Category: Medicare

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Top 5 Ways Telehealth Will Change Under the New Federal Funding Bill

The telemedicine industry has been abuzz upon learning that provider-friendly legislation was included in the new federal Bipartisan Budget Act of 2018, signed into law by the President on February 9, 2018.  But telehealth providers, hospitals, and entrepreneurs need to cut through the hype and understand what the provisions will really do for telehealth.  This article summarizes the key takeaways and insights on how the recent legislation will benefit the telehealth industry.

Significant Changes for Medicare and Telehealth Services

The bill introduces some of “the most significant changes ever made to Medicare law to use telehealth,” according to Senator Brian Schatz, a longtime sponsor and proponent of federal telehealth legislation.  Key elements of the bill include: (1) expanding stroke telemedicine coverage; (2) improving access to telehealth-enabled home dialysis oversight; (3) enabling patients to be provided with  free at-home telehealth dialysis technology without the provider violating the Civil Monetary Penalties Law; (4) allowing Medicare Advantage (MA) plans to include delivery of telehealth services in a plan’s basic benefits; and (5) giving Accountable Care Organizations (ACOs) the ability to expand the use of telehealth services.

No More Originating Site Restrictions for Telestroke?

Historically, only Medicare patients located in rural areas at qualifying originating sites were eligible for reimbursement for telestroke services.  Under Section 50325 of the new bill, beginning Jan. 1, 2019, the geographic and facility-type requirements on originating sites will no longer apply for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke when delivered at certain originating sites.  These are 1) hospitals, 2) critical access hospitals, 3) any mobile stroke unit as defined by the Secretary of Health and Human Services (HHS), or 4) any other site determined appropriate by HHS, at which the eligible telehealth individual is located at the time the service is furnished via telehealth. One potential site that HHS could approve is the patient’s home

The full extent to which telemedicine providers and Medicare beneficiaries will benefit from expanded telestroke reimbursement largely depends on the sites that HHS will permit as qualified originating sites.

Allowing more qualified originating sites, such as the patient’s home, ambulances, and mobile stroke units, will provide broader  options for healthcare systems that do not have constant access to a neurologist and allow institutions with established stroke programs opportunities for destination medicine and new patients.

Now is the time to make your voice heard and inform HHS as to what you believe should be included among the new eligible originating sites for telestroke.

Note, the new reimbursement applies only to the distant site practitioner’s professional fee.  Originating sites qualifying for reimbursement under this provision that do not meet the historical originating site facility-type and rural geographic requirements will not be eligible for a facility fee.

Medicare Will Reimburse for Telehealth Dialysis Services at the Patient’s Home and at Independent Facilities

The new law also extends telehealth reimbursement to dialysis services provided remotely to patients located at home or at independent renal dialysis facilities (neither of which have historically been eligible originating sites under Medicare).  Under Section 50302 and effective January 1, 2019, an individual with end stage renal disease (ESRD) receiving home dialysis may choose to receive monthly ESRD-related oversight visits from their home via telehealth if the patient receives a “face-to-face” visit (in this context, meaning in-person) at least once a month during the initial 3 months of home dialysis and then, after the initial 3 months, at least once every 3 consecutive months.

These two new originating sites, along with hospital-based or critical access hospital-based renal dialysis centers, are also be exempt from the rural geographic are requirement for the monthly telehealth visits.  Keep in mind, however, that no facility fee payment is available when a patient is located at home.

Providers Can Give Free Telehealth Technology/Equipment for At-Home Dialysis Patients

Under the bill, the provision of free telehealth technologies by a provider of services or a renal dialysis facility to an individual with ESRD who is receiving home dialysis for which Medicare payment is received will not constitute illegal remuneration under the Civil Monetary Penalties Law if three factors are met:

  1. The telehealth technologies are not offered as part of any advertisement or solicitation;
  2. The telehealth technologies are provided for the purpose of furnishing telehealth services related to the individual’s ESRD; and
  3. The provision of the telehealth technologies meets any other requirements set forth in regulations promulgated by CMS.

This means telehealth dialysis providers are allowed to provide at-home telehealth technology/equipment at no charge to patients if the above requirements are met.  It is a patient (and provider) –friendly change to the definition of “remuneration” as it relates to patient inducements and  the Civil Monetary Penalties Law.  Providers can benefit from the improved outcomes and cost-effectiveness of delivering services remotely while simultaneously providing comfort for ESRD patients to know that someone is available when concerns arise without requiring that patients travel to the dialysis center.

Medicare Advantage Plans Can Finally Include Telehealth Services as a Basic Benefit

Medicare Advantage (MA) plans will be allowed to offer additional, clinically appropriate telehealth benefits in their annual bid amounts beyond the services that currently receive payment under Medicare Part B.  This has been a major sticking point and a reason why, historically, MA plans have not been as quick to cover telehealth services compared to Medicaid managed care plans.

Section 50323 of the bill gives MA plans the ability to offer telehealth services as part of their basic benefit package (i.e., as if the telehealth services were benefits under the original Medicare fee-for-service program option).  However, exactly what telehealth services will qualify as a “basic benefit” have not been fully defined.  HHS will solicit public comments before November 30, 2018 to determine what types of telehealth items and services (e.g., remote patient monitoring, secure messaging, store and forward technologies, and other non-face-to-face services) should be considered to be an “additional telehealth benefit” (meaning, eligible to be counted as part of the basic benefit package).  HHS will also solicit comments on the requirements for providing and furnishing such telehealth services (e.g., training and coordination rules).  An expansive list of eligible telehealth services by HHS likely would stimulate a big uptick in telehealth service coverage by MA plans.

These new provisions go into effect in 2020, so now is a smart time for hospitals and telehealth providers to engage their MA plan partners in discussions on how to amend their participation agreement and cover telehealth services.

The Patient’s Home is an Eligible Originating Site for Accountable Care Organizations

Accountable Care Organizations (ACOs) have even more flexibility to use telehealth services.  Beginning January 1, 2020, the patient’s home qualifies as an eligible originating site for telehealth services provided by a physician or practitioner participating in certain ACOs (Next Generation, MSSP Track II, MSSP Track III, and certain two-sided risk models).  No payment may be made for telehealth services CMS deems to be inappropriate to furnish in the home setting (e.g., inpatient hospital services).  Additionally, the law eliminates the rural geographic area requirements for ACOs (i.e., the originating site need not be located in a rural health professional shortage area or a non-metropolitan statistical area).  As with many of the other changes introduced by the new law, the patient’s home is not eligible for a facility fee.

Conclusion

The 2018 Act represents federal lawmakers’ continued and increasing support for expanding Medicare telehealth reimbursement.  Telehealth providers should embrace the Act and use it as an opportunity to contribute to and develop meaningful telehealth reimbursement policies.

We will continue to monitor the law’s progress as CMS begins to promulgate regulations, so please check back for updates.  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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New Funding Legislation’s Impact on Health Care Programs

Congress passed a funding bill early this morning just after the February 8th deadline. The new legislation will make several changes to the Medicare program, delay cuts to disproportionate share hospitals, provide two years of funding for community health centers, and renew certain expired or expiring health care programs. The legislation increases government funding caps by about $300 billion over two years, extends government funding through March 23rd, and provides for a one year suspension on the debt ceiling.

The legislation includes several Medicare extenders (legislation that extends Medicare programs that were set to expire or have expired) that have developed out of the House and the Senate along with extensions for other health care programs discussed below.

Medicare Cap for Therapy Services

The new legislation removes Medicare caps for therapy services. Currently, Medicare beneficiaries receive assistance paying for outpatient physical and occupational therapy, and speech-language pathology services.  When a beneficiary receives those services from an outpatient provider, there is a cap on how much Medicare will cover unless an exception applies. This cap will be removed.

Special Needs Plans

Special Needs Plans (SNPs) were set  to expire at the end of 2018 and the legislation makes SNPs permanent. SNPs are Medicaid managed care plans that enroll beneficiaries with low income, chronic conditions, or who reside in a nursing home. The most well-known SNP is the D-SNP that is available to individuals that are eligible for both Medicare and Medicaid. Other SNPs are available to patients who are institutionalized, I-SNPs, or have chronic conditions, C-SNPs.  Several plans have expressed concerns about the temporary nature of SNPs and have lobbied for a permanent solution.

Health Care Program Extensions

The legislation grants a five-year extension for the home health rural add-on payment, a 3% payment increase that expired on January 1. Ambulance providers will receive increased payments for services provided in rural  and underserved areas and will also be required to provide cost reporting for ambulance services and Health and Human Services (HHS) could impose penalties for incomplete reports.

Along with the five-year extensions, the legislation tacks on a two-year extension for health programs such as the National Health Service Corps, the Medicare Dependent Hospital Program, and the low-volume hospital payment adjustment for hospitals that discharge fewer than 1,600 Medicare patients each year.

Medicare Expansion

Several measures in the legislation address expanding Medicare coverage for individuals with chronic conditions. Telehealth services would expand for end-stage renal disease treatments, stroke evaluations, accountable care organizations, and Medicare Advantage plans. The legislation also allows Medicare Advantage plans to offer supplemental benefits to those with chronic conditions and modify Affordable Care Organizations to incentivize primary care programs.

The legislation creates a Medicare payment program for in-home infusion drug services to fill in the gap before the 21st Century Cures Act payment program takes effect and will codify certain Centers for Medicare and Medicaid Service (CMS) changes to the Stark law.

Home Health

The legislation also impacts home health providers. The home health services eligibility determination process documentation review now includes medical records of home health providers. The legislation also directs Health and Human Services (HHS) to modify payments for home health services beginning in 2020.

Funding of the Legislation

The legislation is funded through a variety of fiscal offsets including Medicare payment modifications and shifting money from other funds. The legislation reduces certain Medicare payments such as hospital payments made when a patient is transferred to a hospice after a short stay. Funding in the Medicare and Medicaid Improvement Funds will be withdrawn and the Affordable Care Act’s Prevention and Public Health Fund payment structure will be modified. The proposal also modifies the Medicaid Disproportionate Share Hospital reductions, adding $6 billion to FY21-FY23 to offset the elimination of reductions scheduled for FY18 and FY19. Payment for biosimilars will be included in the Medicare Coverage Gap Discount Program, a program that gives Medicare Part D beneficiaries a discount when out-of-pocket spending meets a certain threshold amount.  And the legislation closes the gap in Medicare prescription drug coverage, known as the “donut hole,” by shifting more of the cost onto drug companies.

We will continue to monitor the changes introduced in the legislation.

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CMS Announces an Advanced Alternative Payment Model – BPCI Advanced

On January 9, 2018, The Centers for Medicare & Medicaid Services (CMS) announced a new voluntary bundled payment model program – Bundled Payment for Care Improvement Advanced (BPCI Advanced). The episode payment model, which is a second generation version of the BPCI program, will qualify as an Advanced Alternative Payment Model (APM) under the Quality Payment Program adopted as part of MACRA, which means that physicians, because they take on financial risk, may earn the Advanced APM incentive payments.

What is BCPI Advanced?

The BPCI Advanced program is a voluntary program that offers a single retrospective bundled payment covering services within a 90-day Clinical Episode.  Participants may be involved in 29 inpatient Clinical Episodes and also, unlike the prior BPCI program, three outpatient clinical episodes –  Percutaneous Coronary Intervention, Cardiac Defibrillator, and Back & Neck except Spinal Fusion.  As with the prior BPCI model, target prices are provided in advance and are measured against the total Medicare fee for service spending and services during the selected Clinical Episodes. Participants who enter into the Participation Agreement with CMS will take on downside-financial risk from the outset of an episode.

Eligible Program Participants

BPCI Advanced will allow participation by Non-Convener Participants and Convener Participants.  Convener Participants may or may not be Medicare enrolled entities and agree to take on risk for downstream entities.  The Convener Participants facilitate coordination among episode initiators and bear the financial risk for the model. Non-Convener Participants are acute-care hospitals or Physician Group Practices, enrolled in Medicare, who are themselves episode initiators. They do not take risk for downstream entities.

Clinical Episodes are attributed at the episode initiator level with a CMS-defined hierarchy for attribution among different types of episode initiators.  The Clinical Episode will begin with an inpatient admission for an inpatient procedure or the start of the outpatient procedure.  Clinical Episodes continue for 90 days after the end of the inpatient stay or the outpatient procedure.

As with the prior BPCI program, payment under the BPCI Advanced program is tied to performance on specified quality measures.

Applications for participation in BPCI Advanced must be submitted by March 12, 2018.  The Model starts on October 1, 2018 and continues through December 31, 2023.

The Future of Alternative Payment Programs

BPCI Advanced is the first Advanced APM announced by the Trump Administration.  Although  it is voluntary, it does reflect continuation of alternative payment programs under the Trump Administration. Some have questioned the new Administration’s commitment to alternative payment programs, although there have been suggestions that HHS Secretary Nominee Alex Azar has indicated enthusiasm for programs that pay providers based on quality, and Nominee Azar has suggested mandatory programs may be appropriate.  Former Secretary Price was opposed to  mandatory programs such as the Episode Payment Models (EPMs),  the Cardiac Rehabilitation (CR) Incentive Payment Model, and the Comprehensive Joint Replacement (CJR) program. At the end of 2017, CMS terminated the EPMs and the CR Incentive Payment Model outright and terminated the mandatory nature of the CJR program.

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New OIG Project Expands Telemedicine Audits to State Medicaid Programs

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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:

  1. Projects originating within the Office of Audit Services (OAS), which conducts financial, billing, and performance audits of HHS programs; and
  2. 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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Medicare Payments for Telehealth Increased 28% in 2016: What You Should Know

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.

  1. 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);
  2. 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);
  3. 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);
  4. 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
  5. 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

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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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Medicare Claims Appeals: D.C. Circuit Reverses and Remands in Case Seeking Relief From Processing Delays

Summary of AHA v. Price, 2017 U.S. App. LEXIS 14887 (D.C. Cir. Aug. 11, 2017)

 

On August 11, 2017, the D.C. Circuit reversed the district court and held that the district court abused its discretion by ordering the Secretary of HHS to clear the backlog of administrative appeals of denied Medicare reimbursement claims within four years, because it failed to seriously test the Secretary’s assertion that this result was impossible. The underlying action demanded relief to address the Secretary’s inability to keep up with “an unexpected and dramatic uptick in appeals [that] produced a jam in the process” starting in fiscal year 2011.

In the initial proceedings, a group of hospitals sought a judicial order compelling the Secretary to provide relief from what they considered to be unreasonable delays in resolving Medicare claims appeals at the administrative appeals level.  The federal district court for the District of Columbia granted the Secretary’s motion to dismiss for lack of jurisdiction, but the D.C. Circuit reversed. The Circuit Court remanded the case back to the district court, with instructions to consider the merits of appeal, i.e., whether relief should be granted and if so the form of the relief.

The Four-Year Plan to Reduce the Backlog

In addressing the merits of plaintiffs’ allegations on remand, the district court adopted the hospitals’ so-called four-year plan and ordered the Secretary to reduce the current backlog of cases pending at the Administrative Law Judge level by 30% by the end of 2017; 60% by the end of  2018; 90% by the end of 2019; and 100% by the end of 2020.  The Secretary then appealed the district court’s order to the D.C. Circuit.  On appeal the Secretary argued that it would be impossible to comply with the timetable, because the only means of meeting the timetable would be to pay claims through mass settlements regardless of their merits, which (according to the Secretary) would be in violation of the Medicare statute.

Without finding whether in fact the Secretary would be unable to lawfully comply with the district court’s order, the D.C. Circuit held that because the Secretary represented that lawful compliance with the district court’s order was impossible, the district court committed reversible error by ordering the Secretary to comply with the timetable without first finding that lawful compliance was indeed possible. The Circuit Court also held that it was an error for the district court not to evaluate the Secretary’s assertion that the timetable would increase, not decrease, the number of backlogged appeals, because the timetable would generate an incentive for claimants to file additional appeals and hold out for big payouts.

The Case is Remanded to District Court to Determine Feasibility of Compliance Timetable

The D.C. Circuit therefore remanded the case again to the district court and ordered the district court to determine whether the Secretary’s compliance with the timetable is impossible. However, the Circuit Court noted that the Secretary will bears a “heavy burden to demonstrate the existence of an impossibility.” The Court further noted that if the district court finds on remand that the Secretary failed to carry his burden of demonstrating impossibility, it could potentially reissue its order without modification.

What Does this Decision Mean for Hospitals?

Many Medicare coverage appeals involve a hospital appealing the denial of a short stay on the basis that admission was not medically necessary, and that the patient could be treated as an outpatient. However, because CMS does not allow hospitals to rebill under Part B (except during the one year period following discharge, which in the majority of cases will have expired long before the RAC reopens and denies the inpatient claim), hospitals  believe that they have no choice but to appeal. It is important to keep in mind that although the D.C. Circuit faulted the district court for not considering the issue of whether the Secretary could legally comply with the prescribed timetable, the fact that the Secretary will bear the burden of proof on this issue may mean that the district court may end up issuing the same type of relief as it did before.

We will be following this case as the district court determines whether the Secretary’s compliance with the timetable is legally possible and will follow up once a decision is rendered.

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OIG to Audit Medicare Telehealth Services: What You Need to Know

medicare telehealth

For what may be the first time, the Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) recently announced a new project to review Medicare payments for telehealth services. Accordingly, providers who bill the Medicare program for telehealth services may expect to have those claims reviewed to confirm the patient was at an eligible originating site and that the statutory conditions for coverage were met. The audit is a new project added as a supplement to the OIG’s 2017 Work Plan.

OIG 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 in June 2017, OIG will update 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:

1) Projects originating within the Office of Audit Services (OAS), which conducts financial, billing, and performance audits of HHS programs; and

2) 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 telehealth project will be run by the OAS.

Review of Medicare Payments for Telehealth Services

OIG describes its new telehealth review project as follows:

“Medicare Part B covers expenses for telehealth services on the telehealth list when those services are delivered via an interactive telecommunications system, provided certain conditions are met (42 CFR § 410.78(b)). To support rural access to care, Medicare pays for telehealth services provided through live, interactive videoconferencing between a beneficiary located at a rural originating site and a practitioner located at a distant site. An eligible originating site must be the practitioner’s office or a specified medical facility, not a beneficiary’s home or office. We will review Medicare claims paid for telehealth services provided at distant sites that do not have corresponding claims from originating sites to determine whether those services met Medicare requirements.”

The expected issue date of the OIG report is 2017, so presumably the review will commence shortly (although OIG Work Plan projects are sometimes continued or extended from year-to-year).

Medicare 2014 Telehealth Claims Data

The new OIG project is not the first time Medicare claims data has identified a potential mismatch regarding the conditions for coverage for telehealth services. A July 2016, Medicare Payment Advisory Commission (MEDPAC) Report to Congress: Medicare and the Health Care Delivery System contained a detailed chapter on telehealth services and the Medicare program.  In it, MEDPAC analyzed Medicare claims data from 2014 for preliminary qualitative assessments on the state of telehealth services under Medicare. The report included a paragraph on telehealth distant site claims without a corresponding originating site claim, stating:

“Among the 175,000 telehealth claims from distant sites, 95,000 (55 percent) were without an originating site claim.  This discrepancy could be due to providers not bothering to bill for the $25 facility fee, or it could be that some services inappropriately originated from a patient’s home, as other research has suggested (Gilman and Stensland 2013).  Among the distant site telehealth claims without an originating site claim, 56 percent (53,000 visits) were associated with rural beneficiaries and 44 percent (41,000 visits) were associated with urban beneficiaries.  Both claims groups suggest that beneficiaries could be inappropriately receiving telehealth services from home or another unapproved location that did not file an originating site claim.  The urban claims are also potentially problematic because they could be occurring in urban originating sites, which is inconsistent with Medicare statute.”

Medicare Coverage of Telehealth Services

Current coverage of telehealth services under Medicare is limited, with the coverage 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.

  1. 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);
  2. 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);
  3. 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);
  4. 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
  5. 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).

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 Medicare 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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DOJ and OIG Focus on Opioid Abuse: Medical Professionals Who Overprescribe May Be Targets

Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal health care program beneficiaries.  The U.S. Department of Justice announced on July 13, 2017 fraud charges involving 412 defendants in 41 federal districts across the country, including 115 doctors, nurses, and licensed professionals.  In what the DOJ asserted was the “largest ever health care fraud enforcement action by the Medicare Fraud Strike Force,” DOJ alleged $1.3 billion in false billings were involved, and the enforcement action had a particular focus on medical professionals involved in the unlawful prescription and distribution of opioids. On a related matter, the Department of Health and Human Services (HHS) initiated payment suspension actions against 295 providers.

Attorney General Sessions attributed the action to tips from people in the affected communities and sophisticated computer programs utilized to identify outliers (i.e., datamining).

Data Brief Issued on Questionable Opioid Prescribing

Nearly simultaneously, the HHS Office of the Inspector General (OIG) issued a data brief entitled Opioids in Medicare Part D: Concerns About Extreme Use and Questionable Prescribing.  The data brief, likely reflecting the computer programs that identify outliers referred to by Attorney General Sessions, recited data on opioid use and overuse in the Medicare Part D population.

The data brief noted that one in three Medicare Part D enrollees, or approximately 14.4 million beneficiaries, received at least one prescription opioid in 2016,* and one-tenth of the Part D beneficiaries received opioids on a regular basis.  The data also showed that over 500,000 beneficiaries, excluding those in hospice care, received high doses of opioids, consisting of more than 120 mg/day over three months, which is in excess of the maximum daily level recommended by the Centers for Disease Control.

The OIG identified nearly 90,000 Medicare beneficiaries who are at serious risk of opioid abuse, because they either received extreme dosages of an opioid (more than 240 mg daily for 12 months, which is more than two and a half times the dose the CDC recommends) or appeared to be doctor shopping (received high amounts and had four or more prescribers and four or more pharmacies).  The OIG also reported data showed beneficiaries receiving opioids from as many as 46 different prescribers from 20 different pharmacies in multiple states.

According to the OIG, such high use shows not only that the beneficiary may be addicted to opioids, but also there is a risk of diversion for resale.

Prescription patterns of various prescribers to the Medicare D population were also reported.  OIG identified over 400 prescribers with “questionable prescribing patterns”; that is where they ordered opioids for those at high risk for abuse because of their extreme use or because of their apparent doctor shopping. OIG also identified that it has information on a smaller subset of prescribers with a high number of beneficiaries who received extreme amounts of opioids or who appeared to be doctor shopping.

OIG Continues  to Focus on Opioid Abuse

OIG is focused on the issue of opioid abuse, and that, through information available as reflected in the data brief, it can readily identify Part D beneficiaries and their prescribers who have high or extreme usage of opioids or appear to be prescriber shopping. OIG indicates that, armed with this data, it will work with its law enforcement partners and CMS to follow up with identified prescribers.  The DOJ enforcement action may well reflect this cooperation.  In the report OIG specifically calls on “Part D sponsors to work with OIG and CMS to better combat opioid abuse in Medicare.”

A clear warning has been given to those prescribing or involved with heavy use of opioids through this data brief. Improved datamining makes prescribing patterns of individual practitioners relatively transparent, at least with respect to Federal healthcare beneficiaries. Combined with the DOJ reported enforcement action, it likely shows that medical professionals who are significant outliers in prescribing opioids to the Medicare population are likely to be viewed as potential targets for enforcement and that the Federal government is serious about pursuing whatever leads it has.

* The most commonly prescribed opioids were tramadol, hydrocodone and oxycodone.

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What To Know About New HHS OIG Exclusion Regs

Regulatory-Developments

On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort  a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary penalty (CMP) regulations, 81 Fed. Reg. 88,334 (Dec. 7, 2016), and safe harbors under the anti-kickback statute and beneficiary inducement prohibitions, 81 Fed. Reg. 88,368 (Dec. 7, 2016).

The final rule codifies the OIG’s expanded authority to impose exclusions under the Affordable Care Act and the Medicare Prescription Drug, Improvement and Modernization Act of 2003, including discretionary exclusions for obstructing an audit and for making false statements, omissions, or misrepresentations in an enrollment or similar application to participate in a Federal health care program.

The final rule notices an effective date of Feb. 13, 2017. However, on Jan. 20, 2017, the new administration postponed for 60 days the effective date of all federal regulations that have not yet taken effect. Although agencies may propose additional rulemaking, for regulations that “raise no substantial questions of law or policy,” agencies are not required to take any additional action. Thus, this rule will likely take effect following the 60-day freeze, which ends on March 21, 2017.

The effect of exclusion is far-reaching. Until an individual or entity that has been excluded is reinstated into the federal health care programs, no payment will be made by Medicare, including Medicare Advantage and Prescription Drug Plans, Medicaid or any other federal health care program for any item or service furnished, on or after the effective date. Additionally, private payers frequently refuse to contract with excluded persons.

Although the majority of exclusion are derivative of other actions (such as convictions or licensure actions), exclusions can be pursued affirmatively and initiated by the OIG, often by the OIG’s recently established (2015) administrative litigation team.

Like the two rules before it, this final rule provides important guidance on the OIG’s administrative enforcement authorities and expands and clarifies existing provisions, including aggravating and mitigating factors used to determine the length of exclusions.

Refresher on Exclusions

Before discussing the new provisions, the following is a brief overview of the OIG’s exclusion authorities. The majority of the OIG’s exclusion authorities are set forth in Section 1128 of the Social Security Act, 42 U.S.C. 1320a–7, and are implemented by regulations at 42 C.F.R. part 1001.

Mandatory Exclusions: There are four mandatory authorities and nearly 20 permissive exclusion authorities. As the name suggests, mandatory exclusions must be imposed by the OIG when individuals or entities (persons) are convicted of crimes related to certain conduct, namely: (1) misdemeanor or felony convictions related to the federal health care programs; (2) misdemeanor or felony convictions relating to patient abuse in connection with the delivery of a health care item or service; (3) felony convictions relating to health care fraud (i.e., relating to fraud, theft, embezzlement, breach of fiduciary responsibility or other financial misconduct); and (4) felony conviction relating to the unlawful manufacture, distribution, prescription or dispensing of a controlled substance.

Permissive Exclusions: Sixteen permissive exclusions are listed in Section 1128 and a handful of others can be found in other sections of the Social Security Act. The OIG has discretion as to whether to pursue an exclusion under its permissive authorities.

Convictions and Enforcement Actions Lead to Derivative Exclusions: Even when it is not required to do so, the OIG is likely to exclude a person who has been convicted of a crime or when another government agency, such as a state medical board, has taken action. These derivative exclusion actions are easy for the OIG to impose and defend, making them an efficient way to protect the programs.

Definition of a Conviction: Because a large number of derivative exclusions, whether mandatory or permissive, are based on convictions, it is worth noting that the term “conviction” is broadly defined in the statute at 1128(i), 42 U.S.C. 1320a–7(i). The term includes convictions where conviction or other records have been expunged, pleas of nolo contendere, findings of guilt by a court, and participation in deferred adjudication and similar arrangements where judgment of conviction has been withheld.

Length of Exclusion: Base exclusion periods for the most frequently used exclusion authorities, including those based on convictions or licensure actions, are set forth in the exclusion statute at 1128(c)(3), 42 U.S.C. 1320a–7(c)(3). Mandatory exclusions must be, at a minimum, five years. Permissive exclusions based on convictions have a base period of three years. Permissive exclusions based on licensure or state actions are coterminous with the underlying state sanction. The OIG uses aggravating and mitigating factors to adjust the period of exclusion, but not below five years for mandatory exclusions.

Major Provisions in the Final Rule

In the final rule, the OIG adopted the majority of the provisions included in its proposed rule, 79 Fed. Reg. 26,810 (May 9, 2014), but revised some of its proposals, generally in response to public comment. Like the OIG’s other recent rulemakings, this final rule offers insight into how the OIG may use its exclusion authorities as key components of its administrative enforcement efforts.

The final rule:

  1. Expands permissive exclusion authority, pursuant to the ACA, for convictions related to obstructing an investigation to include “audits,” a term the OIG interprets broadly.
  2. Adds permissive exclusion authority from the ACA for making false statements, omissions or misrepresentations in an enrollment or similar application to participate in the federal health care programs, including Medicare Advantage organizations, Medicare prescription drug plan sponsors, Medicaid-managed organizations, and entities that apply to participate as providers or suppliers in organizations or plans.
  3. Expands the OIG’s authority to exclude a person for failing to supply (or allow the examination of) payment information by the secretary or a state health care program to apply not only to persons who furnishing services, but also to those referring or certifying the need for items or services.
  4. Expands the OIG’s authority to grant waivers of certain exclusions that are requested by the administrator of a federal health care program.
  5. Adds a process for requesting early reinstatement when a health care license has been lost and not reinstated.
  6. Adds a 10-year statute of limitations for exclusion actions.

Enrollment Exclusions Merit Oral Argument: For the newly added exclusion authority for false statements in an enrollment application, the OIG finalized its proposal to allow the presentation of oral argument to an OIG official before the exclusion is imposed, which is consistent with its practice in exclusion actions brought under Section 1001.701 or Section 1001.801, two other exclusions that also are not based on a conviction or other official action and go into effect within 20 days if not contested and prior to an administrative law judge hearing.

Early Reinstatement for License Revocations: The OIG also finalized its proposed process for early reinstatement, which, when certain conditions are met, is available to those that have been excluded based on the loss of a health care license that has not been reinstated. Normally, a person who is excluded due to a loss of license may not be considered for reinstatement until the person has regained the license in the state where it was originally revoked. Historically, that requirement has led to much longer periods of exclusion for persons subject to licensure actions than those who have been convicted of a crime, including convictions mandating exclusion. However, the OIG decided to prohibit persons who lost their licenses for reasons related to abuse or neglect from applying for early reinstatement.

Changes From the Proposed Rule in the Final Rule

Aggravating Factors: In keeping with changes made in its two final rules issued in December, the OIG raised the dollar amount for the aggravating factors related to financial loss from $5,000 and $1,500 to $50,000. The OIG initially proposed to raise the threshold only to $15,000. This change to $50,000 keeps the financial loss aggravating factors consistent among the OIG’s various authorities with one important exception. For exclusions under Section 1128(b)(6) of the act, 42 U.S.C. 1320a–7(b)(6), the OIG retained its proposed $15,000 threshold because those exclusions are based on unnecessary or substandard care, not convictions.

Statute of Limitations: The OIG scrapped its proposal to implement its position that there is no time limitation to exclusions imposed under Section 1128(b)(7) of the act. Many commenters objected to the OIG’s interpretation that no statute of limitations exists for such exclusions. Some argued that even when a statute is silent on periods of limitations, courts often apply some period of limitation. Other commenters noted the administrative burden this would place on providers because they would be required to retain documentation relevant to OIG authorities indefinitely. In the final rule, the OIG adopted a 10-year period, which it notes is grounded in the False Claims Act’s period of limitations, and which it believes will provide certainty to the industry while preserving the OIG’s ability to protect federal health care programs and beneficiaries from untrustworthy persons identified in FCA cases or otherwise.

Convictions Related to Controlled Substances: The OIG also decided against a proposed limit on its exclusion authority for convictions related to controlled substances. The OIG had proposed to limit the exclusion to those who were convicted for conduct that occurred during a time when they were employed in the health care industry. The OIG was persuaded to make the change based on comments noting that the proposal would not protect beneficiaries from those who leave the health care industry before committing a crime but then re-enter the industry shortly thereafter. The OIG also decided not to remove aggravating and mitigating factors associated with the exclusion authority or the exclusion authority related to exclusion from a state health care program.

Ownership and Control Interest in Sanctioned Entities: Several commenters complained that the proposed rule’s language for the exclusion of individuals with ownership or control interest in sanctioned entities exceeded the OIG’s statutory authority. The OIG modified the regulatory text to clarify that in cases where the sanctioned entity has been excluded, the individual’s exclusion will remain in effect for as long as the term of the entity’s exclusion. 82 Fed. Reg. at 4106.

Key Points for Future Exclusion Enforcement

This final rule shows that the OIG continues to evaluate and update its enforcement authorities with an eye toward increased affirmative enforcement actions but that it is also willing to make practical changes to its enforcement policies.

  1. New early reinstatement process is available for those who have been excluded for loss of license, if certain conditions are met, so long as the loss of license was not due to patient abuse or neglect.
  2. The OIG has updated several aggravating factors in the exclusions regulations.
  3. Despite proposing to codify its interpretation that 1128(b)(7) exclusions do not have a statute of limitations, the OIG was receptive to comments that there should be some statute of limitations, and in the final rule adopted a 10-year statute of limitations.
  4. In line with the December updates to the CMP regulations, the OIG included provisions in this rule that highlight the importance it places on protecting beneficiaries. It increased most financial loss aggravating factors to $50,000, except for exclusions based on unnecessary or substandard care, which were increased to a $15,000 threshold. The OIG also finalized a prohibition in its early reinstatement process providing that those who lost a license for reasons related to abuse or neglect are not eligible for early reinstatement.

The final rule, and the underlying exclusion regulations, should be reviewed closely by any individuals or entities that are facing enforcement actions that, depending upon characterization of the underlying conduct, may give rise to mandatory or permissive exclusions. The “Health Care Fraud and Abuse Control Program Annual Report” for fiscal year 2016 (released in January 2017) reports 3,635 exclusions, indicating that OIG is actively applying its exclusion authorities.

Judith A. Waltz is a partner and health lawyer with Foley & Lardner LLP in San Francisco in the firm’s health care practice. Jill S. Wright is a special counsel and health care lawyer with Foley & Lardner in Washington, D.C., in the firm’s health care practice.

Click here for the original article which appeared in Law360.  

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