chamber’s last opportunity to pass legislation that repeals and replaces the ACA. Senator Rand Paul (R-KY) – who supported earlier repeal and replace efforts – has been highly critical of the measure, but most Senators have been relatively quiet on their position. Without Paul’s vote, the measure will need to maintain support by the Senators who voted for earlier efforts, as well as flip two of the following: Senator Susan Collins (R-ME), Senator Lisa Murkowski (R-AK) or Senator John McCain (R-AZ). Graham is very close friends with Senator McCain (R-AZ), which could prove an interesting dynamic. Last week, Senate Republican Leader McConnell (R-KY) called on the Congressional Budget Office to expedite the score of the proposal, although he has not indicated whether he is willing to take up the measure on the Senate floor this month.
The Senate loses its reconciliation vehicle on September 30, 2017, after which the legislation will require 60 votes to pass the Senate, so it is unclear whether there would even be enough floor time to move this bill. That said, if the Republicans can secure enough votes for this measure, expect them to find a path forward before the end of the month.
The House Republicans have been closely tracking the Graham-Cassidy developments. If the Senate can get to the required 50 votes on a repeal/replace bill, the House is expected to take up the legislation.
A Review of the Graham-Cassidy Legislation
The Graham-Cassidy legislation would make drastic cuts to programs added or expanded by the ACA in 2020, including the termination of the Medicaid expansion, the premium support subsidies for individuals to buy health insurance, elimination of small business tax credits, the ending of cost sharing reduction subsidies for low-income Americans, and removing the individual and employer mandates. In lieu of these programs and requirements, the legislation would provide states with significant federal funds to develop market-based health care initiatives outside the parameters established by the ACA.
Federal Grants for Market-Based Health Care
The centerpiece of these efforts is the proposed appropriation of federal funding for seven years for market-based health care initiatives, starting at $146 billion in 2020 and increasing to $190 billion in 2026. This funding approaches but may not equal estimates of ACA federal spending nationwide. The funding would be apportioned among states in accordance with a statutory formula, and be available to states for expenditures the state makes consistent with a plan submitted to the federal government. Examples of permissible plans include:
- Programs to help high-risk individuals purchase insurance in the individual market
- Programs to stabilize insurance premiums and promote market participation
- Payments to health care providers for the provision of services
- Funding assistance to reduce out-of-pocket costs of individuals in individual market plans
- Reductions of premium cost for individual market plans and for individuals without access to employer coverage
- Insurance coverage for Medicaid beneficiaries through health insurance issuers;
- Coverage programs for individuals not eligible for Medicaid or CHIP through arrangements with managed care organizations.
In connection with these plans, states could receive waivers of ACA requirements, and could allow insurers to vary premium rates based on health status, age, or other considerations (not including sex or classes protected under the U.S. Constitution), or decline to offer the ACA’s “essential health benefits.” States could also waive medical loss ratio requirements for insurance plans.
The legislation would also retain and expand the authority under section 1332 of the ACA, which allows states to request waivers of the ACA’s insurance market requirements if they can demonstrate more effective approaches. The legislation would make approval of such requests mandatory if they meet the current statutory criteria related to cost-effectiveness, access and cost sharing for enrollees, and would extend the length of the waivers to 8 years.
Changes to the Medicaid Program
Similar to previous Republican health care efforts, the Graham-Cassidy legislation would make significant modifications to the Medicaid program. Notable program changes are as follows:
- Ends the Medicaid Expansion. While previous iterations of the legislation had gradually phased out support or allowed the expansion to continue without the enhanced federal matching rate provided for by the ACA, the Graham-Cassidy legislation would entirely remove authority from states to cover the Medicaid expansion population. This change would be effective January 1, 2020, with the exception of certain Native American beneficiaries. As a result, the 30 states that have already expanded their Medicaid programs would need to terminate coverage, and potentially could transition individuals in the expansion population to alternative initiatives funded under the market-based grants described above.
- Disproportionate Share Hospital (DSH) Payment Reductions. Scheduled reductions to state allotments for payments to hospitals that serve a disproportionate share of Medicaid and uninsured beneficiaries are retained, and would take effect as scheduled. In some cases, states could have a portion of their DSH cuts restored if they experience a “grant shortfall,” which occurs when the state’s allotment from the market-based health care grant amount increases slower than an inflation adjuster.
- Per Capita Cap. As in each of the prior Republican health care bills, Graham-Cassidy would create a new “per capita cap” financing structure that significantly reduces the growth in federal spending on the Medicaid program. The structure of this provision mirrors prior legislative efforts, with few modifications.
- Block grants. As in the prior legislation, states would have the option to apply for a block grant of federal funds in lieu of receiving funds under the normal Medicaid matching formula. Graham-Cassidy limits this option to non-elderly, non-disabled adults.
- Work Requirements. Allows states to impose work requirements on Medicaid recipients who are not pregnant, disabled, elderly, children, or caretakers of a child under the age of six or a child with disabilities. Exceptions exist for individuals who are sole parents or caretakers of a young child or a child with disabilities, for full-time students, or individuals participating in outpatient drug addiction or rehabilitation programs. Individuals that do not meet the work requirements imposed by the state would lose access to Medicaid coverage.
- Limitations on Provider Taxes. Would limit the scope of permissible health-care provider taxes that may be used to fund a state’s Medicaid program. If implemented, many states would need to restructure their provider tax programs or restructure the financing of Medicaid expenditures.
- Other Notable Changes:
- Option for states to earn quality performance bonus payments from FY 2023 through FY 2026. States would earn the payments by having lower than expected aggregate medical assistance expenditures; states would be required to distribute the bonus payments on quality improvement.
- Limits the scope of retroactive Medicaid coverage to two months before the date of application. Current law requires coverage three months before the date of application; other Republican proposals would have limited it to services in the month of application.
- New authority for four year Medicaid home and community based service demonstration projects.
- Option to expand coverage for psychiatric hospital services to individuals age of 21 to 65, notwithstanding the general Medicaid prohibition on payment for services for adults in an institution for mental disease (IMD).
- Expansion of federal support for services provided to eligible Native Americans who are Medicaid beneficiaries.
- Retains provisions in prior GOP health care bills that would prohibit federal funding to Planned Parenthood and other entities meeting certain designated criteria. The qualifying criteria have been modified in the Graham-Cassidy legislation so that other non-profit providers that are part of national chains and which provide abortion services outside the scope of the Hyde amendment could potentially be implicated.
The Graham-Cassidy legislation introduces the following insurance changes:
- Effectively eliminates employer mandate penalty, retroactive to calendar year 2016.
- Repeals the reduction of the employer deduction for retiree prescription drug plans receiving Part D subsidies, effective for tax years after December 31, 2016.
- Eliminates age restriction on the sale of catastrophic coverage plans (currently cut off at age 30), effective for plan years beginning on or after January 1, 2019.
Health Savings Account (HSA) Changes
The following HSA changes are also included in the legislation:
- HSA contribution limits will increase to the High Deductible Health Plan (HDHP) out-of-pocket limits and consumers will be permitted to use HSA funds to pay premiums for certain HDHPs, effective tax years after December 31, 2017.
- Will not allow HSA funds to be used for a HDHP that covers abortion, effective for plan years beginning after December 31, 2017.
- Allows HSAs to be used to pay for primary care service arrangements (concierge medicine), effective tax years after December 31, 2016.
- Allows HSAs to be used to pay for expenses of children under age 27, effective tax years after December 31, 2017.
- Establishes a 60-day grace period after enrollment in an HDHP to establish an HSA and also allows reimbursement of medical expenses incurred during that period from new HSA, effective for HDHP plan coverage beginning after December 31, 2017.
- Allows both spouses to make catch-up contributions to the same HSA account, effective tax years after December 31, 2017.
- HSA and FSA funds will be able to be used on over-the-counter medications, effective tax years after December 31, 2016.
- Reduces tax on non-qualified HSA and Archer MSA distributions, effective for distributions made after December 31, 2016.
Other Notable Tax Changes Introduced by Graham-Cassidy
- Eliminates the individual mandate penalty, retroactive to calendar year 2016.
- Eliminates premium tax credits, effective tax years after December 31, 2019.
- Eliminates small business tax credits, effective tax years after December 31, 2019.
- Repeals cost-sharing reduction subsidy program, effective for plan years beginning after December 31, 2019.
- Repeals the medical device tax, effective for sales after December 31, 2017.
- Excludes from definition of “Qualified Health Plan” those plans that cover abortion, effective tax years after December 31, 2017.
Stay tuned as subsequent posts will cover the other activities currently happening including efforts to stabilize the insurance exchanges, Medicare for All, and the CHIP program reauthorization.
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Telehealth providers can celebrate another successful year of growth, as CMS reported a 28% increase over total 2016 payments for telehealth services under the Medicare program. Providers continue to successfully integrate telehealth services into their traditional health care delivery approaches, and are realizing payment opportunities both within the Medicare FFS program and in other sources of revenue. Our thanks to POLITICO Pro Morning eHealth Reporter, David Pittman, who first reported on the story and shared the claims data.
2016 Medicare Telehealth Claims Data
Let’s review the numbers. In CY 2016, Medicare paid a total of $28,748,210 for telehealth services, spread across a total of 496,396 claims. This includes payments to distant site providers and originating site payments. Compare this amount to last year, in which Medicare paid a total of $22,449,968 for telehealth services, spread across a total of 372,518 claims. (The figures are slightly different than reported in prior years, as CMS changed its data collection and calculation methodology this year.)
The result: 2016 saw a 33% increase in the number of Medicare telehealth claims submitted and a 28% increase in total payments. This uptick in total payments is not attributable to fee schedule rate increases, but rather to more providers using telehealth services with their traditional Medicare FFS beneficiaries.
More Originating Site Claims Filed Than Ever Before
Perhaps the most interesting element in the new data is the significant increase in originating site claims (HCPCS Code Q3014).. Before 2015, approximately half of all distant site claims did not have a corresponding originating site claim. This gap has closed in the last two years, and in 2016, 66% of all distant site claims had a corresponding originating site claim. The remaining gap could be due to providers not bothering to bill for the $25 originating site facility fee, or it could be that some claims were billed when the patient was located at home (a different site of service for which a facility would not bill). The federal Office of Inspector General at the Department of Health & Human Services has announced a new audit project to review Medicare payments for telehealth services and understand the reason(s) for this gap.
Despite the increase, Medicare’s $28.7 million payments in 2016 remains a small portion of the $600+ billion overall Medicare program budget. Remember: in 2001, the Congressional Budget Office estimated it would cost the Medicare program $150 million to cover telehealth services for the first five years ($30 million a year). Fifteen years later, total payments (2011-2016) still have not cracked that $150 million forecast and annual spend has not hit $30 million.
Medicare Coverage of Telehealth Services is Limited
Coverage of telehealth services under Medicare remains limited, with the restrictions established via statute under the Social Security Act. Any notable expansion of telehealth coverage under Medicare would require legislation by Congress. There are several bills pending in Congress to remove these limitations, but until such time, there are five main conditions for coverage for telehealth services under Medicare.
- The beneficiary is located in a qualifying rural area (providers can check if the originating site is in a qualifying rural area by using the Medicare Telehealth Payment Eligibility Analyzer);
- The beneficiary is located at one of eight qualifying originating sites (i.e., the offices of physicians or practitioners; Hospitals; Critical Access Hospitals; Rural Health Clinics; Federally Qualified Health Centers; Hospital-based or CAH-based Renal Dialysis Centers (including satellites); Skilled Nursing Facilities; and Community Mental Health Centers);
- The services are provided by one of ten distant site practitioners eligible to furnish and receive Medicare payment for telehealth services (i.e., physicians; nurse practitioners;™physician assistants;™nurse-midwives;™ clinical nurse specialists;™ certified registered nurse anesthetists; clinical psychologists; clinical social workers; registered dietitians; and nutrition professionals);
- The beneficiary and distant site practitioner communicate via an interactive audio and video telecommunications system that permits real-time communication between them (store and forward is covered in Alaska and Hawaii under demonstration programs); and
- The CPT/HCPCS (Current Procedural Terminology/Healthcare Common Procedure Coding System) code for the service itself is named on the CY 2017 (or current year) list of covered Medicare telehealth services.
In order to bill Medicare for telehealth services, the distant site practitioner must fully comply with each of these requirements. If the service does not meet each of these above requirements, the Medicare program will not pay for the service. If, however, the conditions of coverage are met, the use of an interactive telecommunications system substitutes for an in-person encounter (i.e., it satisfies the “face-to-face” element of a service).
How to Request Additional Medicare Telehealth Services
Providers and other interested parties need not wait on federal legislation to pass. Anyone may send CMS a request to add services (HCPCS codes) to the list of covered Medicare telehealth services. This can include medical specialty societies, individual physicians or practitioners, hospitals, state and federal agencies, telehealth companies, vendors, and even patients. Requests may be submitted at any time on an ongoing basis. The requests will be consolidated and considered during the CMS rulemaking cycle that establishes the physician fee schedule rates.
Each request should address the following:
- Name(s), address(es) and contact information of the requestor.
- The HCPCS code(s) that describes the service(s) proposed for addition or deletion to the list of Medicare telehealth services. If the requestor does not know the applicable HCPCS code, the request should include a description of services furnished during the telehealth session.
- A description of the type(s) of medical professional(s) providing the telehealth service at the distant site.
- A detailed discussion of the reasons the proposed service should be added to the definition of Medicare telehealth service.
- An explanation as to why the requested service cannot be billed under the current scope of telehealth services, for example, the reason why the HCPCS codes currently on the list of Medicare telehealth services would not be appropriate for billing the service requested.
- Evidence that supports adding the service(s) to the list on either a category 1 or category 2 basis as explained in the section labeled “CMS Criteria for Submitted Requests.”
Email your request to Telehealth_Review_Process@cms.hhs.gov and title it “Telehealth Review Process.” Alternatively, you can mail the request to: Division of Practitioner Services, Mail Stop: C4-03-06, Centers for Medicare and Medicaid Services, 7500 Security Boulevard Baltimore, Maryland 21244-1850. Attention: Telehealth Review Process.
Continued expansions in reimbursement mean providers should make enhancements to telehealth programs now, both for the immediate cost savings and growing opportunities for revenue generation, to say nothing of patient quality and satisfaction.
For more information on telemedicine, telehealth, and virtual care innovations, including the team, publications, and other materials, visit Foley’s Telemedicine Practice.
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Ninth Circuit Victory Opens the Door to Medicaid Reimbursement Challenges Based on Equal Access Requirement
The Ninth Circuit held August 7 that the Department of Health and Human Services Secretary erred in approving a Medicaid State Plan Amendment (SPA) that cut reimbursement for outpatient hospital services in California by 10% for eight months in 2008-2009. The Hoag Memorial decision sided with the 57 hospitals that challenged the SPA under the theory that the reimbursement cut violated the federal Medicaid requirement that payment rates be sufficient to provide Medicaid beneficiaries with equal access to care and services.
In Hoag Memorial, the Court Did Not Defer to the Secretary’s Interpretation of the Medicaid Statute
The decision is particularly significant because prior Ninth Circuit caselaw had largely deferred to the Secretary when considering how reimbursement cuts would impact the availability of Medicaid services. In 2013, the court rejected a hospital challenge in Managed Pharmacy Care v. Sebelius, in which plaintiffs had alleged that a reimbursement cut did not satisfy the Medicaid requirement under section 1902(a)(30)(A) of the Social Security Act (Section 1902(a)(30)(A)) to “assure that payments are consistent with efficiency, economy, and quality of care” because the Secretary did not consider provider costs.
Hoag Memorial distinguished Managed Pharmacy Care by relying on a different clause in section 1902(a)(30)(A). The court wrote that the requirement that payments “are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area,” unambiguously expressed Congress’ intent such that the court need not defer to the Secretary’s interpretation about whether the requirement was met. It said that the equal-access requirement is a “concrete standard, objectively measurable against the health care access afforded among the general population,” in contrast to the “broad and diffuse” requirement that payments be “consistent with efficiency, economy and quality of care.” Based on this analysis, the court held that the Secretary’s approval of the SPA was arbitrary and capricious under the Administrative Procedure Act (APA) because it failed to consider Medicaid beneficiaries’ access to care relative to that of the general (i.e., non-Medicaid) population.
The APA’s Role in Challenging Medicaid State Plan Amendments
About two years ago, in Armstrong v. Exceptional Child Center, the United States Supreme Court rejected a Section 1902(a)(30)(A) Medicaid reimbursement challenge brought against the state of Idaho for lack of a viable cause of action. In that case, the plaintiff providers had argued that they were entitled to challenge the sufficiency of Idaho’s Medicaid rates pursuant to the Supremacy Clause of the United States Constitution. The Courtheld that the Supremacy Clause “instructs courts what to do when state and federal law clash, but is silent regarding who may enforce federal laws in court, and in what circumstances they may do so.” The Court also asserted that “the Medicaid Act implicitly precludes private enforcement of §30(A)” and expressed skepticism of efforts to “circumvent Congress’s exclusion of private enforcement.” Notwithstanding the Supreme Court’s observation that the Medicaid Act precludes private enforcement, Hoag Memorial allowed a challenge to the sufficiency of Medicaid rates in federal court based on the express statutory cause of action in section 702 of the APA for persons who suffer legal wrong because of agency action.
CMS is Likely to React to the Decision by Considering Additional Evidence When Approving Medicaid Reimbursement SPAs
The holding in Hoag Memorial relied on what the court found to be the Secretary’s failure to consider any evidence regarding the general population’s access to care and services. In the court’s view, such oversight rendered it logically impossible for the Secretary to meet the statutory standard because there could be no way of proving that Medicaid beneficiaries had at least the same level of access to care and services as the general population if the Secretary did not know anything about the general population’s access. Without the ability to make the statutorily mandated comparison, it was not enough that the administrative record included evidence that Medi-Cal beneficiary utilization of hospital outpatient services had not decreased after the payment cut, nor that it included evidence that just as many hospitals provided outpatient services to Medi-Cal beneficiaries.
In 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring states considering reductions or restructuring of Medicaid reimbursement that could have an adverse impact on beneficiary access to care to conduct access reviews and submit those findings to CMS along with the request for approval of the reimbursement change. Although the rule references section 1902(a)(30)(A), it does not provide detailed instruction about the evidence that CMS needs from states to evaluate whether the equal-access-to-service component of section 1902(a)(30)(A) has been satisfied. CMS may propose modifications to the rule in response to the Ninth Circuit’s ruling, and begin directing states to submit the kind of evidence the court did not find in the administrative record in Hoag Memorial —either studies directly comparing access to care and services for Medicaid beneficiaries with access for the general population, or independent evidence of the level of access for both groups that CMS can compare when evaluating the SPA.
If CMS modifies the information it requires states to submit in an access review, or if states independently collect comparison data as part of their access reviews, the next round of litigation over equal access for Medicaid beneficiaries may focus not on the Secretary’s failure to consider any evidence at all, but on whether the Secretary considered the right kinds of evidence and drew reasonable conclusions from it. If so, the question of deference will again become paramount because plaintiffs will continue to face uphill battles challenging SPA approvals if courts defer to CMS’ evaluation and interpretation of the evidence. On the one hand, the complexity of the Medicaid program and CMS’ agency expertise in administering it may counsel in favor of deference to the agency. But on the other hand, plaintiffs are likely to argue that deference is not warranted based on the court’s statement in Hoag Memorial that a “straightforward comparison of data under the equal-access requirement would derive little benefit from the Secretary’s expertise.”
It is also possible that the federal government will appeal Hoag Memorial by requesting en banc review at the Ninth Circuit or by appealing to the Supreme Court. As of publication of this article, no petition for further review had been filed.
The Path for Future Medicaid Reimbursement Challenges
Ultimately, Hoag Memorial proves the continuing viability of section 1902(a)(30)(A) challenges to Medicaid reimbursement, even after the defeats for providers in the last few years in the Ninth Circuit and Supreme Court. While APA litigation over the federal approval of Medicaid SPAs is likely to remain challenging for plaintiffs, Hoag Memorial potentially lays the groundwork for future equal-access-to-care arguments and provides support for an argument that courts need not defer to CMS’ conclusions if they are convinced that the Medicaid statute is clear.
Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.
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The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of its largest suppliers, as is evident in its case against Arriva Medical, LLC. Medicare billing privileges may be revoked for any one (or more) of several grounds laid out in the regulations at 42 C.F.R. § 424.535. In this case, CMS relied upon 42 C.F.R. § 424.535(a)(8), “abuse of billing privileges,” and specifically subsection (i)(A), regarding the submission of a claim for an item or service that could not have been furnished to a specific individual on the date of service because the beneficiary was deceased.
A revocation of billing privileges precludes payment for any claims submitted after the effective date of the revocation, and is accompanied by a ban on re-enrollment. A revocation has much the same impact as an exclusion imposed by the Department of Health and Human Services (HHS) Office of Inspector General (OIG), i.e., no Medicare payment, and in some cases revocations have been imposed after OIG declined to exclude an individual or entity.1 A Medicare revocation can also result in similar actions under Medicaid.
Arriva provides diabetic testing supplies under Medicare’s competitive bidding program, and describes itself as the nation’s largest supplier of home-delivered diabetic testing supplies.2 In October 2016, Arriva was notified by CMS that its billing privileges would be revoked, effective November 4, 2016, with a three year ban on reenrollment, due to the submission of Medicare claims for deceased beneficiaries. On December 6, 2016, Arriva was notified that its competitive bidding contract would be terminated effective January 20, 2017, based upon its lack of Medicare billing privileges.
Arriva filed for administrative review of the revocation of its billing privileges, an appeal that as of this writing is pending with the Departmental Appeals Board (DAB), and filed for a temporary restraining order and injunctive relief in light of the upcoming deadline for termination of its competitive bid contract. In its filing, Arriva alleged that the revocation was based upon 211 claims (0.003%) for supplies shipped to beneficiaries after they had died, out of approximately 5.8 million claims over a five-year period.3 Arriva further noted that CMS found concerns with the supporting claims documentation for 47 of those 211 beneficiaries. However, Arriva argued that any errors in billing for these claims after the beneficiary died were primarily the result of Medicare system flaws, and the revocation itself was related to the backlog of claims appeals before the Office of Medicare Hearings and Appeals.
Defendants (HHS) responded by filing an Opposition to Plaintiff’s First Application for Temporary Restraining Order (TRO) and Preliminary Injunction and Motion to Dismiss Plaintiff’s Complaint (Defendants’ Opposition), in which it was reported that CMS had advised Arriva that CMS was willing to defer the termination of the competitive bidding contract until such time as the DAB rendered the final agency decision on the revocation. Defendants’ Opposition notes that several courts have addressed revocation actions imposed by CMS, including allegations of imminent and irreparable harm, and have dismissed the complaints for lack of jurisdiction. Here, HHS again argued that administrative exhaustion is required before revocation disputes can be heard by a court. Moreover, HHS argued that a post-deprivation avenue for appeal did not violate the supplier’s due process rights, with a lengthy discussion of case law on this issue. Defendants’ Opposition also includes a lengthy discussion of Defendants’ view on the standard for granting a TRO, including arguments that the case law does not support a finding of “irreparable harm” for health care entities even against allegations that they might have to shut down as a result of the challenged action.
By minute order entered on January 4, 2017, the request for a TRO was denied, with the court setting a schedule for plaintiff to file a renewed motion for preliminary injunction and for defendant to file an opposition to that motion as well as a motion to dismiss. The hearing on both motions is currently scheduled for February 8, 2017.
This case should be closely watched for its evaluation of CMS’ revocation authorities.
Originally, this post was an alert sent to the American Health Lawyers Association’s (AHLA) Regulation, Accreditation, and Payment Practice Group Members. It appears here with permission. For more information, visit AHLA’s website.
1 For a discussion of the difference between exclusions and revocations, see Desfosses v. Noridian Healthcare Solutions, LLC, 2015 WL 1196018 (Mar. 16, 2015).
2 Complaint for Declaratory and Injunctive Relief, Arriva Medical, LLC v United States Department of Health and Human Services, Case No. 1:16-cv-02521-JEB (D.D.C.).
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