On September 27, 2019 ASTCT submitted its comments to CMS on the CY2020 Hospital Outpatient Prospective Payment System Proposed Rule. The proposed rule was released on July 29, 2019. The proposed rule follows the directives from the Presidential Executive Order (EO) entitled “Improving Price and Quality Transparency in American Healthcare to Put Patients First.” According to CMS’ press release the EO, “lay[s] the foundation for a patient-driven healthcare system by making prices for items and services provided by all hospitals in the United States more transparent for patients so that they can be more informed about what they might pay for hospital items and services.”
In our response, ASTCT addressed the proposals most important to our membership. ASTCT made suggestions to the Agency regarding the status indicator assignment requests for Category III CPT Codes for CAR-T hospital services. In last month’s Policy Perspectives, we described ASTCT’s engagement with the Hospital Outpatient Payment (HOP) Advisory Panel at their annual meeting. ASTCT presented the Society’s request to the panel to have the status indicator of the CPT III Codes reassigned from status indicator “B” to a status indicator “Q1” to at least make these services eligible for payment. The new CAR-T CPT codes have been in use since January 1 of this year, and the ASTCT continues to receive questions about these codes from our members when it concerns billing Medicare. The crux of the issue is that hospitals are performing services for Medicare patients—collecting patient’s cells, and then preparing, thawing, and handling the cells—without receiving compensation for these services from neither Medicare, nor from manufacturers. When this finding was presented to the HOP Advisory Panel, the panel agreed with the Society’s request and the panel made the recommendation to CMS. ASTCT’s comment letter reiterated the issue again to CMS.
The CY2020 OPPS comment letter to Administrator Verma also looked at the development of a Comprehensive APC for autologous stem cell transplant. ASTCT noted that as we stated last year, we consider the creation of an autologous HCT comprehensive APC to be consistent with CMS’ creation of the C-APC code 5244 for outpatient allogeneic HCT. Auto meets the general guidelines. ASTCT support NMDP’s efforts in raising this issue and we asked CMS to make the change.
The letter also addresses CMS’ proposal to revise the default level of supervision for physician assistants required for coverage of hospital outpatient therapeutic services from direct to general supervision for all hospitals. ASTCT supports this proposal and requested that it be finalized by the Agency.
The proposed rule also addresses price transparency issues and directive put forth in Executive Order (EO) 13877. ASTCT agrees that there is confusion in the healthcare market where transparency is concerned, however, we do not agree with the specific proposals put forth by CMS because we believe their proposals will not accomplish what they are setting out to do. Instead, ASTCT made alternative suggestions to the Agency that may work, such as, providing financial counseling to patients and having payers provide information about their negotiated rates directly to patients.
Other issues in ASTCT’s letter to the Agency address prior authorization, cost reporting, CDMs and related payment issues, and e-Visits. ASTCT’s final comment letter to CMS on the CY2020 OPPS proposed rule can be found on ASTCT’s website.
ASTCT’s PFS Comment Letter
ASTCT also submitted its comments to CMS on September 27, 2019 regarding the CY2020 Revisions to the payment policies under the Physician Fee Schedule. ASTCT’s letter to the agency can be found on our website at www.astct.org. Of note, ASTCT supported some the Agency’s efforts from the proposal. ASTCT supports CMS’ efforts to reduce the administrative burden and to improve the valuation of evaluation and management services for visits (payment for E/M visits). We appreciate the proposal to adopt the revised E/M code definitions and documentation requirements developed by the American Medical Association (AMA) CPT Editorial Panel and Relative Value Scale Update Committee (RUC) recommend values for these services in place of the single payment rate policy for level 2-4 services previously finalized.
We also support the use of extended service add-on code for every 15 minutes of care beyond 74 minutes for 99205 and 54 minutes for 99215 when providers choose to document by time. ASTCT believes this add-on service will be particularly helpful to our members when delivering care to bone marrow transplant patients who our members spend significant amounts of time in counseling and care management. We did not that while these values are a significant improvement, they still do not fully capture the complex care ASTCT members deliver to patients and further refinements may be needed in the coming years.
ASTCT’s comment letter also addressed the revisions CMS put forth for care management services. We agree that care management services have been underutilized and the Society supports the changes CMS proposes to increase utilization of these services. We do believe that CMS should consider additional ways to reduce documentation requirements in accordance with the Patient’s Over Paperwork Initiative.
CMS also has a proposal to adopt six new e-Visit services our members are already delivering the care described by these services. These additional services will reimbursement for currently uncompensated care and will reduce the burden on patients who in some circumstances may make additional trips to see their doctor to receive the type of care that can be delivered electronically. We thank CMS for recognizing the new CPT codes for e-Visits and we understand that CMS intends to create HCPCS Level II codes for e-Visits performed by clinical staff under the direction of the physician/non-physician practitioner in support of the patient.
Lastly, ASTCT urged CMS to finalize its proposal to provide the same relief for review and verification of medical documentation for non-physician practitioners authorized to deliver Part B service, including NPs, CNSs, CNMs, and PAs to alleviate some paperwork burden on clinicians. ASTCT will monitor the progress of these revisions as the come out of the Agency in the next few months.
Drug Pricing Legislation
Since Congress has returned from the August District Work period, there has been a lot of movement and discussions surrounding drug pricing. The Administration has made a strong push for drug pricing legislation to be passed in the 116th Congress. In May 2018, President Trump’s Administration laid out its Drug Pricing Blueprint, which put forth a number of different policy ideas on how to lower the cost of prescription medication. The suggestions included, drug importation, the International Pricing Index, value based purchasing and Medicare program redesign. With the end of the Congressional year quickly approaching, there is pressure from the Administration to get legislation passed.
On July 25, the Senate Finance Committee held a markup on S. 2543, The Prescription Drug Pricing Reduction ACT of 2019 (PDPRA) and passed the bill out of committee. The text of the bill can be found here. PDPRA aims to modernize and improve Medicare Parts B and D. The Congressional Budget Office (CBO) is still reviewing the bill, however, preliminary estimates suggest that taxpayers will save $85 billion in Medicare through the combination of the Part D redesign and the inflation-rebate policies that would save $85 billion over a 10 year period. Provisions in the bill include: improving manufacturers’ reporting of ASP to set accurate payment rates; inclusion of value coupons in determination of ASP under Part B; improvements to Medicare site-of-service transparency; Medicare Part B rebates by manufacturers; simplifying Part D’s program design and capping beneficiary out-of-pocket for high costs; increasing transparency into pharmacy benefit manager (PBM) practices and manufacturer drug pricing decisions; and eliminating excess Part B drug payments that drive up program costs. A section-by section breakdown of the Senate drug pricing bill can be found here. As of now, the Senate bill has only been passed out of committee and bipartisan bicameral negotiations, including the Administration, are currently taking place.
Speaker Pelosi’s drug pricing bill, H.R. 3, was introduced in the House on September 19, 2019. The House bill, Lower Drug Costs Now Act of 2019, aims to establish price negotiations in the Medicare program to protect from excessive price increases and to cap out-of-pocket maximum costs for Part D enrollees. Of note, the Pelosi bill also includes language about the International Pricing Index (IPI) model that was proposed by the Administration when it rolled out its drug pricing blueprint. The IPI model looks at prices for a list of certain in other countries and compares U.S. costs against those. The President was pleased to see this as part of the House bill, however, conservatives do not believe this inclusion is beneficial to lowering drug costs. H.R. 3 was referred to the Energy and Commerce committee who held a hearing on this legislation on September 25, 2019. Currently, there is no CBO score for this legislation, however, testimony from one of the witnesses, Benedic Ippolito, alleges that if the Medicare program would be able to negotiate prices then there would be no savings to the program, because the Agency will have no leverage unless they were to exclude a drug from a formulary. The bill was also reviewed by the House Education and Labor Committee in a hearing on September 26th. Both the House and Senate are working to find commonalities between the two pieces of legislation and we can expect ongoing negotiations to occur. ASTCT will continue to monitor the legislation as it moves through both chambers of congress.
Year End Expectations
As the end of the year draws near there are a few outstanding issues that Congress wishes to address prior to adjourning for the winter break. Two major issues are public health concerns: e-cigarettes and gun violence. Both of these issues effect the American people and there has been Congressional involvement in finding a solution. Senator Isakson introduced a piece of legislation that researches and prevents deadly acts of mass violence in the United States. S. 2554 requires the CDC to conduct research on mass violence; would authorize $75 million annually for five years to establish pilot projects focused on improving collection, completeness, and sharing of information in states participating in the National Death Reporting System. Additionally, over the upcoming Fall Recess, the Energy and Commerce Committee will be holding a field hearing on the public threat posed by gun violence in Chicago, IL. Over the past month there have been various hearings on gun violence. The Ways and Means Committee held a hearing on September 26, 2019 examining the public health consequences and costs of gun violence. On the same day, Homeland Security Committee held a hearing entitled, “Engaging the Community: Perspectives on School Security.” The House Judiciary Committee also held a hearing that looks at community responses to gun violence in our cities. We can expect to see further legislation being introduced that addresses these issues but it is yet to be determined whether or not there will be sweeping policy changes but in place by the Administration.
The other major health policy concern that Congress has been examining is the rising use of e-cigarettes among teenagers. The Energy and Commerce Committee held a hearing on September 25th entitled, “Sounding the Alarm: The Public Health Threats of E-Cigarettes.” One of the witnesses in attendance was Acting Commissioner of the FDA, Ned Sharpless. The hearing examined the rising use of vaping and e-cigarettes and the related lung injuries and reported deaths from these devices. Commissioner Sharpless discussed the Administration’s recent announcement to finalize a compliance policy (ENDS) that would prioritize enforcement against flavored products unless and until companies’ marketing has been shown to be appropriate for the protection of public health. The House Committee on Oversight and Reform also held a hearing looking at the outbreak of lung disease and CDC’s urgent warning not to use e-cigarettes. While it is not clear whether further legislation will be introduced on this topic, we can expect to see further engagement from the Administration and the FDA on ways to warn about the dangers of vaping products. ASTCT will monitor the latest. There are a number of other items that may be addressed by the end of the year, however, the aforementioned items are the most likely health policy changes we will see this year.
Bipartisan Policy Center Report—The BPC released its report on “Expanding the Use of Real-World Evidence in Regulatory and Value-Based Payment in Decision-Making for Drugs and Biologics.” The report looks at examining the data from popular digital health technologies (e.g. fitbits, biosensors, apps, etc.) to improve regulatory decision-making at the FDA to help bring safe and effective therapies more quickly to patients by improving the evidence base for evaluating medical products and value-based arrangements.
FDA Information for the Public—The FDA released its recommendations and warnings associated with the use of vaping and e-cigarette products.
JAMA Network Immunology Investigation Report—This paper looks at the long-term survival and cost effectiveness associated with axicabtagene ciloeucel vs chemotherapy for treatment of B-cell Lymphoma.
Deloitte’s Article on the Future of Healthcare—In an online article, Deloitte explains how innovation in science and the healthcare industry will cause massive disruption in the current healthcare system through data and delivery.
Alycia Maloney is ASTCT's Director of Government Relations.