March 23, 2020
In response to the COVID-19 national emergency, the Centers for Medicare & Medicaid Services (CMS) is using its authority under Section 1135 of the Social Security Act to offer flexibilities with Medicare provider enrollment.
On March 23, CMS released Frequently Asked Questions (FAQs) on Medicare Provider Enrollment Relief related to COVID-19 including the toll-free hotlines available to provide expedited enrollment and answer questions related to COVID-19 enrollment requirements. Access the CMS FAQs .
Posted 3/23/2020
March 23, 2020
In response to the COVID-19 health emergency, the Centers for Medicare & Medicaid Services (CMS) on March 22 announced exceptions from reporting requirements and extensions for clinicians and providers participating in Medicare quality reporting programs with respect to upcoming measure reporting and data submission for those programs. Read agency statement (includes extensions for upcoming measure reporting and submission deadlines) .
CMS states: "For those programs with data submission deadlines in April and May 2020, submission of those data will be optional, based on the facility’s choice to report. In addition, no data reflecting services provided January 1, 2020 through June 30, 2020 will be used in CMS’s calculations for the Medicare quality reporting and value-based purchasing programs."
Posted 3/23/2020
March 13, 2020
On March 12, the Centers for Medicare & Medicaid Services (CMS) released COVID-19 FAQs for Essential Health Benefits (EHB). Read the FAQs here .
Posted 3/12/2020
March 13, 2020
The Centers for Medicare & Medicaid Services (CMS) will be covering COVID-19 tests, and for those original Medicare there is generally no copay (deductible applies). CMS is also permitting Medicare Advantage plans to waive cost-sharing for these tests.
CMS has posted a fact sheet to the agency's website to aid Medicare providers with information relating to the pricing of both the CDC and non-CDC COVID-19 tests. Read the fact sheet .
Visit the CMS " Current Emergencies " webpage for updates on CMS' response to this COVID-19.
Posted 3/13/2020
March 12, 2020
The Annual Report to the Nation on the Status of Cancer finds that from 2001 to 2017, deaths from cancer (all sites combined) continued to decline. The report was released on March 12 and is published in the journal, Cancer.
The annual report, which represents the collaborative efforts of the Centers for Disease Control (CDC), the National Cancer Institute (NCI), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries NAACCR), found decreases in the overall cancer death rates in all major racial and ethnic groups and among men, women, adolescents, young adults, and children. From 2012 to 2016 incidence of new cancers (for all cancers combined) held steady for men and increased slightly for women.
Over a four-year period (2013 to 2017), the report found:
Cancer death rates for men declined in 11 of the 19 most prevalent cancers, remained stable in four cancers (including prostate), and increased in four cancers (oral cavity and pharynx; soft tissue including heart, brain, and other nervous system; and pancreas).
Cancer death rates for women decreased in 14 of the 20 most common cancers, including (lung and bronchus, breast, and colorectal), but increased for cancers of the uterus; liver; brain and other nervous system; soft tissue including heart; and pancreas. Rates for cancers of the oral cavity and pharynx remained stable.
A companion report assesses progress on the federal government’s Healthy People 2020 objectives for four leading cancers: lung, prostate, breast cancer in women, and colorectal cancer. The targets for reducing death rates were met for all cancers combined as well as for lung, prostate, female breast, and colorectal cancers overall. However, these decreases were not consistent across all sociodemographic groups. Despite some progress over the past decade, the report points to the continued need to address disparities in cancer screening and in certain risk behaviors.
In addition, the report finds that Healthy People 2020 targets were not met for decreasing adult cigarette smoking; increasing success in smoking cessation; lowering excessive alcohol use; or reducing obesity—behaviors that have been associated with cancer risk.
Posted 3/11/2020
March 11, 2020
In a memorandum issued on March 10, the Centers for Medicare & Medicaid Services outlines the flexibilities Medicare Advantage (MA) and Part D plans have to waive certain requirements to help prevent the spread of COVID-19. These flexibilities include:
On March 9, the agency issued guidance on the screening, treatment, and transfer procedures healthcare workers must follow when interacting with patients to prevent the spread of COVID-19 in a hospice setting . CMS also issued additional guidance specific to nursing homes to help control and prevent the spread of the virus. View additional information from CMS here .
March 11, 2020
On March 11, 2020, Bristol Myers-Squibb announced that the U.S. Food and Drug Adminstration (FDA) has approved Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate-040 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Read the corporate announcement .
Posted 3/11/2020
March 10, 2020
On Monday, March 9, the U.S. Department of Health and Human Services (HHS) issued The Interoperability and Patient Access final rule (CMS-9115-F) from CMS and the Office of the National Coordinator for Health IT (ONC).
The rule finalizes new policies aimed at giving patients access to their health information, using CMS's authority to regulate Medicare Advantage (MA), Medicaid, CHIP, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). Currently these data are held by health insurers, hospitals, and vendors of electronic health records (EHRs).
New policies include:
Read CMS fact sheet .
Posted 3/10/2020
March 3, 2020
The U.S. Preventive Services Task Force (USPSTF) has published new screening recommends for hepatitis C virus (HCV) infection. The recommendation statement calls for HCV screening in adults 18 to 79 years of age. The new screening guidance was published March 2 in the Journal of the American Medical Association (JAMA) . Access the full JAMA article . View USPSTF recommendtion statement .
Posted 3/3/2020
March 2, 2020
On March, 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa ® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.
Sarclisa has Orphan Drug Designation status from the FDA. Read corporate press release .
Posted 3/2/2020
February 28, 2020
A report published by the Centers for Disease Control and Prevention (CDC) on Feb. 28, examines the prevalence of lung cancer screening by state for 10 states using Behavioral Risk Factor Surveillance System (BRFSS) data. The study found that overall for the 10 states,12.7% adults aged 55–80 years met the U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening.* Of adults meeting USPSTF criteria, 12.5% reported they had received a CT scan to check for lung cancer in the last 12 months.
The study is published in the February 28, Morbidity and Mortality Weekly Report . 2020;69(8);201. Access the report here .
* The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.
February 24, 2020
The College of American Pathologists (CAP), the American Society of Clinical Oncology (ASCO), the Association for Molecular Pathology, and Fight Colorectal Cancer are collaborating to develop clinical guidelines for testing DNA mismatch repair (MMR) and microsatellite instability (MSI) status in patients with a range of cancers.
The groups have opened the public comment period for the guideline “MMR and MSI Testing in Patients Being Considered for Checkpoint Inhibitor Therapy.” Find details, including background information, recommended resources to review before providing comments, and overarching questions for consideration here .
All stakeholders—including pathologists who refer and perform molecular testing, oncologists, laboratory personnel, and allied health professionals—are encouraged to provide feedback on the draft recommendations to ensure the final recommendations are clinically practical. The comment period runs from February 19 to March 13, 2020 .
Posted 2/24/2020
February 19, 2020
The Association of Cancer Care Centers (ACCC) joined in a wide coalition letter to congressional leadership urging that Congress include the bipartisan Clinical Treatment Act (H.R. 913) in the Healthcare Extenders Package that is likely to pass this spring.
Passage of the Clinical Treatment Act would guarantee that routine care costs of clinical trial participation would be covered for Medicaid beneficiaries with a life-threatening condition. Currently, Medicaid is not federally required to cover these clinical trial associated costs.
Because these costs only encompass non-experimental costs of treating patients (e.g., doctor's visits and lab work) on clinical trials, the Clinical Treatment Act would not significantly affect overall cost to Medicaid programs. Read coalition letter .
Posted 2/19/20
February 6, 2020
On Feb. 5, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule and Advance Notice Part II.
The CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P) would:
In the Advance Notice, the agency asks for comments on potentially developing measures of generic and biosimilar utilization in Medicare Part D as part of a plan’s star rating.
Access a fact sheet on the CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P). Download the proposed rule .
Access a fact sheet on the 2021 Medicare Advantage and Part D Advance Notice Part II.
Download Medicare Advantage and Part D Advance Notice Part II .
Posted 2/6/2020
February 3, 2020
The Centers for Medicare & Medicaid Services (CMS) is hosting a webinar on Wednesday, February 12 at 2:30 pm ET to provide an overview of the MIPS Value Pathways (MVPs) participation framework thats outlined in the 2020 Quality Payment Program Final Rule . CMS is committed to co-developing the MIPS Value Pathways with stakeholders and the public, and will be using this webinar to answer questions from organizations interested in providing input on MVPs.
The webinar will:
MIPS Value Pathways Webinar
Wednesday, February 12, 2020
2:30 – 3:30 pm ET
NOTE: This webinar will only cover existing information about the MIPS Value Pathways, as found within the 2020 Final Rule, MVPs webpage , and accompanying materials such as the MVPs fact sheet and illustrative diagrams . No new information about the MVPs will be presented during the webinar.
Posted 2/3/2020
January 28, 2020
On Jan. 27, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded coverage of FDA-approved laboratory diagnostic tests that use next generation sequencing (NGS) for patients with germline, or inherited, ovarian or breast cancer. CMS also gave the Medicare Administrative Contractors (MACs) the ability to determine coverage of NGS laboratory tests for other inherited cancers. Read CMS Decision Memo for NGS for Medicare Beneficiaries with Advanced Cancer (CAG-00450R) . Read CMS announcement .
Posted 1/28/2020
January 15, 2020
A recent report from the Government Accountability Office (GAO) published Jan. 10, 2020, calls on the Health Resources and Services Administration (HRSA) to improve processes to reasonably assure that participating non-governmental hospitals meet 340B Drug Pricing Program eligibility requirements.
The 340 Drug Pricing Program (340B Program) is administered by the U.S. Department of Health and Human Services' (HHS) Health Resources and Services Administration (HRSA) . Under the 340B Program, certain hospitals and other qualified entities that care for many low-income and uninsured individuals receive discounted prices on outpatient drugs from drug manufacturers. About two-thirds of hospitals participating in the 340B Program (approximately 1,700) are non-governmental hospitals (i.e., private, nonprofit hospitals).
The GAO makes several recommendations for achieving greater oversight of hospital eligibility. Among these, the report recommends that HRSA:
HHS agreed with all of the GAO’s recommendations except the recommendation to implement a process to verify that all non-governmental hospitals have contracts in place. HHS says that HRSA does not have the resources to carry out the recommended verification process and it would over-burden the agency. Read the full report . Read GAO recommendations .
January 14, 2020
On Jan. 13, an updated guideline for estrogen and progesterone receptor (ER/PgR) testing in breast cancer was released jointly by the College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO). The updated guideline reaffirms much of the original guidance and includes more specific recommendations for handling and reporting cases with low ER expression. The updated guideline was posted as online early release to the Archives of Pathology & Laboratory Medicine (Jan. 13, 2020, doi: 10.5858/arpa.2019-0904-SA) .
A CAP press release highlights the following changes: "Cases with 1-10% of cells staining for ER expression will now be reported as ER-low positive. Pathology reports for these cases should include a recommended comment that acknowledges the more limited data on endocrine responsiveness in this group. Also in such cases, pathologists should report the status of internal controls, with a special comment for specimens that lack internal positive contr ols."
The CAP press release also notes that the new guideline more clearly recommends that: ". . . ER be tested in cases of newly diagnosed DCIS (without invasion) to help estimate potential benefit of endocrine therapy to reduce the risk of a future breast cancer event. But, specifically, PgR testing in DCIS is optional."Read the CAP press release .
Access the updated Estrogen and Progesterone Receptor Testing in Breast Cancer guideline .
Posted 1/14/2020
January 10, 2020
On Jan. 9, 2020, the U.S. Food and Drug Administration (FDA) announced approval of avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keep the cancer cells from growing. Read the FDA approval announcement .
Posted 1/9/2020.
January 9, 2020
The American Cancer Society’s annual report on U.S. cancer statistics , released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.
In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.
The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.
The American Cancer Society estimates for 2019, the U.S. saw approximately 1,762,450 cancers diagnosed.
Read the full report.Read Facts & Figures 2020 .
Posted 1/9/2019
January 8, 2020
On Jan. 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Read the FDA announcement .
Posted 1/8/2020
December 20, 2019
On December 20, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu ® , Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Read FDA announcement .
Posted 12/20/2019
December 19, 2019
On Dec. 12, 2019, the Association of Cancer Care Centers (ACCC) provided comments to the Center for Medicare and Medicaid Innovation's informal Request for Information on its potential Oncology Care First Model. Applauding CMMI for making the OCF Model voluntary and envisioning a multi-payer model, ACCC urged CMMI to:
Learn more and read comment letter .
Posted 12/19/2019
December 19, 2019
On Dec. 18, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.
Padcev is indicated for the treatment of locally advanced or metastatic urothelial cancer in adults who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. Platinum-containing chemotherapy, PD-1 and PD-L1 inhibitors are standard treatments for patients with bladder cancer, the sixth most common cancer in the U.S. Urothelial cancer, which accounts for more than 90% of bladder cancers, begins in cells that line the bladder and nearby organs. Padcev is a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy. Read FDA announcement .
Posted 12/19/2019