By Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC
On September 11, 2015, the National Comprehensive Cancer Network (NCCN) convened healthcare experts for a policy summit on “Value, Access, and Cost of Cancer Care.” ACCC policy staff was in attendance, along with a host of provider and patient organizations. The summit explored methods to achieve optimum cancer patient care while considering rising care costs, and NCCN’s work groups on Value, Access and Cost also reported their findings. Some key takeaways follow.
Views on Value
The discussion on value centered on appropriate measures for value from the patient, provider, and payer perspectives. Panelists generally agreed that a broader view of healthcare is necessary to assess value. This includes consideration of the continuum of care, rather than just a specific episode of care. The full cost burden of cancer care on patients must also be addressed, and may include employment, caregiver, and housing and transportation issues.
Panelists explored access issues, focusing on the growing demand for cancer care services and its impact on access. Health exchange plans were identified as a source of disparate care, in that enrollees choose plans based on cost and then, upon cancer diagnosis, are faced with inadequate provider networks and prescription drug coverage. The discussion also touched on recent legislation driving providers to value-based reimbursement, and projected impacts on patient access to academic cancer centers. For the employer-insured population, one panelist commented on a shift to contracts with specific hospitals for second opinion and potential treatment of specific malignancies.
Among potential methods for curbing costs, panelists cited caution in use of high-cost diagnostics, treatments and therapies; avoidance of hospitalizations and emergency room use; and increased emphasis on palliative and end-of-life care. The panel noted that savings in provider care costs are possible, particularly through increased care planning and patient navigator uptake.
In discussing the cost of anti-cancer therapies, panelists pointed out that oncology is unique in that there is currently maximum use of generics with little opportunity for shifting to lower-cost prescription drugs until the further introduction of biosimilars. While drug costs make up just 15% of cancer care costs, they represent the fastest rising cost in cancer care. The panel acknowledged the challenges to containing prescription drug costs, and noted that some pharmacy benefit managers (PBMs) are looking to employ an indication-based formula for drug pricing, reimbursing for drugs by value and differentiating claims by condition. In the context of biologics, greater approval and high usage rates of biosimilars will be important to cost containment in the coming years.
The policy team at ACCC will continue to engage in this discussion of rising cancer costs and challenges in patient access to care.
Continue the Conversation
Join ACCC in Portland, Oregon, Oct. 21-23, at the 32nd National Oncology Conference and continue the conversation in sessions that will explore issues of value, cost, and patient access to care including:
Patient Access and the Cost of Cancer Care Across Specialties
Peter B. Bach, MD, MAPP, Center for Health Policy and Outcomes,
Memorial Sloan Kettering Cancer Center
What Will It Take? Must-Haves for Alternative Payment Models
Erich Mounce, MSHA, The West Clinic, PC
Palliative Care Models: Solutions for Programs of All Sizes
Moderator: Michael Kolodziej, MD, FACP, Aetna; Amy J. Berman, BS, RN, The John A. Hartford Foundation;
Sibel Blau, MD, Northwest Medical Specialties; and Brad Smith, Aspire Health
The full conference agenda and registration information is available here.
By Leah Ralph, Manager, Provider Economics and Public Policy, ACCC
On September 8th, ACCC submitted comments on CMS’ proposed 2016 Physician Fee Schedule rule. This year, the proposed PFS was released later than usual and contained a number of provisions that ACCC will be watching closely in the coming months.
Read on for a quick roundup of major provisions and ACCC recommendations to CMS:
Radiation Oncology Cuts
CMS proposes several significant changes to payment for radiation oncology procedures that would collectively result in drastic cuts for radiation oncology providers – an estimated 3% for radiation oncology and 9% for freestanding radiation therapy centers. CMS is proposing payment rates for new CPT codes that would effectively reduce Medicare reimbursement for IMRT and other radiation treatment delivery services. The agency also proposes to remove several essential direct practice expense inputs from the new radiation treatment delivery codes, including the on-boarding imaging equipment that is essential to providing safe and accurate radiation treatment. Finally, CMS proposes to adjust the equipment utilization rate assumption for the linear accelerator used in image guidance from 50% of available time to 70% of available time over two years, reducing reimbursement for services that make use of that equipment.
In our comments, ACCC expressed significant concern to CMS that these deep, simultaneous cuts in radiation oncology reimbursement will have the effect of forcing some cancer care providers, particularly those operating in rural and underserved areas, to close their doors. ACCC urges CMS to take the necessary steps to mitigate this threat, for example, by not implementing the proposed increase in the equipment utilization rate. ACCC will be monitoring this closely and stands ready to work with CMS to find ways to implement any appropriate changes over a period sufficient to allow providers to absorb the changes while not compromising access to critical radiation oncology services.
CMS proposes a payment methodology for biosimilar products in which all biosimilars with the same reference product would be assigned a single HCPCS code and reimbursed based on the volume-weighted average sales price (ASP) for all products under the code plus 6% of the reference product’s ASP.
ACCC asks CMS not to finalize this proposal. We expressed concern that assigning multiple biosimilar products a single HCPCS code would create new and unnecessary administrative burdens for physicians and other providers when treating patients with biosimilar products, as they would not only need to enter the HCPCS code into the medical record, as they do now, but also the specific biosimilar therapy used for the patient. Additionally, this approach could significantly impede effective tracking of safety information and other information about the patient experience with specific biosimilar products—after these enter the market. We urge CMS to promote effective tracing of safety information and to minimize administrative burdens on providers who prescribe biosimilars.
Advance Care Planning
CMS proposes to establish payment rates for the two CPT codes adopted by the AMA CPT Editorial Panel to describe advance care planning services. ACCC strongly supports this proposal and asks that the payment rates for these services adequately reflect the cost to physicians of providing advance care planning.
As ACCC believes advance care planning services are equally important in the hospital outpatient setting, where they also take substantial time and resources and contribute significantly to the quality of patient care. In our comments to the proposed 2016 Outpatient Prospective Payment System rule, we urged CMS to pay separately for these two CPT codes in the outpatient setting as well.
Chronic Care Management
CMS recognizes that Medicare’s payment rates for the CPT codes for transitional care management (TCM) and chronic care management (CCM) do not fully account for the cognitive work that primary care physicians and other practitioners perform in managing and delivering care, particularly to chronically ill beneficiaries. CMS identifies add-on codes as one potential means of establishing payment rates that appropriately value the additional time and intensity of physicians’ cognitive work often involved in delivering care management services. ACCC encourages CMS to develop such codes, and to work with ACCC and other provider organizations to ensure that any new add-on codes are structured and valued appropriately.
ACCC also has concerns related to CMS’ proposal for chronic care management in the 2016 OPPS proposed rule. On the hospital outpatient side, CMS is proposing to permit only one hospital to bill for CCM services during a calendar month. ACCC points out to CMS that because cancer care is highly multidisciplinary, it can be difficult to agree upon who should be the designated CCM physician, and we are concerned that CMS’ rules for these services already make it very difficult for hospitals to seek payment for them. We urge CMS to continue to consult with hospitals and physicians on the best way to determine which entities should bill for these services.
“Incident To” Services
CMS proposes to require that the physician or other provider who bills for an “incident to” service must also be the physician or other provider who directly supervises the auxiliary personnel in providing that service. If CMS were to finalize this proposal, ACCC urges the agency to provide education to physicians and other providers on the revised requirement to ensure providers do not experience unwarranted disruption in billing for appropriate “incident to” services.
CMS is expected to finalize the 2016 Physician Fee Schedule rule in late October. Stay tuned, as ACCC will keep members updated as CMS revises and finalizes these important proposals.
On August 27, 2015, the Health Resources and Services Administration (HRSA) released the much-anticipated mega-guidance for the 340B Drug Pricing Program. The 340B program provides discounted outpatient drug pricing for specified safety-net healthcare organizations, known as covered entities. The guidance was long-requested by covered entities and drug manufacturers, both of whom seek clarity in definitions and various elements of the program. HRSA considered proposing a regulation last year, but determined it did not have rulemaking authority. Consequentially, it has now proposed guidance, which while not legally binding, does inform 340B program participants on how HRSA believes the program should operate. From the perspective of a healthcare provider seeking to avoid audit under the 340B program, HRSA’s guidance should be given significant weight.
Providers should note HRSA’s definitions of both a 340B patient and a covered entity. The guidance appears to narrow the definition of a patient, allowing 340B drug eligibility on a drug-by-drug basis, specific to the medical issue for which the patient is being treated as an outpatient at the covered entity. Previously, a covered entity could provide a patient with any necessary drugs under 340B pricing, regardless of the scope of treatment.
The guidance also proposes a new standard that a child site of a covered entity hospital must provide services with associated Medicare outpatient costs and charges, in addition to the current standard that the child site be listed on a reimbursable line of the covered entity’s Medicare cost report. HRSA also makes clear that a covered entity’s inclusion in a larger organization such as an accountable care organization, does not qualify the larger organization for the 340B program. Finally, HRSA requests feedback on ways to demonstrate eligibility of off-site facilities.
Also notable from the provider perspective is guidance related to audit processes. HRSA proposes a notice and hearing process for 340B audits by the agency. Covered entities found not to be in compliance may be subject to corrective action plans, and loss of eligibility in the 340B program. HRSA also tightens standards for manufacturer audits of covered entities, requiring “reasonable cause,” while failing to impose any requirement that the agency act upon manufacturer audit results.
ACCC will continue to review this 340B mega guidance leading up to the October 28, 2015 comment deadline, and welcomes member input and questions.
Earlier this summer, ASCO released its much anticipated “value framework,” a proposed methodology designed to assist physicians and patients in assessing the value of different cancer treatment options. Comments on the framework were due last week, and a variety of stakeholders – including providers, patient groups, and manufacturers – provided feedback on the model.
While most would agree the framework is not yet ready for the clinical setting, it represents an important step in the broader conversation about measuring value in cancer care. As a conceptual framework, it seems to have done its job. But as ASCO points out, it is critical to consider this tool in context. The methodology contains notable limitations in data, practicality, and scope, and payers and policymakers should be cautioned that this framework is not meant to serve as a basis for reimbursement or coverage determinations.
ASCO’s approach uses randomized clinical trial data to compare new treatments with an established standard of care under two different scenarios: the advanced disease setting and the adjuvant (potentially curable) setting. A treatment receives a net health benefit (NHB) score (up to 130 points for advanced and 100 points for adjuvant) by combining a score for clinical benefit (up to 80 points), toxicity (up to 20 points), and up to 30 bonus points for quality of life measures, including palliation of symptoms and treatment-free intervals in the advanced disease setting. The NHB score is intended to demonstrate the added benefit patients may receive from a new cancer drug compared with a current standard of care.
Under the proposed framework, the clinical benefit score gives most weight to therapies that increase overall survival, followed by progression-free survival, and response rate. ASCO chose these clinical endpoints because they represent data most commonly collected and reported in clinical trials. So, for example, when survival data is not available and/or only noncomparative trials have been preformed, as is often the case with breakthrough therapies, response rate will be used to determine the effectiveness of the drug until survival data becomes available.
The combined clinical benefit, toxicity, and bonus points make up the NHB score, which is then displayed next to (and, notably, separately from) cost. Here ASCO uses drug acquisition cost, and concedes that while this is not the most complete or meaningful measure, particularly for the patient, it was the most straightforward to quantify. Of course any methodology to truly determine value should include total cost of care, including estimated costs for diagnostics, surgery, imaging, hospitalization, and provider charges. Ultimately ASCO envisions including another figure, the cost to the patient, which will have to be individualized based on the patient’s specific health benefit design. ASCO also notes the goal is that the patient will also be able to modify the importance of both clinical benefit and/or toxicity based on his or her personal values and treatment goals.
As we know, defining value is not an easy task and ASCO recognizes several limitations to this model. The first is that the NHB calculation is only valid within the context of the clinical trial, which does not allow for intertrial comparisons. Additionally, this model does not include the patient’s perspective on value, excluding critical endpoints such as quality of life and patient-reported outcomes in the calculation of NHB. We also know that the relative value of a given treatment will likely change over its lifetime; how will this conceptual framework become a practical, dynamic tool that will repopulate data and update NHB scores over time?
From the physician’s perspective, many questions remain. How exactly will this tool be used in a clinical setting? When will this conversation happen at the point of care? Who will ultimately perform the analysis, input the patient’s cost-sharing data and preferences, and present the numbers to patients? Some physicians will use the tools themselves, while others will rely on nurses, administrators, or pharmacists to perform the analytics. While ASCO is clear the proposed framework is “not meant to substitute for physician judgment or patient preference,” in current form, it may leave the patient with more questions than answers. We encourage ASCO to develop a strategy to provide the appropriate guidance, support, and education to providers to assist them in explaining these values to patients in the next iteration of this framework.
ACCC recently submitted comments on ASCO’s value framework, and we look forward to continuing to engage with ASCO and others on the challenging issue of cost and quality in the cancer care delivery system.
By Steven L. D’Amato, BSPharm, BCOP, President, ACCC
The current pillars of cancer treatment incorporate radiation, surgery, and chemotherapy, with the goal of targeting the tumor and inducing complete or partial responses. Immuno-oncology (I-O) is a rapidly developing area of science and treatment that focuses on harnessing the ability of the patient’s own immune system to fight cancer. While great strides have been made in the fight against cancer, improved survival remains a challenge for some advanced malignancies. Surveillance, Epidemiology, and End Results (SEER) program data from 2014 show the five-year survival for lung, colorectal, kidney and renal pelvis, and melanoma to be 3.9, 12.5, 12.3 and 16 percent respectively. Specifically, malignant melanoma, renal cancer, and prostate cancer are potentially immunogenic, which makes them good candidates for immunotherapeutic approaches. Currently, more than 900 I-O clinical trials are in various phases of development.
A Long Road
The history of immunotherapy dates all the way back to 1796 when Edward Jenner used cowpox to induce immunity to smallpox. In 1890, Coley demonstrated that bacterial products (Coley toxins) had benefits for inoperable cancers, which led to the application of Bacillus Calmette-Guerin (BCG) in the 1960s. More than two decades later interferon-alpha was approved as hairy cell leukemia cancer immunotherapy, followed closely by interleukin-2 which was approved for the treatment of renal cell carcinoma and melanoma. Then came the birth of the monoclonal antibodies bevacizumab and cetuximab in 2004, followed by panitumumab in 2006. The first cellular immunotherapy (sipuleucel-T) was approved for prostate cancer in 2010. Ipilimumab (anti-CTLA-4) was approved for advanced melanoma in 2011. This year saw the first programmed cell death protein 1 (PD-1) monoclonal antibody inhibitors (nivolumab and pembrolizumab) approved.
These two new PD-1 inhibitors are currently indicated for the treatment of advanced melanoma (nivolumab, pembrolizumab) and squamous non-small cell lung cancer (nivolumab). These agents also have activity in a variety of other disease states and are currently being evaluated in numerous clinical trials. In addition to the development of anti-PD-1 agents, agents are being developed that target the PD-1 receptor and its ligands (PD-L1/2). I-O therapies have the potential to be used as monotherapy or as a part of combination regimens. Combinations of complementary I-O therapies with chemotherapy, radiotherapy, and targeted therapy have the potential to enhance antitumor effects. One can imagine the complexities of incorporating these new agents into the treatment of various diseases as more agents are developed and approved for use.
The anti-PD-1/PD-L1 agents are relatively well tolerated. However, there are many drug-related adverse events with potential immune-related causes, such as pneumonitis, vitiligo (a skin condition where skin loses its pigmentation), colitis, hepatitis, hypophysitis (inflammation of the pituitary gland due to autoimmunity), and thyroiditis. Because most tumor-associated antigens are also expressed in normal cells, the potential exists for toxicity against healthy tissues. Adverse events can be serious and potentially lethal, demanding vigilance throughout and after treatment. When combined with other forms of cancer treatment, I-O therapies can lead to numerous toxicities that must be identified early and managed appropriately. Another caveat with I-O is the monitoring of response with these new agents. Therapies that affect the immune system may not induce a measurable effect on tumor growth immediately. After initiating I-O therapy, immune activation and T-cell proliferation can start within days to weeks, but measurable antitumor effects may not be realized until weeks to months after initial treatment; the potential effects on survival may not be seen until several months after initial administration.
A New Frontier
This new frontier of medicine requires specialized education so that we can understand the immune system, its relationship to different tumor types, how these new agents interact with the immune system, and how to identify and manage immune-related events. To meet this critical need, ACCC formed the Institute for Clinical Immuno-Oncology (ICLIO), which launched in June 2015. ICLIO translates the latest I-O scientific research and findings for the multidisciplinary cancer care team, making the information accessible and—most importantly—breaking it into digestible action items that can be easily implemented in the community setting. ICLIO has brought the new frontier of immuno-oncology to your door. The next step is up to you. Visit accc-iclio.org today for information about clinical optimization, coverage and reimbursement, management best practices, patient access and advocacy, and training and development.
On Oct. 2, the ICLIO National Conference in Philadelphia, Pa., will bring together multi-disciplinary oncology team members to discuss the “how to’s” for putting immunotherapy into practice. I hope you’ll join me for this exceptional event.
Steven L. D’Amato, BSPharm, BCOP, is President of the Association of Community Cancer Centers, 2015-2016. He is Executive Director of New England Cancer Specialists.
The Centers for Medicare & Medicaid Services (CMS) 2016 proposed rules are out, and, not surprisingly, we continue to see the agency push outpatient payments toward more bundled services and move full steam ahead to tie Medicare payments at large to quality and value in the coming year.
2016 HOPPS Proposed Rule
Generally speaking, the proposed Hospital Outpatient Prospective Payment System (OPPS) rule includes few surprises, most notably CMS is proposing a -2% across-the-board reduction to compensate for “excessive” packaged payments for laboratory services in CY14. The rule also includes nine new comprehensive ambulatory payment classifications (C-APCs) to add to the 25 introduced last year and proposes consolidation and restructuring of nine APC clinical families. Importantly, CMS will continue to reimburse drugs at ASP+6% in the hospital outpatient department. The agency also provides some flexibility on the “two-midnight” rule. Currently the rule requires that a beneficiary to remain in the hospital for longer than two midnights in order for the stay to be reimbursed as an inpatient stay. Under the proposed rule, CMS would recognize some shorter stays as inpatient, and would evaluate on a “case-by-case” basis.
2016 PFS Proposed Rule
The proposed Physician Fee Schedule (PFS) rule was released later than expected this year, perhaps due to slightly more contentious provisions. The good news – perhaps – is that, as proposed, the 2016 PFS would have no (0%) impact on Medicare payments in hematology/oncology. However, on the radiation oncology side the news is not so good. If all of the proposals in the rule are finalized, radiation oncology will face an estimated -3% cut and freestanding radiation therapy centers will see a -9% cut due to a combination of new code values and a change in assumption involving the overall use of linear accelerators. CMS also indicates how it will treat biosimilars for the purposes of Part B reimbursement, proposing to assign the same HCPCS code to all biosimilars that reference the same innovator drug. These would be paid based on their volume-weighted ASP+6% of the reference product’s ASP. If no ASP data is available, biosimilars would be reimbursed at 100% of their wholesale acquisition cost.
Under the PFS, CMS also proposes to create two new CPT codes for advanced care planning services, one to start the conversation with a patient and the other for continued discussion. The rule also begins the phasing out of the PQRS (the 2018 payment adjustment will be the last); adjustments for quality reporting will now be made under the new Merit-Based Incentive Program (MIPS), created by the legislation that repealed the Medicare Sustainable Growth Rate (SGR). CMS seeks comments on MIPS on issues like the definition of clinical practice improvement activities, how to define a physician-focused payment model, and more.
ACCC will be submitting comments on both rules, due August 31 and September 8, respectively. On Tuesday, July 21, 4:00-5:00 PM EST, ACCC is hosting a members-only conference call with a full rundown of both proposed rules. Stayed tuned.
On June 25, the Supreme Court issued their decision in the highly watched King v. Burwell case, ruling that the more than 6 million people currently purchasing insurance through a federal exchange can continue to access subsidies. At issue was the legality of federal subsidies for those in states that opted not to create a state health insurance exchange. Without these subsidies, the Court felt that the insurance markets would have essentially collapsed in the 34 states with federally run marketplaces, with the majority of those accessing subsidies unable to afford coverage when faced with full premium costs and, as a result, costs rising exponentially for those remaining in the market. Specifically, the court said: “[t]he combination of no tax credits and an ineffective coverage requirement could well push a State’s individual insurance market into a death spiral.”
A different decision in King would have likely created much disruption in the marketplace for both patients and providers. According to Kaiser Family Foundation, more than 6 million Americans might have lost subsidies, and faced an average premium increase of 287%. RAND estimated the number of insured Americans would have declined by 9.6 million. The healthy insured may have elected to discontinue coverage, leaving high-cost patients to constitute the majority of the insurance pool. Cancer patients might have been faced with paying unsubsidized and substantially increased premiums, which for some may have been unattainable.
Overturning subsidies would have also placed providers in the precarious position of caring for patients that became uninsured. The financial and ethical implications of treating newly uninsured patients are great. While providers may have chosen not to terminate patients undergoing a course of treatment regardless of a change in insurance status out of ethical obligation, the financial result would have been challenging, particularly for those community-based practices that lacked programs for low-income patients. For hospital-based providers, the financial implications would also have been great, undermining provisions in the Affordable Care Act that reduced Disproportionate Share Hospital (DSH) Medicare payments in exchange for a substantially reduced uninsured population. In short, without current federal subsidies in place, the mechanisms for providing and funding care for millions of Americans would have needed to be revisited. With a lack of agreement in Congress on the best approach to renewed healthcare reform, providers would have faced a great deal of uncertainty.
With a 6-3 decision, Justice Roberts’ Court concluded that “Congress passed the Affordable Care Act to improve health insurance markets, not destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”
Post updated 6/26/2015
A proposed rule regarding 340B pricing enforcement was published in the Federal Register on June 17. The proposed rule responds to a mandate in the Affordable Care Act, which required the Health Resources and Services Administration (HRSA) to provide for imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge 340B-covered entities. The rule also provides a methodology for ceiling price calculation.
While not addressing more controversial aspects of the 340B program, such as patient definition, hospital eligibility criteria, and contract pharmacy arrangements, the rule does provide some important clarifications. Codification of the ceiling price calculation would provide 340B-covered entities with needed clarity in ensuring appropriate pricing. The rule would also impose a civil monetary penalty of up to $5,000 per instance of knowing and intentional overcharge of a covered entity, regardless of whether the order is placed with a manufacturer, wholesaler, authorized distributor or agent.
ACCC continues to closely watch for developments related to 340B, including expected release this summer of HRSA’s “mega-guidance,” anticipated to clarify several issues for which the agency does not believe it has rulemaking authority. HRSA has also indicated that it intends to release another rule on the administrative dispute resolution process in the near future. Stay tuned.
By Maureen Leddy, JD, Policy Coordinator, ACCC
Recently, ACCC submitted comments on the U.S. Pharmacopeia (USP) draft Chapter <800>, proposed standards for handling hazardous drugs in healthcare settings. The comments are in response to USP’s latest draft of Chapter <800>.
As you likely recall, USP released a first draft of Chapter <800> in March 2014. In response to comments by ACCC and other stakeholder groups, USP issued a revised Chapter <800> draft in December 2014.
In responding to the initial draft, ACCC and other stakeholder groups expressed concern about the difficulties providers would face implementing the proposed Chapter <800> standards, in large part due to the financial investment they would require. Many, including ACCC, anticipated that if USP Chapter <800> was adopted as first drafted, some cancer facilities would no longer be able to offer compounding services to patients or might even close altogether.
ACCC is pleased that USP’s revised Chapter <800> draft provides more flexibility, but concerns remain. We continue to request additional pathways to comply with the new USP standards and to ask for more clarity on specific requirements. ACCC supports USP’s ultimate goal of ensuring healthcare worker safety; however, we believe that in several instances there are more cost-efficient protective measures that would provide more certain safety enhancements.
USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP standards, such as Chapter <800>, are generally adopted by states and enforced by state Boards of Pharmacy or other regulatory entities. USP has indicated that the earliest likely effective date for Chapter <800> is August 2016; however, the many structural and procedural changes in the current draft would make compliance by that date a stretch for oncology programs.
The ACCC policy team is watching closely for a further revised or final draft of Chapter <800>; we will keep you posted.
By Leah Ralph, Manager, Provider Economics & Public Policy, ACCC
Once again attention is focusing on the 340B Drug Pricing Program. With policymakers – and a variety of stakeholders – increasingly clamoring for more clarity and with some calling for more restrictions, HRSA has struggled with its authority to issue regulations on certain topics, including patient definition, hospital eligibility criteria, and contract pharmacy arrangements.
Last week, it looked like policymakers might address the issue legislatively, attempting to insert last-minute language into the House Energy and Commerce Committee-led effort, 21st Century Cures legislation, that would “overhaul” the program and include many of the issues HRSA has attempted to address in regulations and guidance. However, the Committee ran out of time to find consensus on the comprehensive 340B reform plan, and the language ultimately did not make it into HR 6, the bill that passed out of committee last week.
In keeping with the growing momentum, last week MedPAC also released a report on the 340B Program at the request of Congress. The report provides an overview of the program and evaluates the trend in program growth and spending since its inception. This report could be used to set the stage for future reforms.
Perhaps most important, following HRSA’s withdrawal of its “mega-rule” last fall due to a court ruling against the agency’s treatment of orphan drugs under the program, HRSA recently submitted “mega-guidance” to OMB for review. While language is not yet public, we expect the guidance to cover topics where HRSA does not believe it has the rule-making authority, including patient definition, hospital eligibility, contract pharmacy, and audits. While OMB typically has up to 90 days to review submissions, the agency is not required to take the whole period, and we may see guidance published as early as June.
ACCC continues to follow the 340B dialogue closely, and looks forward to seeing clear, comprehensive rules and definitions to ensure compliance and the long-term viability of the program. For more, see the ACCC position statement.