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

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) seeks to address Part D drug prices. CMS proposes making certain changes that might lower drug costs (for Plan Sponsors and beneficiaries) and requests information regarding avenues to potentially lower Medicare beneficiaries’ point-of-sale drug costs. The three provisions in the Proposed Rule that most directly relate to drug pricing address: (1) generic drug formulary placement, (2) cost-sharing for follow-on biological products, and (3) whether and how to reduce point-of-sale drug prices based on manufacturer rebates and pharmacy price concessions that a Plan Sponsor might receive months after the beneficiary receives the drugs. We will concentrate on the first two provision in this post. The third provision, which is a request for information, will be discussed in a later post.  Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

Congress has its work cut out for itself between now and the end of the year. Between addressing the programs that constitute the Health Care Minibus, funding the government, and tax reform, there are also questions related to a market stabilization package (Alexander-Murray), the 340B program, the opioid epidemic, and another hurricane relief package. For the complete December preview, please click here.

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.

Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending. This score is significant as it marks the first time that CBO has concluded that providing enhanced Medicare coverage for telehealth services would be budget neutral and clears the path for Congress to pass the legislation in a tough political climate.  Continue Reading CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act

Patient assistance programs have been a staple within the health care industry for over a decade.  These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, copayments, deductibles, premiums, or other related services.   The Office of the Inspector General (OIG) and the Centers of Medicare & Medicare Services (CMS) have acknowledged the role of provider- and manufacturer-supported charitable premium assistance and have established parameters for these charities to operate in compliance with the Anti-Kickback Statute.

Over the last two years, however, government scrutiny and enforcement related to charitable patient assistance programs has increased.   During this time, nearly a dozen pharmaceutical manufacturers and providers have publicly disclosed receipt of government subpoenas investigating their contributions to patient assistance charities.

These new investigations raise a number of questions when it comes to structuring relationships with patient assistance programs.  On May 16th, we will be holding a webinar to review these current investigations and outline what providers, payors, pharmacy benefit managers (PBMs), and pharmacies working with manufacturers and patient assistance programs need to know in light of these investigations.

We hope you join us!  For more information and to register for this webinar, please click here.

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, CMS published the Revised Draft 2018 Medicare Marketing Guidelines and requested feedback from all interested parties.

The draft includes many small changes to the Marketing Guidelines, including but not limited to those in the following areas:

  • Multi-language inserts – CMS wants to defer to the more robust requirements established by Section 1557 of the Affordable Care Act
  • Non-English Language Disclaimer – Plan Sponsors will be required to include the non-English language disclaimer on ANOC/EOC, LIS Rider, Comprehensive or Abridged Formulary, Star Ratings, Summary of Benefits, Part D Transition Letters.
  • Use of Star Ratings – The draft includes multiple changes relating to how and when a Plan Sponsor can use its Star Ratings, including that CMS will provide a Gold Star icon each fall to 5 Star Plans that the Plans can use on their marketing material.  Plans may not create their own gold star icon.
  • Unsolicited Electronic Communication – Plan Sponsors will be required to include an opt-out process for enrollees and the draft instructs Plan Sponsors that an individual “liking” the Plan’s social media page does not constitute the individual agreeing to receive communications from the Plan Sponsor outside of the social media forum.
  • Provider Affiliation Announcements – Plan Sponsors and providers will be allowed to announce new or continuing affiliations only once an agreement between the parties has been approved and the draft clarifies that such announcements that describe plan benefits, premiums, or cost sharing are marketing materials and must be submitted to HPMS, and that the Plan Sponsor is responsible for ensuring that providers comply with the MMG distribution and mailing guidance for Provider-Based Activities.
  • Review of Materials in the Marketplace – Plan Sponsors are reminded that they must report to CMS all self-identified errors in all marketing materials.
  • Third-Party Websites – This is a new section, at 100.7.  The draft requires Plan Sponsors to submit third-party marketing websites to HPMS, even if there is no benefit information included on the third-party website.  CMS recognizes that website owners may work with multiple Plan Sponsors and recommends that the Plan Sponsors coordinate the multi-plan submission.  The section also lists activities that third-party websites are prohibited from doing.

CMS explains that it is interested in comments on all sections and changes, but is particularly interested in comments regarding changes to provider-affiliation announcements and the newly added section regarding third-party websites.   Comments on the draft are due to CMS by 5:00pm (ET) Friday, February 3, 2017 and may be submitted through CMS’s survey site.

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP). These amendments and updates to the AKS and CMP regulations attempt to clarify the OIG’s enforcement position in light of changes due to health reforms, to streamline the OIG’s advisory opinion workload, and to implement long-existing mandates enacted in statutes. This post discusses the amendments to the beneficiary inducement provisions of the CMP codified in 42 C.F.R. Part 1003 (CMP Regulations). Continue Reading At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

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