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 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.