In our previous posts, we mentioned that the Medicare Secondary Payer (MSP) law imposes obligations upon Group Health Plans (GHPs).   This post will explain those obligations, both provided for in the regulations and in the CMS guidance, in more detail, and highlight the potential compliance pitfalls for GHPs. Given recent enforcement trends, and the risk of raising damages for non-compliance from double to treble, including a minimum fine of $1000 per day per unreported beneficiary, GHPs may want to review and audit their compliance with MSP requirements.

Generally, a GHP is sponsored by an employer to provide healthcare to employees and their families.[1]  These include self-insured plans that may be administered through a third party administrator (TPA) and plans arranged by employers through a health insurer.  The MSP requires that GHPs with 20 or more employees report certain information to CMS to avoid payment conflicts (although smaller companies have certain limited reporting obligations).  CMS refers to these plans as Responsible Reporting Entities (RREs), and they must report all Active Covered Individuals to Medicare.  An Active Covered Individual is defined as:

  • Those between 45 and 64 years of age covered through the GHP based on their own or a family member’s current employment status;
  • Those 65 and older covered based on their own or their spouse’s current employment status;
  • All individuals covered under a GHP who have been receiving kidney dialysis or have received a kidney transplant (ESRD); and
  • All individuals covered under a GHP who are under 45, are known to be entitled to Medicare, and have coverage in the plan based on their own or a family member’s current employment status.[2]

There are exceptions to this definition for (i) employers with less than 20 employees, who need not report unless a covered individual has ESRD, in which case the ESRD covered individuals must be reported, and (ii) employers with less than 20 employees who must report if they are part of a multi-employer/multiple employer GHP.[3]

CMS recognizes that this will constitute a large class of individuals for many GHPs, and also recognizes that many people who are currently not eligible for Medicare will have their information reported as a part of this process.[4]  Retirees and their spouses who are covered under a GHP do not count as Active Covered Individuals, but are termed Inactive Covered Individuals and do not need to be reported in the same manner as Active Covered Individuals.  The reason for this is that in most cases Inactive Covered Individuals (retirees) have Medicare as a primary payer.

GHP RREs have multiple reporting options, but the basic option requires a GHP RRE to submit an MSP Input File containing information about each Active Covered Individual, as outlined in the CMS manual.  The GHP RRE submits reports to a CMS website known as the Coordination of Benefits Secure Website (COBSW).[5]  The GHP may submit a Query Only Input File to the website, which helps the GHP assess if potential employees are covered by Medicare.

There are many situations that create potential pitfalls for GHPs.  For example, if an employer hires several new employees and adds them to its health plan, a GHP administrator may fail to ask the essential questions necessary to determine if any employee is an Active Covered Individual.  While it is clear that those over the age of 45 need to be reported, if the plan does not inquire about the current health coverage for an employee’s family, the plan might fall out of compliance with MSP reporting requirements if it did not know that a family member receives health care coverage due to a disability or has ESRD. In addition, while a GHP with less than 20 employees generally does not have to submit a report, the small GHP may forget to inquire about the coverage status of a new employee’s family.

The basic rules are summarized in the following chart:

Acting Party Responsibilities Liabilities for Non-Compliance
Group Health Plans (GHPs) (Generally Employer-Sponsored Plans)

 

 

·         20+ GHPs[6] must generally be the primary payer for all Active Covered Individuals except for ESRD patients

·         100+ GHPs[7] must generally be the primary payer for all Active Covered Individuals

·         20+ GHPs must report quarterly all Active Covered Individuals (includes all covered individuals over 45, including employees or spouses/partners, and those with ESRD regardless of age, and those under 45 who are known to be entitled to Medicare.)

·         Failure to report results in a minimum fine of $1000 a day per unreported beneficiary, with CMS reserving the right to collect double damages

 

This is part 3 of 7 in the Medicare Secondary Payer Compliance series. Subscribe to our blog for future updates. Part 2 can be accessed here: Medicare Secondary Payer Compliance: Conditional Payments (Part II)

Andrew Kuder, a Law Clerk (not admitted to the practice of law) in the firm’s Newark office, contributed significantly to the preparation of this post.

[1] 26 USC § 5000(b)(1).

[2] CMS, MMSEA Section 111 MSP Mandatory Reporting: GHP User Guide 7-2—7-3 (v5.0 2017).

[3] CMS, MMSEA Section 111 MSP Mandatory Reporting: GHP User Guide 7-3 (v5.0 2017).

[4] CMS, MMSEA Section 111 MSP Mandatory Reporting: GHP User Guide 7-2 (v5.0 2017).

[5] https://www.cob.cms.hhs.gov/Section111/LoginWarning.action

[6] 20+” means GHPs with 20 or more employees

[7] 100+” means GHPs with 100 or more employees

On February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018 (“BBA”). Among the most notable changes that will occur with the enactment of the BBA is the inclusion of certain provisions taken from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (“CHRONIC”) Care Act of 2017 bill (S.870) which the Senate passed in September 2017. Among other things, the CHRONIC Care provisions will have the effect of redefining new criteria for special-needs plans (“SNPs”), in particular the special-needs Medicare Advantage (“MA”) plans for chronically ill enrollees. The CHRONIC Care provisions also will expand the integration and coverage under Medicare for certain telehealth-based chronic care services.

Impact on MA Special Needs and Other MA Plans

The BBA includes provisions taken from the CHRONIC Care Act that largely affect MA SNPs, though other types of MA plans may also be affected by the enacted changes.

The critical issue Congress finally settled through the enactment of the BBA is the long-term status of the MA SNP Program (the “Program”).  Congress created the Program through the Medicare Modernization Act of 2003 (enacted Dec. 8, 2004).  However, the Program was time limited, with a scheduled end date of December 2008.  The Program has since been extended a total of 7 times, with Congress generally pushing out the Program’s end date by a year or two but never giving stakeholders a clear signal of support for the Program, leaving many stakeholders hesitant in making large investments in a program that was scheduled to terminate.[1]

The amendments made by the BBA have provided not only a more secure future to encourage plan sponsors and other stakeholders to further invest in the Program, but have also made changes to strengthen these programs. With respect to those SNPs targeting the dual eligible population (“Dual SNPs”), statutory changes provide for:  increasing integration through use of mechanisms to better coordinate contact with and information dissemination to State partners; requiring the Secretary to develop a unified grievances and appeals process for Dual SNPs to implement by 2021; and imposing more stringent standards to demonstrate integration. With respect to those SNPs focused on serving the chronically ill (“Chronic SNPs”), the BBA broadens the definition of beneficiaries who qualify to enroll in a Chronic SNP, imposes more stringent care management standards, and authorizes Chronic SNPs to provide certain Supplemental Benefits. The BBA further amends the Social Security Act to authorize the Secretary to require quality reporting at the plan level for SNPs, and, subsequently, for all MA plan offerings.

Impact on Accountable Care Organizations

The BBA makes several statutory changes impacting Accountable Care Organizations (“ACOs”) and beneficiary participation in such entities. Specifically, under the terms of the Act, fee-for-service (“FFS”) beneficiaries will be able to prospectively and voluntarily select an ACO-participating professional as their primary care provider and for purposes of being assigned to that ACO. The BBA further authorizes ACOs to provide incentive payments to encourage fee-for-service beneficiaries to obtain medically necessary primary care services.

Expansion of Medicare FFS Telehealth Coverage for Chronic Care Services

Additionally, the BBA includes certain provisions taken from the CHRONIC Care Act that will provide a needed expansion of Medicare FFS coverage for certain telehealth-based chronic care services. The BBA preserves many of the telehealth-focused aspects of the original 2017 bill equivalent and, seemingly, reflects a commitment by the federal government to improving access to telehealth services for qualified Medicare beneficiaries and further integrating these services into the U.S. health care system. For example, with the enactment of the BBA, Medicare coverage of telehealth services will be expanded to include services provided at home for beneficiaries dealing with end-stage renal disease (“ESRD”) or those being treated by practitioners participating in Accountable Care Organizations (“ACOs”). Additionally, with the enactment of the BBA, some of the geographic requirements traditionally required by Medicare’s coverage rules for telehealth services (e.g., originating sites, rural health professional shortage areas, counties outside Metropolitan Statistical Areas) will be lifted if such telehealth services are rendered to beneficiaries with ESRD, or who are being treated by ACO practitioners, or who are being diagnosed, evaluated, or treated for symptoms of an acute stroke. There are some important caveats to these changes in the coverage rules. For example, for ESRD beneficiaries who utilize telehealth services from their homes, an in-person clinical assessment will be required for such beneficiaries every month for the first 3 months and then once every 3 months thereafter. Likewise, payments will not be made for any telehealth services rendered by ACO practitioners to beneficiaries in their homes if such services typically are furnished in inpatient settings (e.g., hospitals).

As part of increasing benefits offered to special needs MA plan enrollees (as discussed above), the enactment of the BBA also will allow MA plans to offer more telehealth services to its enrollees, including services provided through supplemental health care benefits, starting in the year 2020. However, this provision requires that the same types of items and services an MA plans offers to its enrollees via telehealth are also offered to enrollees in-person. CMS is required to solicit public comments regarding this particular provision by November 30, 2018.

*          *          *

With the BBA establishing a long-term MA SNP Program, we are more likely to see increased investment into the Program by stakeholders and plan sponsors, thus growing and strengthening the Program. But, as explained above, the BBA also introduces several amendments that will certainly affect Dual and Chronic SNP standards, benefits, and coordination of care.  Although CMS has not formally solicited public comments regarding implementation of the referenced changes to SNP requirements, stakeholders and plan sponsors may want to consider the impact these changes may have on them and their industry and submit comments and input to help CMS in developing its proposed regulations.

For telehealth advocates, the inclusion of so many meaningful provisions in the BBA signals a newly energized willingness on the part of policymakers to work to expand use of telehealth services for Medicare beneficiaries, even in an environment where there are financial incentives for providers and health plans to restrain costs. Although lawmakers have historically resisted expanding these types of services in a FFS context, the belief being that doing so would add to (and not replace) services already otherwise being delivered, the enactment of the BBA signals strong potential for change in this regard.  As telehealth integration into various Federal programs increases, the enactment of the BBA being a critical step in this process, stakeholders and plan sponsors may want to consider the various implementation strategies by which telehealth items and services will be offered since each program carries its own set of standards and requirements.

[1] Pub. L. 110–173, §[  ], substituted ‘‘2010’’ for ‘‘2009’’; Pub. L. 110–275, §164(a), substituted ‘‘2011’’ for ‘‘2010”; Pub. L. 111–148, § 3205(a), substituted “2014” for “2011”;  P.L. 112-240, §607, struck out “2014” and inserted “2015”; P.L. 113-67, §1107, struck out “2015” and inserted “2016”; P.L. 113-93, §107, struck out “2016” and inserted “2017”; P.L. 114-10, §206 struck “2017”, inserted “2019″.

 

This is our second blog post on compliance with the Medicare Secondary Payer (MSP) law. Over the past three years, enforcement trends have focused attention on this often-overlooked area of law and highlighted why providers and suppliers need to know more about it. In this post, we will discuss Medicare conditional payment and subsequent repayment requirements.

As a general rule, Medicare will make a conditional payment to a beneficiary if there is a delay in payment by the primary payer to keep the beneficiary from experiencing a gap in coverage.[1] Medicare may then pursue reimbursement of conditional payments from:

  • A beneficiary or other party, if both a primary and conditional payment were received;
  • A primary payer, if a conditional payment was made pursuant to liability insurance settlements, disputed claims under group health plans, workers’ compensation plans, or no-fault insurance; and
  • The beneficiary or provider, if the filing of an improper claim resulted in a conditional payment, unless the claim was a result of false information provided by the beneficiary and the provider complied with certain regulatory procedures.

These conditional payments must be reimbursed to Medicare within 60 days of receipt of payment. If a primary payer or provider fails to pay back the conditional payments, CMS may recover double the amount of the Medicare primary payment.[2]

Both beneficiaries and their fiduciary agents, such as attorneys, can be sued for recovery of improper conditional payments. In one recent case, a Medicare Advantage (MA) plan operated by Humana made a conditional payment to a beneficiary injured in a motor vehicle accident.[3] The beneficiary sued several insurance companies for payment, resulting in a settlement and the disbursement of settlement funds to the beneficiary’s attorney. Humana issued a demand letter to the beneficiary seeking reimbursement for its conditional payment, which it alleged was partly contained in the settlement amount. When the beneficiary failed to pay, Humana commenced a lawsuit against both the beneficiary and the beneficiary’s counsel to recover the funds. On a motion to dismiss by the beneficiary’s attorneys, the court ruled that the MSP allowed the MA plan to pursue recovery of conditional payments and double damages against beneficiary’s counsel, as “plain language fails to limit the parties against whom suit may be maintained” and that there is a private right of action that a MA can use to recover conditional payments pursuant to 42 USC §1395y(b)(3)(A).[4]

The take-away from this decision is that all parties involved in the medical treatment and payment process of a Medicare beneficiary, including payers, providers, the beneficiaries, and their counsel, as well as fiduciaries, should be conscious that payment obligations do not end once Medicare has cut a check. Counsel may also want to be aware of Medicare conditional payment obligations in settlement negotiations. For example, in an unpublished opinion, the Third Circuit affirmed a District Court’s ruling that the estate of David Trostle had not exhausted administrative review procedures and therefore the court lacked subject matter jurisdiction. The action was brought after Trostle received the wrong prescription from a pharmacy, causing him to fall gravely ill. While hospitalized, Trostle received a conditional payment, stopping Trostle from experiencing a gap in insurance coverage. As a result of the conditional payment, CMS asserted a lien against any potential recovery Trostle possibly would receive in order to recoup the funds disbursed in the conditional payment. CMS stated that the lien was for $1,212 and reserved the right to adjust the amount if necessary. Trostle’s actual medical costs paid by CMS for a sixty-six day hospital stay was nearly $100,000. Trostle settled the tort claim against the pharmacy which allegedly caused the injury, receiving $225,000 in July of 2014. After Trostle informed CMS of the settlement amount, CMS revised the lien amount substantially upward to $53,295. Trostle challenged the $53,295 lien, arguing that CMS induced Trostle to rely upon the $1,212 lien, a much lower number, when negotiating the settlement.

While the court found it could not assess the claim since Trostle had failed to exhaust all administrative review procedures, and therefore did not reach this issue, the facts of this case demonstrate a potential area of unknown for counsel, beneficiaries, and other fiduciaries who may attempt to secure settlements from NGHP’s without full knowledge of how conditional payments function.[5]

This is part 2 of 7 in the Medicare Secondary Payer Compliance series. Subscribe to our blog for future updates. Part 1 can be accessed here: Medicare Secondary Payer Compliance: An Introduction (Part I)

Andrew Kuder, a Law Clerk (not admitted to the practice of law) in the firm’s Newark office, contributed significantly to the preparation of this post.

[1] 42 USC § 1395y(b)(2)(B); 42 CFR §§ 411.21 & 411.24.

[2] 42 CFR § 411.24(c)

[3] Humana Ins. Co. v. Paris Blank LLP, 187 F. Supp. 3d 676 (E.D. Va. 2016).

[4] Id. at 681.

[5] Trostle v. Ctrs. for Medicare & Medicaid Servs., No. 16-4062, 2017 U.S. App. LEXIS 19431 (3d Cir. Oct. 5, 2017).

The Centers for Medicare and Medicaid Services’ (“CMS”) recently announced its intent to expand what may be considered “supplemental benefits,” broadening the scope of items and services that could be offered to Medicare Advantage (“MA”) plan enrollees over and above the benefits covered under original Medicare. However, in articulating the standards for covering this broadened group of items and services, CMS proposed a new requirement that could greatly limit enrollees’ ability to access all types of supplemental benefits and increase the already substantial burden on MA participating providers; CMS now proposes to require that the supplemental benefits be ordered by a licensed provider.

Under current CMS guidance, supplemental benefits may not be a Part A or Part B covered service, must be primarily health related in that “the primary purpose of the item or service is to prevent, cure or diminish an illness or injury,” and the plan sponsor must incur a non-zero cost for the benefit. Medicare Managed Care Manual, Ch. 4, Sec. 30.1. Within the draft 2019 Call Letter, released on February 1, 2018, CMS proposes to expand the scope of items and services considered “primarily health related” to now include items and services to help maintain health status and not only those that “prevent, cure or diminish illness or injury.” According to CMS, under its new interpretation, in order for a service or item to be primarily health related “it must diagnose, prevent, or treat an illness or injury, compensate for physical impairments, act to ameliorate the functional psychological impact of injuries or health conditions, or reduce avoidable emergency and healthcare utilization.” Current CMS guidance explicitly excludes from being a supplemental benefit those items or services which are solely for daily maintenance purposes.  CMS’s broadened definition follows medical and health care research studies which have shown the value of certain ‘maintenance’ items and services in diminishing the effects of injuries or health conditions and decreasing avoidable emergency and health care services.

While broadening the scope of items and services eligible to be considered supplemental benefits, CMS concurrently proposes to add a more stringent standard to an enrollee’s receipt of such benefits. “Supplemental benefits under this broader interpretation must be medically appropriate and ordered by a licensed provider as part of a care plan if not directly provided by one.” Although current guidance specifies medical necessity as a standard for supplemental benefits that extend the coverage of original Medicare, there is no requirement that supplemental benefits be ordered by a licensed provider. Depending upon the nature of the supplemental benefit, such a rule could prevent an enrollee from accessing certain benefits. For example, plan sponsors may provide acupuncture or other alternative therapies as supplemental benefits, but enrollees would only be able to access such services if their provider accepts the value of such services and agrees that they are medically necessary. Given that many in traditional medicine do not support the use of alternative therapies, it is likely that at least some enrollees will be unable to access these benefits under this newly proposed standard.  Also, requiring a provider to review and order other types of supplemental benefits would likely create a paperwork burden with no benefit, including, for example, with respect to a supplemental transportation benefit, fitness benefit or over-the-counter drug benefit.

Although CMS should be applauded for seeking to expand the definition of “health related” in identifying eligible supplemental benefits, its proposal to require that such benefits be ordered by a provider as part of a treatment plan will decrease plan flexibility and increase burden for providers and enrollees alike, with minimal benefit.

CMS is accepting comments on the draft Call Letter through 6pm EST, Monday March 5, 2018.

Over the past week, the White House administration (the “Administration”) has issued two documents addressing drug pricing. First, on February 9, 2018, the White House’s Council of Economic Advisers released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad” (the “White Paper”).  Second, on February 12, 2018, the Administration issued its 2019 Budget Proposal (“2019 Budget”).

Whereas the recommendations set forth in the White Paper are more conceptual or exploratory, the 2019 Budget purportedly reflects the Administration’s more specific priorities for 2019. The developments are significant because, after outspoken pledges to reduce drug prices over a year ago, the White Paper and the 2019 Budget, taken together, are the Administration’s first attempt to set forth its drug pricing policy framework.

FY 2019 Budget Proposal Outline

The Administration’s 2019 Budget proposes strategies to address drug pricing reform in several areas.

  • Medicaid: The 2019 Budget proposes for new Medicaid demonstration authority to allow five states to test drug coverage and financing reform. Under this demonstration, instead of participating in the Medicaid Drug Rebate Program, these states would determine their own drug formularies and negotiate drug prices directly with manufacturers, with the resulting negotiated prices being exempt from Best Price.
  • Medicare Part B: With respect to the Medicare program, the 2019 Budget provides several proposals. First, the 2019 Budget would require all manufacturers of Part B drugs to report average sales price (“ASP”) data, and to penalize those who do not report ASP data. Additionally, the 2019 Budget proposes to limit the increase in ASP-based drug payment to the annual rate of inflation. For drugs reimbursed based on wholesale acquisition cost (“WAC”) rather than ASP, the 2019 Budget proposes to reduce this payment rate from 106% of WAC down to 103% of WAC. The 2019 Budget also proposes to modify reimbursement to hospitals for drugs acquired at 340B discounts by rewarding hospitals that provide charity care, and reducing payments to hospitals that provide little to no charity care. The 2019 Budget proposes to consolidate certain drugs covered under Part B into Part D coverage.
  • Medicare Part D: For beneficiaries enrolled in Part D plans, the 2019 Budget proposes to establish an out-of-pocket maximum in the catastrophic coverage phase, eliminate cost-sharing for generic drugs for low-income seniors, and permanently authorize a Part D demonstration that provides retroactive and point-of-sale coverage to certain low-income patients.
  • FDA: The 2019 Budget proposes to give the FDA greater ability to bring generics to market more quickly. If a first-to-file generic application is not yet approved due to deficiencies, the 2019 Budget proposes to allow the FDA to tentatively approve a subsequent generic application rather than waiting for the first-to-file application to amend its application deficiencies.

Council of Economic Advisers White Paper

The White Paper discusses options for drug pricing reforms that would impact Medicaid, Medicare, the 340B drug discount program, and FDA. The following provides a summary of the major ideas proposed in the White Paper:

  • Medicaid: The White Paper contends that the determination of Best Price on a single unit of drug under the Medicaid Drug Rebate Program operates as an inducement to manufacturers to inflate commercial prices. The White Paper posits that CMS could revise the applicable rules for Best Price without conflicting with the statutory language, such that Best Price could be determined post-sale based on “the patient’s recovery”, i.e., the health outcome or effectiveness of the drug. The White Paper suggests that more clarity from CMS on value-based contracting would encourage drug purchasers to negotiate for lower prices.
  • Medicare Part B: With respect to drugs reimbursable under Medicare Part B, the White Paper focuses on expensive specialty drugs and biologics administered by physicians. The White Paper contends that due to the cost-plus reimbursement methodology under Medicare Part B (ASP plus 6 per cent), physicians do not have incentives to prescribe cheaper medications to control costs. The White Paper cites solutions proposed by MedPAC and other government agencies to realign incentives including: (i) introducing physician reimbursement that is not tied to drug prices, (ii) moving Medicare Part B drug coverage into Medicare Part D, where price-competition over drug prices is better structured, and (iii) changing how pricing data is reported to increase transparency.
  • Medicare Part D: The White Paper scrutinizes the Part D program as being structured in a manner that prevents pricing competition and causes “perverse incentives.” Specifically, the White Paper suggests that Part D’s requirement to cover at least two non-therapeutically equivalent products within each class and category prevents Part D sponsors from competitively negotiating lower prices and that the prohibition of formulary tier-based cost-sharing for low income beneficiaries creates a disincentive to use “high value” rather than high cost drugs. In addition, the White Paper states that since the 50% discount drug manufacturers are required to provide during the coverage gap is applied to the patient’s true out-of-pocket costs, enrollees have an incentive to use high cost drugs while in the coverage gap.In addition to making the specific observations above, the White Paper cites more general options proposed by MedPAC, OIG and other government agencies to address “misaligned incentives”: (i) requiring plans to share drug manufacturer discounts with patients, (ii) allowing plans to manage formularies to negotiate better prices for patients, (iii) lowering co-pays for generic drugs for patients; and (iv) discouraging plan formulary design that speeds patients to the catastrophic coverage phase of benefit and increases overall spending.
  • 340B Drug Discount Program: The White Paper posits that there are two significant issues with the 340B Program. The first is “imprecise eligibility criteria has allowed for significant program growth beyond the intended purpose of the program.” The second is the use of program revenue for purposes other than providing care for low-income patients, which is what the Administration believes was originally intended. While not providing specifics, the White Paper suggests establishing “more precise” eligibility criteria as an alternative to the DSH percentage currently used to establish hospital eligibility, and requiring that the 340B discount more directly benefit poor patient populations.
  • FDA: The White Paper suggests modifying the existing FDA criteria for expedited review to include new molecular entities that are second or third in a class, or second or third for a given indication for which there are no generic competitors. The White Paper states that this would reduce the time period a particular drug would be able to benefit from a higher price before facing generic competition. The White Paper also suggests policies aimed at reducing the cost of innovation, including having the FDA continue to facilitate the validation and qualification of new drug development tools that allow manufacturers to demonstrate safety and efficacy more efficiently and earlier, and speeding up the issuance of FDA final guidelines to add certainty and attract additional biosimilar applicants to the marketplace.
  • Pharmacy Benefit Managers: The White Paper scrutinizes the PBM industry as having “outsized profits” due to the high concentration of the PBM market (3 PBMs account for 85% of the market) and criticizes the lack of transparency with respect to the rebates that PBMs receive. The White Paper states that the “undue market power” causes manufacturers to set artificially high list prices, which are reduced via rebates to PBMs without reducing the costs to consumers. The White Paper suggests that policies to decrease concentration in the PBM market could reduce the price of drugs paid by consumers.
  • Drug Pricing in Foreign Countries: The White Paper discusses in detail how the United States bears a disproportionate share of the burden of the cost of innovation, since foreign governments, in exercising price control, are able to set drug prices lower than that in the United States. The White Paper suggests drug pricing reform abroad with the United States changing the incentives of foreign governments to price drugs at levels that reward innovation. The White Paper broadly suggests achieving this goal through enhanced trade policy or policies tying reimbursement levels in the United States to prices paid by foreign governments that set lower prices or other methods.

EBG Considerations

The combined result of the 2019 Budget and the White Paper is a hodgepodge of policy ideas that could impact a wide range of government programs and industry stakeholders throughout the drug distribution and reimbursement channel. While the proposals set forth in the 2019 Budget are more specific, the ideas in the White Paper are more conceptual and less developed.  For example, policies to address the high concentration of the PBM market and foreign government drug price control appear more aspirational and lack detail on what such policies would entail or how they would be accomplished.  This suggests that, while the 2019 Budget and White Paper are indicative of the Administration’s direction with respect to drug pricing policy, the policy is likely still a “work in progress” and subject to further development.

We will continue to report on how these ideas take shape in this Administration.

This post is the first in a series from Epstein Becker Green on the growing area of enforcement of the Medicare Secondary Payer Act (MSP). There has been a recent growth in enforcement actions and regulatory interest that may not have yet attracted the attention of many providers and traditional and non-traditional payers. Noncompliance with the MSP can result in monetary penalties and government enforcement action. In particular, the MSP is garnering attention as an enforcement tool under the False Claims Act (FCA).  This series of blogs provides a general overview of the MSP, discusses requirements for compliance for differing entities, describes recent MSP enforcement actions under the False Claims Act (FCA), and sets forth  key takeaways to potentially reduce liability.

The Medicare Secondary Payer Act: The Basics

In order to understand why the MSP is relevant and may create new risks for payers and providers, we’ll start with an overview of the law and why Congress wanted to remedy a problem with the Medicare program. Before the MSP was enacted, Medicare made payments on behalf of its beneficiaries for any medical services, except those covered by workers’ compensation.  In many cases, claims were paid by the Medicare program even though beneficiaries had other sources of coverage for their care. This resulted in a rapid depletion of the Medicare Trust Fund, and in 1980 Congress passed the MSP statute to cut health care costs and reduce Medicare disbursements. The MSP currently affects providers, employer sponsored group health plans (GHPs), liability and no-fault insurers, workers’ compensation funds and plans (collectively, Non-Group Health Plans, or NGHPs), and Medicare beneficiaries.  Generally, the MSP:

(1) requires that Medicare be a secondary payer if a beneficiary carries certain types of employer sponsored health plans[1];

(2) prohibits the Centers for Medicare and Medicaid Services (CMS) from making payments for Medicare-covered services if payment has been made, or can reasonably be expected to be made, by a another payer[2]; and

(3) permits CMS to make “conditional payments” to the beneficiary if there is a delay in reimbursement from another entity for a covered service.[3]

Congress also enacted a parallel MSP provision that applies to state Medicaid plans.[4]

Special rules apply to Medicare beneficiaries covered under a GHP,[5] and Medicare is generally the secondary payer for these covered services when:

  • A beneficiary is entitled to Medicare on the basis of age, but is covered under a GHP by virtue of his or her current employment or the current employment status of a spouse of any age; or
  • A beneficiary is entitled to Medicare on the basis of End Stage Renal Disease (ESRD) for the first 18 months of eligibility; or
  • A beneficiary is entitled to Medicare on the basis of disability, but is covered under a GHP by virtue of his or her current employment status or the current employment status of a family member.[6]

In order to help primary payers and providers in meeting their MSP obligations, CMS established a Coordination of Benefits (COB) system that collects beneficiary coverage data.  The Benefits Coordination & Recovery Center (BCRC) administers the COB by ensuring the accuracy of the Common Working File (CWF), a CMS database that stores information regarding MSP data and investigations.  CMS shares this data with other payers to ensure proper claim submission to Medicare.  The COB collects data from a variety of sources, including:

  • IRS/SSA/CMS Claims Data Match – By law, the IRS, Social Security Administration (SSA) and CMS must share information regarding beneficiaries. Employers must complete the IRS/SSA/CMS Claims Data Match questionnaire for each GHP that Medicare eligible beneficiaries and their spouses choose.
  • Voluntary Data Sharing Agreements (VDSAs) – These agreements allow employers and CMS to exchange GHP enrollment information.
  • COB Agreement (COBA) Program – This program established a national standard contract between the BCRC and other health insurance organizations for the purpose of transmitting beneficiary eligibility data and Medicare paid claims data.
  • Section 111 Required Reporting Requirements – Under this law, GHPs, workers’ compensation, self-insurance, and no-fault insurance (collectively, non-group health plans, or NGHPs) must register as a Responsible Reporting Entity (RRE) and report certain information pertaining to each enrollee’s Medicare eligibility, as discussed in more detail below.
  • Other Data Exchanges – CMS has created data exchanges with other entities, such as Pharmaceutical Benefit Managers, State Pharmaceutical Assistance Programs, and other prescription drug payers for the purpose of educating these entities regarding COB processes and the MSP framework.

Through these databases, the COB coordinates efforts between CMS, primary payers, and providers to ensure that Medicare is billed properly.

This wide variety of reporting sources may be daunting for many providers and payers who are required to report. However, these  fears can be overcome by incorporating these tasks into the organization’s existing compliance program if the requirements for reporting are known. In the next blog post, we will be addressing compliance with conditional payment requirements provided by Medicare.

This is part 1 of 7 in the Medicare Secondary Payer Compliance series. Subscribe to our blog for future updates.

Andrew Kuder, a Law Clerk (not admitted to the practice of law) in the firm’s Newark office, contributed significantly to the preparation of this post.

[1] 42 USC § 1395y(b)(2)(A)(i); 42 CFR § 411.20.

[2] 42 USC § 1395y(b)(2)(A)(ii); 42 CFR § 411.20.

[3] 42 USC § 1395y(b)(2)(B); 42 CFR §§ 411.21 & 411.24.

[4] 42 USC § 1396a(a)(25); 42 CFR §§ 433.135-140.

[5] 42 USC § 1395y(b)(1); 26 USC § 5000(b)(1).

[6] 42 CFR § 411.20

For health care providers and other government contractors, perhaps no law causes more angst than the False Claims Act, 31 U.S.C. §§ 3729 et seq. (“FCA”).  A Civil War-era statute initially designed to prevent fraud against the government, the FCA is often leveraged by whistleblowers (also known as “relators”) and their counsel who bring actions on behalf of the government in the hope of securing a statutorily mandated share of any recovery.  These qui tam actions often can be paralyzing for health care entities, which, while committed to compliance, suddenly find themselves subject to false claims allegations that reflect a lack of understanding about the complex (and sometimes ambiguous) regulatory framework that they operate under.

Apart from the substantial costs associated with defending against qui tam allegations, the threatened financial exposure is heart-stopping: penalties under the FCA currently range from $10,957 to $21,916 per improper claim, plus three times the amount of damages sustained by the government (meaning, for example, if a health care provider is found liable for improperly submitting a level one evaluation and management (or “E/M”) code, the potential maximum exposure would be treble damages—i.e., three times the payment for the service—plus up to $21,916 in penalties per claim).  For this reason, even when facing a meritless FCA suit, a defendant often settles to avoid the cost of litigation and the unpredictability of a jury.  Indeed, very few FCA cases ever go to trial.

Until recently, health care providers facing the prospect of a qui tam suit have had little reason for optimism, particularly given the steady increase in cases being filed (674 new qui tam matters were filed in fiscal year 2017, and more than 70 percent of these related to federal health care programs) and the trend of relators continuing to pursue cases after the government declines to intervene.  However, two recent U.S. Department of Justice (“DOJ”) internal policy memoranda issued this month suggest that, at least in some circumstances, the government may be reevaluating its approach in two key areas relating to FCA enforcement: (i) the dismissal of meritless qui tam actions when the government declines to intervene, and (ii) the prohibition of DOJ attorneys relying on a party’s noncompliance with agency guidance as presumptive or conclusive evidence that the party violated the law.

The Granston Memo

Recently, Michael D. Granston, the Director of the DOJ’s Civil Fraud Section, Commercial Litigation Branch, issued an internal memorandum to all attorneys in his branch and all Assistant U.S. Attorneys handling FCA cases (the “Granston Memo”).  The Granston Memo, dated January 10, 2018, addresses “Factors for Evaluating Dismissal Pursuant to 31 U.S.C. 3730(c)(2)(A)” and potentially represents a significant shift in how DOJ treats meritless FCA cases.

DOJ has long had the authority via 31 U.S.C. § 3730(c)(2)(A) to dismiss FCA actions brought by whistleblowers.  However, and as the Granston Memo acknowledges, DOJ has used this power sparingly.  Instead, even in circumstances where a relator’s claims may have no basis in fact or law, DOJ has traditionally elected not to intervene and has permitted the relator to proceed, causing health care providers to spend considerable resources defending against a meritless claim.  The Granston Memo suggests that simple declination may no longer be the status quo and provides a list of factors, not intended to be exhaustive, that DOJ attorneys should consider when evaluating whether the dismissal of a FCA claim is warranted in circumstances where DOJ declines to intervene.  These factors focus on the following areas:

  1. curbing meritless qui tams,
  2. preventing parasitic or opportunistic qui tam actions,
  3. preventing interference with agency policies and programs,
  4. controlling litigation brought on behalf of the United States,
  5. safeguarding classified information and national security interests,
  6. preserving government resources, and
  7. addressing egregious procedural errors.

The Granston Memo instructs DOJ attorneys working on FCA cases to consider alternative grounds for dismissal other than 31 U.S.C. § 3730(c)(2)(A) and to consult affected federal agencies as to whether dismissal may be warranted.

The importance of this potential shift in DOJ policy should not be understated.  While only time will tell how the Granston Memo will effect non-intervened qui tam matters, its issuance should come as a welcome sign to entities potentially subject to, or actively involved in, defending FCA cases, as well as to their defense counsel, who should view the memorandum as an opportunity to establish a dialogue—beyond pressing for declination—to pursue a wholesale dismissal of FCA allegations in a case that previously was thought likely futile.

The Brand Memo

While the Granston Memo represents a potentially significant change in DOJ’s approach to FCA litigation and role in non-intervened cases, on January 25, 2018, Associate Attorney General Rachel L. Brand issued a memorandum to the Heads of Civil Litigating Components / U.S. Attorneys and the Regulatory Reform Task Force, an internal working group within DOJ, titled “Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases” (the “Brand Memo”).

The Brand Memo provides that, “effective immediately,” DOJ (i) “may not use its enforcement authority to effectively convert agency guidance documents into binding rules”[1] (emphasis added), and (ii) “may not use noncompliance with guidance documents as the basis for proving violations of application law . . . .”  The Brand Memo goes on to state the following:

[DOJ] should not treat a party’s noncompliance with an agency guidance document as presumptively or conclusively establishing that the party violated the applicable statute or regulation.  That a party fails to comply with agency guidance expanding upon statutory or regulatory requirements does not mean that the party violated those underlying legal requirements; agency guidance documents cannot create any additional legal obligations.

Critically, the Brand Memo explicitly provides that “this memorandum applies when [DOJ] is enforcing the False Claims Act, alleging that a party knowingly submitted a false claim for payment by falsely certifying compliance with material statutory or regulatory requirements.”

As with the Granston Memo, it is too soon to predict the impact that the Brand Memo will have on FCA litigation.  But, at least on its face, the Brand Memo could be a game-changer.  Medicare is the largest payer for health care services and the Centers for Medicare & Medicaid Services and its Medicare Administrative Contractors (“MACs”) have produced an enormous body of sub-regulatory guidance that governs health care providers.  Because this informal guidance does not go through the rigorous review of the rule-making process mandated by the Administrative Procedure Act, it often can be ambiguous both in its application and its implementation.  Such guidance also routinely results in different standards being applied to providers in different geographic regions depending upon which MAC has jurisdiction.  The Brand Memo states that in circumstances where noncompliance with guidance is alleged, DOJ litigators are not to presume FCA liability or, perhaps more importantly, not to use such guidance to support or prove FCA violations.

Moreover, to the extent that the Brand Memo prohibits reliance on agency guidance documents, it may present an opportunity to argue that such prohibition must necessarily extend to similar documents prepared by government contractors that do not have agency status.  DOJ attorneys frequently treat contractor guidance as conclusive in deciding whether there has been a violation of an underlying statute or regulation—even when guidance is released after the conduct at issue or by a government contractor in a different jurisdiction occurs.  For example, reliance by DOJ attorneys upon statements in local coverage determinations when investigating and prosecuting FCA cases is commonplace.  The Brand Memo may present an avenue for health care entities to argue that these determinations are fundamentally “guidance documents,” and, as such, DOJ should not reflexively and exclusively rely upon them when pursuing potential FCA liability.

At a minimum, the Brand Memo casts a cloud over practices that DOJ attorneys regularly employ when investigating, evaluating, and proving FCA allegations.  It could have a major impact on the way in which the government handles FCA matters and evaluates both whether to intervene in a qui tam suit or bring an affirmative civil enforcement action.

***

Much remains to be seen as to the implications of the Granston and Brand Memos in practice.  But for those individuals and entities participating in the health sector, as well as all other government contractors, these memoranda are reason for cautious optimism.

 

ENDNOTE

[1] The Brand Memo defines a “guidance document” as “any agency statement of general applicability and future effect, whether styled as ‘guidance’ or not, that is designed to advise parties outside of the federal Executive Branch about legal rights and obligations.”  This definition largely mirrors the definition set forth by Attorney General Jeff Sessions in his November 16, 2017, memorandum setting forth a prohibition on improper guidance documents.

In the last couple of months, ballot initiatives have significantly affected health policy and the health industry as a whole. Constituents are becoming more involved in policy matters that have traditionally been left to elected officials in state legislatures. On January 25, 2018, Oregon held a special election for a ballot initiative that asked whether Oregonians would support funding the state Medicaid program by taxing health plans and hospitals. The ballot initiative passed with a margin of 62 percent of voters supporting the measure. The measure proposed a 1.5 percent tax on insurance premiums and a .7 percent tax on large hospitals to help fund Medicaid expansion. Proponents argued that 350,000 people who receive health coverage through Medicaid expansion would lose coverage if the measure was not supported.

Oregon is not the only state that has used a ballot initiative to substantially affect health policy. On November 7, 2017, Maine was the first state to use a ballot initiative to expand Medicaid coverage. The ballot measure overwhelming passed without the support of the Governor. The Governor is now withholding the implementation of the measure due to fundamental issues on how to fund Medicaid expansion.

Traditionally, ballot initiatives are frequently used to amend state constitutions or topics regarding public health. Health policy issues such as Medicaid and funding for health care seldom had direct input from constituents. However, as many states are faced with one party legislature, ballot initiatives have become a way to circumvent the traditional means of legislating. Constituents are actively using ballot initiative to help shape policy issues that directly affect the health industry. About 24 states have ballot initiative processes that allow constituents to bypass state legislatures by placing proposed statutes on the ballot. Although states have different processes, a ballot initiative requires a specific number of signatures for an initiative to be placed on a ballot. In states with an indirect initiative process, such as Maine, ballots with enough signatures are submitted to the legislature where elected officials have an opportunity to act on the proposal. If the legislature rejects the measure, submits a different proposal or takes no action, the measure goes to the ballot for a vote. In states with direct initiatives, such as Oregon, proposals go directly on the ballot for a vote.

With the success of Oregon and Maine, other states may utilize the ballot initiative process to substantially change health policy in their state. For example, after years of failing to expand Medicaid in Utah, advocates have already begun to gather signatures needed by April 15, 2018 to put Medicaid expansion on the 2018 ballot. Additionally, advocates in Idaho have filed paperwork for a ballot initiative to expand Medicaid.

As more states consider ballot initiatives as a legislative tool for health policy, stakeholders should not only look to legislative assemblies for changes in health policy but ballot initiatives that can affect the industry. Grassroots advocacy has always played a major role in shaping state policy and now substantial health policy can be added to the list.

On January 16, 2018, the Department of Health and Human Services Office of Inspector General (OIG) published its most recent update to the agency’s “Work Plan.”  Of note to Durable Medical Equipment (DME) manufacturers, suppliers and prescribers, OIG signaled increased interest in the investigation of three specific off-the-shelf orthotic devices identified by the HCPCS codes:

  • L0648—back bracing
  • L0650—back bracing
  • L1833—knee bracing

According to OIG, the government paid out $349 million for these braces in 2016, representing a 97% increase from just 2014.  OIG expressed concern that many of the braces were being prescribed without adequate documentation of medical necessity in patient records and also fulfillment in cases where actual physical examination of the patient had occurred over a year prior to the device being provided.

DME manufacturers, suppliers and prescribers of back and knee bracing should be advised that OIG has, and will, start taking a much closer look at any Medicare/Medicaid reimbursements for these devices and one can expect increased scrutiny in this area.

For additional information about this issue, contact the author of this post, Clay Lee, or the Epstein Becker Green attorney who regularly assists you.

On January 5, 2018, consistent with the 21st Century Cures Act’s focus on creating interoperability and correspondingly a Trusted Exchange, the Office of the National Coordinator for Health Information Technology (“ONC”) released its “Draft Trusted Exchange Framework” (“Draft Framework”).  The Draft Framework is intended to streamline the exchange of Electronic Health Information (“EHI”) so that both health care providers and patients have better access to health information, thus improving communication and quality health care.  EHI includes information beyond protected health information, such as health information from other consumer driven devices.  ONC has asked for public comments; the comment period is open until February 18, 2018.

ONC’s Draft Framework develops a mechanism to connect Health Integrated Networks (“Qualified HINs”) across the country. The ONC intends to select a single Recognized Coordinating Entity (“RCE”) through a competitive bidding process, which will be open in the spring of 2018.  The RCE’s responsibilities will be to develop the Common Agreement and operationalize the Trusted Exchange.  The Draft Framework includes the Principles of a Trusted Exchange (Part A) and the minimum terms and conditions that will be required for a Trusted Exchange (Part B) (the contractual terms that operationalize the principles of Part A).

The Draft Framework sets a number of conditions on Qualified HINs, some of which may require more direct interaction with patients than currently exists, or may require the Qualified HIN to disclose information that might otherwise be considered proprietary to the Qualified HIN. The biggest takeaways from the Principles (Part A) are:

  • Qualified HINs will be expected to use standards adopted or recognized by ONC’s Health IT Certification Program and Interoperability Standards Advisory (“ISA”) or industry standards readily available to all stakeholders;
    • Participants of Qualified HINs that provide services and functionality to providers are expected to follow the 2015 Edition Health IT Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modification final rule (“2015 Edition final rule”), and associated guidance for the certification of health IT; and
    • Qualified HINs and participants will be expected to implement processes that encourage more “person-centered” care;
  • Qualified HINs will be required to operate openly and transparently by:
    • Making terms and conditions for participation publicly available;
    • Supporting permitted uses and disclosures of EHI. Qualified HINs that only support HIPAA Treatment purpose exchanges, may want to support additional permitted purposes;
    • Making their privacy practices publicly available;
  • Qualified HINs must cooperate with and not discriminate among the various stakeholders across the continuum of care by not implementing policies, procedures, technology or fees that will obstruct access and exchange of EHI between other Qualified HINs, participants, and end users;
  • Qualified HINs must exchange EHI securely and in a manner that preserves data integrity by:
    • Including appropriate information to ensure the correct matching of individuals to their EHI; and
    • Ensuring providers and other organizations are confident that appropriate consents and authorizations have been captured;
  • Qualified HINs must ensure that individuals have easy access to their information by:
    • Ensuring full and consistent access to information; and
    • Having policies in place to allow an individual to withdraw or revoke his or her participation in the Qualified HIN; and
  • Qualified HINs will be expected to support the ability for participants to pull and push population level records—bulk transfer—in a single transaction rather than transmit one record at a time.

The Draft Framework is ONC’s most significant push toward interoperability among electronic health care systems and most likely will affect all stakeholders in the health IT industry and their participants at some point.