April 10, 2020
The Centers for Medicare & Medicaid Services (CMS) plans to stay on schedule for publicizing Open Payments data by the end of June, despite the COVID-19 crisis. Thus, if stakeholders want to review information on payments from drug and device manufacturers and group purchasing organizations to certain providers before publication, they must do so before May 15.
Source: InsideHealthPolicy 4/8/2020
Posted 4/10/2020
April 9, 2020
On April 8, 2020, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. Read FDA announcements.
Posted 4/9/2020
April 9, 2020
On April 8, the Centers for Medicare & Medicaid Services (CMS) announced the agency has issued a series of updated guidance documents focused on infection control to prevent the spread of the 2019 Novel Coronavirus (COVID-19) in a variety of inpatient and outpatient care settings. The updates aim to help clinicians in a variety of healthcare setting prevent and mitigate spread of the novel coronavirus.
CMS states that the guidance, based on Centers for Disease Control and Prevention (CDC) guidelines, will help ensure infection control in a wide range of areas, according to the agency, including: of patient triage, screening and treatment, the use of alternate testing and treatment sites and telehealth, drive-through screenings, limiting visitations, cleaning and disinfection guidelines, staffing, and more.
Read CMS press release .
For hospitals, psychiatric hospitals and Critical Access Hospitals (CAHs), the revised guidance, for example, provides expanded recommendations on screening and visitation restrictions, discharge to subsequent care locations for patients with COVID-19, recommendations related to staff screening and testing, and return-to-work policies.
In addition, for hospitals and CAHs, the revised guidance on the Emergency Medical Labor and Treatment Act (EMTALA) includes a detailed discussion of: patient triage, appropriate medical screening and treatment; the use of alternate testing sites; telehealth; and appropriate medical screening examinations performed at alternate screening locations, which are not subject to EMTALA, as long as the national emergency remains in force.
Find latest CMS updates (dated 4/8/20) to guidance documents on infection control here (listed under Clinical & technical guidance. )
Posted 4/8/2020
April 6, 2020
On Monday, April 6, the U.S. Department of Health and Human Services (HHS) announced upcoming action by the Centers for Disease Control and Prevention (CDC) to provide $186,000,000 in funding for additional resources to state and local jurisdictions in support of the nation’s response to the 2019 novel coronavirus (COVID-19). An HHS press release states that the CDC will use the funding to:
CDC will use existing networks to reach out to state and local jurisdictions to access this initial funding.
To view the list of CDC funding actions to jurisdictions, click here . Read HHS press release here .
Posted 4/6/2020
March 30, 2020
On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Read FDA announcement .
Posted 3/30/2020
March 30, 2020
On March 28, the Centers for Medicare & Medicaid Services (CMS) announced it is expanding the Accelerated and Advance Payment Program for all Medicare providers throughout the country during the COVID-19 public health emergency. The payments can be requested by hospitals, doctors, durable medical equipment suppliers, and other Medicare Part A and Part B providers and suppliers.
To qualify for accelerated or advance payments, the provider or supplier must:
Medicare will start accepting and processing the Accelerated/Advance Payment Requests immediately. CMS anticipates that the payments will be issued within seven days of the provider’s request. Access CMS fact sheet for more information .
Posted 3/29/2020
March 27, 2020
On March 27, President Trump signed the $2 trillion coronavirus emergency aid bill, known as the CARES Act , into law.
The legislation includes relief for state and local governments, businesses (large and small), hospitals, and individuals affected by the coronavirus emergency. This is the third coronavirus aid package from Congress this month.
Posted 3/27/2020
March 24, 2020
The American Society of Clinical Oncology (ASCO) announced on March 24 that it will not be holding its 2020 Annual Meeting in person due to COVID-19. The scientific program will now be presented in a virtual format during the scheduled Annual Meeting timeframe. Please find more details from ASCO statement here .
Posted 3/24/2020
March 24, 2020
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued a message on March 23 that outlines how critical issues for patients with cancer and their healthcare providers are continuing to be addressed despite the national COVID-19 health emergency. The message highlights the following as among the OCE's current priorities:
Read message .
Posted 3/24/2020
Post updated 4/1/2020
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