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 U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model. These models were mandatory for hospitals in certain geographic areas. The current administration had delayed the implementation of these models until January 1, 2018.   Continue Reading CMS Proposes to Cancel Bundled Payment and Incentive Models

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.  The DOS rules are important to laboratories and hospitals because they dictate which party must bill Medicare for certain laboratory testing performed on stored specimens collected during a hospital procedure but ordered after the patient has left the hospital.  If revisions are ultimately finalized, the proposal could have significant business implications for independent laboratories and hospitals.

Continue Reading CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government safety net programs share in 340B savings.”

I reasoned that CMS already knew that “Medicare pays more for 340B drugs than the covered entities’ acquisitions cost.”   Continue Reading Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.

The current policy requires all biosimilars that are related to a reference product to be given a shared Healthcare Common Procedure Coding System (HCPCS) code. For Medicare Part B, reimbursement is then calculated based on the average sales price (ASP) of all of the biosimilars with that HCPCS code plus 6% of their reference product’s ASP. Continue Reading CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

shutterstock_282978377Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies. That is the core finding of a report issued by the Government Accountability Office (GAO) this month on telehealth and remote patient monitoring use for Medicare beneficiaries.

The GAO report was issued as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which included a provision for the GAO to study telehealth and remote patient monitoring. In compiling the report, the GAO interviewed representatives of nine provider, patient, and payor associations who provided feedback on, among other things, barriers to providing telehealth services to Medicare beneficiaries. Continue Reading GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

The Stark Law has caused angst for many a physician and many a health care lawyer over the years. The Stark Law has also troubled hospital and health system CEOs looking for ways to align incentives with physicians. Some stakeholders say Congress should do away with the myriad statutes and regulations that comprise the strict liability federal law banning physician self-referral. Those stakeholders suggest either repealing it altogether and letting other fraud and abuse laws do the work, or – as its namesake former-Representative Pete Stark has suggested – replace it with a much simpler prohibition on soliciting referrals for kickbacks or other special treatment.

My colleague, Tom Crane, suggests another approach – revamp the Stark Law’s advisory opinion process so the Centers for Medicare and Medicaid Services (“CMS”) can protect arrangements from sanctions, similar to the Office of the Attorney General’s (“OIG’s)  Anti-Kickback Statute (“AKS”) advisory opinion process. Continue Reading Changes Needed to Stark Law Advisory Opinion Process

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

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.