You Don’t Need to Drink the Sea: 2021 Program Audit Protocols 30-day Comment

On June 4, 2020, the Centers for Medicare & Medicaid Services released 95 ever-loving pages of industry comments received for the draft 2021 Program Audit protocol. The document includes their responses and actions taken, including what edits they have made to the 60-day package released a few months ago. In my opinion, there is a general feeling of streamlining and simplification to focus on the agency’s areas of priority. 

As I was pulling out clarifications that I am unsure will end up in any FAQ, methodology, or audit process document, I realized the entire responses document should have a proper place on the shelf along with the finalized protocols. Why? Because not all clarifications provided resulted in changes to instructions or data request information. This document can be helpful in communicating expectations to employees and first tier entities alike. 

While it seems like a lot to digest, there was no sign of eliminating an entire review area, or creating a new care delivery branch of review, which is the current focus at the moment due to the public health emergency. If you reviewed the 60-day package thoroughly, the 74-page crosswalk posted with the 30-day package could be your best friend. Therefore, take the comments, hold a meeting, divide and conquer to make sure your business partners and colleagues understand the changes. Comments on this collection must be received by July 6, 2020.

PRA Listing: 2021 ANOCs and EOCs and Network Adequacy

Over the past month or so, we’ve seen a number of items posted in the Paperwork Reduction Act, or PRA, listing. Today I’m focusing on a couple and provide some thoughts.  

On April 6, the Centers for Medicare & Medicaid Services (CMS) posted the Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) models along with their summary of changes based on the 60-day Federal Register public comments. The supporting statement packaged with the ANOCs outlined the standard information, including estimates of labor burden. The agency estimates 732 Medicare Advantage (MA) Organizations and 63 Part D sponsor contracts will be responsible for producing ANOCs and EOCs. Hours and wage estimates and total burden of hours are also included. They estimate it will take an average of 12 hours to develop and submit the required information to CMS. This estimate has to include different factors, such as number of plan benefit packages a sponsor has, and the fact that ANOCs are much smaller than EOCs. They again anticipate the average EOC will be 238 pages. 

In recent years, these documents have been posted as final, but are followed by supplemental memoranda with additional corrections. If you notice anything substantively amiss in these documents, alert the agency now, as it may save you time and corrections later. 

Also, on April 6, CMS posted CMS-10636 regarding the triennial network adequacy review. CMS reviews MA provider networks on a 3-year cycle, unless there is an event that triggers an intermediate full network review. According to the agency, when selecting contracts for the triennial review period, they will pull a random sample from the list of active contracts, including contracts that have never undergone a full network review and other active contracts, regardless of when the contract’s last full network review occurred in the Health Plan Management System (HPMS). CMS will review all contracts that have never undergone a full network review in HPMS. In the posted package, CMS removed some references to procedural changes, and they note there are no changes to network adequacy requirements. 

This will be an interesting one to follow, looking at the numbers. As part of the network reviews, they expect to review 140 of an estimated 633 contracts in the first year of the triennial review cycle. Keep in mind, between June 2018 and June 2019, CMS performed full network reviews on 438 of the active contracts at that time. 

Another interesting factor is that CMS has proposed in CMS-4190-P to codify network adequacy methodology for MA plans, including proposing to reduce the required percentage of beneficiaries that must reside within the maximum time and distance standards from 90% to 85%. It is unclear if CMS has data showing if this slight adjustment would help sponsors meet the adequacy requirements, as each rural area tells its own story. We shall see if this provision is finalized.

Compliance is the Conscience

I’ve been struggling to consider what might be helpful, applicable information to apply during this health crisis. The questions abound: Should we still do credentialing? Do I need to send written appeal responses? When will program audits start up again? How long do waivers last?

After weeks of reading updates, guidance, the new law signed on Friday, and emails from just about every retail store I’ve patronized, I’ve returned to the foundation to offer advice for my buried audience. It is the first principle as outlined in the Code of Ethics for Health Care Compliance Professionals published by the Health Care Compliance Association

Principle I, Obligations to the Public: “Health care compliance professionals should embrace the spirit and the letter of the law governing their employing organization’s conduct and exemplify the highest ethical standards in their conduct in order to contribute to the public good.”

It is incredibly difficult for even the most astute to read through the CMS Current Emergencies guidance. Who is keeping track of the changes and business decisions your organization and vendors are considering? As CMS said on a recent industry call for PACE and states, they understand the desire for everyone to get more guidance for every specific scenario, but this is a rapidly evolving circumstance. The bottom line: you need to evaluate how to meet your obligations with consideration to health and safety needs. 

The compliance officer is the conscience of the organization. And right now, public health is paramount like I’ve never seen, and like our parents have never seen. Therefore, when reviewing memos, waivers, and fact sheets, please let your obligations to the public, now more than ever, drive your decision-making. The public includes not only your members, but also your employees, contractors, and your surrounding community. Document any modifications and rationale with start and end dates. This is not the time to stop the presses: CMS reminded us on March 10 that business continuity plan requirements are codified. This is the time to get creative. 

2021 CMS Application Season: 133 Days

Now that October first is behind us, and everyone has had time to evaluate all the new benefits being offered for 2020 (Just kidding – reviewing what’s out there is an enormous task!), it is time to think about the 2021 plan year.  There is no rest in the field of Medicare Advantage and Part D.

Some folks have already started with their 2021 application and expansion planning. Network providers might be in negotiations, state licensure filings are being drafted, and perhaps organizations are conducting feasibility studies to determine how to put their best foot forward in this market.

Other organizations might be taking a more cautious approach, and perhaps may not have gotten the head start that others have. If this sounds familiar, don’t worry, this is pretty common, but it’s time to make some decisions.

CMS has released the draft applications for both Medicare Advantage and Part D for industry comment. There were no major changes, but drafts are always worth a look as this is your opportunity to give the agency valuable feedback.

If you have not submitted a new application or a service area expansion request in a while, it is important to understand how the process has evolved. Document requests have changed, time frames may be different, and the CMS review process can be a challenge if you do not know what to expect. If you have never submitted an application, be assured that the agency releases templates, instructions, and training. However, not everything is straightforward, and I say this having worked with many experienced plans who on an annual basis still struggle to understand the requirements or the review process.

Review the applications and if you have questions about the process or the requirements, start working them out now. You have 133 days until applications are due on February 12.

CMS Scales Back 2020 Program Audit Changes

With current program audit protocols set to expire on April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) have decided to scale back the sweeping proposed changes published in 2018, as reflected in their recent notice posted on August 16.

According to CMS’ supporting statement, over 700 comments were received by the agency in response to the proposed changes, which covered not only program audit protocol but also timeliness monitoring data requests. It was acknowledged most commenters supported the goal to simplify data collection for audits, but many were concerned about the time needed to reprogram systems to accommodate the changes.

CMS has had the authority to extend the current documents, which is how the agency is proceeding, with some minor updates. The package including supporting statement may be reviewed here.

Updates: Timeliness Test tables in Coverage Determinations, Appeals and Grievances (CDAG) and Organization Determinations, Appeals and Grievances (ODAG) regulatory references; increase of grievance samples from 10 to 20; edits to Compliance Program Effectiveness (CPE) questionnaires, and various table edits affecting each program audit data request tool.

Removed: Medication Therapy Management (MTM) materials (protocol suspended); CPE self-assessment questionnaire; CDAG questionnaire; ODAG questionnaire (reducing duplication and burden); CDAG Tables 9, 10, and 16, addressing Standard IRE Auto-forwarded Coverage Determinations and Redeterminations, Expedited IRE Auto-forwarded Coverage Determinations and Redeterminations, and Part D Call Logs, respectively; ODAG Table 14, Part C Call Logs; Website Review of Formulary Administration protocol; Enrollment Verification of the Special Needs Plan Model of Care protocol.

For the organizations responsible for supporting Medicare Advantage and Part D functions subject to program audits, the scaling back of revisions should be a welcome change, as it reduces the amount of re-programming to be done. One of the most impactful initial proposals was to consolidate certain CDAG and ODAG universes. On the other hand, while CMS had proposed to eliminate the impact analysis (IA) excel documents and instead leverage universe record layouts for requesting data, the IA documents remain.

CMS’ next step is to publish a new data collection request under a separate Office of Management and Budget (OMB) control number. Expect this request to reflect recent regulatory changes (think of the new appeals chapter), the simplification of tools, and to allow for more time to implement system changes.

Comments from the public are due October 15, 2019.