skip to Main Content

September 2018 Compliance Newsletter

September 2018 Compliance Newsletter

Clarifications from CMS

To Classify or not to Classify as a Coverage Determination or Inquiry for a Part D on Formulary Drug Request?
Most plans tend to treat requests for Coverage Determinations for an on-formulary drug as a Coverage Determination. This goes back to a directive many years ago from the Centers for Medicare and Medicaid Services (CMS). During the 2018 audit year, several plans have now been advised that is not necessarily the correct treatment. While some auditors have not raised an issue with this historic practice, others have. We asked CMS the question directly and we were told if a beneficiary or prescriber submits a request for a drug on formulary with no UM requirement, the plan should consider this an inquiry. The plan should neither process the request as a coverage determination nor dismiss the case.

Physician Review of Cases Denied for Medical Necessity
Historically, while Chapter 18 said otherwise, many plans have allowed non-physician decision-makers to overturn the original pharmacy prior authorization denial and plans generally did not have any audit findings. The rationale was that the Coverage Determination denial was being overturned and it provided an expeditious way for the member to get the medication in need. We are now hearing on several audits that plans are being told they must follow the Chapter 18 guidance. We asked CMS directly whether a physician had to review all Part D redeterminations if the original request was denied for lack of medical necessity. The answer: yes, a physician must review such appeals. More importantly, this applies for those cases denied because medical necessity was not met but also for those cases denied because insufficient information was originally submitted (CMS views these denials, too, as lacking medical necessity).
For more information, see our recent blog post here.
Update post blog:  Since Chapter 13 also requires physicians to review medical necessity appeals, we asked CMS to confirm their Part D guidance applied to Part C. We received CMS’ response and they confirmed their guidance is the same for Part C and Part D.

Does a Copy of Previously Submitted Appointment of Representation (AOR) Need to Be Attached to Future Organization Determination, Coverage Determination, Appeal or Grievance Requests?

Chapter 13 and Chapter 18 guidance requires a photocopy of a previously submitted representative form to be submitted with future organization determination, coverage determination, appeal or grievance requests. However, we know some plans are retrieving a copy of the AOR from past cases instead of requiring the form to be submitted with the case.

We asked CMS to provide clarity on this topic and they confirmed if the representative form is maintained and accessible by the plan, a photocopy of the signed representative form is not required to be filed with future grievances, coverage requests, or appeals made on behalf of the enrollee to continue representation. If the plan uses a representative form that is on file for requests, it must include a copy when sending a case file to higher level adjudicators, if applicable. Additionally, a representative form is valid for one year from the date it is signed by both the enrollee and the appointee, unless revoked. If the enrollee would like the same individual to continue serving as a representative after one year, the enrollee must reappoint that person by submitting a new representative form.

NCQA

NCQA has a long history of supporting states that use managed care in their Medicaid programs. In August, North Carolina became the 40th state to take this step, and they will be relying on NCQA’s Health Plan Accreditation (HPA) program to ensure the care provided is high quality and in-step with the latest medical science. To read more on this, click here.

Part C

Enrollment Changes for Medicare Advantage

As part of the 21st Century Cures Act, the Medicare Advantage Disenrollment Period (MADP) (Jan. 1 to Feb. 14 of each year) was discontinued. This period allowed beneficiaries who had enrolled during the Annual Election Period (AEP) from Oct. 15 to Dec. 7 of the prior year to disenroll from that MA plan and re-enroll in traditional Medicare fee-for-service (FFS). The MADP is being replaced with a new Medicare Advantage Open Enrollment Period (MA OEP). Beneficiaries who enroll in an MA plan during AEP can now switch to another MA plan or disenroll and enter Medicare FFS. This period goes from Jan. 1 through Mar. 31.
The second change impacts certain dual eligibles who now effectively have a Special Enrollment Period (SEP) throughout the first nine months of the calendar year (they are already covered by the AEP). These duals are able to enroll in, disenroll from, or switch MA plans as often as monthly. A new rule change effective Jan. 1 will limit these duals from making changes to once per calendar quarter. In addition, those “at risk” or “potentially at risk” for misuse or abuse of a frequently abused drug will not be able to take advantage of this change.

Part D

Medicare Part D Coverage of Multi-Ingredient Compounds

On Aug. 10, 2018, CMS released an HPMS memo clarifying current CMS policies with respect to Part D coverage of multi-ingredient compounds and provided insight on why clarification was needed.

  • The U.S. Department of Health & Human Services Office of the Inspector General (OIG) issued a Report: Questionable Billing for Compounded Topical Drugs in Medicare Part D, OEI-02-16-00440 on Aug. 7, 2018 highlighting that Medicare Part D spending associated with topical compounds (such as creams and ointments) was 24 times higher in 2016 than in 2010.
  • While multi-ingredient compounds account for a very small fraction of overall Part D spending, this level of growth has prompted questions of possible fraud, waste, and abuse.
  • CMS will incorporate training on fraud schemes into ongoing training programs and is encouraging sponsors to continue efforts to ensure medical necessity of Part D compounds through the use of utilization management tools and when considering exception requests.
  • CMS continues to receive questions that indicate additional guidance surrounding multi-ingredient compounds is needed to help inform appropriate coverage of these products.
  • The HPMS memo can be found here.

Changes in the Redetermination SLA 

CMS is lengthening existing timeframes for adjudicating enrollee payment appeal requests at the redetermination and independent review entity (IRE) reconsideration levels from a maximum of seven calendar days to a maximum of 14 calendar days. This change will provide additional time to adjudicate payment requests in situations where beneficiaries have already obtained the requested medications. MedHOK is working with our clients to ensure the configuration change is made effective Jan. 1, 2019.

Part C & Part D

2019 Medicare Communications and Marketing Guidelines (MCMG) – Revised
On Sept. 6, 2018, CMS released the revised 2019 Medicare Communications and Marketing Guidelines. A few notable items are:

  • CMS redefined ‘Marketing’ and established a definition for ‘Communication’
    • Communications: all materials/activities that provide information to current and prospective enrollees
    • Marketing: a subset of communications that have the intent to influence a beneficiary’s decision about their healthcare coverage
  • Email is no longer considered an unsolicited contact, so email can be used to communicate materials to members that opt in

The updated document can be found on CMS’ website.  All substantive changes are reflected in the MCMG via red text. Additionally, the CMS Fall Conference training slides can be found here. A notable update is as follows:

Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage

CMS rescinded their September 17, 2012, HPMS memo “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services,” and issued new guidance that recognizes Medicare Advantage (MA) plans may use step therapy for Part B drugs, beginning January 1, 2019, as part of a patient-centered care coordination program. Here are a few highlights from the August 7, 2018 HPMS memo:

  • Plans must comply with National Coverage Determinations (NCDs) and in some cases Local Coverage Determinations (LCDs).
  • In addition to requiring one Part B drug be used before a different Part B drug, MA plans that also offer prescription drug may use step therapy to require a Part D drug therapy prior to allowing a Part B drug therapy.
  • MAPD plans may also apply step therapy to require a Part B drug therapy prior to allowing a Part D drug therapy. Plans must ensure these requirements are clearly outlined in the Part D prior authorization criteria for the affected Part D drugs.
  • If an MA plan decides to adopt and apply step therapy to Part B drugs, the MA plan must disclose that Part B drugs may be subject to step therapy requirements in the plan’s Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents.

2019 Policy Rule Means Host of Changes for Medicare Plans

While plans look predominantly at the annual Call Letter for guidance on policy changes, this year’s Centers for Medicare and Medicaid Services (CMS) policy rule had a host of changes that plans need to be aware of for 2019. Some major items are noted below and additional information can be found in our recent blog.

  • The Final Rule allows plans to use notice of electronic posting for certain bulky documents to Medicare beneficiaries. This was just supplemented in late July with CMS’ announcement of a digital initiative (see our recent blog here). It is also separating the delivery date of the Annual Notice of Change (ANOC) from the Evidence of Coverage (EOC) so Medicare beneficiaries receive the ANOC first as a stand-alone document.
  • CMS codified key aspects of the Part C and D Star Ratings methodology, including its ability to add, update, and remove measures, as well as calculating and weighting measures. CMS is also cracking down on plan consolidation and the benefit plans traditionally received by deeming Star ratings from higher performing plans to lower ones when merged in. It will also add scaled reductions for data issues related to Star measures.
  • CMS is eliminating certain meaningful difference requirements for plan offerings within counties.
  • CMS is reinterpreting uniformity requirements for Part C benefits to allow plans to reduce cost-sharing for certain covered benefits, offer specific tailored supplemental benefits, and offer different deductibles for beneficiaries that meet specific medical criteria. As we noted in a recent blog, this variability of benefits provision, as well as the ability to include non-traditional Medicare benefits in the bid, is a change for the program.
  • CMS will give plans more leeway in what communications need approval.
  • CMS is implementing the CARA Act requirements for a drug management or lock-in program for at-risk drug abusers. See our recent blog on this topic here.
  • CMS is revising the existing policy related to tiering exceptions and will no longer allow plans to exclude a dedicated generic tier from the tiering exceptions process. The lowest applicable cost-share will now apply. This change has already been enforced through a variety of means.
  • Special Enrollment Periods for dual eligible and Low-Income Subsidy (LIS) members will be limited to one change in each calendar quarter in the first nine months of the year. This should reduce the major churn seen by plans in high dual and LIS areas.
  • The transition policy fill amount for those in long-term care settings will change from 90 days to a one month’s supply.
  • Plans will be able to immediately substitute generics for brand name drugs on the same or lower cost-sharing tier if they meet certain requirements, which include advising enrollees beforehand that such changes can occur.
  • Application of generic cost-sharing to lower-cost generic biosimilars and similar drugs will occur through all phases of Part D coverage.
  • Delivering on its commitment to push the application of rebates at the point of sale in the Part D program (and thereby giving members immediate savings), CMS is issuing a Request for Information soliciting comments on potential policy approaches to implement the strategy.
  • Due to the 21stCentury Cures Act, CMS is replacing the MA disenrollment period (where members can disenroll from MA plans back to Medicare FFS only) from January 1 to Feb. 14 with a new MA open enrollment period from Jan. 1 to Mar. 31. This will allow members to disenroll from one MA plan and enroll in another or go to Medicare FFS – a boon for MA sales.
  • The turnaround time for decisioning a Part D payment appeal at the plan redetermination and independent review entity (IRE) reconsideration levels will move from seven calendar days to a maximum of 14 calendar days. The plan will still have 30 days to fulfill a favorable reimbursement.
  • CMS is removing the current requirement that MA plans send notice to an appellant when his/her appeal case file is forwarded to Medicare’s Part C IRE. The plan notification is redundant of the IRE notification process.
  • CMS is removing the Quality Improvement Project (QIP) from the Quality Improvement (QI) requirements as it is duplicative of other current requirements.
  • CMS is codifying the existing policy of treating FFS premium adjustments as initial determinations, which gives beneficiaries subject to these adjustments full appeal rights.

SECURITY NEWS

It’s early. The office is quiet and you are cuddled up with your first cup of coffee. You start reading through your emails and there it is, management’s invite for all employees to begin using the new enterprise social media tool. Did the lights just dim? Is the room spinning? Of course, as a security professional you would like to keep collaboration under a cone of silence and communication shared using encrypted messages sent by crows. Before your head begins to spin around, do what you do best and assess the risk.
Social media is the preferred method of communication. It can increase productivity and employee satisfaction by strengthening collaboration. There’s that word again, collaboration. It means employees will be sharing information and data.  For many employees, sharing via social media has become so second nature that they may not realize how information innocently posted on a social network can harm a business.
Employee training is key. Include types of social media attacks and how to spot them in your user security awareness training. Review current policies and procedures. Ensure they include clear direction for employees to follow regarding data sensitivity and acceptable use of both external and internal social media sites. If it is a new service or cloud provider perform a vendor assessment and include them in your vendor management program.  Assess the tool and make sure it meets your Information Security Policies. Some important technical controls to consider are:

  • Access controls
  • Data encryption both in transit and at rest
  • Key management
  • Accessibility from mobile devices
  • Accessibility from outside the corporate network
  • Malware protection on devices accessing the service
  • Ability to control integration with other tools and social media sites
  • Data Loss Protection
  • Logging and monitoring
  • Backup and recovery
  • Data retention

Establishing security requirements around an enterprise social network can be challenging. Use your well-written policies and procedures to help guide you.

Levo Health

This is Levo Health Bio.

Back To Top