CMS Enforcement: Recent CMP Notices

Like clockwork, the civil money penalty (CMP) notices issued as a result of 2019 Program Audits are out. CMPs are issued by the Centers for Medicare & Medicaid Services (CMS) when conditions of non-compliance adversely affect or have a substantial likelihood of adversely affecting enrollees. These conditions can be identified in Program Audits, through complaints to CMS, through self-disclosure, and through other means. This year, beneficiaries from Hawaii to Maine are enrolled in plans that received an enforcement notice from the Centers for Medicare & Medicaid Services. 

In 2019, CMS released a memo regarding the posted notices, indicating five parent organizations were issued CMPs for Program Audits at that time. This year’s memo notes six parent organizations were issued CMPs on February 28: five relative to 2019 Program Audits and one as for 2018 Program Audit results. Almost 19% of currently enrolled beneficiaries are in affected Medicare Advantage or Part D contracts in receipt of a CMP. Here is additional information by the numbers:

6 parent organizations issued CMP

82 affected contracts 

$1,190,370 total CMP dollars (ranging from $28,302 to $381,272)

9,435,133 members in affected contracts (February 2020)

Ask any conference presenter for their slide decks and there is bound to be a statistic or chart showing how quickly enrollment is growing in Medicare Advantage. According to the Congressional Budget Office, it is expected by 2029, 47% of all Medicare beneficiaries will be enrolled in the program. 

What to expect

While over the past few years, the agency has issued proposed rules and guidance to refine program administration, and President Trump has issued his Executive Order focused on protecting and improving Medicare, do not expect to rest on laurels when it comes to quality or adherence to regulations. Furthermore, expect continued oversight from the Medicare Parts C and D Oversight and Enforcement Group, or MOEG. In fact, the division is revising audit protocols and is seeking to memorialize the approach to increase minimum penalty amounts in regulation, consistent with the 3-year audit cycle. In addition, expect more to come regarding the 2019 audit results and the future of CMP methodology.

Medicare Pricing & Contracting Conference

This week, Informa Connect – CBI held their Medicare Pricing & Contracting conference in Alexandria. One of the best things about this conference was the variety of the speakers who shared different perspectives from pharma, think tanks, advocacy organizations, and pharmacy benefit managers. I shared some resonating sound bites on Twitter, but every speaker came very prepared with relevant, timely content.

Much of the discussion surrounded the future for Part D, with a number of redesign proposals on the table in Congress. We also heard about physician payment policy, including some 2021 changes in documentation requirements and increased payments for certain office/outpatient evaluation and management visits.

From the beneficiary perspective, we heard some statistics on Part D prescription use, income, and general savings. With unarguable growth of Medicare Advantage (MA), so grow the expenditures. Audience members were keen on understanding how to best control costs for long term stability.

We are in the dawn of benefit design which can impact social determinants of health, or SDOH. Factors such as physical environment, level of family support, diet and exercise, and availability of community offerings should all be considered by MA plans. How to pay for these items was another discussion in itself.

On a personal note, it was fantastic to learn from people representing different industries. I shared with attendees that joining the board of a federally-qualified health center gave me an appreciation and an education on how payer decisions and legislation affects a provider. Attending this conference which was geared heavily towards pharma was an equally beneficial learning experience, so I am looking forward to the next one.

Proposed Rule CMS-4190-P: Appeal Escalation

Today the Centers for Medicare & Medicaid Services (CMS) published their proposed rule CMS-4190-P. This post focuses on the automatic appeal escalation to external review for Medicare Part D drugs under the Drug Management Program, or DMP.

Background: Under DMPs, a plan engages in case management by contacting prescribers to determine whether a beneficiary is at-risk for misuse or abuse of frequently abused drugs. If a determination is made that the beneficiary is at-risk, the beneficiary is notified in writing and the plan may limit their access to coverage of opioids and/or benzodiazepines to a certain prescriber and/or certain pharmacies. (CMS is proposing to make DMPs mandatory effective January 1, 2022, noting the majority of Part D sponsors have already voluntarily implemented DMPs.)

CMS is also proposing to require the automatic forwarding of redeterminations of a DMP appeal to the independent review entity (IRE) responsible for conducting Part D reconsiderations (Part D level 2 appeals). Medicare Advantage plans have been familiar with the auto-forward requirement for years, as affirmed reconsiderations (Part C level 1 appeals) must be forwarded by the expiration of the adjudication timeframe. However, this process would be new for Part D-only plans such as standalone Prescription Drug Plans, or PDPs, as today only untimely decisions are auto-forwarded to the IRE.

What would this finalized provision mean for a beneficiary? For members who receive an affirmed denial of a DMP appeal, this means their appeal will automatically be forwarded to the IRE. Currently, other affirmed Part D redeterminations are not auto-forwarded. The appellant must make an additional request for an independent review. If this proposal moves forward, those who have been denied their medications due to a DMP decision will be guaranteed that “outside look” to either affirm or overturn the plan’s decision. This streamlines the steps the appellant has to take in this special circumstance. 

What would this finalized provision mean for a plan? If this moves forward, the plan will need to ensure procedures are changed and training is conducted, not only for the appeals department, but also for member services and the case management team working on the DMP decisions. It would be anticipated that member notices would change should this proposed rule become final. Plan and delegate parties to the process must understand how the member’s rights will change. 

Is the volume going to be high? CMS thinks not. The agency expects there will be approximately 28,600 appeals per year, of which 0.08 percent (or 23 cases) will be subject to this auto-forward. Based on this estimate, some plans might never process one of these appeals. However, even if one is received and denied, it is going to be important to auto-forward the case correctly and timely. CMS has been reviewing appeals in their program audit protocol for years, and if this provision is finalized, it could be anticipated DMP appeals may be targeted for sample selection to ensure adherence to the new rule. 

Looking Ahead: Proposed Rule, CBI Conference

CMS-4190-P is scheduled to be published on February 18, 2020. It is published for public inspection now, giving the industry an early start in reviewing and drafting comments prior to the April 6, 2020 submission deadline. There are 895 pages of proposed rulemaking, and although the Centers for Medicare & Medicaid Services (CMS) released a fact sheet about the rule, the summary is just the tip of the iceberg. There are other important aspects of the proposal meriting consideration, not only for operational impact but also beneficiary impact. Think Star Ratings, past performance evaluation, and supplemental benefit eligibility, criteria, and documentation. 

This month I will be speaking with John Wells and Scott Ptacek at the CBI Medicare Pricing and Contracting Congress. This proposed rule could not have come at a better time for presenters. Speakers include representatives of the U.S. Government Accountability Office, Milliman, and NORC at the University of Chicago. If you happen to be in the Alexandria, VA area at the end of the month, this should be an information-packed event, so please join us!

Also approaching is the CMS deadline for Medicare Advantage and Part D new applications and expansions. I wrote about the application process in October. CMS also released their annual calendar of key dates last week. 

For compliance professionals out there, February should be an intense month of reading, partnering with your operational areas, and though it seems unreal, planning for 2021 and 2022. This is especially important for those managing D-SNPs. As always, feel free to contact me to discuss any of these topics. 

2020 HCCA Managed Care Compliance Conference

I am just back from the Health Care Compliance Association’s annual managed care compliance conference, which was held from January 26-29. All presenters I heard were really prepared and delivered timely and valuable information. Here are some of my favorite points from the conference.

Data is now more valuable than oil as a resource.

Michael Gray, Eliza Jennings

One of my favorite sessions pertained to cyber threats and compliance challenges. Learning how ransomware is on the rise will help me educate clients on the importance of following their own internal security policies, and connecting with their Security Officer if they are unsure of the risks. Thieves appear to be getting more savvy in tailoring emails that you or your employees will tend to click. Another wise lesson for everyone pertained to credential theft. As people use the same passwords across different platforms, theft of credentials is common and can wreak havoc on your other accounts. Unique passwords, everyone!

Another fantastic session pertained to dual products and Medicare Medicaid Plans, and how to navigate state and federal oversight. Sponsors face a tough hurdle especially if they are multi-state plans, because if you know one Medicaid program, you know one Medicaid program. With continued push for integration, maintaining effective communication between you, the state and CMS is imperative.

Hallway chats and networking breaks are the best ways to connect with others to see what is on their minds. What’s on their minds today? 2021 draft program audit protocols; RADV audits; risk assessments, and doing more about fraud, waste and abuse. The common concern of those I talked to was staying on top of everything with expansion of business, increase in regulatory changes, and the constant stream of audits to which their organizations are subject. More than once was the phrase “Wild West” used to describe this current era of compliance management.

A number of sessions (including my own) addressed first tier entity, delegate or subcontractor oversight and relationships. Sponsors manage these relationships in a variety of ways, and with new partners entering the market to work with plans, establishing proper oversight is imperative now more than ever. Contact me if you would like to chat about my session, Compliance in the New Age of Supplemental Benefits, or any other aspects of the conference.