Brain Food | GHG Advisors

Provider Network Management New Year’s Resolutions for 2018

Many of you and your teams are in the frantic, end-of-year trenches renegotiating current provider agreements or working on contracting new providers for a service area expansion, and it is easy to lose sight of all the changes swirling around the provider network arena. As we head into 2018, we would encourage you to incorporate these three key items into your Provider Network Management Department’s performance appraisal goals.

Dust off the antiquated access and availability policy and procedure and take the opportunity to develop an organic network monitoring program that fosters growth, collaboration, and partnerships with your providers. By the Centers for Medicare & Medicaid Services (CMS) moving network reviews from an application process to a plan operational requirement, plans will be subjected to stronger compliance actions. The short time frame in which a plan will have to submit their compliant Health Service Delivery (HSD) tables to CMS leaves no time for mitigation of network deficiencies. Plans need to be more diligent than ever to build a continuous network monitoring program to ensure continual compliance with CMS. In addition, while we have the policy down off the shelf, why not take the opportunity to break down the silos and see how that policy is working for Medical Management, Member Services, and your Star Ratings work plan.

Plans have been making strides in shifting their networks towards value-based contracting, incorporating quality metrics, Star Ratings, and a variety of population health initiatives. However, a significant portion of Medicare Advantage (MA) remains based on traditional fee-for-service (FFS) reimbursement. As we evaluate the impact Medicare Access and CHIP Reauthorization Act (MACRA) will have on MA provider contracting starting 1/1/19, the traditional reimbursement statement current MA contracts typically use, “Provider will be reimbursed according to X% of the Medicare Fee Schedule,” becomes an old stand-by with potentially serious consequences. At a minimum, plans need to clarify the change MACRA will bring to the definition of “Medicare Fee Schedule” in their existing provider agreements and carefully evaluate how it aligns with any penalties/bonuses that can occur under both Advanced Alternative Payment Models (APMs) and Merit-based Incentive Payment System (MIPS).

As much as I would like to say there have been significant improvements in data integrity, inaccurate provider data continues to plague health plans and has far-reaching tentacles into health plan operations as a whole. We saw plans have quick success in updating provider directories only to fail at building sustainable processes with checks and balances and end up only slightly better than the first effort.

Please reach out to Gorman Health Group for assistance in developing a network management strategy to include the key items above.

Resources:

Registration is now open for the Gorman Health Group 2018 Forum, April 25-26, 2018, at the Red Rock Resort ideally located near the Red Rock Canyon in Las Vegas.

Want to stay up to date on policy and regulation changes? The Insider is GHG’s exclusive intelligence briefing, providing in-depth analysis and expert summaries of the most critical legislative and political activities impacting and shaping your organization. Read our full press release >>

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by GHG Advisors

Benefit Administration Testing – From a Compliance, Audit, and Best Practice Perspective

In 2016, 41 million individuals (72 percent of all Medicare beneficiaries) were enrolled in Medicare Part D. Of those enrolled, 60 percent were in stand-alone Prescription Drug Plans (PDPs), and 40 percent were in Medicare Advantage Prescription Drug plans (MA-PDs). Plan sponsors must adjudicate pharmacy claims for the Part D benefit in accordance with their Centers for Medicare & Medicaid Services (CMS)-approved formulary and Plan Benefit Package (PBP) bids.

Most Part D sponsors delegate prescription claim adjudication to their Pharmacy Benefit Manager (PBM). Formulary and benefit coding performed by a plan sponsor’s PBM is a compliance risk area. Sponsor oversight and auditing of their PBM’s claim processing systems include key formulary administration and transition processes for new and current enrollees that are consistent with 42 CFR §423.120(b)(3).

Benefit Administration Testing on a yearly basis allows for prompt identification and correction of formulary and benefit coding errors prior to go-live. Early detection and correction of areas of non-compliant Part D claim adjudication ensures accurate benefit set-up, minimizes member disruption and access to care issues, and is paramount for a compliant Part D formulary and compliant benefits administration.

A comprehensive Benefit Administration Testing review requires a strategic and systematic process to ensure accurate adjudication of the CMS-approved formulary and PBP. This includes testing for accuracy of all covered drug copayments, tiering, and Utilization Management (UM) and confirming pharmacy claim processing is in compliance with CMS guidance as stipulated in 42 CFR Parts 422 and 423, including guidance located in the Medicare Managed Care Manual, Prescription Drug Benefit Manual, and CMS Program Audit Findings and Best Practices Memos.

Gorman Health Group's (GHG’s) Benefit Administration Testing service provides MA and Part D sponsors with an assessment from not only a compliance, audit, and best practice perspective but also an indication of how the organization would likely perform in an actual CMS audit.

The GHG comprehensive Benefit Administration Testing review includes:

Test suite that validates a broad sample of claim types for copayment, pharmacy network, True Out-of-Pocket (TrOOP)/Maximum Out-of-Pocket (MOOP) accumulator, lesser of logic, formulary and non-formulary, excluded drugs, etc.
Strategic custom scenarios for each formulary and plan design variation and includes point of sale National Council for Prescription Drug Programs (NCPDP) and custom messaging review.
UM edits for Prior Authorization (PA), Quantity Limit (QL), Step Therapy (ST), and grandfathering.
A special focus on protected class drugs, transition of care, and look-back logic.
Concurrent drug utilization review (cDUR) logic per CMS recommendations for the following, but not limited to, criteria: therapeutic duplication, age/gender-related contraindications, over-utilization and under-utilization (e.g., early refill), drug-drug interactions, incorrect drug dosage, or duration of drug therapy and drug-allergy contraindications.

Common coding errors identified and corrected include:

Coding of QLs resulting in inappropriate rejections:
Maximum daily dose limits that were more restrictive than the CMS-approved QLs and/or Food and Drug Administration (FDA) maximum recommended daily doses.
Quantity over time coding that failed to consider unbreakable packaging.
Applying a CMS-approved QL specific to brand drugs only to generic versions of the drugs.
Coding errors for transition logic resulting in inappropriate claim rejections for new and continuing beneficiaries transition supplies:
Applying PA edits on claims for continuing beneficiaries with a utilization history of protected class drugs.
Failure to afford long-term care beneficiaries multiple transition fills as necessary during the entire length of the transition period.
Failure to correctly identify drugs with a negative cross-year formulary change.
Imposing UM edits that are not appropriate during transition (e.g., edits are not related to Part A or B vs. Part D determination, FDA maximum daily dose, early refill, etc.).
Benefit was coded to reject transition-eligible claims for drugs in their smallest available unbreakable package size when the calculated days’ supply exceeded the transition days’ supply limits.

GHG additional offerings include:

Marketing Materials Review
Post Go-Live Claims Review

Now is the time to lock in your Benefit Administration Testing project for go-live January 1, 2018. GHG’s Pharmacy experts can create and conduct a thorough and strategic Benefit Administration Testing plan for your organization to ensure your PBM is processing claims consistent with your CMS-approved prescription drug benefit before the new plan year begins as well as on an ongoing basis throughout the year through post go-live claim reviews.

Resources:

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by GHG Advisors

Now Is The Time To Start Planning For 2019 Medicare Advantage Growth

Here are three planning questions you need to ask yourself right now:

Are you losing market share because you are not offering the right products or product mix?
How could the profitability of your Medicare Advantage (MA) enrollment change if you expanded your service area?
Is now the time to begin offering an MA plan?

There is a proven process to go about answering these questions.

The first step begins with a market analysis to assess both current and/or proposed markets. Looking at market enrollment trends and understanding the market demographics with product and premium analyses help you understand what levers are driving the market. Plus, a benefit analysis starts to show which benefits at which premium price points are most favorable.

You then want to take the results from the market assessment and build an enrollment projection to understand what the five-year trend might be with a new product at a certain benefit level and price point or how your current product might perform in a new service area.

The next step is to pressure-test your hypothesis with a financial feasibility study. Although a feasibility study is not an actuarial study, it tests whether a hypothetical benefit design could work in a target market based on the revenue and cost characteristics of that market. It also takes into account assumptions about the Centers for Medicare & Medicaid Services (CMS) payment trends, enrollment, premium, and costs.

This process allows you to make smart, informed decisions about your current or potential market without all the investment upfront. Now is the time to start planning since the Notice of Intent to Apply (NOIA) is right around the corner in November. This type of process is not a one and done! It tends to be a very iterative process to understand how to dial the levers in the market to see if you can develop additional, profitable growth. So take the time now to get it done right, or spend the money later by guessing incorrectly.

Resources:

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by GHG Advisors

Three-Year Network Adequacy Review for Medicare Advantage Plans

If the Centers for Medicare & Medicaid Services (CMS) knocked on your door today, would you be ready to submit a compliant provider network within 60 days? CMS estimates the proposed three-year network adequacy review for Medicare Advantage (MA) plans would mean just that for approximately 304 MA plans for calendar year 2019.

Normally this time of year we remind plans to start contracting with providers in order to meet CMS network requirements for new and service area expansion needs. This reminder still rings true. Given the lead-time it can take to negotiate contracts with providers and facilities, plans need to be proactive in the recruitment/contracting department to ensure you have a compliant network within your proposed expansion area. Moreover, while the proposed CMS changes may not require plans to submit a Health Service Delivery (HSD) table with the initial or service area expansion application, it does not negate the requirement to meet CMS standards for an adequate provider network.

The three-year network review would require plans that have not had a triggering event within the past three years to submit their HSD provider and facility files via the Network Management Module within the CMS Health Plan Management System (HPMS). Currently the triggering events are:

1. Initial Application
2. Service Area Expansion (SAE) Application
3. Initial Offering of a Provider-Specific Plan
4. Potentially Significant Provider/Facility Contract Termination
5. Change of Ownership
6. Network Access Complaints
7. Organization-Disclosed Network Deficiency

Reviewing plan network adequacy was born out of beneficiary protections and member complaints. And while there is some concern moving to a three-year cycle could impact beneficiaries negatively by lessening the upfront review, there is greater concern for beneficiaries enrolled in a plan that may not have had any sort of triggering event and have never had their provider network reviewed since they first applied. By moving the network reviews from an application process to a plan operational requirement, plans will be subjected to stronger compliance actions. The short time frame in which a plan will have to submit their compliant HSD tables to CMS leaves no time for mitigation of network deficiencies. Plans need to be more diligent than ever to build a continuous network monitoring program to ensure continual compliance with CMS.

If you are looking to expand your network footprint or want to be proactive in reviewing your current network status and building a compliant network monitoring plan, Gorman Health Group can help. Our veteran teams of consultants are available to assist with all your contracting and expansion needs as well as with the review of your current network and helping you develop a monitoring plan before CMS knocks on your door.

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by GHG Advisors

10 CMS Program Audit Risks

Program audits and oversight activities must be designed with many factors to balance: accuracy, consistency, efficiency, and in an effort to be least disruptive to a plan sponsor. Correspondingly, a plan should be tailoring its response to these audits with those same factors in mind. A colleague and I outline ten common risk areas we observe in plans large and small.

Comprehensive Part D Benefit Administration Testing: Plans accept the standard Pharmacy Benefit Manager (PBM) testing scenarios and do not endeavor to do full benefit testing on the Part D formulary prior to the beginning of the plan year. This puts the plan at risk for transition issues and inappropriate rejected claims during the critical data universe window the Centers for Medicare & Medicaid Services (CMS) uses.
Coverage Determinations and Redeterminations: Plans continue to experience issues with decision and notification timeliness as well as notice content that is unclear to the member and provider.
Organization Determinations: Plans fail to do appropriate provider outreach and experience decision and notification timeliness issues.
Claims Determinations: Claims are not fully developed, out-of-area emergency and plan-directed care denials continue to appear in universes, and appeals language is missing from notices.
Delegated Function Audits: Plans do not complete annual delegation oversight audits (a CMS recommendation) for both the PBM and Part C delegates.
Misclassification of Grievances/Appeals/Inquiries: Plans continue to struggle with multiple entry points of information into the plan, which increases the risk for misclassification and thus timeliness of outreach and decision notification.
Special Needs Plan Model of Care (MOC): Oftentimes, it is found plans have misinterpreted the MOC requirements, leading to the realization a MOC was incorrectly written, regardless of high scoring from the National Committee for Quality Assurance.
Failure to Connect the Compliance Dots: Plan staff struggle to articulate their roles and responsibilities when it comes to program oversight, whether it pertains to internal or delegated operations. With only six tracer samples to evaluate, each sample matters a great deal in the evaluation of the three Compliance Program audit areas.
Data Integrity in Universe Preparation: Incomplete or inaccurate universes continue to plague Operations and Compliance teams, an indication of readiness and a possible indicator on the state of delegation oversight.
Commitment: Plans operate in full-on reactive mode, which may be palpable to CMS. They agency has noted in the past they can tell within five minutes whether or not a plan has a culture of compliance. Demonstrated organizational commitment changes the “have to do it” mindset to a “we are glad to do it” attitude.

If any of the 10 items listed resonate with you, contact us. Do you already have a dedicated audit team, comprised of the specialists in your plan, who can speak to your operations and samples? Practice with and exposure to the CMS program audit process gives you and your colleagues a leg up on expectations. Secondly, are the program audit areas on your auditing and monitoring plan for this year? These are areas of particular concern for Medicare Parts C and D. We are more than halfway through 2017 – are you on track to meet your audit plan goals? Contact us for information on how Gorman Health Group can help with your 2017 internal audit activities and your CMS audit preparedness.

Resources:

Want to stay up to date on policy and regulation changes? The Insider is GHG’s exclusive intelligence briefing, providing in-depth analysis and expert summaries of the most critical legislative and political activities impacting and shaping your organization. Read our full press release >>

Our clinical team has compiled a checklist to ensure your clinical operations are where they should be by identifying what’s working and what’s not. Download the checklist >>

Stay connected to industry news and gain perspective on how to navigate the latest issues through GHG’s weekly newsletter. Subscribe >>

by GHG Advisors

Addressing Key Questions on the 2018 Medicare Marketing Guidelines

We had a fantastic turnout for our webinar last week on the 2018 Medicare Marketing Guidelines (MMG). Something I’ll reiterate is that the MMG are for everyone. Nilsa Rudisill and I had plenty of spirited discussions when working to narrow down the content to fit in a single hour. We know your time is valuable, and we appreciate everyone’s attendance.

Some great questions were received that Nilsa and I thought would be beneficial to share in case others in the industry are contemplating similar themes. Some of our clients even shared their responses from the Centers for Medicare & Medicaid Services (CMS). While we cannot share those specific responses, it does confirm to us there are ambiguities in certain sections, and the agency is responding in a timely manner. Therefore, if you are in doubt, reach out!

Let’s address the sample Summary of Benefits (SB), a key document for beneficiaries. By no means is the sample a “model” document in the same vein as CMS releases model Evidence of Coverage documents. Most readers already have their SBs under development, which is great.
A few questions came in pertinent to the submission of events to CMS in the Health Plan Management System (HPMS). When does the change take place? The guidance applies to 2018 activities. Unless CMS says otherwise, continue to submit events pertinent to the 2017 plan year.
Does the change in HPMS submission of events signal a change in surveillance activities? From the outside looking in, the answer is yes. CMS used the information submitted by sponsors to select events for surveillance. A change in the agency’s direct monitoring activities should not change your own internal monitoring and auditing, unless, that is, you already know you need to step it up.
How should Scopes of Appointment (SOAs) now be tracked? Nothing much has changed. The documentation may be in writing in the form of a signed agreement by the beneficiary or a recorded oral agreement. Any technology (e.g., conference calls, fax machines, designated recording line, pre-paid envelopes, and email) can be used to document the SOA. Remember, you must document the scope of the appointment prior to the appointment. Be prepared to demonstrate this in your documentation.

As we’ve stated before, you’ve got to wonder if each revised chapter CMS issues is a collection of lessons learned from the previous period of time. Regardless, the agency seems to be streamlining and refining guidance not only to ease burden on sponsors but to also provide necessary clarification as needed. What changes are impacting your organization and to what extent? Contact us on ways we can help your operations be successful in implementing the MMG.

Resources:

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by GHG Advisors

2018 Medicare Marketing Guidelines

It was a hot summer night when the Centers for Medicare & Medicaid Services (CMS) released the final version of the calendar year 2018 Medicare Marketing Guidelines (MMG), and a few hot summer days have passed while the industry digests the changes. Don’t make the mistake and only share the MMG with sales and marketing; those handling enrollment, customer service, mailings, printing, Star Ratings and quality, compliance and oversight, legal affairs, provider relations, and finance (including delegates handling these functions) all have a stake in this chapter.

My colleague Nilsa Lennig Rudisill and I will be hosting a free webinar to address some of the key changes in the guidelines on August 15. Register for the webinar here. In the meantime, highlights include the following:

Some no-brainer language was added in Section 30.4, Anti-Discrimination. Plans/Part D Sponsors must comply with their obligations under other anti-discrimination rules and requirements, including Section 1557 of the Patient Protection and Affordable Care Act. This may sound simple, but unless you are a legal professional, you may be unsure of which rules and requirements apply to your organization. Partner with your legal team to ensure you not only have policies and procedures addressing your organization’s commitment to these rules, but make sure everyone is walking the talk, especially in member-facing operations. You may be discriminating and might not even know it.
For those living in the material world, CMS has finalized Appendices 4 and 5 for Summary of Benefits Instructions and Disclaimers, respectively. This should be a welcome change for sponsors who have used the MMG and other CMS memos in the past as a reference and have created their own tools for use.
CMS provides additional guidance regarding the mailing of materials to enrollees at the same address. The organization needs to either have reasonable assurance the individuals are related or have otherwise received consent from the recipients in case they are not related. We recognize CMS provided flexibility here, but we implore organizations not to take any shortcuts in documenting their criteria for “reasonable assurance.”
Speaking of materials, CMS has provided sponsors the flexibility to either send enrollees a hard copy of the full or abridged formulary at the time of enrollment and annually, or send a hard copy notice describing where enrollees can find the online formulary and how to request the formulary in hard copy. Sponsors should note, however, the 2018 Evidence of Coverage template states the formulary is either attached or mailed separately, indicating a slight disconnect. This was not addressed in the July 27 corrections memo either, so perhaps more is to come.
Sponsors no longer need to upload educational or formal or informal marketing and sales events into the Health Plan Management System. CMS still requires the sponsor to keep accurate records of events as they may request the information at any time, so we anticipate sponsors will still require reporting of events from agents and brokers. None of the secret shopping tools have been updated in the Surveillance Module for quite some time, and some sponsors have experienced a drop in surveillance activities conducted by the agency. This change could indicate a shift in focus for the agency and their resources.
For those who were eagerly awaiting the final language pertaining to agent compensation, see my colleague's blog for the detail on that topic.
CMS is now allowing sponsors to market via electronic communications, including email. “Although in the past, email has not typically garnered a large return of leads, it will be interesting for marketers to test this channel again to understand its effectiveness in the marketplace today,” notes Diane Hollie, Senior Director of Sales, Marketing & Strategy. Remember to review the disclaimers in Appendix 5 since there are disclaimers particular to email.
There remains no mention of the 48-hour time frame for Scopes of Appointment (SOAs), only that the sponsor must document the SOA prior to the appointment. Given that this provides significant flexibility for agents, it stands to reason SOAs may be obtained minutes before an appointment takes place. CMS requires the SOA documentation to include the date of appointment, but if the SOA date and appointment date are the same, this leaves an organization open to scrutiny as to whether the SOA was obtained after the appointment. Capturing the time on SOA methods not currently capturing the time would fill this gap.
In case you may have missed it, CMS released a sample Summary of Benefits document. Organizations are not required to use this document as long as they follow the requirements outlined in the MMG.

You’ve got to wonder if each revised chapter CMS issues is a collection of lessons learned from the previous period of time. Regardless, the agency seems to be streamlining and refining guidance not only to ease burden on sponsors but to also provide necessary clarification as needed. More to come during our webinar scheduled for August 15. If there are any questions you’d like us to review ahead of time, send them to us here. What changes are impacting your organization and to what extent? Contact us on ways we can help your operations be successful in implementing the MMG.

Resources:

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by GHG Advisors

Digital Marketing in the Medicare Advantage World

“Internet shopping rates have surpassed the rates of all other shopping activities.” As marketers, we have heard for years now that omnichannel is the way to go and that baby boomers are online. But we still see a lack of focus on digital in many Medicare Advantage marketing strategies. Deft Research’s “2016 Age-in Study” shows for the first time that internet shopping is the highest utilized channel for researching products (the shopping part) among age-ins in 2016. Clearly, digital can no longer be considered an additional channel—it is the channel. And the best thing about digital marketing, it is data-driven. In nearly real time, you have the opportunity to understand what is working and what isn’t.

So, now that you are underway with pre-Annual Election Period (AEP) marketing and implementing your sales and marketing strategies, how does your digital marketing stack up? Consider the following…

Be the local authority on Medicare Advantage: Not only ensure that you are the result in local website searches on Medicare Advantage but that your Medicare Advantage website includes educational information. Think easy-to-read visuals and 10-minute educational videos intended to provide common answers to Medicare Advantage questions and explain Medicare Advantage to those aging in. Consider making these videos searchable on video sharing sites like YouTube, then post your videos on social media sites like Facebook, Instagram, and Twitter. You want beneficiaries in your service area to go to you with their questions, not your competition.
Internet shopping tool is a must! Internet shopping is the most widely used shopping channel by the Medicare Advantage age-in population. As more baby boomers age in to Medicare, this trend is expected to continue. If you don’t have an online shopping tool, make this a priority now. The shopping tool should support a potential member in clearly comparing plan options all the way through to completing an enrollment form.
Current member email and cell phone communication programs (MA or other lines of business)Traditionally, email and cell phone communication programs have been rare in the Medicare Advantage world, but for the younger population, this method of communication is expected. It is what they are used to pre-Medicare Advantage. As we see more tech-savvy and internet-savvy beneficiaries, there is a huge opportunity to stay connected with your members, drive Star Ratings, and keep your members happy and healthy. You may want to consider care management text messages, reminding members of upcoming doctor appointments, seasonal at-home care tips (e.g., allergy season, flu season, etc.), and targeted medical tips and information for members with certain clinical conditions. And finally, when developing your mobile strategy, Gorman Health Group recommends considering a mobile application that allows members to access their personal, password-protected member portal. We recommend enhancing your member portal to include not only newsletters, member education videos (see #2) and plan information but also premium payment abilities, claims status checks, and doctor appointment tracking.

Interested in giving your marketing strategy a digital boost? We are here to help! Contact GHG today to see how we can partner with your Marketing team to develop a robust digital marketing strategy.

Resources:

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by GHG Advisors

Rising Drug Costs Continue to be a Concern

During the presidential campaign, Donald Trump highlighted the need to address rising drug costs, stating the drug industry was “getting away with murder.” Several recent high-price drug increases for HIV/AIDS drugs, hepatitis C drugs, and the EpiPen^®, among others, have also raised Congressional, state, and public concern about the issue. During the campaign, Trump discussed allowing re-importation of cheaper drugs or allowing the government to negotiate drug prices as ways to lower prices.

The Trump administration has now established a working group, led by the Office of Management and Budget (OMB), which includes top officials from the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), the Health Resources & Services Administration (HRSA), the National Economic Council, and the Office of the Trade Representative, and work has begun on development of an Executive Order on the subject. According to press reports, the Executive Order is expected to include more modest proposals than discussed during the campaign such as speeding up approval of generic drugs as well as proposals that are supported by the drug industry. There is no announced schedule for release of the Executive Order, however, working group members have discussed a July release as well as continued work throughout the summer.

Politico has obtained a copy of a draft Executive Order and is reporting the policy changes provide broad authority for federal agencies including FDA, CMS, the U.S. Trade Representative, and other health agencies to develop measures to deal with drug prices. For example, CMS could design Medicare and Medicaid benefits that would reduce out-of-pocket costs for beneficiaries or modify the Part D protected classes. The Executive Order could also include a focus on value-based drug pricing, which would allow agreements between insurers (including Medicare and Medicaid) and manufacturers that tie payment to drug efficacy. This proposal is supported by the pharmaceutical industry. The order is also expected to roll back a federal 340B drug discount program, which was expanded during the Obama administration, and provides discounts to hospitals and clinics that serve a large number of low-income patients. Not all of these proposals would actually reduce total health system drug prices. In some cases, they would merely shift who is paying. House and Senate Democrats have written a letter to the administration requesting a more comprehensive approach in the Executive Order such as measures to increase transparency in drug pricing and increase price competition.

The FDA has already moved to implement a proposal that is focused on speeding up drug approvals. On June 19, the FDA issued draft guidance for comments which is intended to assist companies in getting shorter reviews of generic drug applications. Initially, this policy will focus on older drugs that have limited competition https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563507.pdf. On June 27, the FDA published a list of off-patent, off-exclusivity branded drugs without approved generics as part of a new policy to speed up generic reviews. Previously, the FDA Commissioner announced the FDA will develop a “drug competition action plan” to facilitate competition among expensive drugs after holding a public hearing on ways to accomplish this goal and will move to clear the backlog of FDA reviews of generic drugs.

Initially, curbing excessive drug prices had bipartisan support in Congress, and Congress started to move on drug prices. However, it appears partisan gridlock over the Affordable Care Act (ACA) repeal and replace legislation will thwart any real congressional action this year. The Senate Health, Education, Labor, and Pension (HELP) Committee held a hearing in early June which focused on patient costs for drugs. The HELP hearing demonstrated a lack of bipartisan consensus on the problem and potential solutions, with Republicans focusing on bringing more drugs to the market faster to promote competition and the Democrats focusing on more active policies like government negotiation of Part D prices. A second HELP hearing scheduled for July has been canceled, and it is unlikely a third hearing planned for the fall will be held. The House Energy and Commerce Committee said they are planning a hearing on the issue, but there is no scheduled date.

States have also moved to address drug prices. In June, Nevada enacted legislation to require increased transparency of drug prices for treatment of diabetes. Companies that have raised a drug’s list price over a certain amount must disclose information about the costs of making and marketing the drug and any rebates provided to Pharmacy Benefit Managers (PBMs). The legislation also includes provisions for more PBM transparency. Vermont already has a drug price transparency statute on the books and has produced a report on egregious drug price spikes. Maryland recently passed legislation that provides authority for the Attorney General to target generic drug makers who increase the acquisition cost of a generic drug more than 50 percent in one year and to impose civil penalties or lower the price, though this has recently been challenged in court.

Resources:

Our clinical team has compiled a checklist to ensure your clinical operations are where they should be by identifying what’s working and what’s not. Download the checklist >>

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by GHG Advisors

Three Compliance-Minded Steps to Take for 2018 Marketing and Sales

Is it me, or is time flying by? Applications are done, bids are in, new plans are in planning stages, and existing plans are getting ready for the launch of the next benefit year.

The 2018 model materials were released late last month, and any second now, we should see the release of the 2018 Medicare Marketing Guidelines (MMG). The industry is expecting additional Summary of Benefits guidance to be incorporated in the MMG by the Centers for Medicare & Medicaid Services (CMS) as my colleague Diane Hollie noted in her article on the CMS Spring Conference. We are also interested to see if any modifications are made to CMS’ draft MMG language on Additional Marketing Fees as discussed in this article. Time will tell!

What is the compliance professional to do to help sales and marketing professionals prepare while we are in this holding pattern for the finalized guidance? Three things:

Evaluate what worked and what didn’t work well in the material review process last year. Did you conduct a lessons learned session at the end of the season? Any top performers that contributed to the success of last year’s material creation, review, and submission activities? If you did not have a chance to do a lessons learned session, take some time to reflect this week. This way, you can set expectations with your team and colleagues.
Identify greatest risks and rewards in sales and marketing activities, and take proactive steps to correct. We all understand the obligation to conduct a risk assessment. As Carrie Barker-Settles told an engaged audience at this year’s Gorman Health Group Forum, it is important to understand both the risks and rewards of each sales channel. Did your organization have an upswing in marketing misrepresentation complaints? What sort of turnover did the prospective member call center experience over the past year? Ongoing review of potential risks of non-compliance and fraud, waste, and abuse is necessary to help drive continued customization to monitoring and auditing plans.
Develop training tools and checklists. If these are not in place already at your organization, these resources are integral to helping marketing and sales stay in between the lines.

Does this quick hit list warrant additional discussion within your team? If you are doing the above already, fantastic! As a good friend so alliteratively once told me, proper prior planning prevents poor performance. That said, are you inundated with the day-to-day of CMS requests, six+ hours of meetings a day, and little time to catch up on what new guidance was released? Do you need temporary help during the material review season? At anytime of the year when things go wrong, we often see it become an “us vs. them” situation between Operations and Compliance; it’s demoralizing and unproductive, and we don’t like to see anyone in that situation.

Contact me directly at rpennypacker@ghgadvisors.com for more information on how we can help.

Resources:

New Webinar! Join us on Tuesday, June 20, from 1-2 pm ET, for a webinar on best practices for agent onboarding and oversight, compliant and efficient solutions to onboard and certify agents for the 2018 selling season and more! Register now >>

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by GHG Advisors