April 22, 2020
The Office of the National Coordinator for Health Information Technology (ONC) announced April 21 that due to the COVID-19 public health emergency, ONC will exercise its discretion in enforcing all new requirements that have compliance dates and time frames until three months after each initial compliance date or timeline identified in the ONC Cures Act Final Rule. Learn more.Cures Final Act Rule Enforcement Discretion Dates & Timeframes . CMS press release . CMS announcement .
Posted 4/22/2020
April 21, 2020
On Tuesday, April 21, the U.S. Senate passed by voice vote a $484 billion coronavirus relief bill that includes $75 billion for providers. It is anticipated that House members will vote on the legislation on Thursday.
Source: InsideHealthPolicy Posted 4/21/2020
April 21, 2020
On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
This review was conducted under Project Orbis , an initiative of the FDA Oncology Center of Excellence. Read the FDA announcement .
Posted 4/21/2020
April 20, 2020
On April 19, the Centers for Medicare & Medicaid Services (CMS) released guidance for facilities in areas with a low, or relatively low and stable incidence of COVID-19, to resume providing non-emergent, non-COVID-19 healthcare services. Many non-essential surgeries and procedures have been curtailed since March 18 when the agency recommended that facilities limit non-essential care to preserve personal protective equipment (PPE) and prepare for potential surge areas.
The CMS guidance references the White House plan for Opening Up America, released on Friday, April 17. The agency's guidance titled, Opening Up America Again, Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I , notes that "if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I." Access the CMS guidance .
Posted 4/20/2020
April 20, 2020
On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
The FDA also approved the FoundationOne ® CDX (Foundation Medicine, Inc.) as a companion diagnostic for patient selection. Read FDA announcement .
Posted 4/20/2020
April 17, 2020
On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments. Read FDA announcement.
Posted 4/17/2020
April 17, 2020
Novartis Pharmaceuticals Corporation has announced that the US Food and Drug Administration approved Promacta ® (eltrombopag) 25-mg powder for suspension package size on March 23, 2020. Read corporate announcement .
4/17/2020
April 15, 2020
On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials, according to the company press release.
Read company announcement .
4/15/2020
April 13, 2020
On April 11, the Centers for Medicare & Medicaid Services (CMS) released guidance for implementation of the requirement for group health plans and group and individual health insurance to cover both COVID-19 diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
The guidance also ensures that COVID-19 antibody testing will be covered. When a COVID-19 antibody test becomes widely available, it could become a key element in fighting the pandemic.
Access the guidance .
4/13/2020
April 13, 2020
The American Society of Clinical Oncology (ASCO) has announced the launch of the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry) to help the cancer community learn about the pattern of symptoms and severity of COVID-19 among patients with cancer. The registry will also aim to gain insight into how COVID-19 infections impact the delivery of cancer care and patient outcomes. The registry will collect both baseline and follow-up data throughout the pandemic and into 2021. Learn more .
Posted 4/13/2020
April 10, 2020
The bipartisan CARES Act, signed into law March 27, provides for $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response. On April 10, the U.S. Department of Health and Human Services (HHS) announced the immediate start to distribution of $30 billion in relief funds to providers. HHS states that eligible providers will begin receiving payment via direct deposit starting April 10, 2020.
Full details including who is eligible, how payment distributions are determined, what to do if you are an eligible provider, and more here .
Posted 4/10/2020
April 10, 2020
On April 9, the Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules so that hospitals, clinics, and other healthcare facilities can boost their frontline medical staffs during the novel Coronavirus (COVID-19) pandemic.
These changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.Access CMS fact sheet on detailing Blanket Waivers for Healthcare Providers (includes information on the new waivers and those announced previously ).
Posted 4/10/2020
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