CMS Publishes Final Rule on Section 111 Civil Monetary Penalties

By on October 11, 2023

On October 11, 2023, the Federal Register published the long-awaited Final Rule regarding Section 111 Civil Monetary Penalties.  This rule has an effective date of December 11, 2023, and an applicability date on or after October 11, 2024.

The Rule’s salient points can be summarized as follows, with key differences between the requirements for group health plans (GHP) and non-group health plans (NGHP).

Method of Penalty Assessment:  CMS will audit a possible 1000 records per calendar year across all RRE submissions (250 beneficiary records per quarter) and will evaluate a proportionate number of GHP and NGHP records.  At the end of each calendar quarter, CMS will randomly select the indicated number of records and analyze each to determine if it is in compliance with reporting requirements.

Grounds for Penalty:  The final rule removes any basis other than timeliness from the penalties considered in the proposed rule.  All references to “contradictory reporting” and “exceeding error tolerance” have been removed; timeliness is the sole basis for CMP per the Final Rule.

What is timeliness?  Timely is defined as reporting to CMS within one year of

  • the date GHP coverage became effective;
  • the date a settlement, judgment, award, or other payment determination was made (or the funding of a settlement, judgment, award, or other payment, if delayed); OR
  • the date when an entity’s ORM (ongoing responsibility for medicals) became effective

Penalties for GHP: For any selected record that is more than 1 year (365) calendar days late, a penalty of $1,000 per day as adjusted of noncompliance will be imposed

Penalties for NGHP:  For any audited record where the NGHP RRE submitted the information more than one year after the date of settlement, judgment/award, or other payment (including the effective date of the assumption of ORM), the penalty will be:

  • $250  as adjusted annually under 45 CFR part 102 for each calendar day of noncompliance where the record was reported on year or more but less than two years after the required reporting date
  • $500 for each calendar day of noncompliance where the record was reported two years or more but less than three years after the required reporting date
  • $1,000 for each calendar day of noncompliance where the record was reported three years or more after the required reporting date

Penalty Calculation Method:  CMS will multiply the number of audited records found to be noncompliant by the number of days that each record was late (in excess of 365 days).  That product will be multiplied by the appropriate penalty amount.

Penalty Cap: Total penalty for any one instance of noncompliance for a given record will be no greater than $365

Inflation: Penalties may be adjusted for inflation.

Penalty exceptions for GHP: Penalties will not be assessed for GHP in the following instances

  • Where noncompliance is associated with a specific reporting policy or procedural change on the part of CMS that has been in effect for less than 6 months following the implementation of the policy change (or for a year, should CMS be unable to provide a minimum of 6 months’ notice prior to implementing change)
  • The entity complies with any reporting thresholds or other reporting exclusions

Penalty exceptions for NGHP: The GHP exceptions are applicable for NGHP with the following addition

  • Where an NGHP fails to report required information as a result of the plan’s inability to obtain the individual’s first or last name, date of birth, gender, Medicare beneficiary number (MBI), SSN, or last five digits of the SSN and the plan has made good faith effort to obtain this info as follows:
  • The plan has communicated the need for the info to the individual and his or her attorney or other representative, if applicable, or both
  • The plan has requested the info from the individual and his/her attorney/other representative at least 3 times (once in writing, including email; at least once more by mail; at least once more by phone or other means)
  • The plan has not received a response or has received a response clearly indicating the individual refuses to provide the needed info
  • The plan has documented its efforts to obtain the info.  This documentation, including written rejection correspondence, must be retained for a minimum of 5 years

Relief:   CMPs imposed in accordance with the final rule are subject to a formal appeals process.  Parties subject to CMPs will receive formal written notice at the time the penalty is proposed and may request a hearing with an ALJ within sixty (60) calendar days of receipt.  An ALJ decision may be appealed to the Departmental Appeals Board (DAB) within 30 days, with DAB decision binding sixty (60) days thereafter absent petition for judicial review.

Given the audit structure, the rule specifies that smaller entities are much less likely to have their records audited.  The rule also confirms that it imposes no new information collection requirements—e.g. reporting, record-keeping or third-party disclosure requirements.  We anticipate that CMS will host webinars and town halls in the future to discuss the new rule and will keep abreast of same.

Disclaimer: Please note, this article is intended to be a high-level summary of the proposed regulation and is not intended to be an exhaustive review of every detail and requirement contained within the text of the proposed regulation. We will be providing updates as the program unrolls from CMS.

Given the timeframes of the rule, RREs have time to ensure that their reporting is compliant.  Let us know if you want to schedule a meeting to discuss how your program can ensure compliance with the formal rule.

Please feel free to reach out to one of our team members:

Travis Smith – twsmith@grsm.com

Kimberly Young – kyoung@grsm.com

Melanie Schafer – mschafer@grsm.com

Rachel Maldonado – rmaldonado@grsm.com

Heather Eversole – heversole@grsm.com

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Commercial Repayment Center Address Change – Effective March 15, 2023

By on March 3, 2023

We want to provide you with an update we have recently received in relation to an address change for the Commercial Repayment Center (NGHP). As of March 15, 2023, the new address to send correspondence as well as payments is as follows:

Medicare Commercial Repayment Center – NGHP
P.O. Box 1610
Lathrop, CA 95330

We advise that you please update your records accordingly to be sure correspondence and maybe more importantly, payments are being sent to the correct address. As previously, please be sure when you remit correspondence and/or payment, include the CRC Case ID to which you are referring.

The CRC has asked that nothing be sent to the updated address until March 15, 2023; however as of that date, please be sure to utilize the above address.

Should you have any questions in relation to this update, please do not hesitate to contact us. We are here as your partner to assist in all of your Medicare Compliance issues.

Thank you!
Gordon & Rees Scully Mansukhani Medicare Compliance Department

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Are Liability and No-Fault MSAs finally here?

By on July 7, 2022
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CMS recently published a proposed rule regarding liability insurance and the future medicals associated with such cases.  Per the proposed rule:

This proposed rule would clarify existing Medicare Secondary Payer (MSP) obligations associated with future medical items services related to liability insurance (including self-insurance), no fault insurance, and worker’s compensation settlements, judgments, awards, or other payments. This proposed rule would also remove obsolete regulations.

This proposed rule will also give “Economically Significant” Priority which, per the Office of Information and Regulatory Affairs means:

These regulatory actions are a subset of those designated by OIRA as significant. A regulatory action is determined to be “economically significant” if OIRA determines that it is likely to have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

What this information means for those who work in the world of liability and compliance is that the government is potentially making way for submission of liability and no-fault MSAs in the upcoming year. However, how this program will be implemented and address several legal and practical issues is unclear. This has been a recurring question when liability and no fault MSAs are discussed as many of these claims are governed by state laws which dictate future medical awards and coverage.

The Gordon and Rees Medicare Group will continue to follow this issue closely and will update you as soon as additional information is available.

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Workers’ Compensation Medicare Set-Aside Reference Guide Issued for Spring

By on April 27, 2021
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Today CMS issued an announcement that they have released Version 3.3 of the Workers’ Compensation Medicare Set-Aside Arrangement Reference Guide (Reference Guide), which can be found here.  Per the new version, the changes included in this version of the guide are as follows:

  • The CDC Life Table link was updated (Section 10.3).
  • Language around surgeries to be covered by seed money in a structured settlement was clarified, and a disclaimer was added to the proposal review reference tools list in Appendix 4, along with the Conduent Strataware® tool (Sections 5.2 and 9.4.4,
  • Appendix 4).
  • Miscellaneous clarifications were added as follows (Sections 9.4.5, 10.2, 16.2, and 19.4):
    • On pricing: include refills when pricing intrathecal pumps.
    • On documentation: clarification was added on Consent to Release signatures.
    • On WCMSA Portal case access: clarification was added on case access for Professional Administrators who are not the original submitter.
  • The Major Medical Centers table was updated for a Missouri entry (Appendix 7).

The most noteworthy changes are those in regards to the seed money in a structured settlement, pricing regarding intrathecal pain pumps, allowance of an electric signature for consent to releases, and access to the portal for non-original submitters.

In regards to the seed money, CMS specifically included in this version that “In a structured WCMSA, an initial deposit is required to cover the first surgery or procedure for each body part, and/or replacement and the first two years of annual payments.” Furthermore, CMS goes on to note that “The seed includes the cost of the first surgery/procedure for each body part, including all costs such as prescription drugs, physician fees, anesthesia fees, and facility fees. If the surgery is preceded by an associated trial, i.e., trial SCS or trial intrathecal (IT) pump, the cost of the trial is also included since it is considered part of the same procedure. If there are no surgeries, the first procedure (if any, such as injections) is included. Series of spinal injections are not included, but series of knee viscosupplementation are included if three are anticipated to be accomplished as a series of three weekly injections.”

This differs from the current standards as in the past the most expensive procedure is what is utilized for the seed money. However, this seems to differ in that if there are procedures for several different body parts, all of those must be included in the seed amount and if said procedures include atrial and/or are administered in a series (i.e. specifically viscosupplementation injections which are traditionally given in a series of three) are to be included in the seed as well. This is interesting as annuities are commonly utilized to reduce the cost of MSAs will be less effective if larger seed amounts are required.

Additionally, CMS has expressly indicated that “Pricing includes necessary pump refills over the claimant’s life expectancy.”

In a change to enable easier submission of Consent to Releases, CMS has announced that they will now accept electronic signatures. As many may recall, the difficulty in getting a hand signature from Claimants with inadequate technology was a struggle, especially during the past year. However, in a loosening of requirements, CMS will now allow for individuals to sign via computer/electronic signature.

Finally, in regards to vendors that have taken over a submission and are not the original submitter of record, CMS has indicated “If there is a change in submitters, CMS requires a written release from services by the original submitter and a new signed Consent to Release form authorizing the new submitter. Both must be provided in order to continue the WCMSA review process. Professional Administrators whose EIN does not match the EIN of the original submitter, contact BCRC to gain access to the case via the WCMSA Portal; otherwise you must submit by mail. Submitter changes will not be accepted after settlement, and does not constitute a reason for a re-review (See Section 16.0 for re-review requirements). CMS will not provide copies of existing documentation to the new submitter. Any documentation must be obtained from the incumbent submitter or insurer.

CMS has previously required a signed withdrawal/release from the previous vendor and new authorization for the new submitter to go forward. However, CMS has interestingly now expressly stated that a change of submitter post settlement is not allowable and will not be a reason for re-review. Additionally, CMS has also indicated that it will not provide any copies of existing documentation to the new submitter. While this has been CMS’s historical practice, CMS has now expressly warned new submitters with this updated language.

The Gordon and Rees Medicare group will continue to follow this issue closely and will update you as soon as additional information is available.

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Civil Monetary Penalty Proposed Regulations Are Here

By on February 14, 2020
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The Medicare Secondary Payer law rendering a potential $1,000 per day penalty for noncompliance against primary payers has finally been demystified to some extent. The proposed regulation issuing guidance about Medicare Secondary Payer Civil Monetary Penalties relative to Section 111 reporting was unofficially disseminated on February 13, 2020, and the full text can be found here. The official document is scheduled to be published in the Federal Register on 2/18/2020 and available online at https://federalregister.gov/d/2020-03069.

By way of history, this rule has been in progress since 2013, pursuant to the Strengthening Medicare and Repaying Taxpayers Act (SMART Act) of 2012, which amended the Medicare, Medicaid and SCHIP Extension Act of 2007. The 2007 law rocked the industry by calling for mandatory penalties against NGHP primary payers of $1,000 per day per claimant for failure to properly report Section 111 data to Medicare. The SMART Act softened this, making the penalty discretionary rather than mandatory. The details of what would constitute a full penalty, diminished penalty and/or safe harbor from Civil Monetary Penalties have not been promulgated by the Agency until now. As of this date, no penalties have been assessed against NGHP primary payers. Having a rule in place could change this.

With 44 pages in all, there is a great deal of content within the proposed rule, the highlights of which are summarized below. As always, the Gordon & Rees Medicare Compliance Group will issue an Official Comment to this proposed rule. We will accept client feedback regarding this rule, through April 15, 2020, as Official Comments which must be received no later than 60 days from the date of official publication.

If more information is needed and/or you have questions about how this may impact your business please contact us at Section111 Reporting Section111Reporting@grsm.com.

Highlights:

• The regulation outlines proposed specific criteria for when CMPs would not be imposed, in circumstances when a NGHP entity fails to comply (either on its own or through a reporting agent) with Section 111 reporting guidelines.
• CMPs will be levied in addition to any MSP conditional payment reimbursement obligations.
• The rule is prospective and CMS will evaluate compliance based only upon files submitted by the RRE on or after the effective date of the final rule.
• There will be a formal appeal process for RREs if they disagree with the CMPs assessed against them.

CMS generally identified three categories of CMPs:

  • Failure to report
  • Submitting responses to recovery efforts contradicting reporting
  • Submitting records with errors that exceed CMS’s error tolerance threshold
    Statute of Limitations:
  • CMS may only impose a CMP within 5 years from the date when the non-compliance was identified by CMS. The regulation outlines specifically how this will be calculated for each of the three proposed types of CMPs.
    • If an RRE fails to report within the required timeframe (no more than 1 year from the TPOC date), the penalty would be calculated on a daily basis, based on the actual number of individual beneficiaries’ records that the entity submitted untimely.
    TPOC Reporting:
  • Penalty would be up to $1,000 (as adjusted annually for inflation based on 42 CFR part 102) for each calendar day of noncompliance for each individual, as counted from the day after the last day of the RRE’s assigned reporting window where the information should have been submitted, through the day that CMS received the information, up to a maximum penalty of $365K per individual per year.
    ORM Reporting:
  • If an RRE fails to report an ORM termination date, the penalty would be calculated based on the number of calendar days that the entity failed to report updates to the record. The penalty would be up to $1,000 (as adjusted annually for inflation) per calendar day of noncompliance for each individual, for a max annual penalty of $365K per year.
  • Please note, while most of the penalties listed are prospective, the ORM termination reporting is retroactive if not terminated properly.
    CMPs Will be Imposed for the Following Errors:
  • If the RRE exceeds any error tolerance(s) threshold in any 4 out of 8 consecutive reporting periods.
  • The initial and maximum error tolerance threshold would be 20% (representing errors that prevent 20% or more of the beneficiary records from being processed).
  • CMS intends for this tolerance to be applied as an absolute percentage of the records submitted in a given reporting cycle.
  • CMS will maintain current notification process where RREs receive notice via response file and direct outreach (email and, in more serious cases, telephone calls) when there are errors with their file submissions.
  • An RRE is out of compliance for the entire reporting period when the RRE exceeds the error tolerance threshold. (90 calendar days equals one reporting quarter)
  • CMS is proposing a maximum 20 percent per file submission error tolerance. The errors that would be used to determine whether the error tolerance is met shall be defined by CMS 6 months prior to imposition of any CMPs.
  • CMPs would be imposed on a tiered approach if the RRE exceeded the error tolerance(s) in the entity’s fourth above-tolerance submission. Penalties and calculation percentages are outlined in detail within the regulation; however, we have included the chart below directly from the regulation that summarizes the tiered penalty approach CMS is proposing. For a more detailed discussion of this, please reference the proposed regulation itself.
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• No CMP will be imposed in the following circumstances where all applicable conditions are met:

  1. If you report a claim timely; and
  2. Comply with TPOC reporting thresholds and any other reporting exclusions; and
  3. Don’t exceed any error tolerances in any 4 out of 8 consecutive reporting periods; and
  4. If the RRE fails to report required information because they were unable to obtain the necessary information from the beneficiary following a good faith effort to obtain this information which is defined in the regulation as communicating the need for the information twice by mail and at least once by phone or electronic communication. The RRE should maintain these records for a period of 5 years.

Disclaimer: Please note, this article is intended to be a high-level summary of the proposed regulation and is not intended to be an exhaustive review of every detail and requirement contained within the text of the proposed regulation. We will be providing a Webinar Series to discuss the fine details, business implications and best practices surrounding Section 111 Mandatory Insurer Reporting for NGHPs.

Let us know if you want to schedule a meeting to discuss in detail how this rule impacts your business.

Filed under CMS, Legislation, Medicare, Medicare Secondary Payer, Medicare Set Aside, Section 111 Tagged with , ,

Long Awaited Regulations Pushed Back, Again

By on November 22, 2019
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Rulemaking for Civil Monetary Penalties and regulations believed to promulgate formality to Liability and No-Fault Medicare Set-Asides has been pushed back to December 2019 and February 2020, respectively.

Rules clarifying when and how penalties may be issued for Section 111 Medicare Mandatory Insurer Reporting noncompliance could possibly be issued by year’s end. The industry has been anticipating this rule since the initial $1,000 per day per claim penalty was softened into a discretionary penalty per the SMART Act of 2012, enacted in 2013. The updated notice can be viewed here.

Rulemaking for an LMSA or NFMSA policy no longer appears to be imminent. The last date published was October of 2019, which is now delayed another three months, at least. CMS approached such policymaking in 2012, redacting it in 2014 only to revisit it again in 2016. The industry remains in a holding pattern, which will continue through the first several months of 2020, if not longer. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0938-AT85

The Office of Information and Regulatory Affairs’ (OIRA) Office of Management and Budget (OMB) page shows some changes to the Miscellaneous Medicare Secondary Payer Clarifications and Updates proposed rule. Of note is the priority for this rule, which has been shifted from Economically Significant to Other Significant.

According to the OIRA/OMB Frequently Asked Questions, page, a proposed rule that is Economically Significant can be defined as follows:

“A regulatory action is determined to be “economically significant” if OIRA determines that it is likely to have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. For all “economically significant” regulations, the Executive Order directs agencies to provide (among other things) a more detailed assessment of the likely benefits and costs of the regulatory action, including a quantification of those effects, as well as a similar analysis of potentially effective and reasonably feasible alternatives.”

The term “Significant” is also defined on the OIRA page, and it can be distinguished from Economically Significant status as the proposed rule could:

  • Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
  • Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
  • Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive order.

The OIRA page further distinguishes “Significant” status as follows:

The Executive Order requires that significant regulatory actions be reviewed by OIRA before they are published in the Federal Register or otherwise issued to the public. The Executive Order also requires agencies to provide an explanation of the need for the regulatory action and an assessment of potential costs and benefits. OIRA generally designates between 500-700 regulatory actions as significant each year.

Of interest is the bit about the proposed rule raising novel legal or policy issues arising out of legal mandates. Of further interest is the removal of some of the abstract language on the OIRA agenda page, which removes the following part of the rule’s description,

“Currently, Medicare does not provide its beneficiaries with guidance to help them make choices regarding their future medical care expenses when they receive automobile and liability insurance (including self-insurance), no fault insurance, and workers’ compensation settlements, judgments, awards, or payments, and need to satisfy their Medicare Secondary Payer (MSP) obligations.”

This leaves only the following description of the rule in the Abstract: “This proposed rule would ensure that beneficiaries are making the best healthcare choices possible by providing them and their representatives with the opportunity to select an option for meeting future medical obligations that fits their individual circumstances, while also protecting the Medicare Trust Fund.” Essentially, Medicare is no longer indicating that the Beneficiaries do not have guidance about future medical. This could possibly correlate to the prior Medicare Learning Network publications the Agency had disseminated to medical providers, suppliers and facilities. These publications suggested that Medicare Beneficiaries could be billed directly for services if Section 111 reporting was filed, demonstrating a primary payment plan’s availability, with Medicare as a Secondary Payer. The removal of language that there has been no guidance by Medicare could indicate positioning for greater accountability about Medicare Set-Aside usage. This is consistent with recent changes in the Workers’ Compensation Medicare Set-Aside Reference Guide (WCMSA) Version 3.0, which requires a Beneficiary’s acknowledgement of MSA content, intent, submission processes and associated administration within the Consent Form, as of April 1, 2020. See our article on this here.

What has not changed in the Abstract is Medicare’s suggestion that any proposed rule will be voluntary in nature, although the change to “Significant” status broaches the possibility that there could be a policy concern or legal mandate involved.

GRSM’s Medicare Compliance Group will continue to monitor the status of any forthcoming rulemaking.

Filed under CMS, Legislation, Medicare, Medicare Secondary Payer, Medicare Set Aside

Section 111 Mandatory Insurer Civil Monetary Penalties: CMS Announces an Update to the Issue Date for Proposed Rulemaking

By on September 27, 2019
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CMS has recently announced that it has pushed back the proposed rulemaking and public comment solicitation period for assessment of civil monetary penalties for noncompliance with the Section 111 Mandatory Insurer Reporting guidelines to October 2019.

The Medicare Secondary Payer Act (MSPA) provides for civil monetary penalties to be assessed for noncompliance with the Section 111 Mandatory Insurer Reporting requirements. Specifically, 42 USC 1395y(b)(8) provides that a civil monetary penalty (CMP) of $1,000 per day per claim shall be assessed for noncompliance. Subsequently, the SMART Act clarified this provision to indicate that any such penalty shall be discretionary, and penalties of up to $1,000 per day per claim may be assessed for noncompliance. However, prior to assessing any CMPs to a Responsible Reporting Entity, we will first need regulations in place outlining exactly what constitutes noncompliance as well as the criteria for which penalties will and will not be assessed.

CMS has announced its intent to issue a Notice of Proposed Rulemaking in order to propose the criteria for which CMPs will and will not be assessed. The full announcement can be found here. Clarification regarding Section 111 CMPs is something that this industry has been awaiting for quite some time. This announcement extends the original timeline published by CMS on this topic. Earlier this year, a similar announcement indicated that this rulemaking and comment period would open in September 2019. That timeline has now been pushed back one month.

While the date listed for the Notice of Proposed Rulemaking is now October 2019, and it will no doubt take some time before any recovery audits are started and any CMPs are assessed, this notice makes it clear that Section 111 reporting penalties are in the pipeline. With that said, ensuring that your claim data is compliant with the Section 111 requirements can also take a considerable amount of time. We at Gordon & Rees have extensive experience in running Section 111 reporting programs for all types of carriers and self-insured entities, as well as performing full internal audits of Responsible Reporting Entities’ claim data to ensure full compliance with the Section 111 reporting guidelines.

Please keep an eye out in the coming weeks for a comprehensive webinar by the Gordon & Rees Section 111 Reporting team discussing how to get compliant with the Section 111 Mandatory Insurer Reporting requirements, how to perform an internal audit, and the most up-to-date information regarding the coming civil monetary penalties.

Gordon & Rees will continue to monitor all activity regarding Section 111 CMPs as it develops. For any questions or concerns regarding Section 111 reporting penalties or Medicare Secondary Payer compliance in general, please contact us at CMSReporting@grsm.com.

Filed under CMS, Medicare, Medicare Secondary Payer, Medicare Set Aside, Section 111 Tagged with , ,

Senate Bill 135 Amends the Georgia Workers’ Compensation Act to Limit Certain Durable Medical Equipment and Treatments

By on July 25, 2019
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Recently, Georgia has amended its Workers’ Compensation legislation to limit certain treatments in non-catastrophic cases. Becoming effective on July 1, 2019, the amended act now eliminates the 400-week cap for certain medical items and services that were furnished within 400 weeks of the date of injury and prescribed by an authorized physician.

Specifically, O.C.G.A Sec. 34-9-200 now states:

For injuries arising on or after July 1, 2013, that are not designated as catastrophic injuries pursuant to subsection (g) of Code Section 34-9-200.1, the maximum period of 400 weeks referenced in paragraph (2) of this subsection shall not be applicable to the following care, treatment, services, and items when prescribed by an authorized physician:

(i) Maintenance, repair, revision, replacement, or removal of any prosthetic device, provided that the prosthetic device was originally furnished within 400 weeks of date of injury or occupational disease arising out of and in the course of employment; 

(ii) Maintenance, repair, revision, replacement, or removal of a spinal cord stimulator or intrathecal pump device, provided that such items were originally furnished within 400 weeks of the date of injury or occupational disease arising out of and in the course of employment; and 

(iii) Maintenance, repair, revision, replacement, or removal of durable medical equipment, orthotics, corrective eyeglasses, or hearing aids, provided that such items were originally furnished within 400 weeks of the date of injury or occupational disease arising out of and in the course of employment.

The bill then goes on to define the following:

For the purposes of this subsection, the term:

(i) ‘Durable medical equipment’ means an apparatus that provides therapeutic benefits, is primarily and customarily used to serve a medical purpose, and is reusable and appropriate for use in the home. Such term includes, but shall not be limited to, manual and electric wheelchairs, beds and mattresses, traction equipment, canes, crutches, walkers, oxygen, and nebulizers. 

(ii) ‘Prosthetic device’ means an artificial device that has, in whole or in part, replaced a joint lost or damaged or other body part lost or damaged as a result of an injury or occupational disease arising out of and in the course of employment.

Per the Workers’ Compensation Medicare Set-Aside Reference Guide note “CMS will recognize or honor any state-legislated [1], non-compensable medical services and will separately evaluate any special situations regarding WC case”. Therefore, this amendment is of import as with this specific language, arguments can now be made to exclude pricey treatment such as intrathecal pain pumps and dreaded spinal cord stimulators. This could significantly impact WMCSA values in Georgia starting July 2019.

The GRSM Medicare Compliance Group will continue to monitor this, and other compensability matters. Please contact rmaldonado@grsm.com should you have any questions or concerns.

[1] Workers’ Compensation Medicare Set-Aside Reference Guide., Version 2.9, January 4, 2019.

Filed under Medicare, Medicare Secondary Payer, Medicare Set Aside

CMS Proposes to Cover Acupuncture for Chronic Low Back Pain for Medicare Beneficiaries Enrolled in Approved Studies

By on July 25, 2019
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On July 5, 2019, CMS issued a proposed decision to cover acupuncture for the treatment of low back pain in very specific circumstances.

Citing an effort to avoid opioid use, this decision would allow access to acupuncture for Medicare benefiaries who are enrolled in medical studies to allow CMS to review the data and the effect of acupuncture on the treatment of chronic low back pain.

Per the decision, CMS proposed to cover acupuncture with patients with chronic low back pain who are enrolled in clinical trials sponsored by the National Institutes of Health (NIH) or in a CMS approved study. Furthermore, the rule indicates that the aforementioned studies must address and adhere to the following:

  • Enrollment of Medicare beneficiaries based on broad eligibility criteria to maximize diversity and minimize intentional or unintentional exclusions based on risk, multi-morbidity, age, health literacy, demographics, or expected adherence.
  • For the purpose of this decision, chronic low back pain (CLBP) is defined as:
    • lasting 12 weeks or longer;
    • nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc. disease);
    • not associated with surgery within 12 weeks of enrollment in the study; and
    • not associated with pregnancy.
  • A minimum 12-week acupuncture intervention versus usual care or other intervention for chronic low back pain.
  • Endpoints must be measured at 12 weeks, 6 months, and 12 months after enrollment, with comparison to usual care, or other planned comparator arm.  
  • The protocol design must incorporate rigorous controls, prospectively identified, preferably by randomization.  If another method is used to generate the comparison group, it should provide comparable rigor.
  • Be consistent with for the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines.

In summary, CMS has been actively working towards their agenda of fighting the opioid crisis through policy. However, although this is certainly a move in the right direction, this benefit will not be immediately seen for most beneficiaries. Unless prescribers begin to refer to clinical studies that meet the above mentioned qualifications, this treatment will still not be covered until a second decision is made upon the review of the data collected from clinical studies.

To read the notification in its entirety, the link can be found here.

The GRSM Medicare Compliance Group will continue to monitor this, and other coverage matters. Please contact rmaldonado@grsm.com should you have any questions or concerns.

Filed under Medicare, Medicare Secondary Payer, Medicare Set Aside

CMS Issues Updated Section 111 NGHP User Guide Version 5.6

By on July 25, 2019
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On July 1, 2019, CMS issued an updated version of the of the MMSEA Section 111 NGHP User Guide. The latest version of the User Guide provides some much needed clarity as to the submission of multiple claim files per reporting quarter. GRSM has received numerous inquiries regarding the submission of multiple claim input files per quarter, and in light of potential misinformation disseminated by various other Section 111 service providers, these updates come at an opportune time.

CMS did not change the fact that an RRE can submit more than one claim input file per quarter. Rather, Ch. II, Sect. 4.2.2 of the User Guide now states that Responsible Reporting Entities (RREs) should submit one Claim Input file per quarter but also provides in Ch. IV that under appropriate circumstances RREs may submit multiple files within a single quarter. The User Guide specifically states that the primary purpose for multiple submissions in a quarter is to permit RREs to provide ORM termination updates in an expedited manner. An RRE may want to submit more than one claim file per quarter for a number of reasons. For example, in order to trigger a conditional payment notice/letter to aid in the recovery process, an RRE may want to submit an off-cycle claim input file; or to avoid receiving a late flag for timeliness, an RRE may want to submit TPOC or ORM termination information off-cycle.

A full list of the updates made to the latest version of the User Guide is as follows:

– Ch. II of the User Guide added clarity regarding the submission of multiple claim input files. As discussed above, Ch. II Sect. 4.2.2. now states that “RREs should submit one Claim Input file per quarter. Please See CH. IV: Technical Information for more information.” (pg. 4-10).  Whereas this same section previously stated that “File submitters can only submit one Claim Input File on a quarterly basis for each RRE ID.”

– Ch. IV of the User Guide now states that the retention period for downloading response files from the Section 111 site has been updated from 180 days to 60 days (Sect. 10.3 and 10.4).

– RREs can now download the latest PC/server version of the HIPAA Eligibility Wrapper (HEW) software from the Section 111 MRA application, which is compatible with Windows 10. (Sect. 9.3 and 10.4).

– RREs using the HTTPS file transmission method can only upload files with the extension of .txt. Other file types will generate an Invalid Error message (Sect. 9.3 and 10.4). – Finally, Ch. V now provides the same update mentioned above in Ch. IV regarding downloading the HEW software, i.e. RREs can now download the latest PC/server version of the HIPAA Eligibility Wrapper (HEW) software from the Section 111 MRA application.

Version 5.6 of the NCHP Section 111 User Guide can be downloaded here (link https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Mandatory-Insurer-Reporting-For-Non-Group-Health-Plans/NGHP-User-Guide/NGHP-User-Guide.html).

The GRSM Medicare Compliance Group will continue to follow all trends and updates issued by CMS and provide you with the latest updates. If you would like to discuss these updates, or Section 111 Reporting in general, please contact our Section 111 Reporting team at CMSReporting@grsm.com.

Filed under Medicare, Medicare Secondary Payer, Medicare Set Aside

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