By the time you are reading this, we will have submitted our last official comment letter of the year to CMS – a feeling that is akin to completing your last exam before summer. There will be more off-cycle communications between ASBMT and CMS, but those will be driven by a different, more internally controlled process. For those of you that submitted comments during this busy year – THANK YOU! Those efforts can seem pointless – like sending a postcard into the void – but they really do add up and matter. We have a host of information to share with you this month, so I won’t drag this out further. As always, please contact me with any concerns about policy issues we are not currently addressing.
ASBMT Comments on Proposed Physician Fee Schedule
The deadline for comment on the proposed Medicare Physician Fee Schedule (MPFS) for 2019 closed on September 10, 2018, and CMS received over 15,000 comments. ASBMT submitted a letter in response to the proposal, which can be found here. Our response addresses the proposed changes to payments for “communication technology-based services” (telehealth) as well as the Centers’ plan to collapse the coding levels for Evaluation & Management Services. ASBMT worked closely with representatives of other specialty providers in developing coalition responses to the proposal as well, and our efforts are detailed below.
ASBMT Comments on Proposed Outpatient Payment Rule
The deadline for comment on the proposed Medicare Outpatient Prospective Payment System (OPPS) for 2019 closed on September 24, 2018. ASBMT also issued a detailed comment in response to this proposal, which can be found here. Our response specifically addresses the status indicators assigned to the new CPT codes for CAR-T therapy; the lack of APC payment rates for these codes has been a significant concern for ASBMT and our clinicians. ASBMT staff will work to keep members updated as to any new developments, and the final OPPS rule is expected in late November.
E/M Coalition
As discussed in our August newsletter, CMS proposed significant modifications to the codes billed for office visits – Evaluation & Management (E/M) codes – for CY19. The general concept is replacing five levels of E/M coding (all with different levels of RVUs/payments assigned) to two, in conjunction with a reduction in the documentation required to bill these visits. ASBMT has been concerned with the proposal’s implications for compensation for high-intensity clinicians, and has joined with approximately 40 other societies to form the Patient-Centered Evaluation & Management Services Coalition. The Coalition has worked over the past two months to develop and present a united response to the proposal, and issued a combined letter to CMS as well as to congressional leadership to voice the community’s concerns. The Coalition’s letter to CMS can be found here.
ASBMT will closely monitor any additional changes to the proposal over the next few months, as the final rule is expected in late November, and relate any updates to the ASBMT membership.
ASBMT Meets with CMS Administrator Verma
On August 30, ASBMT met with Seema Verma, Administrator for CMS, to discuss the issue of Medicare payment levels for inpatient administration of CAR-T therapy. Dr. John DiPersio (ASBMT President), Dr. Navneet Majhail (ASBMT President-Elect), Andre Williams (ASBMT Executive Director) attended the meeting along with Stephanie Farnia (ASBMT Director of Health Policy). The ASBMT team discussed the ongoing National Coverage Analysis for CAR-T, the importance of utilizing site-neutral payments, and the role of ASBMT as an expert resource for cellular therapy.
Presentations on ICD-10 Procedure Codes and Coverage Hacks for Cellular Therapy
This month, Stephanie delivered two presentations potentially of use to ASBMT members.
As discussed in previous newsletters, ASBMT has been pursuing a request for a new ICD-10 Procedure code for T-Cell Depleted Hematopoietic Stem Cell Transplants. To learn more about our proposal and the background of the procedure, click here.
At the Fall Clinical Education Conference in Nashville, TN, Stephanie provided a primer for coverage of cellular therapies, and an overview of some new developments for HCT, CAR-T, and other coverages in Medicare. To view the presentation slides, click here.
Senate Approves Opioid Package
On September 17, the Senate overwhelmingly passed the chamber’s long-gestating package aimed at addressing the opioid epidemic. Following an effort by both chambers to bring the House and Senate bills closer together, congressional leaders announced a conference agreement September 25th. The bill is expected to pass formal votes in each chamber easily, and the package will be sent to the White House for approval. Of note, the conference agreement includes a provision to lift the “IMD exclusion,” which prohibits Medicare from making payments to treatment facilities with more than 16 beds, but does not include language to fix the Medicare Part D “donut hole,” which the pharmaceutical industry lobbied for heavily. Additionally, changes to 42 CFR Part 2, the privacy protections for individuals with substance use disorders that some argue prevent medical information from being shared with care providers, were not included in the final bill. The package does include language supporting the development of non-addictive painkillers, limiting opioid prescription packaging, and cracking down on shipments of illegal drugs such as fentanyl through the mail.
To read the full text of the conference package, click here.
Senate Passes Bipartisan Gag Clause Legislation
On September 7, the Senate unanimously passed S. 2553, the Know the Lowest Price Act. The bill would prevent health-benefits plans and pharmacy benefit managers (PBMs) who participate in Medicare or Medicare Advantage from including “gag clauses” in their contracts with pharmacies. Currently, plans are allowed to prohibit pharmacies from informing their customers that they could save money by purchasing certain drugs out-of-pocket rather than through their insurance plan. To read a statement on the bill’s passage from sponsor Debbie Stabenow (MI), click here. On September 17, the Senate passed S. 2554, the Patient Right to Know Drug Prices Act, which would ban gag clauses for exchange and employer-sponsored health plans after defeating an amendment seeking to limit the restrictions to self-insured plans. Both bills were approved by voice vote in the House September 25th, and they are expected to be signed by the White House shortly.
Congress Releases Agreement on Labor, Defense, HHS Funding
On September 13, congressional leaders announced an agreement on a funding package to provide appropriations for the Departments of Defense, Labor, Education, and Health & Human Services (HHS). The “minibus” package comes after a conference committee from both the House and Senate met to develop a compromise between the two chambers’ packages. The Senate voted overwhelmingly (93-7) to approve the conference report on September 17, and will send the bill back to the House for final approval before going to the White House for a signature. In addition to the full appropriations for the agencies listed above, the package includes stopgap funding for the rest of the government through December 7, which would avoid a partial shutdown of agencies by October 1.
The bill includes a total of $90.5 billion for HHS, including $39.1 billion for the National Institutes of Health (with increases for various research initiatives including the Cancer Moonshot, All of Us, and the Kids First pediatric cancer research venture), $7.9 billion for the Centers for Disease Control & Prevention (CDC), and $338 million for the Agency for Healthcare Research & Quality (AHRQ). The bill left out a Senate provision requiring drug companies to disclose prices in their advertisements.
An official summary of the bill’s provisions can be found here.
Energy & Commerce Leaders Examine PBM Impact on Drug Pricing
On August 30, leaders from the House Energy & Commerce committee sent letters to seven leading pharmacy benefit managers (PBMs) seeking to better understand the role of PBMs in the drug supply chain and their impact on pricing. Full committee chairman Greg Walden (OR), Health Subcommittee chairman Michael Burgess (TX), and Oversight and Investigations Subcommittee chairman Gregg Harper (MS) signed the letters that went out to CVS, EnvisionRXOptions, ExpressScripts, Humana, Prime Therapeutics, ProCare, and United Health. The effort comes as part of the ongoing effort by Congress and the administration to address drug prices nationwide, further outlined below. The letters to the PBMs can be found here.
House Passes Bipartisan Health Bills
On September 12, the House unanimously passed four healthcare bills sponsored by members of the Ways & Means Committee.
- H.R. 6662, the Empowering Seniors’ Enrollment Decision Act of 2018, extends a special enrollment period for enrollees in certain Medicare Cost plans that are not transitioning into qualifying Medicare Advantage plans.
- H.R. 3635, the Local Coverage Determination Clarification Act of 2018, would revise the process for Medicare administrative contractors (MACs) to issue and reconsider local coverage determinations (LCDs).
- H.R. 6561, the Comprehensive Care for Seniors Act of 2018, would require CMS to issue a final rule on Programs of All-Inclusive Care for the Elderly (PACE) by the end of 2018. PACE is a program through which Medicare and Medicaid provide in-home and community services for elderly beneficiaries as an alternative to nursing home care.
- H.R. 6690, the Fighting Fraud to Protect Care for Seniors Act of 2018, would direct CMS to create a pilot program exploring smart card technology for Medicare beneficiaries, suppliers, and providers to combat fraud in the program.
To read Ways & Means Chairman Kevin Brady’s press release on the passage of the bills, click here.
CMS Announces Indication-Based Formulary Design Policy for CY 2020
On August 29, CMS announced a change in the requirements for Medicare Part D plans and their drug formularies. Currently, if a plan includes coverage for a specific drug, the drug must be covered for all FDA-recognized use (indication) of that drug. The new policy would allow plans increased flexibility in covering drugs for specific indications only. CMS argues that the change will allow more flexibility for Part D plans to negotiate lower drug prices beginning in 2020. The full memo to Part D plans can be found here.
MedPAC Holds September Meeting on Post-Acute Care, Quality Reporting, and Payment Policy
On September 6 and 7, the Medicare Payment Advisory Committee (MedPAC) held a public meeting focusing on post-acute care (PAC) providers. The commission approved of a two-tiered framework for PAC providers, which would institute common requirements for home health agencies (HHAs) and institutions, and a second set of additional requirements for institutional settings. Additionally, the framework would implement secondary requirements based on condition, rather than setting. For more details about the September meeting, click here. MedPAC will hold its next meeting October 4 and 5 and expects to discuss PAC quality.
CMS Issues Proposal to Streamline Medicare Compliance Requirements
On September 17, CMS released a new proposed rule overhauling some Medicare regulations identified by the agency as “unnecessary, obsolete, or excessively burdensome on health care providers and suppliers.” The proposal comes as part of the agency’s “Patients Over Paperwork” initiative, and is estimated to save $1.12 billion per year for providers. Regulations targeted in the proposal include a duplicative requirement on “re-approval” submissions for transplant programs, outpatient and ASC requirements for physical assessments and medical histories, Critical Access Hospital ownership disclosures requirements, streamlining the process for ordering portable X-ray machines, and a proposal to allow multi-hospital systems to unify and integrate their quality assessment and improvement programs.
To read the proposed rule, click here. Public comments will be accepted until November 20, 2018.
HHS Issues 100-Day Update on Administration Drug Pricing Blueprint
On May 11, Health and Human Services (HHS) Secretary Alex Azar released the American Patients First drug pricing blueprint, outlining the administration’s priorities on addressing pharmaceutical prices for American consumers. On August 20, HHS released an update on the first hundred days of action on the blueprint. The update cited efforts to lower out-of-pocket costs, increase competition, improve negotiation, and incentivize lower list prices, and can be read in full here.
ICYMI
Novartis CAR-T Therapy Snags UK Coverage, Cutting List Price 23% from US – HealthCareDive reports on the newly announced agreement for Britain’s National Health Service to cover the Kymriah drug.
Can Paying for a Health Problem as a Whole, Not Piece by Piece, Save Medicare Money? – The Upshot examines the rise of bundled payments programs within Medicare and analyzes new data on their effectiveness.
Podcast: Health Policy Goes to Court – Kaiser Health News’ “What the Health?” podcast runs through the various legal challenges involving the Affordable Care Act and the Supreme Court nomination’s impact on health care.