The government is focusing on opioids.  Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials.  It is also a major piece of the health care legislation moving in both the House and the Senate.

In the Senate, the Judiciary Committee advanced five bills relating to the opioid crisis, and the HELP Committee advanced the “Opioid Crisis Response Act of 2018,” which has over 40 measures relating to opioids. Most recently (6/12), the Senate Finance Committee unanimously approved the Helping To End Addiction And Lessen (HEAL) Substance Use Disorders Act Of 2018.  That Act includes the expansion of the Physician Payment Sunshine Act to include payments to mid-level providers, as we previously blogged about here.  Click here for a summary of all Senate bills.

On the House side, over the last two weeks, the House passed over 50 bills to combat the opioid crisis and have received bipartisan support. Additional opioid related bills have been introduced and passed out of committee. On June 20, the House voted and passed three additional opioid bills (HR 5925, HR 9797, and HR 6082). Two of these bills were considered controversial. H.R. 5797, The IMD CARE Act, repeals the Medicaid IMD exclusion for individuals with opioid use disorders. H.R. 6082, The Overdose Prevention and Patient Safety Act, amends 42 CFR Part 2 confidentiality protections pertaining to substance use disorder patient records.  Continue Reading Opioids Have Our Attention

As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time, so there is a lot of information for Medicare Advantage organizations and Part D plan sponsors to absorb. One major topic area that CMS focuses on in these documents is the prevention of opioid misuse and abuse.

As you know, we have been following this topic closely in the last few months: first, we discussed how the proposed rules set out a framework for plan sponsors to monitor and reduce the potential misuse of frequently abused prescription drugs. We then discussed the Advance Notice and Call Letter outlining utilization review controls for Part D plans to use to address opioid misuse and abuse.

The Final Rules and 2019 Call Letter work together to establish a number of new policies aimed at helping Medicare plan sponsors prevent and combat prescription opioid overuse. There is significant discussion, including CMS’s response to commenters, in the final documents linked above. Here, we provide a high-level overview of the new policies.

Continue Reading CMS Continues to Focus Medicare Plans on Preventing Opioid Abuse

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D  Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. (Those interested in a high-level overview of the Proposed Rules should see our post from last month). Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the Federal Register on November 28, 2017.

The proposed rule focuses on many issues including but not limited to:

  • Implementing certain parts of the Comprehensive Addiction and Recovery Act of 2016, aimed at establishing additional methods that Part D plans can use to reduce abuse or misuse of frequently abused drugs;
  • Changes to certain Medicare Advantage provisions relating to marketing and delivery of information;
  • Establishing “preclusion lists” under Medicare Advantage and Part D to limit when a Medicare Advantage organization and Part D plan sponsor may pay for a service or drug based on the provider who prescribed or furnished the service or drug;
  • Part D Network requirements relating to any willing provider, including defining mail-order pharmacy;
  • Part D beneficiaries’ access to generic drugs and follow-on biological products;
  • Changes to medical loss ratio calculation and reporting; and
  • Updates to the Medicare Advantage and Part D Star Rating System.

Within the proposed rule, CMS also included a request for information regarding the application of manufacturer rebates and pharmacy price concessions to drug prices at the point of sale. CMS has been gathering information regarding this topic for a number of years but appears to be seeking more detailed information in this request.

In the coming weeks we will be issuing detailed posts on these topics as well as others.

Based on the significance and number of the changes proposed, we anticipate that CMS will receive many comments from all segments of industry and beneficiary groups that may be affected by the proposed changes.  Comments are due to CMS before 5:00 pm on January 16, 2018.

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Advantage and Part D Advance Notice and Draft Call Letter (“Draft Call Letter”).  For the majority of the letter’s provisions, CMS is proposing to continue its current course of action and is refraining from introducing new policies.  With that said, however, CMS is proposing several notable updates, including updates to the use of encounter data for risk adjustment and the 2018 Star Ratings.  This blog is to highlight some key provisions and changes as MA and Part D plans prepare and finalize comments.

Continue Reading CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies

Last week, the OIG posted its Work Plan for 2017.  In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service, TANF and Head Start.  Below are some of the OIG’s action items that Medicare Advantage and Part D plans should be aware of.  As in years past, most of the OIG’s goals relating to the Medicare program focus on whether CMS is properly administering and monitoring the programs. Although the OIG often targets CMS, this focus can result in increased OIG and CMS scrutiny for plans and plans’ first tier, downstream, and related entities. Continue Reading 2017 OIG Work Plan: For Medicare Plans

CMS issued its Audit Protocols and Data Requests for Medicare Advantage and Part D plans on November 4, 2016 (the “Protocols”).  The Protocols have been updated based on the over 500 comments CMS received in response to the draft released in June.  The Protocols are open for comments until December 5, 2016.

A review of the crosswalk detailing the changes made to 2016’s Audit Protocols and Data Requests shows that CMS largely retained the same elements as in years past and made a few notable changes.

  • CMS is no longer asking for “self-identified issues.”  Self-identified issues were issues that had been discovered by the plan but not reported to CMS prior to the audit.  Practically speaking, this now means that plans only receive “credit” for reporting issues to CMS, whereas previously plans received some favorable treatment for reporting self-identified issues through the audit.
  • CMS added language to provide plans more instruction regarding what documentation and detail expected for tracer cases.
  • The Protocols added more emphasis on fraud, waste, and abuse policies and operations as applied to a plan’s first tier, downstream and related entities (“FDR”).
  • The Protocols asked plans in multiple areas to identify whether they classify actions as compliance or FWA.
  • CMS modified (edited, deleted, and added) many questions that appear in the Protocols questionnaires.  Some changes include:
    • Providing more detail to plans about what should be produced when conducting a formal audit under the plan’s compliance program.
    • Asking for examples of issues the plan had to deal with that involved an FDR and impacted a significant number of enrollees.
    • Asking for an example of when communicating compliance issues to the senior management/governing body was challenging.
    • Asking for a plan to share best practices.

All plans should carefully review the Protocols, consider how they would perform under the updated structure, and consider how they would update their internal audit and monitoring activities to reflect changes that CMS is considering.  As all plans know, undergoing a CMS audit requires an enormous amount of time and resources and CMS’s audit findings can greatly impact plans in many ways, including how a plan performs in the Star ratings system.

Last week, CMS released a Fact Sheet announcing that it is further delaying enforcement of the Medicare Part D Prescriber Enrollment Requirements, with full enforcement to begin on January 1, 2019.  Under the Medicare Part D Prescriber Requirements, Medicare Advantage and Part D plans must deny coverage of drugs prescribed by providers who are not enrolled in Medicare or who have not validly opted out of Medicare (except under limited circumstances).  This represents the third delay since the requirements were finalized.

In an HPMS memo addressed to Part D Sponsors, CMS stated that this delay is in recognition of the need to minimize disruption to beneficiaries and to ensure that they have continued access to the care they need.  It also provides Part D sponsors, their pharmacy benefit managers, and Medicare Advantage plans “sufficient time” to finalize system enhancements necessary to comply with these requirements.  Continue Reading CMS Delays Enforcement of Part D Prescriber Enrollment Requirements

As reported in yesterday’s Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of brand-name drugs. The Globe article relates to a ProPublica analysis of physician prescribing patterns and payments from the pharmaceutical industry. To perform the analysis, ProPublica researchers tapped into two important sources of information about prescribers collected nationwide: information on payments received by physicians from pharmaceutical and device manufacturers (available through the Open Payments website) and Medicare Part D prescribing data. The analysis was limited to data from both sources for 2013 and 2014 (with only limited data available from Open Payments for 2013). Continue Reading Drug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier

Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs.  With the final 2017 Call Letter to be released April 4, 2015, CMS is providing interested stakeholders until this Friday, March 4th to provide comments.

The 2017 Call Letter proposes a variety of updates to the program, many that are designed to improve the accuracy of payments to plans serving beneficiaries dually eligible for Medicare and Medicaid (“dual eligibles”).  Of note, CMS proposes updates to the risk adjustment model used to calculate payments to MA plans and to the Star Rating system used to evaluate plan performance.  CMS stated that these proposed changes reflect the public comments received when it shared research findings on the accuracy of the CMS-HCC model for paying dual eligible beneficiaries and the impact of socioeconomic factors on the Star Ratings and solicited input.  A few of the interesting 2017 proposals include: Continue Reading CMS Releases 2017 Advance Notice and Draft Call Letter