Workers’ Compensation Medicare Set-Aside Reference Guide Update, Summer 2023

By on May 15, 2023

On May 15, 2023, the Centers for Medicare and Medicaid Services (CMS) released an updated Workers’ Compensation Medicare Set-Aside Arrangement (WCMSA) Reference Guide, found here: WCMSA Reference Guide v3.9, May 15, 2023 (off-release).  The changes included in this version of the guide are as follows:

  • Letters signed with CMS’ Director of Financial Services Group name and signature image have been updated with current contact information
  • CMS Regional Offices are no longer responsible for approving initial determinations.  MSAs are first reviewed for completeness through a computerized system—when and only when a full package of evidence is received by the agency will the file be forwarded to the WCRC for review
  • Clarification has been provided regarding intrathecal pump, SCS, and PNS replacement
  • The maximum time limit for eligibility has been removed from the Amended Review process
  • Zip code 94585 has been added to the major medical center appendix
  • The CDC Life Table link was updated

Of note, CMS has lifted the six (6) year limit on Amended Review—meaning legacy claims with previous approvals too old formerly for reconsideration may now be eligible for reduction, assuming the other parameters of the program are met.  This may allow for complete closure of open claims, with additional potential to reduce conditional payment obligations by facilitating final, legal closure of medical and thereby tolling the statue of limitations on conditional payments.

Additionally, CMS has clarified the replacement frequency for IT pumps, SCS, and PNS units.  The new calculation will consider the unit’s implantation date and will presume implantation within the year for units not yet implanted. The number of replacements is calculated by subtracting the number of years since implantation (using 1 if the unit has not been implanted) and dividing the remaining life expectancy by the implantation frequency.  If the unit has not yet been implanted, the allocation would need to include an initial placement at year one and the number of replacements warranted by the new formula.

For instance, pain pumps have a replacement frequency of seven (7) years.  Assuming a 22 year life expectancy, CMS would calculate the frequency of replacements as follows:

  • If the unit has not been implanted, CMS will include the initial placement plus 3 replacements (e.g. Initial replacement + ((22-1)/7), for a total of four (4) units
  • If the unit was implanted three years prior to submission, CMS will exclude an initial placement as it has already been done and calculate the number of replacements as follows: ((22-4)/7), or 2 replacements.

Where no unit has yet been placed, this can (but will not always) result in a greater funding obligation than previous.

  • E.g. previously, the calculation for total number of units was the life expectancy divided by the funding frequency, which would have resulted in only three (3) pumps in the above scenario.

Of additional note, CMS has clarified that revisions for spinal cord stimulators involve only the lead implantation up to the number of leads related to the associated code; revision surgeries should be used only where a historical pattern of a need to relocate leads exists.  By its plain language, this provision suggests that revision SCS should be less expensive than previous, though it remains to be seen whether or not CMS will continue to include revision laminectomy coding in its SCS revision pricing decisions.

CMS has retained the distinction between rechargeable and non-rechargeable SCS units, with additional distinction for the number of leads.  If the nature of the SCS is unknown, CMS will default to a non-rechargeable, single-lead system, despite rechargeable units being the medical standard of care.  CMS has also allowed for inpatient vs outpatient pricing on SCS units and has reiterated its long-standing policy of reviewing itemized pricing proposals when issuing its opinion of value.

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

Filed under CMS, Medicare Set Aside Tagged with , ,

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

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

By on June 10, 2019
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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.

Filed under Medicare, Medicare Secondary Payer, Medicare Set Aside

Gordon Rees Scully Mansukhani Becomes First 50-State Law Firm

By on April 16, 2019
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With 68th office opening, Gordon Rees Scully Mansukhani expands reach, services to every state.

Gordon Rees Scully Mansukhani (GRSM) has opened its 68th office, creating the world’s first 50-state law firm.

Name partner Miles Scully heralded the move as a game-changing moment in the legal services industry. “As the first and only law firm to feature offices in all fifty states, we are poised to meet our clients’ needs whenever or wherever they may arise. Our deep bench of talented lawyers coupled with our forward-thinking use of technology enables us to lead the industry in providing efficient and cost effective representation virtually anywhere in the country.”

Managing partner Dion Cominos added, “With an already established national platform, the firm was well-positioned to take the next step of providing full territorial coverage throughout the United States. This milestone represents both the culmination of our journey toward becoming a truly national firm, and the next chapter in a new era of delivering seamless and comprehensive legal services to clients on a nationwide basis.”

Since its founding 45 years ago in San Francisco, GRSM has strategically expanded across the nation, opening offices in markets critical to its clients. And as the firm’s clients have continued to consolidate, grow in size, and span additional industries, GRSM has grown to match and service their needs – initially on the west coast, and eventually throughout the country. The full list of GRSM’s offices and local contacts can be found here.

The firm’s strong growth was recognized by The American Lawyer in 2018, which named GRSM number 103 in top grossing law firms, moving up seven spots from the previous year. Law360 recognized the firm as the 40th largest in the United States in its annual rankings by domestic attorney headcount. The firm was also recognized among the top 45 for diversity on The American Lawyer Diversity Scorecard.

GRSM is a national litigation and business transactions firm with more than 900 lawyers providing full service representation to public and private companies ranging from the Fortune 500 to start-ups. Founded in 1974, GRSM is recognized among the fastest growing and largest law firms in the country.

Highlights of Resulting Media Coverage:
Bloomberg Law, April 15, 2019
Law360, April 15, 2019 (subscription may be required)

Contacts
Dion N. Cominos
Miles D. Scully

Filed under In the News, Medicare, Medicare Secondary Payer, Medicare Set Aside Tagged with , ,

CMS Announces Webinars for Upcoming Enhancements to the Medicare Secondary Payment Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP)

By on February 27, 2019
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CMS  announced two webinars for Upcoming Enhancements to the Medicare Secondary Payment Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP).

More to the point, the webinars will be addressing the fact that that effective April 1, 2019, electronic payment functionality will be added to both the MSPRP and the CRCP.  Taking place on March 13, 2019 for MSPRP users and March 14, 2019 for CRCP users, the webinars will provide more information on this new feature.

Practitioner’s Note: This enhancement could make paying outstanding Medicare conditional payments so much easier for debtors. Instead of sending a check and ensuring it’s applied to the proper claim, this function will hopefully give payers assurance that payment has been received and applied in a prompt manner and cut down on error when applying payments to claims that are not in final demand status. Additionally, it may be interesting to see how this may impact refunds as well.

The Gordon & Rees Medicare Compliance team will continue to follow these trends and update you as new developments arise.

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

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