The frequency of screening depends upon the screening approach selected, according to a statement from ACP, which suggests any of the following screening strategies:
Read the ACP press release.
On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.
The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).
Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD.
Read FDA press release.
Late Friday, Nov. 1, the Center for Medicare and Medicaid Innovation (the Innovation Center) released an informal Request for Information (RFI), on value-based payment to support high-quality oncology care. In the Nov. 1 announcement the Innovation Center stated they hope to gather feedback during today's Public Listening Session that will outline a potential Oncology Care First (OCF) Model.
The Innovation Center stated Friday at the Nov. 4 Public Listening Session and in submitted written feedback, they hope to solicit stakeholder input on the following targeted topics:
We invite feedback on the interest of physician group practices (PGPs) and hospital outpatient departments (HOPDs) in participating in a potential OCF Model. We are particularly interested in hearing from PGPs and HOPDs about the conceptualized participation eligibility parameters (e.g., the grouping concept), and whether they think that meeting those parameters would be feasible. We also invite feedback from potential payer partners, including commercial payers and state Medicaid agencies. We welcome suggestions about the model concept that would better incentivize participation in the potential model.
CMMI Public Listening Session on Potential Oncology Payment Model
Monday, Nov. 4, 2019
1:00 to 4:00 PM EST
On Wednesday, November 6 from 2:15 p.m. to 3:45 PM, EST, the Centers for Medicare & Medicaid Services (CMS) through the CMS Medicare Learning Network is holding a call on provisions in the CMS CY 2020 final Outpatient Prospective Payment System and Physician Fee Schedule and Quality Payment Program final rules.
A question and answer session follows the presentation.
Target Audience: Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent health care providers; all hospitals operating in the United States; and other stakeholders.
On Friday, Nov. 1, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2020 Hospital Outpatient Prospective Payment System (OPPS) rule (CMS-1717-FC) and the final CY 2020 Physician Fee Schedule (PFS) and Quality Payment Rule (CMS 1715-F).
The CMS CY 2020 OPPS fact sheet states that:
As finalized in last year’s rule, CMS is completing the two-year phase-in of the method to reduce unnecessary utilization in outpatient services by addressing payments for clinic visits furnished in the off-campus hospital outpatient setting.
And further states:
We acknowledge that the United States District Court for the District of Columbia vacated the volume control policy for CY 2019 and we are working to ensure affected 2019 claims for clinic visits are paid consistent with the court’s order. We do not believe it is appropriate at this time to make a change to the second year of the two-year phase-in of the clinic visit policy. The government has appeal rights, and is still evaluating the rulings and considering, at the time of this writing, whether to appeal from the final judgment.
340B Drug Pricing Program
The CMS 2020 OPPS final rule fact sheet states that:
For CY 2020, CMS is finalizing its proposal to continue to pay an adjusted amount of ASP minus 22.5 percent for separately payable drugs or biologicals that are acquired through the 340B Program. In the proposed rule, CMS acknowledged that the CY 2018 and 2019 OPPS payment policies for 340B-acquired drugs are the subject of ongoing litigation, and the agency is currently appealing the decision in the United States Court of Appeals for the District of Columbia Circuit.
Access full CMS Fact Sheet on the CY 2020 OPPS final rule.
Access the CY 2020 OPPS final rule here.
CY 2020 Physician Fee Schedule (PFS) and Quality Payment Rule
The CMS fact sheet on the final CY 2020 PFS and Quality Payment rule states that:
. . . we are aligning our E/M coding with changes adopted by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel for office/outpatient E/M visits. The CPT coding changes retain 5 levels of coding for established patients, reduce the number of levels to 4 for office/outpatient E/M visits for new patients, and revise the code definitions. The CPT code changes also revise the times and medical decision making process for all of the codes, and requires performance of history and exam only as medically appropriate. The CPT code changes also allow clinicians to choose the E/M visit level based on either medical decision making or time.
Physician Supervision Requirements for Physician Assistants
In its 2020 PFS file rule fact sheet, the agency states:
We are updating our regulation on physician supervision of PAs to give PAs greater flexibility to practice more broadly in the current health care system in accordance with state law and state scope of practice. In the absence of any state rules, CMS is finalizing a revision to the current supervision requirement to clarify that physician supervision is a process in which a PA has a working relationship with one or more physicians to supervise the delivery of their health care services. Such physician supervision is evidenced by documenting the PA’s scope of practice and indicating the working relationship(s) the PA has with the supervising physician(s) when furnishing professional services.
Access the CMS 2020 PFS final rule fact sheet.
Access the 2020 QPP Final Rule Fact Sheet
Access the CMS 2020 PFS final rule here.
ACCC's policy team is analyzing these final rules and will provide more in-depth information to members soon.
Congressional bipartisan legislation to address surprise medical billing (H.R. 3502) has received 102 cosponsors. The bill, Protecting People From Surprise Medical Bills Act was introduced Raul Ruiz, MD, (D-Calif.) and Phil Roe, MD, (R-Tenn.). The legislation would end the practice of unexpected healthcare bills by implementing independent dispute resolution. This process would require neutral arbitrated resolution on the billing cost between insurers and providers.
The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) has announced a Public Listening Session on Potential Future Oncology Payment Model. Through the session CMMI seeks to gather feedback on value-based payment to support high-quality oncology care. According to the announcement, CMMI plans to release additional materials before the Nov. 4, 2019, Public Listening Session, and will announce when additional materials have been posted to the Innovation Center website.
CMMI Public Listening Session on Potential Oncology Payment Model
Monday, Nov. 4, 2019
1:00 to 4:00 pm EST
Hubert H. Humphrey Building (Great Hall)
200 Independence Avenue,
SW Washington, DC
Registration for the Public Listening Session is required. There are three ways to participate: in person, via livestream video, or via teleconference.
On Monday, the Nobel Assembly announced the Nobel Prize in Physiology or Medicine would be jointly awarded to William G. Kaelin Jr., of the Dana-Farber Cancer Institute and Harvard University; Peter J. Ratcliffe of Oxford University and the Francis Crick Institute; and Gregg L. Semenza, of Johns Hopkins University. The three scientists are being honored for their work in revealing how cells manage responses to changes in oxygen levels. The results of their work have implications for treating a number of diseases, including cancer, anemia, heart attacks, and stroke.
On Sept.19, House Speaker Nancy Pelosi introduced her much-anticipated government price negotiation plan that would empower the U.S. Department of Health and Human Services (HHS) to negotiate drug prices that would apply to all payers. A summary of the revised bill includes one major change from a draft plan (leaked on Sept. 9): the final version instructs HHS to negotiate prices on drugs without generic or biosimilar competition. Price negotiation would apply to drugs with no competition that are among the top 250 most costly drugs to Medicare and the U.S. health system. Under Pelosi's plan, the negotiated prices would be available to all payers, including commercial payers, and HHS would be required to negotiate a minimum of 25 drugs per year. (The earlier draft plan included price negotiation on drugs with less than two competing two competing generics or biosimilars.)
Pelosi's plan also proposes a $2,000 out-of-pocket cap on prescription drugs for Medicare beneficiaries and disabled individuals.
The House Energy & Commerce Committee's Health Subcommittee is scheduled to hold a hearing on drug pricing legislation next week on Wednesday, Sept 25.