Weekly Spotlight
When the Congressional Budget Office re-scored the Seniors’ Timely Access to Care Act last February, the $10 billion price tag might have been a fatal blow to efforts to address the use of prior authorization in the Medicare Advantage (MA) program. With a score that high, the success of the bill became dependent on the Administration finalizing rules clarifying and modernizing prior authorization practices.
Last month, the final prior auth rules were finally published and last week, I had the opportunity to sit down with Peggy Tighe, Principal at Powers law and the brain, chief strategist, and advocacy might behind the Seniors’ Timely Access to Care Act and the massive Regulatory Relief Coalition.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
MA Growth May Not Be As It Seems
Stat reports the number of people in a Medicare Advantage plan has more than tripled since 2010, enriching health insurance companies that made a bet on covering more seniors. In 2023, 52% of all Medicare beneficiaries were in a Medicare Advantage plan. That number will creep even higher for 2024. However, the federal data from last year erroneously undercounted some membership, said Gary Taylor, a managing director and health care analyst at TD Cowen. He estimates this year’s annual growth rate is closer to 6%, which would make it the lowest since 2016. Further, MA plans are taking another look at their profit expectations as a higher number of medical claims has eaten into their projected margins.
#All
Commonwealth Fund Survey Finds MA Beneficiaries More Likely to Experience Care Delays Than Those in Traditional Medicare
According to a new survey published by The Commonwealth Fund, beneficiaries in both traditional Medicare and Medicare Advantage (MA) reported challenges in accessing care in the past two years. But more beneficiaries in MA plans said they experienced delays in getting care because of the need to obtain plan approval to get a test or procedure. A larger share of those in MA plans also said they could not afford care because of copayments or deductibles. Those who said it fell short of expectations pointed to a lack of coverage for needed services, high costs, or uncertainty about what benefits are covered.
#All
CMS Hopes You Wont Notice: Prior Auth Demo for ASCs
CMS seeks to develop and implement a Medicare demonstration project, requiring prior authorization for services provided to Medicare beneficiaries at Ambulatory Surgical Centers (ASCs). CMS believes prior authorization by Medicare Administrative Contractors (MACs) will assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring in ASCs.
#Hospital, #Provider, #Patient, #Payer
Surprise Medical Billing Arbitration Is Still a Mess – But Arbiters Are Siding With the Docs
New data from CMS shows that in over 80% of payment disputes, the arbiter settled on an amount that was more than the median in-network rate for that service. In other words, insurers were ordered to pay more to an out-of-network provider than they’d pay to a contracted one. Not only that, the sheer volume of disputes means the three federal agencies that run the program are devoting much more time to it than expected. The data also show that the top three dispute-initiating parties, SCP Health, Team Health, and Radiology Partners, represented about 58% of all disputes in the time period studied. All three are private-equity-based staffing companies.
#Patient, #Provider, #Payer
The Real COST of CMS’s New Data Use Requirements Coming to Light
Starting in August, new research projects will be able to access data only through CMS’ cloud environment rather than the current practice of storing the data on highly secure computing infrastructure at research institutions. In principle, this doesn’t sound so bad. In practice, the costs associated with each “seat” at the virtual table severely limits the number of researchers who can use the data. CMS is also imposing new fees to continue to use their data that is stored outside of their cloud — a $20,000 fee to start any new project (before August) and a $10,000 annual fee to keep existing projects going. In unrelated news, IQVIA reported strong 4th quarter and full year results, largely on the back of its contract research division.
#Provider
Additional Education / Information From CMS
Details on Health Equity Services in the 2024 Physician Fee Schedule Final Rule
New MLN booklet describes 4 new services to help address health-related social needs: Caregiver training, Social determinants of health risk assessment, Community health integration, Principal illness navigation.
#Patient, #Provider
CMS Virtual Education Session on Interoperability and Prior Authorization Final Rule
CMS’s Office of Burden Reduction & Health Informatics will host a virtual education session on March 26, 2024, from 1:00 to 2:00 PM ET on the CMS Interoperability and Prior Authorization final rule Registration will remain open through March 25, however please register by March 19 to ensure consideration of any submitted questions.
#Patient, #Provider, #Payer, #Hospital
Food and Drug Administration (FDA)
First Ever CAR-T Cell Treatment for Solid Tumors Approved
FDA approved the first cell therapy that can treat solid tumors, a long-awaited milestone in oncology.
#Drug, #Patient
An Interview with Dr. June Raine, CEO of the Medicines and Healthcare products Regulatory Agency in the UK
FDA published an interview with Dr. June Raine, CEO of the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator of medicines, medical devices and blood components for transfusion. The interview was conducted in advance of her meeting in London with a delegation of the FDA’s senior leaders, including the FDA Commissioner Dr. Robert Califf.
#All
FDA Warns Device Manufacturers to Check Data
The U.S. Food and Drug Administration (FDA) is reminding sponsors of device studies and manufacturers of devices (“device firms”) to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. It is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate.
#Device
Additional Education / Information from FDA
FDA Publishes Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance
FDA has proposed select updates to the FDA guidance document Medical Device User Fee Small Business Qualification and Certification to provide additional information for the granting of the small business registration fee waiver.
#Device
Registration Open for CDER Generic Drug Forum on Regulatory Considerations to Enhance Generic Drug Access
At an April 10-11 meeting, FDA subject matter experts will address essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Presentations will focus on resources, best practices, common deficiencies, and opportunities to engage with the Agency from pre-ANDA to post-approval submissions They will provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications in an effort to facilitate timely access to safe, effective, and high-quality generic medicines.
#Drug
Now Available: Office of Generic Drugs 2023 Annual Report
Office of Generic Drugs 2023 Annual Report
#Drug
Other News from HHS
Biden Administration Publishes Update to Health Equity Plan
The Department of Health and Human Services (HHS) released the 2023 update to its Equity Action Plan, in coordination with the Biden-Harris Administration’s whole-of-government equity agenda.
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Hill Happenings
E&C Dems Urge FDA to Finalize Plans for Clinical Trial Dicersity Action Plans
Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Anna G. Eshoo (D-CA), and Oversight and Investigations Subcommittee Ranking Member Kathy Castor (D-FL) wrote to Food and Drug Administration (FDA) Commissioner Robert M. Califf, M.D. to urge the agency to move forward with guidance to improve the diversity of populations represented in clinical trials.
#Device, #Drug, #Patient
AGs Urge Congress to Address Abuses by PBMs
Attorneys general from 39 states sent a letter to House and Senate leadership ruing them to pass legislation to “reform PBM practices to curtail their ability to unreasonably raise the price of drugs and to require greater transparency.”
#Drug
Members of House Oversight Ask Durg Manufacturers About Shortages
Members of the House Committee on Oversight and Accountability sent letters to Teva Pharmaceuticals, Pfizer, and Sandoz requesting information about ongoing shortages of a number of three generic drugs commonly used to treat cancer (Pfizer), powder amoxicillin (Sandoz), and Adderal (Teva).
#Drug, #Patient
Sen. Cassidy Publishes Report on “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era”
The Senate HELP Committee published a request for information in Sept. 2023 asking interested parties to provide responses to a spectrum of questions on health data privacy. Respondents included trade associations, hospitals, electronic health record vendors, health technology companies, and think tanks. The recently-published report features recommendations that fall into three categories: 1. Updates to the existing health privacy framework (i.e., updates to the Health Insurance Portability and Accountability Act (HIPAA)); 2. Health data in the HIPAA “gray area”; and 3. Data outside of HIPAA.
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Notable Notes
Consumer Groups Place A Marker for Consumer-Focused Healthcare Payment Reform
Families USA, American Heart Association, National Consumers League, National Partnerships for Women and Families, and Third Way introduced “A Pro-Consumer Policy Agenda to Achieve Meaningful Health System Transformation.” This Agenda outlines 6 policy priorities necessary to shift America’s health care payment and delivery system away from the inefficiencies of fee-for-service and toward population-based economics.
#All
While New Jersey’s PDAB Has Failed to Launch, Its Counterpart in Colorado Is Making Waves
Last summer, New Jersey Gov. Phil Murphy signed a bill into law that created a Drug Affordability Council, a five-member board designed to gather information about drug prices and make recommendations to the state legislature. However, he missed his own deadline to nominate members to the council. Eight states have now created PDABs, which are sometimes lauded by patient advocacy groups and generally opposed by pharmaceutical manufacturers who fear they may do more harm than good. For example, Colorado’s Prescription Drug Affordability Board voted that the injectable drug Enbrel is unaffordable to patients in the state. The vote allows the board to consider setting a maximum price for Enbrel in Colorado when it meets again next week, which would be the first time any state took that step with any prescription drug. The board also considered Genvoya, a combination pill for HIV, but determined that medication was affordable because of patient assistance programs. The Colorado General Assembly is also considering legislation that would exempt orphan drugs for consideration by the state’s PDAB.
#Drug
EU’s Health Data Plan Draws Ire from US Innovators
Drug and medical device companies warn that a new EU plan for sharing health data could deter firms from conducting research in Europe for fear of competitors learning trade secrets.
