Civil Monetary Penalty Proposed Regulations Are Here

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.

How does CMS interpret the three-year Statute of Limitations?

On Tuesday, January 14, 2020, the CRC had a Town Hall conference in relation to NGHP recovery. The big news coming out of today’s question and answer segment was how does the three-year statute of limitations apply to recovery efforts by the CRC and BCRC?

According to Tuesday’s Town Hall, it does not apply to CMS contractors recovering on their behalf as this recovery is considered an “administrative” task. CMS’s interpretation of the statute is that the three-year statute of limitations only applies to legal actions brought by CMS (i.e. CMS pursing double damages). Operating under this interpretation of the statute, the CRC and/or BCRC can recovery conditional payments indefinitely.

This is drastically different from the previous stance, as arguments based upon statute of limitations was historically accepted by CMS. Under this interpretation, the CRC or BCRC could potentially attempt to collect on claims that have been closed for more than three (3) years. From a practice standpoint, this could be especially frustrating as Claimants no longer have an incentive to cooperate in the process.

The other aspects of Tuesday’s call revolved around Pre-CPN worksheets and Open Debt reports. While this information is highly beneficial to Responsible Reporting Entities (RREs) the access to these reports is still only available to an RRE’s MSPRP Account Manager. Therefore, one must be the RRE on file in order to access this specific information. To date, this information is not even available to the RRE’s assigned Recovery Agent. Thus, in order for an RRE to obtain this information, you will need to have an account on the MSPRP.

It appears while bringing the portal up to the technologic times, CMS is still restricting access to much of the beneficial information the portal offers and is requiring strict standards in accessing this data.

Another point of interest is what CMS didn’t say about penalties regarding Section 111 reporting. Although it has continually been hinted at being implemented, CMS did not discuss this topic at the Town Hall Meeting. This, however, does not mean that they may not make an announcement in the near future about this issue.

The slides and transcript from Tuesday’s Town Hall should be posted on the CMS website within a few weeks for those that would like to see the entirety of the presentation.

Long Awaited Regulations Pushed Back, Again

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.

WCMSA REFERENCE GUIDE 3.0 EMPHASIZES ADMINISTRATION

Several changes regarding administration details have been made in Version 3.0. The biggest changes include new Consent Form language for WCMSA submissions requiring the Beneficiary acknowledge his or her understanding of administration, references to Medicare Part D coverage guidelines for Frequently Abused Drugs, and a link for professional administrators to upload account transactions and view account details. Also, among these significant changes are the extension of Amended Review timeframes and hospital fee clarifications.

It must be the end of October, as the Medicare Secondary Payer industry is seeing new program changes, with plenty more in sight. Today the Centers for Medicare and Medicaid Services disseminated the updated Workers’ Compensation Medicare Set-Aside (WCMSA) Reference Guide version 3.0, dated October 10, 2019. The 3.0 Reference Guide is geared toward greater emphasis on Medicare Set-Aside administration, from several different fronts. Proper administration of CMS-approved Medicare Set-Asides ensures the preservation of post-account exhaustion Medicare entitlements. So is this emphasis on administration a warning signal of Medicare benefit jeopardization and/or increased vigilance in monitoring accounts on Medicare’s part?

CONSENT FORMS

In Section 10.2, Consent to Release Note, Version 3.0 adds the following language:

“As of April 1, 2020, all consent-to-release notes must include language indicating that the beneficiary reviewed the submission package and understands the WCMSA intent, submission process, and associated administration. This section of the consent form must include at least the beneficiary’s initials to indicate their validation.”

It has been independently confirmed by CMS that current Consent Forms do not require this content prior to April 1, 2020. Figure 10-2: Example Consent to Release with Instructions, illustrates the location of the initial line and provides the necessary language to pass muster with CMS. Such language brings to mind the Medicare Learning Network literature of the last several years, which directed medical providers, suppliers and facilities to direct bill Beneficiaries with Medicare Set-Aside accounts, so that Medicare would not be billed when a case reached settlement, judgment, award or other payment. Including this new language in the Consent Form documents the Beneficiary’s awareness of, and agreement with, a Medicare Set-Aside and its content, as well as the intent, process and administration of an MSA, all prior to submission. While Beneficiaries and their attorneys have always had access to the contents of a submitted Medicare Set-Aside and supporting documentation, this adds a new layer of accountability for the Beneficiary in the Medicare Set-Aside process.

FREQUENTLY ABUSED DRUGS

Version 3.0 includes a new provision in Section 17.1 Administrators, which explains account administration. New language states, “CMS highly recommends professional administration where a claimant is taking controlled substances that CMS determines are ‘frequently abused drugs’ according to CMS’ Part D Drug Utilization Review (DUR) policy. That policy and supporting information are available on the web at:
https://cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxUtilization.html

Further, Section 17.3 Use of the Account, also includes new language reinforcing the latter provision: “CMS expects that WCMSA funds be competently administered in accordance with all Medicare coverage guidelines, including but not limited to CMS’ Part D Drug Utilization Review (DUR) policy. As a result, all WCMSA administration programs should institute Drug Management Programs (DMPs) (as described at: https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf) for claimants at risk for abuse or misuse of ‘frequently abused drugs’.”

This aspect of the Reference Guide reflects Medicare’s new prescription drug policy that had started January 1, 2019 in which Part D plan sponsors could adopt drug management programs concerning beneficiary use of frequently abused drugs in an effort to combat opioid overuse as per the Comprehensive Addiction and Recovery Act (CARA).

ADMINISTRATION LINKS

In Version 2.9, Beneficiaries could review all documents submitted to CMS via http://www.mymedicare.gov. A physical address for also existed for beneficiaries or their representatives to mail exhaustion documentation. Version 3.0 maintains this option in item 17.7, but adds to Section 17.6 Electronic Attestation, options for electronic submissions of annual and final attestations, usable for either self-administered or professionally administered accounts respectively:

For more information about how to submit an attestation electronically, please see the WCMSAP User Guide, at https://www.cob.cms.hhs.gov/WCMSA/assets/wcmsa/userManual/WCMSAUserManual.pdf.

For more information on Professional Administrator accounts, please see the WCMSAP User Guide, at https://www.cob.cms.hhs.gov/WCMSA/assets/wcmsa/userManual/WCMSAUserManual.pdf.

The new links come on the heels of other CMS efforts concerning MSA account administration. On October 17, 2019, disseminated CMS updated its Self-Administration Toolkit for WCMSAs to Version 1.3, dated October 10, 2019, the same date as Version 3.0 of the WCMSA Reference Guide. The Toolkit Version 1.3 can be found here: https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Workers-Compensation-Medicare-Set-Aside-Arrangements/Downloads/Self-Administration-Toolkit-for-WCMSAs-Version-1_3.pdf

Additionally, Medicare disseminated information about two new webinars focused on WCMSA Electronic Attestation Enhancements. The first was to be held today for Medicare Beneficiaries and their representatives. https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Workers-Compensation-Medicare-Set-Aside-Arrangements/Downloads/WCMSA-Electronic-Attestation-Enhancement-Webinar-October-30-2019.pdf

The second is to be held November 6, 2019 and is for professional administrators. https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Workers-Compensation-Medicare-Set-Aside-Arrangements/Downloads/WCMSA-Electronic-Attestation-Enhancement-for-Professional-Administrators-Webinar-November-6-2019.pdf

AMENDED REVIEW TIMEFRAME EXTENDED

In its own new Section 16.2 Amended Review, Medicare pushes the timeframe in which an Amended Review will be considered from 12-48 months from the date of the original approval letter to 12-72 months from the original approval. This is a welcome expansion to the workload threshold as many cases more than four years past the original approval date have still not settled. Additional language in Section 16.2 fleshes out details surrounding some of the parameters for Amended Review. With regard to a change in treatment, the new version states that changes in treatment plans won’t be considered without supporting medical documentation. Also, Version 3.0 offers a link for details on electronic submission:

See the WCMSAP User Guide at: https://www.cob.cms.hhs.gov/WCMSA/assets/wcmsa/userManual/WCMSAUserManual. Pdf

HOSPITAL FEE SCHEDULES

The new Reference Guide offers much-needed specificity to the sources of hospital pricing for surgical procedures. In the previous version, Reference Guide 2.9 stated within Section 9.4.3 WCRC Review Considerations, “Currently the WCRC prices WCMSAs according to the correct region for the state of venue. Hospital fee schedules are currently determined using the Diagnosis-Related Groups (DRG) payment for a Major Medical Center within the state, and this fee is applied to all locations within the state.” Changes to this Section in the 3.0 version are that the hospital fee schedules are determined using DRG payments for the “median” Major Medical Center within the “appropriate fee jurisdiction for the ZIP code, unless otherwise identified by state law.” (Emphasis added).

ADDITIONAL CHANGES:

• Section 2.2 Reporting a WC Case now includes an address change to:

Medicare – Medicare Secondary Payer
Medicare Secondary Payer Claims Investigation Project
P.O. Box 138897
Oklahoma City, OK 73113-8897

• Section 17.5 Annual Attestation and Record-Keeping has clarified the following address for submitting yearly attestation material:

NGHP
P.O. Box 138832
Oklahoma City, OK 73113

• Section 10.3 Rated Age Information and Life Expectancy has been updated to reflect the most recent life table link:

“CMS will project the cost of the claimant’s future treatment over the claimant’s life expectancy, using the Centers for Disease Control (CDC) Tables. https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_04-508.pdf

NOT IN THE REFERENCE GUIDE, BUT ON THE HORIZON

• Rulemakings! Civil Monetary Penalties for Section 111 Medicare Mandatory Insurer Reporting have not yet been issued. According to the OIRA office, rulemaking should be issued in October of 2019. Similarly situated is possible rulemaking for Liability and No-Fault Medicare Set-Asides, also slated for this month. Both of these items have been collecting dust for years and were scheduled for action in September, which gave way to October. Will what little remaining of October bring the proposed regulations? Or will these rulemakings be pushed into November or beyond?

• Speaking of November, we are only a few weeks away from the annual announcement of the low dollar recovery threshold. Will this amount increase for 2020?

Future updates regarding Medicare Secondary Payer laws will be monitored by the Gordon & Rees Medicare Compliance Team. Please stay tuned for more information as it becomes available!

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

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.

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

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.

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

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.

CMS Issues Updated Section 111 NGHP User Guide Version 5.6

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.

CMS Issues Final Rule Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses

On May 23, 2019, CMS issued a final rule regarding Part D expenses and the Agency’s ongoing efforts in lowering the cost of prescription medications for its beneficiaries.

Per the rule, CMS reports that this final rule amends the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans’ negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees.

CMS then goes on to outline the major provisions of the new rule. Per the announcement there are 5 provisions that CMS plans to implement. They are as follows:

1.) Providing Plan Flexibility to Manage Protected Classes:

According to CMS, except in limited circumstances, current Part D policy requires Part D sponsors to include on their formularies all Part D drugs in six categories or classes: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics. The new proposed rule provides for three exceptions to this protected class policy that would allow Part D sponsors to: (1) implement broader use of prior authorization (PA) and step therapy (ST) for protected class Part D drugs, including to determine use for protected class indications; (2) exclude a protected class Part D drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, and (3) exclude a protected class Part D drug from a formulary if the price of the drug increased beyond a certain threshold. This rule is purported to be effective as of January 1, 2020.

2.) Updates to Part D E-Prescribing Standards

The requirement for this provision is that Part D plan sponsors implement an electronic real-time benefit tool (RTBT) capable of integrating with at least one prescriber’s electronic prescribing (eRx) system or electronic health record (EHR). According to CMS, this would support interactive real-time standards whenever feasible, and for standards that improve the cost-effectiveness of the Part D benefit. This provision would not go into effect until January 1, 2021.

3.) Medicare Advantage and Step Therapy for Part B Drugs

CMS indicated that in this final rule, CMS is reaffirming Medicare Advantage plans’ existing authority to implement appropriate utilization management and prior authorization programs (meaning policies and procedures) for managing Part B drugs to reduce costs for both beneficiaries and the Medicare program.

4.) Part D Explanation of Benefit

With this new rule, CMS is requiring the inclusion of negotiated drug pricing information and lower cost alternatives in the Part D Explanation of Benefits beginning on 01/01/2021. CMS cites its ongoing goal to be more transparent for beneficiaries’ which hypothetically would in turn create more competition and therefore lower costs.

5.) Prohibition Against Gag Clauses in Pharmacy Contracts

This rule also implements the statutory requirement that restricts Part D sponsors from prohibiting or penalizing a pharmacy from disclosing a lower cash price to an enrollee. Again, this is purported to help lower out-of-pocket costs of prescription drugs for Medicare beneficiaries by helping inform them about lower cost alternatives.

In summary, CMS has been actively working towards their agenda of lowering prescription medicines for beneficiaries. However, considering that these rules are set to be enacted in 2020 and some even in 2021, it may be some time before beneficiaries see the benefits of such provisions.

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

The Gordon & Rees Medicare Compliance Group will continue to monitor this case and bring you updates as they become available. Please contact me at (412) 588-2283 or rmaldonado@grsm.com should you wish to discuss this or any other Medicare Secondary Payer matters.

ELECTRONIC PAYMENTS VIA MSPRP NOW LIVE

Effective April 1, the Medicare Secondary Payer Recovery Portal (MSPRP) is equipped to accept electronic payments for Medicare conditional payment reimbursements. Answers to common inquiries were subsequently released by CMS on April 12, 2019 called “Electronic Payments on the Medicare Secondary Payer Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP) Frequently Asked Questions and Answers.” Such functionality was originally referenced in the Strengthening Medicare and Repaying Taxpayers (SMART) Act of 2012.

In the alert, CMS specifically indicated that to make an electronic payment through the MSPRP, one does not need a new or updated user access. The option is available to any user on any matter to which the user already has access.

Payments are not required to be made through the MSPRP. Payers may continue to remit a paper check to satisfy Medicare conditional payment demands. However, any refund issued by the Medicare recovery contractor will still be made via paper check and will not be made electronically, to date.

Interestingly, CMS specifically reports that in order to make an electronic payment through the MSPRP, the matter to which you wish to apply payment must be in “demand” status. There is no option to remit payment electronically unless the amount has been demanded. Therefore, if payment is desired to be made on a Conditional Payment Notice instead of a Demand for Reimbursement, a written check still must be mailed to the CRC/BCRC for application to the claim. Furthermore, CMS clarifies that when paying online, this does not mean that the full demand amount must be paid. If a Redetermination Request has been submitted on a portion of the conditional payments being asserted, a user can still submit a partial electronic payment.

Finally, CMS reported that the electronic payments utilize Pay.gov to secure the transaction, where payments can be made utilizing a savings/check account, debit card, or PayPal linked to a bank account. Credit cards, however, are not being accepted for payment at present. Also, the limit for each payment method is posted, as well. Once payment has been made. a confirmation of payment will be posted to the MSPRP on the Payment Status page. Additionally, an Electronic Payment History status will list the status of all electronic payments, as well as the amount and payment date.

In summary, the new electronic payment system appears to streamline the payment process significantly, with much quicker application times and updates to the portal. However, as indicated above, it is still requiring that non-demand claims must be paid via paper check. This can be frustrating for those that are attempting to make payments before the demand and can potentially complicate settlements.

We at Gordon and Rees will continue to monitor these issues and will continue to report any updates.