July 31, 2019
The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.
Pathway 1: A Notice of Proposed Rulemaking (NPRM) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada.
Pathway 2: Manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. Read the HHS press release . Read the administration's Action Plan .
Posted 7/31/2019
July 31, 2019
On July 31, Merck announced U.S. Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. Read the corporate press release .
Posted 7/31/2019
July 31, 2019
On July 30, Bayer announced U.S. Food and Drug Administration (FDA) approval of Nubeqa ® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa was approved under the FDA's Priority Review designation. Read corporate press release .
Posted 7/31/2019
July 29, 2019
On Monday, July 29, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) proposed rule and the CY 2020 Physician Fee Schedule (PFS) and Quality Payment Program proposed rule.
CMS states that the OPPS proposed rule puts forward price transparency requirements that will increase competition among all hospitals by requiring them to make pricing information publicly available.
According the agency, the policy changes included under the proposed 2020 PFS rule align with the administration's aims to reduce providers' paperwork burden, remove unnecessary reporting measures, and reward clinicians for time spent with patients.
The ACCC policy team is currently reviewing both proposed rules and will provide a more in-depth summary for ACCC members shortly.
Posted 7/29/2019
July 24, 2019
To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders.
The company agreed and is removing these products from the global market.
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.
These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan.
A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found here .
The FDA notes that the macro-textured implants, like the BIOCELL textured implants manufactured by Allergan, represent less than 5% of breast implants sold in the U.S.
Read the full FDA announcement , which includes recommendations for patients and providers. Posted 7/24/2019
July 24, 2019
On July 23, the U.S. Senate Finance Committee released a long-anticipated drug-pricing bill. The legislation, which is slated for mark up on Thursday, July 25, includes significant changes to drug-pricing policy in Medicare and Medicaid. As written, the bill calls for restructuring of the Part D benefit, imposing much-debated inflationary rebates in Medicare Parts B and D, and increasing the rebate cap in Medicaid. New Structure for Part D
The bill restructures Part D, eliminating the donut hole and shifting manufacturer liability to the catastrophic phase. Beneficiaries would pay costs up to $415 deductible. After meeting their deductible, during an initial coverage phase, beneficiaries would pay 25% of drug costs and plans would cover 75%. The out-of-pocket spending cap for beneficiaries would be $3,100.
During the catastrophic phase, Medicare would pay 20% for brand drugs, plans would cover 60%, and drug makers would pay 20%. For generics, Medicare would pay 40% and plans would pay 60%. As written, the legislation calls for this new structure to be phased in starting in 2022, and be in full effect by 2024. Part B
The drug-pricing bill includes the following changes to Part B:
The Senate is not slated to vote on the legislation until September.
Concurrently, the House is working on its own drug-pricing legislation that is due for release in September.ACCC's policy team will be following developments on Capitol Hill closely and providing updates to its membership.
Source: Inside Health Policy
Posted 07/24/2019
July 24, 2019
Pfizer Inc. announced on July 23, the U.S. Food and Drug Administration (FDA) approval of Ruxience™ (rituximab-pvvr), a biosimilar to Rituxan ® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Read the corporate press release .
Posted 7/24/2019
July 22, 2019
On July 19, the American College of Surgeons (ACS) launched a new Geriatric Surgery Verification (GSV) Program at the ACS Quality and Safety Conference. The new surgical quality improvement program introduces 30 new surgical standards designed to systematically improve surgical care and outcomes for the aging adult population. Hospitals can implement to continuously optimize surgical care for this vulnerable population. Read the ACS press release here.
Posted 7/22/2019
July 18, 2019
On July 11, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule [CMS-1711-P] that provides for routine updates to the home health payment rates for calendar year (CY) 2020, in accordance with existing statutory and regulatory requirements. The rule includes proposals related to implementation of the permanent home infusion therapy benefit in 2021.
The 21st Century Cures Act established the Medicare home infusion benefit, which will reimburse for nursing services, patient training and education, remote monitoring services and monitoring services for home infusion therapy treatments. The benefit enables home infusion of certain drugs including anti-infectives, chemotherapy, or treatment for immune deficiencies.
The proposed rule would permit therapist assistants to provide maintenance therapy. The proposal includes proposed payment categories, amounts, and required and optional adjustments. Read CMS fact sheet . Access the proposed rule . Posted 7/18/2019
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