August 30, 2019
The Centers for Medicare & Medicaid Services (CMS) Aug. 30 announced efforts underway to support Florida in response to Hurricane Dorian. Health and Human Services Secretary Alex Azar declared a public health emergency in the state. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Dorian. CMS will be waiving certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare quickly; and taking steps to ensure dialysis patients obtain critical life-saving services.
Below are key administrative actions CMS will be taking in response to the public health emergency declared in Florida:
Waivers and Flexibilities for Hospitals and other Healthcare Facilities: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will also issue a number of blanket waivers, listed on the website below, and the CMS Regional Office will grant other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. More information is available here .
Special Enrollment Opportunities for Hurricane Victims: CMS will make available special enrollment periods for certain Medicare beneficiaries and individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange if eligible for the special enrollment period. More information available here and here .
Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. Access more information and the toolkit .
Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease (ESRD) Network of Florida, ESRD NW7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility, the ESRD NW hotline number, and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The ESRD NW7 toll-free hotline is 800-826-3773 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website .
Medical equipment and supplies replacements: CMS will be temporarily suspending certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.
Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in Florida, but will continue to investigate allegations of immediate threat to patient health and safety.
Ensuring Access to Care in Medicare Advantage and Part D: During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.
Posted 8/30/2019
August 20, 2019
The U.S. Preventive Services Task Force has updated its Recommendation Statement on BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing . The full recommendation is published online in the Aug. 20 issue of JAMA .
The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 ( BRCA1/2 ) gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing.
The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations.
Read the Recommendation Statement on the USPSTF website .
Posted 8/20/2019
August 16, 2019
On August 16, 2019, the Food and Drug Administration approved fedratinib (Inrebic, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
The prescribing information for fedratinib includes a Boxed Warning to advise healthcare professionals and patients about the risk of serious and fatal encephalopathy, including Wernicke’s encephalopathy. Healthcare professionals are advised to assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. If encephalopathy is suspected, fedratinib should be immediately discontinued and parenteral thiamine initiated. Read FDA announcement .
Posted 8/16/2019
August 16, 2019
Roche announced August 16 that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).
The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Read corporate press release .
8/16/2019
August 7, 2019
On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy . FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.
Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia .
The NCD continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.
In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible." Read the CMS Decision Memo.Download CMS Decision Memo.
Posted 8/07/2019
August 1, 2019
On August 1, the National Comprehensive Cancer Network (NCCN) announced release of new NCCN Guidelines for Small Bowel Adenocarcinoma . These are the first clinical guidelines in the U.S. to address this rare but growing cancer type, which is sometimes associated with hereditary causes like Lynch syndrome.
NCCN also recently released Updated NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer and Colorectal Cancer Screening, which clarify how to use genetic testing and screening to detect cancer in high-risk individuals at an earlier stage. Read NCCN press release.
Posted 8/1/2019
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