CMS CY2025 MA & Part D Final Rule

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Background

On April 4, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that revises the Medicare Advantage Program, Medicare Prescription Drug Benefit Program (Medicare Part D), Medicare Cost Plan Program, Programs of All-Inclusive Care for the Elderly (PACE), and Health Information Technology Standards and Implementation Specifications. Additionally, this final rule addresses several key provisions that remain from the CY 2024 Medicare Advantage and Part D proposed rule, CMS-4201-P, published on December 14, 2022. Together, the changes in this final rule build on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. In addition, these policies promote access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.

This fact sheet discusses the major provisions of the 2025 final rule which can be downloaded here: https://www.federalregister.gov/public-inspection/2024-07105/medicare-program-medicare-advantage-and-the-medicare-prescription-drug-benefit-program-for-contract

 

CMS Newsroom Medicare Part D

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Final CY 2025 Part D Redesign Program Instructions Fact Sheet

| Medicare Part DToday, the Centers for Medicare & Medicaid Services (CMS) released the Final Calendar Year (CY) 2025 Part D Redesign Program Instructions (the Final Program Instructions) concurrently with the CY 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Rate Announcement). The purpose of the Final Program Instructions is to provide interested parties with guidance for CY 2025 regarding, among other topics, the implementation of section 11201 of the Inflation Reduction Act of 2022 (IRA) (P.L. 117-169), signed into law on August 16, 2022, which made several amendments and additions to the Social Security Act (“the Act”) that affect the structure of the defined standard Part D drug benefit.

READ FULL RELEASE

Prepare for a potential shift in the Medicare Agent/FMO distribution model

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Exclusively from our partners at Deft Research:

The Value of the Health Insurance Agent/FMO Model

DEFT RESEARCH SPECIAL EXECUTIVE RESEARCH BRIEF

 

CLICK HERE TO READ FULL BRIEF 

CMS Releases Revised Guidance for Medicare Prescription Drug Inflation Rebate Program

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December 14, 2023

Contact: CMS Media Relations
CMS Media Inquiries

FOR IMMEDIATE RELEASE
December 14, 2023Contact: CMS Media Relations
CMS Media Inquiries

 

CMS Releases Revised Guidance for Medicare Prescription Drug Inflation Rebate Program 

Under President Biden’s lower-cost prescription drug law, drug companies will pay rebates to Medicare for raising prescription drug prices faster than the rate of inflation

 

As a result of President Biden’s historic prescription drug law, the Inflation Reduction Act, drug companies will pay rebates to Medicare when prices of certain prescription drugs administered or dispensed to people with Medicare increase faster than the rate of inflation. In addition, people with Medicare may pay a lower coinsurance for some Part B drugs if the drugs’ prices increase faster than the rate of inflation.

Today, the Centers for Medicare & Medicaid Services (CMS) released revised guidance detailing key requirements and procedures for calculating rebates and invoicing manufacturers that owe rebates to Medicare under the Medicare Prescription Drug Inflation Rebate Program for certain drugs covered under Medicare Part B and Part D. CMS also released the list of 48 prescription drugs for which Part B beneficiary coinsurances may be lower between January 1, 2024 – March 31, 2024. Some people with Medicare who take these drugs may save between $1 and $2,786 per average dose starting January 1, 2024, depending on their individual coverage.

“The Inflation Reduction Act is making health care and prescription drugs more affordable while improving the sustainability of the Medicare program,” said CMS Administrator Chiquita Brooks-LaSure. “The Medicare Prescription Drug Inflation Rebate Program is an important tool to discourage excessive price increases and protect people with Medicare, and today’s revised guidance for the Inflation Rebate Program finalizes key requirements and outlines the process by which CMS will calculate and invoice inflation rebates beginning in 2025.”

When drug companies of certain drugs covered under Medicare Part B and Part D raise prices at a rate that exceeds the rate of inflation, these drug companies will pay rebates to the Medicare Trust Fund under the Medicare Prescription Drug Inflation Rebate Program. CMS will issue invoices to drug companies for these rebates starting in 2025, including for years 2022, 2023, and 2024. The Part D inflation rebate period began on October 1, 2022, and the Part B inflation rebate period began on January 1, 2023. In addition, CMS will continue to apply lower beneficiary coinsurances for certain Part B drugs if prices increase faster than inflation. Including the drugs announced today, CMS has lowered coinsurance for 64 drugs and biologicals.

CMS issued initial guidance on the Medicare Prescription Drug Inflation Rebate Program in February 2023 and voluntarily sought public comment on key topics. The agency received and analyzed more than 90 comments on the initial guidance from consumer and patient groups, drug companies, and other interested parties.

CMS gathered feedback on how best to address challenges drug companies are facing due to likely or actual drug shortages and severe supply chain disruptions, particularly for events outside of their control, and provides for appropriate reduced rebate amounts consistent with the Inflation Reduction Act. The revised guidance also includes guardrails to minimize incentives for drug companies to remain on a shortage list, delay resolving a severe supply chain disruption, or maintain a situation in which a generic drug would be at risk of shortage in order to avoid paying an inflation rebate. While the inflation rebates do not apply to multi-source generic drugs, which are the drugs most likely to be in shortage, the revised guidance provides a greater rebate reduction for Part D sole-source generic drugs as well as Part B and Part D plasma-derived products in shortage.

“Today’s guidance strikes a balance between discouraging large price increases by drug companies and providing appropriate relief to drug companies experiencing shortages or severe supply chain disruptions,” said Dr. Meena Seshamani, M.D., Ph.D., CMS Deputy Administrator and the Director of the Center for Medicare. “Our goal at CMS is to make sure drugs are more affordable and accessible, which includes helping to safeguard and ensure that the pharmaceutical supply chain can deliver critical medicines to providers and patients.”

Key dates for implementing the Medicare Prescription Drug Inflation Rebate Program include:

  • October 1, 2022: Began the first 12-month period for which drug companies will be required to pay rebates to Medicare for raising prices that outpace inflation on certain Part D drugs.
  • January 1, 2023: Began the first quarterly period for which drug companies will be required to pay rebates for raising prices that outpace inflation on certain Part B drugs.
  • April 1, 2023: Some people with Traditional Medicare and Medicare Advantage started paying a lower coinsurance for certain Part B drugs with prices increasing at a rate faster than inflation.
  • 2025: CMS intends to send the first invoices to drug companies for the rebates owed.

View a fact sheet on the Medicare Prescription Drug Inflation Rebate Program revised guidance.

Read the Medicare Part B Prescription Drug Inflation Rebate revised guidance.

Read the Medicare Part D Prescription Drug Inflation Rebate revised guidance.

The lower Part B coinsurance on the list of drugs will be in effect from January 1, 2024, to March 31, 2024. This coinsurance adjustment applies to certain drugs and biologicals paid under Medicare Part B. The Part B drugs impacted by this coinsurance adjustment may change quarterly.

More information about these 48 Part B drugs and biological products can be found in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.

View an ASPE fact sheet on prescription drugs with reduced coinsurances in 2023.

 

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CMS Newsroom: Biden-Harris Administration Proposes to Protect People with Medicare Advantage and Prescription Drug Coverage from Predatory Marketing…

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FOR IMMEDIATE RELEASE
November 6, 2023

Biden-Harris Administration Proposes to Protect People with Medicare Advantage and Prescription Drug Coverage from Predatory Marketing, Promote Healthy Competition, and Increase Access to Behavioral Health Care in the Medicare Advantage Program

Today, the Biden-Harris Administration is proposing important steps to strengthen Medicare Advantage and the Medicare Prescription Drug Benefit Program (Part D). As part of his Bidenomics agenda, President Biden has worked to increase competition in the health care industry and other sectors, lower costs for families, and make sure every American has access to affordable, high-quality health care.

The Centers for Medicare & Medicaid Services’ (CMS’) proposed rule will help people with Medicare select and enroll in coverage options that best meet their health care needs by preventing plans from engaging in anti-competitive steering of prospective enrollees based on excessive compensation to agents and brokers, rather than the enrollee’s best interests. The proposed guardrails protect people with Medicare and promote a competitive marketplace in Medicare Advantage, consistent with the goals of President Biden’s historic Executive Order on Promoting Competition in the American Economy.

The proposed rule will also improve access to behavioral health care by adding a new facility type that includes several behavioral health provider types to Medicare Advantage network adequacy requirements. CMS is also proposing policies to increase the utilization and appropriateness of supplemental benefits to ensure taxpayer dollars actually provide meaningful benefits to enrollees. Additionally, the proposed rule would improve transparency on the effects of prior authorization on underserved communities and proposes more flexibility for Part D plans to more quickly substitute lower cost biosimilar biological products for their reference products.

“The Biden-Harris Administration remains committed to making health care more affordable and accessible for all Americans. By ensuring Medicare recipients have the information they need to make critical decisions about their health care coverage, we are doing just that,” said U.S. Department of Health and Human Services Secretary Xavier Becerra. “Promoting competition in the marketplace helps to lower costs and protect access to care while making the whole process more transparent and accountable.”

“CMS continues to improve the Medicare Advantage and Part D prescription drug programs and maintain high-quality health care coverage choices for all Medicare enrollees,” said CMS Administrator Chiquita Brooks-LaSure. “People with Medicare deserve to have accurate and unbiased information when they make important decisions about their health coverage. Today’s proposals further our efforts to curb predatory marketing and inappropriate steering that distorts healthy competition among plans.”

CMS has previously taken unprecedented steps to address predatory marketing of Medicare Advantage plans, such as banning misleading TV ads. Many people on Medicare rely on agents and brokers to help navigate Medicare choices. CMS is concerned that some Medicare Advantage plans are compensating agents and brokers in a way that may circumvent existing payment rules, inappropriately steer individuals to enroll in plans that do not best meet their health care needs, and lead to further consolidation in the Medicare Advantage market. To further protect people with Medicare through stronger marketing policies and to promote a competitive marketplace in Medicare Advantage, CMS is proposing added guardrails to plan compensation for agents and brokers, including standardization. These proposals are consistent with the statutory requirement that CMS develop guidelines to ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage plan that is intended to best meet their health care needs.

CMS also proposes to strengthen and improve access to behavioral health care by adding a new facility type, which includes marriage and family therapists, mental health counselors, addiction medicine clinicians, opioid treatment providers, and others, to CMS’ Medicare Advantage network adequacy requirements. This proposed addition builds on changes finalized last year to strengthen these requirements and would ensure people with Medicare Advantage can access vital mental health and substance use disorder treatment.

“The people we serve are at the center of the Medicare program, and we work each day to make sure the program works for them. Agents and brokers play an important role in guiding people with Medicare to the option that is tuned in to their medical needs. Our proposals on how plans compensate agents and brokers seek to support a competitive marketplace that best serves people with Medicare,” said Dr. Meena Seshamani, CMS Deputy Administrator and Director of the Center for Medicare.

Currently, 99% of Medicare Advantage plans offer at least one supplemental benefit. Over time, the benefits offered have become broader in scope and variety, with more rebate dollars directed toward these benefits. CMS is committed to ensuring these offerings are effectively reaching enrollees and actually meeting their needs, and not just used for attracting enrollees. In today’s rule, CMS proposes requiring Medicare Advantage plans to send a personalized notification to their enrollees mid-year of the unused supplemental benefits available to them to encourage higher utilization. Furthermore, CMS is proposing additional requirements designed to help ensure that benefits offered as special supplemental benefits for the chronically ill (SSBCI) are backed by evidence. CMS is also proposing new marketing and transparency guardrails around these benefits. These proposals will help ensure a robust and competitive Medicare Advantage marketplace made up of plan options with meaningful benefits.

Additionally, CMS is concerned that certain prior authorization policies may disproportionately inhibit access to needed care for underserved enrollees. To provide additional safeguards, CMS is proposing to require that Medicare Advantage plans include an expert in health equity on their utilization management committees and that the committees conduct an annual health equity analysis of the plans’ prior authorization policies and procedures. This analysis would examine the impact of prior authorization on enrollees with one or more of the following social risk factors—eligibility for Part D low-income subsidies, dual eligibility for Medicare and Medicaid, or having a disability—compared to enrollees without these risk factors. These analyses would have to be posted publicly to improve transparency into the effects of prior authorization on underserved populations. To further promote health equity, CMS is also proposing to streamline enrollment options for individuals with both Medicare and Medicaid, providing more opportunities for integrated care.

To support competition in the prescription drug marketplace, CMS is also proposing to provide more flexibility to substitute biosimilar biological products other than interchangeable biological products for their reference products to give people with Medicare more timely access to lower-cost biosimilar drugs. This proposal would permit Part D plans to treat such substitutions as maintenance changes so that the substitutions apply to all enrollees, not only those who begin the therapy after the effective date of the change, following a 30-day notice.

There will be a 60-day comment period for the notice of proposed rulemaking, and comments must be submitted at one of the addresses provided in the Federal Register no later than January 5, 2024. The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/2023-24118/medicare-program-contract-year-2025-policy-and-technical-changes-to-the-medicare-advantage-program

View a fact sheet on the proposed rule at cms.gov/newsroom.

View the CMS Blog Important New Changes to Improve Access to Behavioral Health in Medicare at https://www.cms.gov/blog/important-new-changes-improve-access-behavioral-health-medicare-0

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Just Released: 2024 Medicare Parts A & B Premiums & Deductibles

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On October 12, 2023, the Centers for Medicare & Medicaid Services (CMS) released the 2024 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs, and the 2024 Medicare Part D income-related monthly adjustment amounts.

 

CLICK TO READ THE FULL CMS RELEASE

CMS Responding to Data Breach at Contractor

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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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Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSgov

 

Released: 2024 CMS Broker Compensation Rates

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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

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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

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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.