CMS Responding to Data Breach at Contractor

CMS Notifying Potentially Involved Beneficiaries and Providing Information on Free Credit Monitoring

The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have responded to a May 2023 data breach in Progress Software’s MOVEit Transfer software on the corporate network of Maximus Federal Services, Inc. (Maximus), a contractor to the Medicare program, that involved Medicare beneficiaries’ personally identifiable information (PII) and/or protected health information (PHI). No HHS or CMS systems were impacted. Maximus is among the many organizations in the United States that have been impacted by the MOVEit vulnerability. This week, CMS and Maximus are sending letters to individuals who may have been impacted notifying them of the breach, and explaining actions being taken in response. CMS estimates the MOVEit breach impacted approximately 612,000 current Medicare beneficiaries.

CMS and Maximus are notifying Medicare beneficiaries whose PII and/or PHI may have been exposed that they are being offered free-of-charge credit monitoring services for 24 months. This notification also contains information about how impacted individuals can obtain a free credit report, and, for those beneficiaries whose Medicare Beneficiary Identifier number may have been impacted, information on receiving a new Medicare card with a new number.

Below please find a sample of the letter being sent to those who are potentially affected:

 

Dear <<Name 1>>

The Centers for Medicare & Medicaid Services (CMS), the federal agency that manages the Medicare program, and Maximus Federal Services, Inc. (Maximus), are writing to inform you of an incident involving your personal information related to services provided by Maximus. Maximus is a CMS contractor that provides appeals services in support of the Medicare program.

The incident involved a security vulnerability in the MOVEit software, a third-party application which allows for the transfer of files during the Medicare appeals process. Maximus is among the many organizations in the United States that have been impacted by the MOVEit vulnerability.

We are sending you this letter so that you can understand more about this incident, how we are addressing it, and additional steps you can take to further protect your privacy. We are providing information with this notice on free credit monitoring services and, if your Medicare Beneficiary Identifier (MBI) was impacted, will be giving you a new Medicare card with a new Medicare Number. This does not impact your current Medicare benefits or coverage.

What Happened?

Our understanding is as follows:  On May 30, 2023, Maximus detected unusual activity in its MOVEit application. Maximus began to investigate and stopped all use of the MOVEit application early on May 31, 2023. Later that same day, the third-party application provider, Progress Software Corporation, announced that a vulnerability in its MOVEit software had allowed an unauthorized party to gain access to files across many organizations in both the government and private sectors.

Maximus notified CMS of the incident on June 2, 2023. To date, the ongoing investigation indicates that on approximately May 27 through 31, 2023, the unauthorized party obtained copies of files that were saved in the Maximus MOVEit application, but that no CMS system has been compromised. After notifying CMS, Maximus then began to analyze the files to determine which data had been affected. As part of that analysis, it was determined that those files contained some of your personal information.

What Information Was Involved?

We have determined that your personal and Medicare information was involved in this incident. This information may have included the following:

  • Name
  • Social Security Number or Individual Taxpayer Identification Number
  • Date of Birth
  • Mailing Address
  • Telephone Number, Fax Number, & Email Address
  • Medicare Beneficiary Identifier (MBI) or Health Insurance Claim Number (HICN)
  • Driver’s License Number and State Identification Number
  • Medical History/Notes (including medical record/account numbers, conditions, diagnoses, dates of service, images, treatments, etc.)
  • Healthcare Provider and Prescription Information
  • Health Insurance Claims and Policy/Subscriber Information
  • Health Benefits & Enrollment Information

What Are We Doing?

When the incident was discovered, Maximus began an investigation, took the MOVEit application offline, applied MOVEit software patches, and notified law enforcement. CMS is continuing to investigate this incident in coordination with Maximus and will take all appropriate actions to safeguard the information entrusted to CMS.

What Can You Do?

  1. Enroll in Experian Identity and Credit Monitoring Services

Maximus is offering a complimentary 24 months of credit monitoring and other services from Experian at no cost to you. You do not need to use your credit card or any other form of payment to enroll in the service.

Please see Attachment #1 for information on how to utilize your free Experian Services.

  1. Obtain a Free Credit Report

Under federal law, you are entitled to one free credit report every 12 months from each of the three major nationwide credit reporting companies listed above. Call 1-877-322-8228 or request your free credit reports online at www.annualcreditreport.com. When you receive your credit reports, review them for problems. Identify any accounts you didn’t open or inquiries from creditors that you did not authorize. Verify all information is correct. If you have questions or notice incorrect information, contact the credit reporting company.

Even if you don’t find any suspicious activity on your initial credit reports, the Federal Trade Commission (FTC) recommends that you still check your credit reports periodically. Checking your credit report periodically can help you spot problems and address them quickly.

If you find suspicious activity on your credit reports or have reason to believe your information is being misused, call your local law enforcement agency and file a police report. Be sure to obtain a copy of the police report, as many creditors will want the information it contains to absolve you of the fraudulent debts. You may also file a complaint with the FTC by contacting them on the web at www.ftc.gov/idtheft, by phone at 1-877-IDTHEFT (1-877-438-4338), or by mail at Federal Trade Commission, Consumer Response Center, 600 Pennsylvania Avenue, NW, Washington, DC 20580. Your complaint will be added to the FTC’s Identity Theft Data Clearinghouse, where it will be accessible to law enforcement for their investigations. In addition, you may obtain information from the FTC about fraud alerts and security freezes.

Please see Attachment #2 for additional steps you can take to protect your information.

  1. Continue to Use Your Existing Medicare Card

At this time, we are not aware of any reports of identity fraud or improper use of your information as a direct result of this incident. However, if your MBI was impacted, a new Medicare card with a new number will be issued to you. CMS will mail the new card to your address in the coming weeks. In the meantime, you can continue to use your existing Medicare card. After you get your new card, you should:

  1. Follow the instructions in the letter that comes with your new card.
  2. Destroy your old Medicare card.
  3. Inform your providers that you have a new Medicare Number.

For More Information

We take the privacy and security of your Medicare information very seriously. CMS and Maximus apologize for the inconvenience this privacy incident might have caused you.

If you have any further questions regarding this incident, please call the Experian dedicated and confidential toll-free response line at xxx-xxx-xxxx. This response line is staffed with professionals familiar with this incident who know what you can do to protect against misuse of your information. The response line is available Monday through Friday from 8 am – 10 pm Central, or Saturday and Sunday from 10 am – 7 pm Central (excluding major U.S. holidays).

You can also call 1-800-MEDICARE (1-800-633-4227) with any general questions or concerns about Medicare.

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Released: 2024 CMS Broker Compensation Rates

Each year CMS publishes the fair market value amounts for initial and renewal compensation for MA and PDP’s, as well as referral fees.

Review the full amounts below for 2024 provided by CMS.

View Full CMS Release

Important CMS Update to Definition of Marketing Eff July 10, 2023

CMS has made an update to the Definition of Marketing as it relates to Medicare Advantage/PDP.  Any content included in a MA/PDP piece (mailer, flyer, television, social media, website, etc.) that a beneficiary can receive/view that includes mention of benefits such as Dental, Vision, Hearing, and cost-savings, will meet the standard definition of marketing.  Previously, unless a specific dollar amount was listed, these mentions in a piece would not meet the content standard for marketing and the piece would be considered ‘generic communication’. 

Beginning July 10, 2023, any material or activity that is distributed via any means (e.g., mailing, tv., social media, etc.) that mentions any benefit will be considered marketing and must be submitted for review/approval by CMS. 

What do I need to do?

Review any client-facing assets in-use/planned to use on/after July 10, 2023, either created in-house, through a third-party vendor, or from the Marketing team at Cornerstone Senior Marketing (mailers, flyers, brochures, ads, web pages, social media, etc.).  If any contain benefit information, (ie: mention of dental, vision, hearing, travel, cost-savings, etc. in relation to MA/PDP) and have not already been filed with CMS for review/approval, discontinue use or modify, removing benefit information, on or before July 10, 2023. 

 Alternately, you may send any such materials to Cornerstone Senior Marketing to submit to CMS for review/approval.  Please note the review and approval process may take upwards of 75 days to complete and use of the material on/after July 10, 2023, must be suspended until approval is granted.

 

Compliance Services from Cornerstone Senior Marketing

Client-facing materials for the Medicare market, specifically those that include information about MA/PDP, can be submitted for a compliance review prior to use, by sending via email to: compliance@cornerstoneseniormarketing.com.

 

We highly recommend submitting scripts with storyboards for television/video prior to recording or development of these projects to ensure compliance and avoid potential, costly re-work if the content requires changes in order to be compliant.

 

 CLICK TO READ FULL NEWS RELEASE: MAY 10, 2023| CMS NEWSROOM 

CMS Updates on Coverage for COVID-19 Tests

CMS Official Communication from 5/1/23:

What you need to know: 

The COVID-19 Public Health Emergency is to end on May 11, 2023. The ending of the Public Health Emergency may impact an individual’s coverage of COVID-19 tests. We encourage you to know these changes and share the New Consumer Fact Sheet on COVID-19 tests.

 

Consumer Fact Sheets:

 

What to tell consumers:

 

Before May 11, 2023

If you have any type of health insurance, you can get up to eight over-the-counter tests per month with no out-of-pocket costs. Over-the-counter tests are available in most pharmacies and may also be available online for delivery.

 

After May 11, 2023 

Laboratory tests for COVID-19 that are ordered by your provider will still be covered with no out-of-pocket costs for people with Medicare. Over-the-counter tests will still be available, but there may be out-of-pocket costs. Coverage of over-the-counter tests may vary by your insurance type, as described below.

 

What does this mean for Medicare Beneficiaries?

Generally, Medicare doesn’t cover or pay for over-the counter products. The demonstration that has allowed us to offer coverage for COVID-19 over-the-counter tests at no cost ends on May 11, 2023.

 

However, if you are enrolled in Medicare Part B, you will continue to have coverage with no out-of-pocket costs for appropriate laboratory-based COVID-19 PCR and antigen tests, when a provider orders them (such as drive-through PCR and antigen testing or testing in a provider’s office).

 

If you are enrolled in a Medicare Advantage plan, you may have more access to tests depending on your benefits. Check with your plan.

 

What does this mean for people with Medicaid or Children’s Health Insurance Program? 

If you have coverage through Medicaid or the Children’s Health Insurance Program, you will have access to COVID-19 over-the-counter and laboratory testing through September 30, 2024. After that date, coverage of testing may vary by state.

 

What does this mean for people with Private Insurance?

If you have private insurance, coverage will vary depending on your health plan. However, private plans won’t be required by federal law to cover over-the counter and laboratory-based COVID-19 tests after May 11, 2023.

 

If your insurance chooses to cover COVID-19 testing, they may require cost sharing, prior authorization, or other forms of medical management.

CMS: FAQ’s on CMS Waivers, Flexibilities, and the end of the COVID -19 Public Health Emergency

The Department of Health and Human Services is planning for the federal Public Health Emergency for COVID-19 (PHE), declared under Section 319 of the Public Health Service Act, to expire at the end of the day on May 11, 2023. Today, the Centers for Medicare & Medicaid Services (CMS) issued FAQs on CMS Waivers, Flexibilities, and the End of the COVID-19 PHE. The FAQs will help you prepare for the expiration of the COVID-19 PHE and are relevant for all CMS programs; including, Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and private insurance.

CMS resources for the expiration of the COVID-19 PHE:

 

CMS UPDATE

FOR IMMEDIATE RELEASE
April 17, 2023

Contact: CMS Media Relations
CMS Media Inquiries

Today, the Biden-Harris Administration, through the Centers for Medicare & Medicaid Services (CMS), announced measures that will make coverage more accessible, expand behavioral health care access, simplify choice, and make it easier for millions of Americans to select a health plan in 2024. 

“The Biden-Harris Administration has worked tirelessly to expand access to health insurance and lower health care costs for America’s families,” said HHS Secretary Xavier Becerra. “Today’s announcement of the 2024 Notice of Benefit and Payment Parameters Final Rule is a step forward toward creating a health care system which prioritizes equity, access, and affordability. HHS remains committed to removing barriers to care to ensure quality health care is within reach for everyone who needs it.” 

“We’ve made great progress with record insured rates, but affordable health care remains a concern across the nation,” said CMS Administrator Chiquita Brooks-LaSure. “As we continue to work toward accessible and equitable health care for all Americans, the 2024 Notice of Benefit and Payment Parameters Final Rule we’re finalizing today will make it easier for consumers to access, choose and maintain the health coverage that best fits their needs.”

The 2024 Notice of Benefit and Payment Parameters Final Rule (final 2024 Payment Notice) finalizes standards for issuers and Marketplaces, as well as requirements for agents, brokers, web-brokers, and Assisters that help consumers with enrollment through Marketplaces that use the federal platform. These changes further the Biden-Harris Administration’s goals of advancing health equity by addressing the health disparities that underlie our health system, such as strengthening network adequacy standards and creating a new special enrollment period (SEP) for those who lose Medicaid or Children’s Health Insurance Plan (CHIP) coverage, among others. The rule also builds on the Affordable Care Act by expanding access to quality, affordable health coverage and care, especially behavioral health care, and making it easier to select and enroll in health coverage. 

Making it easier to enroll in coverage 

While the administration previously announced a temporary SEP for individuals losing Medicaid or CHIP until July 31, 2024 in recognition of the end of the continuous coverage requirement in Medicaid, the final rule establishes a permanent policy. Beginning January 1, 2024, Federally-facilitated Marketplaces (FFMs) and State-based Marketplaces (SBMs) will have the option to implement a new SEP for people losing Medicaid or CHIP coverage, allowing consumers to select a plan for Marketplace coverage 60 days before, or 90 days after, losing Medicaid or CHIP coverage. This SEP works to reduce gaps in coverage and allows for a more seamless transition into Marketplace coverage. 

The final rule also allows Assisters to provide more convenient and efficient help to consumers.  Assisters currently conduct direct outreach, education, and schedule follow-up appointments, but are generally prohibited from providing enrollment assistance upon an initial interaction if initiated by the Assister. Removing this barrier will make it easier for consumers to get help when enrolling in coverage. Additionally, this policy change will likely improve health literacy in rural and underserved communities and reduce burden on consumers, especially for consumers with a lack of access transportation, inflexible job schedules, and those who are immunocompromised. 

Increasing access to health care services 

Expanding access to behavioral health care remains a top priority for the Biden-Harris Administration. As part of that effort, the final rule includes two new essential community provider (ECP) categories that are critical to delivering needed behavioral health care: Substance Use Disorder Treatment Centers and Mental Health Facilities. 

The final rule will also help expand access to care by extending the requirement for plans to contract with at least 35% of available ECPs in a plan’s service area to apply to two individual ECP categories: Federally Qualified Health Centers and Family Planning Providers. The overall 35% threshold requirement also remains in place. These changes, in conjunction with other expanded Network Adequacy requirements in the final rule, increase provider choice, advance health equity, and expand access to care for consumers who have low incomes, complex or chronic health care conditions, or who reside in underserved areas, as these consumers are often disproportionately affected by unanticipated costs associated with out-of-network providers and limited access to providers. 

Simplifying choice and improving the plan selection process 

The final rule includes provisions to make it easier for consumers to select a health plan that best fits their individual needs and budget by refining designs for standardized plan options. The final rule is also limiting the number of non-standardized plan options offered by issuers of qualified health plans (QHPs) through the FFMs and SBMs on the Federal Platform (SBM-FPs) to four in each area for the 2024 plan year. This will reduce plan choice overload while continuing to provide a robust number of options for consumers to help fit their health needs. 

For more information on the final rule, consult the fact sheet: https://www.cms.gov/newsroom/fact-sheets/hhs-notice-benefit-and-payment-parameters-2024-final-rule

How 2024 Medicare Part D drug coverage is changing and will help save on prescription costs.

Article from Q1Medicare.com

Category: Annual Medicare Plan Changes
Published: Apr, 04 2023 09:04:59

The Centers for Medicare and Medicaid Services (CMS) released the “Announcement of Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies” (Rate Announcement) on March 31, 2023 and the 2024 Rate Announcement includes the finalized defined standard Part D benefit increases for 2024 Medicare drug plan coverage.

 

READ FULL ARTICLE HERE! 

HHS Updates 2024 Medicare Advantage Program and Part D Payment Policies

CMS NEWS

 

FOR IMMEDIATE RELEASE

March 31, 2023

 

Contact: CMS Media Relations

(202) 690-6145 | CMS Media Inquiries

HHS Updates 2024 Medicare Advantage Program and Part D Payment Policies

 

Updated Medicare Advantage and Part D policies ensure the overall Medicare program remains strong and stable for the 65 million beneficiaries today and future generations to come, payments to private insurance companies are accurate, and taxpayer dollars are well spent.

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), released the Calendar Year (CY) 2024 Medicare Advantage (MA) and Part D Rate Announcement that finalized payment policies for these programs. The final policies in the Rate Announcement improve payment accuracy and ensure taxpayer dollars are well spent. CMS will phase-in certain updates, and on average, CMS anticipates a payment increase for MA plans of 3.32% from 2023 to 2024, which is approximately a $13.8 billion increase in MA payments for next year.

The Biden-Harris Administration is committed to protecting and strengthening Medicare, and delivering quality health care for Medicare beneficiaries today and in the future. Today’s payment rule will ensure that benefits remain strong and stable for beneficiaries and that payments are accurate and appropriate. The Administration is committed to holding health insurance companies that participate in the Medicare Advantage program accountable to America’s seniors.

“This year’s update strengthens Medicare for our seniors and Americans with disabilities,” said HHS Secretary Xavier Becerra. “We are committed to ensuring private companies are holding up their end of the deal to provide quality care to beneficiaries and that payments to these companies are accurate. Together with President Biden’s Budget, this update protects Medicare for beneficiaries today and beyond 2050.”

“Medicare should be providing equitable, high-quality affordable care that will be available for our children and grandchildren,” said CMS Administrator Chiquita Brooks-LaSure. “Paying Medicare Advantage plans more accurately for the care they provide is how we ensure that people enrolled in Medicare Advantage, especially populations with the highest health disparities and people in underserved communities, can continue to access the care they deserve.”

In addition to today’s final rule, the Biden-Harris Administration has taken action to make the Medicare program stronger and hold industry accountable. This year, it will start recovering improper payments made to insurance companies in Medicare Advantage. Recovering these improper payments and returning this money to the Medicare Trust Funds will protect the fiscal sustainability of Medicare and allow the program to better serve seniors and people with disabilities.

The Administration has also proposed policies to strengthen the MA managed care program that will hold health insurance companies to higher standards by:

  • cracking down on abusive and confusing marketing schemes;
  • addressing problematic prior authorization practices that prevent timely access to needed care;
  • making it easier to access vital behavioral health care; and
  • raising the bar on quality and driving toward more equitable care.

Taken together, these actions will make the overall Medicare program stronger.

“The commonsense policies in the Rate Announcement ensure these important programs continue to meet the health care needs of all people with Medicare while improving the quality and long-term stability of the Medicare program,” said CMS Deputy Administrator and Director of the Center for Medicare Meena Seshamani, MD, Ph.D.

The Rate Announcement finalizes updates to MA payment growth rates and changes to the MA and Part D payment methodologies. These include technical and clinical updates to the MA risk adjustment model to keep it up to date and improve payment accuracy. Two such changes are the transition to the Internal Classification of Diseases (ICD)-10 system, which is the coding classification system used throughout the U.S health care system since 2015, and updated data years. Modernizing the Medicare Advantage risk adjustment model by aligning it with the ICD-10 system will ensure the payment models are using more up-to-date data – bringing Medicare Advantage payments in line with current health care practices and making them consistent with other federal health care programs. The finalized risk adjustment model also reflects revisions focused on conditions that are subject to more coding variation. As in past years, CMS is finalizing policies to address these inconsistencies in order to ensure the model more accurately predicts medical costs.

The changes in risk adjustment payment policies finalized as part of this Rate Announcement were developed in collaboration with expert clinicians to take into account how well different conditions predict costs. The policies finalized in this Rate Announcement will help make more accurate payments. This reduces incentives to cherry-pick healthy beneficiaries and discriminate against sicker patients. In addition, CMS will continue to pay more for someone who is dually eligible for Medicare and Medicaid than someone who is not when they have the same diagnoses.

In finalizing these proposed policies, CMS is making commonsense updates to ensure the MA program remains strong and viable. Consistent with prior practice, CMS will phase in both the technical revisions to the risk adjustment model and changes to the per capita cost calculations to better account for medical education costs over a period of three years.

View a fact sheet on the CY 2024 Medicare Advantage and Part D Rate Announcement.

The 2024 Rate Announcement can be viewed at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2024 Announcement.”

 

CMS Press Release: HHS Secretary Responds to the President’s Executive Order on Drug Prices

FOR IMMEDIATE RELEASE
February 14, 2023 

Action announces new models and supports access to $2 generic drugs

Today, the Centers for Medicare & Medicaid Services (CMS) announced that the Secretary of the Department of Health and Human Services (HHS) has selected three new models for testing by the CMS Innovation Center to help lower the high cost of drugs, promote accessibility to life-changing drug therapies, and improve quality of care. The Secretary released a report describing these three models to respond to President Biden’s Executive Order 14087, “Lowering Prescription Drug Costs for Americans,” which complements the historic provisions in the Inflation Reduction Act of 2022 (IRA) that will lower prescription drug costs.

“HHS is using every tool available to us to lower health care costs and increase access to high-quality, affordable health care,” said HHS Secretary Xavier Becerra. “We are full steam ahead in delivering the cost savings from the President’s Inflation Reduction Act of 2022, and people on Medicare are already feeling the benefits. But as President Biden has made clear, we must build on the new prescription drug law with further action, which is why HHS is implementing these new projects to bring down prescription drug costs.”

“Prescription drug prices in the United States are the highest in the developed world, resulting in affordability and access challenges,” said CMS Administrator Chiquita Brooks-LaSure. “The prescription drug law is making lifesaving prescription drugs more affordable for millions of people who have Medicare, and through the selected models, the Innovation Center will lower prescription drug costs and improve access for people with Medicare and Medicaid, ranging from $2 access to certain generic drugs to better deals for expensive new therapies.”

Tackling the high costs of prescription drugs and increasing access to novel therapies continue to be priorities of the Biden-Harris Administration. As part of the Inflation Reduction Act of 2022, for the first time in history, Medicare will be able to negotiate lower prescription drug prices for beneficiaries, and starting this year, drug companies that raise their prices faster than inflation will have to pay Medicare a rebate. But the Administration recognizes there is more work to do to lower prescription drug costs for more American families. That’s why on October 14, 2022, President Biden issued an executive order directing Secretary Becerra to consider additional actions to further drive down prescription drug costs. In particular, the executive order directs the Secretary to consider whether to select for testing, by the CMS Innovation Center, new health care payment and delivery models that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care.

“These selected models will test strategies to make it easier for Medicare patients to afford and access needed prescriptions at $2 or less, help expand access to cutting-edge cell and gene therapies for people with Medicaid, and help ensure drugs already on the market are safe and effective,” said CMS Deputy Administrator and Director of the CMS Innovation Center Liz Fowler, PhD, JD. “We look forward to working on these models and helping to lower drug costs for Americans with Medicare and Medicaid.”

The three models selected by the Secretary for testing by the CMS Innovation Center and described in the report address the themes outlined in the executive order and meet the selection criteria thresholds of affordability, accessibility, and feasibility of implementation. The models are:

  • The Medicare $2 Drug List: For chronic conditions like high blood pressure and high cholesterol, there are many relatively inexpensive generic medications that have significant clinical benefits, but cost-sharing can vary widely across insurance plans based on the specific formulation a doctor prescribes. This means patients may experience unexpected changes in their cost-sharing and may pay more than they have to. Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that participate in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.
  • The Cell and Gene Therapy Access Model: Cell and Gene Therapies are an emerging area of new drug development that holds significant potential, but these therapies can cost upwards of $1 million. Under this model, state Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies. As new therapies come to market, this will help Medicaid beneficiaries gain access to potentially life-changing, high-cost specialty drugs for illnesses like sickle cell disease and cancer.
  • The Accelerating Clinical Evidence Model: Some drugs are approved before they have established evidence of improvement in a clinical endpoint, which is called accelerated approval. CMS would develop payment methods for drugs approved under accelerated approval, in consultation with the Food and Drug Administration, to encourage timely confirmatory trial completion and improve access to post-market safety and efficacy data. This would reduce Medicare spending on drugs that have no confirmed clinical benefit.

To help identify model options, the CMS Innovation Center solicited input from a variety of sources, including beneficiary advocates, health care providers, prescription drug manufacturers, and more. The CMS Innovation Center looks forward to additional input as these models are further developed.

In addition to the three selected models, the Secretary has identified additional areas for research with the potential to lower prescription drug costs. The CMS Innovation Center looks forward to feedback on these ideas and will continue research into the design and feasibility of these ideas.

For more information on the selected models and the additional areas of research that address the executive order, a Fact Sheet is available at https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report-summary.

Frequently Asked Questions are available at https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report-faqs.

View the report at https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report.

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Biden Administration Releases Timeline IRA Medicare Provisions

Biden Administration Releases Timeline for Implementation of Inflation Reduction Act Medicare Provisions

The administration released a timeline for implementation of certain Inflation Reduction Act (IRA) provisions, including provisions related to Medicare drug price negotiations.

As we have mentioned previously, the IRA grants the secretary of HHS the ability to negotiate the prices of certain drugs for the Medicare program with new prices beginning in 2026. Ten Part D drugs will be negotiated in 2026, with an additional 15 Part D drugs in 2027, 15 Part B or D drugs in 2028, 20 Part B or D drugs in 2029, and 20 more drugs each year beyond that. The bill dictates that the secretary can only negotiate prices on costly single-source drugs, those among the highest-spend products in Part B or Part D that do not have competing small-molecule generics or biosimilars that are both FDA-approved and marketed. The legislation also exempts “small biotech drugs” from negotiation until 2028….

 

READ FULL ARTICLE

PLUS! DOWNLOAD A CMS PDF OF THE IRA TIMELINE FOR A QUICK REFERENCE