July 15, 2019
On July 10, 2019, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (“RO Model”). As proposed, the model would make fundamental (but temporary) changes to the way that Medicare pays for radiation therapy in certain randomly chosen geographic areas. Under the proposed model, Medicare would pay providers a pre-determined, site-neutral bundled rate for most services provided in a 90-day episode of radiation therapy, rather than paying for each service individually. The proposed model would be mandatory for providers selected to participate and is intended to incentivize providers to deliver radiation therapy services more cost-effectively while maintaining or improving the quality of care delivered.
The Association of Cancer Care Centers has released a summary of the proposed RO Model, including potential implications for providers and manufacturers offering radiation therapy services and products. The summary covers top-of-mind consideration for this model, as proposed, and outlines questions for further analysis going forward as ACCC works with stakeholders to further evaluate the proposal.
Based on the proposed rule’s anticipated date of publication date in the Federal Register, comments on the proposal will be due September 16, 2019.
Posted 7/16/2019
July 11, 2019
On July 11, the White House announced withdrawal of its proposed drug rebate rule that would have removed rebates from government drug plans.
“Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule,” said White House spokesman Judd Deere. “The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline.”
The controversial proposed rule fueled a rift in the Administration with HHS Secretary Alex Azar supporting the curbing of drug rebates and other White House officials in opposition due to the potential for the proposal to increase Medicare spending by nearly $200 billion.
The proposed rule was considered central to the Administration's drug pricing reform plan . Withdrawal of the proposal likely signals an even greater focus by the Administration on its proposed International Pricing Index Model for Medicare Part B Drugs , which is currently undergoing review at the White House.
Posted 7/11/2019
July 10, 2019
On July 10, 2019, the Centers for Medicare and Medicaid Services (CMS) released its proposal for a new mandatory Medicare Payment Model – the Radiation Oncology Model (RO Model) that seeks to promote the inclusion of radiation oncology in the evolution of value-based care arrangements in cancer care.
This model would be conducted under the Center for Medicare and Medicaid Innovation (CMMI) at CMS, and is proposed as a four-year model, running from 2020 through 2024. The proposal seeks to include 17 cancer types in the RO Model that would make prospective episode-based payments to participants in a site-neutral manner. The RO Model would also be furnished to provide physicians the opportunity to participate in an Advanced Alternative Payment Model (APM) under the Quality Payment Program (QPP). Participation in the RO Model would be required based upon radiation therapy (RT) services furnished in randomly selected Core Based Statistical Areas (CBST). More details on the proposed model if available from CMMI here .
The ACCC policy team is continuing to analyze the effect of this proposal across our entire membership. CMS is accepting comments from relevant stakeholders up to 60 days after the release of this proposed rule into the Federal Register .
Posted 7/10/2019
July 3, 2019
On July 3, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
As a condition of accelerated approval, further clinical trials may be required to verify and describe selinexor’s benefit. FDA granted this application fast track designation and orphan drug designation. Read FDA announcement .
Posted 7/3/2019
June 28, 2019
On June 27, the U.S. Food and Drug Administration (FDA) announced approval of daratumumab (Darzalex ® ) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Read FDA announcement .
June 28, 2019
On June 28, Pfizer Inc. announced that the U.S. Food and Drug Administration(FDA) has approved Zirvabev™ (bevacizumab-bvzr), a biosimilar to Avastin ® (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer. Read corporate press release .
Posted 6/28/2019
June 25, 2019
On June 25, the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee leaders added bipartisan legislation to S. 1895 (116), the Lower Health Care Costs Act . In marking up the bill, legislators are expected to incorporate large-scale proposals to tackle drug pricing reform from Congress, including, surprise medical billing legislation, telehealth access legislation, generics competition legislation, and a tobacco 21 proposal.
Posted 6/25/2019
June 25, 2019
On Monday, President Trump signed an executive order that aims to make hospital and other healthcare cost more transparent for consumers.
The order calls for health officials to propose a regulation within 60 days that would ultimately require hospitals and hospital-employed physicians to post their charges — including the discounted rates they negotiate with insurers. Read Executive Order .
Posted 6/25/2019
June 18, 2019
On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Read FDA announcement .
Posted 6/18/2019
June 14, 2019
On June 13, 2019, Amgen and Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved Kanjinti ™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin ® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Read corporate press release .
Posted 6/14/2019
June 13, 2019
The Association of Community Cancer Centers (ACCC) has joined with oncology stakeholder organizations in a comment letter to the Centers for Medicare & Medicaid Services (CMS) on National Coverage Determination (NCD) 90.2 for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R).
Section 90.2 of NCD describes conditions of coverage for NGS. The section is being interpreted to apply to NGS tests for somatic and germline mutations. Additionally, Section 90.2 of the NCD states criteria that patients must meet to qualify for NGS testing, and stipulates specific requirements that the diagnostic laboratory test using NGS must meet.
The comment letter to CMS cites specific concerns regarding the potentially deleterious effect of the Section 90.2 NCD on access to germline testing. The stakeholder letter recommends to CMS "that NCD 90.2 be revised to indicate that NGS-based germline genetic tests are exempt from the policy. This National Coverage Determination should specifically apply to somatic mutation testing and be renamed:National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) for Somatic."Read the comment letter .
June 11, 2019
The Association of Cancer Care Centers (ACCC) joined the American Cancer Society Cancer Action Network, the American Lung Association, the American Society of Clinical Oncology, the Cancer Support Community, and a number of other oncology clinical, professional, and patient advocacy organizations in a June 6, letter of support for S. 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019 .
The legislation is aimed at eliminating barriers in patient access to cancer clinical trials, with a special emphasis on decreasing disparities in cancer clinical trials. Read the letter .
June 10, 2019
On June 10, Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to polatuzumab vedotin-piiq (Polivy TM ) in combination with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. Read the Genentech press release .
Posted 6/10/2019
June 6, 2019
On Wednesday, June 5, a bipartisan group of legislators introduced the “Improving Seniors’ Timely Access to Care Act of 2019” (H.R. 3107) . The bill would require the Centers for Medicare & Medicaid Services (CMS) to regulate the use of prior authorizations by Medicare Advantage (MA) plans in order to streamline the current MA prior authorization system.
The bill also calls for increased transparency in the prior authorization process and would require MA plans to report the extent of their prior authorization use to CMS, as well as their rate of approvals or denials.
Cosponsors of the bipartisan bill include Rep. Roger Marshall, MD (R-Kan.), Rep. Mike Kelly (R-Pa.), Rep. Ami Bera, MD (D-Calif.), and Rep. Suzan DelBene (D-Wash.).
Posted 6/6/2019
June 6, 2019
On June 6, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) seeking new ideas from the public to continue the administration's Patients over Paperwork initiative. The RFI will be published in the Federal Register on June 11.
The RFI invites patients and their families, the medical community, and other healthcare stakeholders to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and healthcare system’s resources from paperwork to high-quality care that improves patient health.
According to the agency's press release, CMS is seeking innovative ideas to relieve burden and improve:
Comments must be submitted by August 12, 2019.
Posted 6/6/2019
May 30, 2019
The Annual Report to the Nation on the Status of Cancer released on May 30, finds that for all cancer sites combined the overall cancer death rate continued to decrease in U.S. men, women, and children from 1999 to 2016. In men, the overall cancer incidence rates decreased from 2008 to 2015, after increasing from 1999 to 2008. Cancer incidence rates were stable in women from 1999 to 2015.
This year's report includes a special section on cancer rates and trends in adults ages 20 to 49. Among adults 20-49 years, researchers report that incidence and death rates were lower among men than women. The most common cancers in this age group were:
The report is jointly issued by the Centers for Disease Control and Prevention (CDC), the North American Association of Central Cancer Registries (NAACCR), the American Cancer Society (ACS), and the National Cancer Institute (NCI).
Access highlights and the full report on the CDC website here . Read NCI press release here .
Posted 5/30/2019
May 28, 2019
On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). Read FDA announcement .
Posted 5/28/2019
May 28, 2019
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Read FDA announcement .
Posted 5/28/2019
May 24, 2019
On May 24, Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) for adults and pediatric patients ≥12 years of age. It is the first and only FDA-approved treatment for this indication. Read the Incyte press release here .
Posted 5/24/2019
May 23, 2019
Since April 19, a proposed rule titled "Potential Model Updates" has been under Office of Management and Budget review. Healthcare stakeholders and members of the oncology community are speculating that this proposed rule could offer the public a more finalized look into a radiation oncology specific alternative payment model (APM) that Administration healthcare leadership has been hinting at since last year.
Stakeholders anticipate that more information about the RO-APM will come either in this proposed rule or in the larger Medicare outpatient prospective payment system proposed rule later this summer. Posted 5/23/2019
May 23, 2019
The Trump Administration's spring regulatory agenda, released on May 22, shows a slow down of next steps for regulatory action on two pivotal drug-pricing reform measures: the International Pricing Index (IPI) model and the revamping of the rebate system.
The IPI model was outlined last fall in an advance notice of proposed rulemaking from the Department of Health and Human Services (HHS). The rule, originally expected this spring, is now slated to be proposed in August .
The regulatory agenda also indicates that Administration's proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system are now scheduled to be released later than originally anticipated. Source: Inside Health PolicyPosted 5/23/2019
May 23, 2019
On May 17, the Centers for Medicare & Medicaid Services (CMS) abruptly announced a delay in its release of a Medicare National Coverage Determination (NCD) for CAR T-cell therapy, which was due to be published that same day. The agency statement did not provide an explanation for the delay.
In a meeting with reporters on Wednesday, May 22, CMS Administrator Seema Verma said that the agency is taking care with the NCD because not only is the technology "new ground" for CMS, but also application of CAR-T therapy is expected to expand to other types of cancer beyond lymphoma. “So we want to make sure that we’re doing this appropriately, dotting our i’s and crossing our t’s. It’s just taking a little bit more time because it’s not a routine type of decision,” Verma said. Source: Inside Health PolicyPosted 5/23/2019
May 17, 2019
On May 16, the Centers for Medicare & Medicaid Services(CMS) released their final rule titled “Modernizing Part D and MedicareAdvantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Highlightsfrom this final rule include:
The ACCC policy team will continue to analyze this rule andprovide a more detailed analysis at a later date. Readthe CMS final rule here .
Posted 5/17/2019
May 15, 2019
On May 15, AbbVie Inc. and Genentech Inc. announced that the U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA had previously granted Breakthrough Therapy designation to this chemotherapy-free combination. Read the Genentech press release .
Posted 5/15/2019