PMC Letters

 UHC on PGX Panels

https://www.personalizedmedicinecoalition.org/wp-content/uploads/2024/12/letter.pdf

AHRQ on MCED (Drafts)

https://www.personalizedmedicinecoalition.org/wp-content/uploads/2024/11/PMC-AHRQ-MCED-FINAL-022420251.pdf

Above, sounds like AHRQ posted and (as custom) pulled down a draft after a review period.

Means Testing Medicare (Letter)

"Means Testing Medicare" WSJ

https://www.wsj.com/opinion/means-testing-medicare-would-do-no-harm-spending-rich-healthcare-d48a7441

BQ:

Means-testing Medicare is much odder than this indicates, and I'm glad comments are open. 

First, Medicare Part B and Part D are heavily means testing - earn $150K while getting Medicare and your premium will be $1000 a month, not $200. Part B and D are minimaly subsidized today, for higher-earners. 

Second, Medicare Part A is the same for everyone. But if you want free markets for "the top 20 percenters," and no government involved, look to having exclusion for pre-existing conditions in 75 year olds, and look to hospitalizations costing $300,000 out of pocket instead of the $30,000 Medicare Part A pays at. 

Richardson Waiver 1971

 Office of the Secretary

PUBLIC PARTICIPATION IN RULE MAKING
Statement of Policy

Notice is hereby given of a statement of policy on public participation in rule making issued by the Secretary. As a matter of policy, the Department will use notice of proposed rule making procedures in certain cases where not required by law. The Secretary's statement reads as follows:

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Generally, before rules and regulations are issued by Government agencies, the Administrative Procedure Act (APA) provides that notice of the proposed rule making must be published in the Federal Register and interested persons must be given an opportunity to participate in the rule making through submission of data, views, or arguments.

The APA exempts from this requirement matters relating to public property, loans, grants, benefits, or contracts. Legislation has been introduced to repeal this exemption. The Administrative Conference of the United States has recommended, however, that Government agencies require public participation in accordance with the APA provisions when formulating rules in the five exempt categories listed above, without waiting for the statute to be amended.

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Our implementation of the Conference's recommendation should result in greater participation by the public in the formulation of this Department’s rules and regulations. The public benefit from such participation should outweigh any administrative inconvenience or delay which may result from use of the APA procedures in the five exempt categories.

Effective immediately, all agencies and offices of the Department which issue rules and regulations relating to public property, loans, grants, benefits, or contracts are directed to utilize the public participation procedures of the APA, 5 U.S.C. 553. Although the APA permits exceptions from these procedures when an agency for good cause finds that such procedures would be impracticable, unnecessary or contrary to the public interest, such exceptions should be used sparingly, as for example in emergencies and in instances where public participation would be useless or wasteful because proposed amendments to regulations cover minor technical matters.

Dated: January 28, 1971.

RODNEY H. BRADY,
Assistant Secretary for Administration.

[FR Doc. 71-1604 Filed 2-4-71; 8:48 am]

ALSO:

https://archives.federalregister.gov/issue_slice/1971/2/5/2527-2534.pdf#page=6

36 FR 2532   January 28, 1971 (dated) February 5, 1971 (published)

My Encounter with RFK Jr; Radical Ideas for HHS Innovation?

Ok, I did not have a "meeting" with RFK Jr, but we did have an "encounter" - said hello to each other on a flight from Washington to LAX on Friday.   Interestingly, this led me to four or five ideas about HHS innovation on the way home in an Uber.   

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The principal here is that change could be sudden and unsettling.   For example, in the last couple days the House voted for what could become large cutbacks in some parts of Medicaid, while HHS issued a policy change (see Fed Reg March 3) rescinding a 1971 position regarding the Administrative Procedures Act (APA).   

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FDA LDT Court Case

The ACLA/AMP challenge to the FDA LDT regulation continues.  I've generally felt they had a strong case, both as to the definition of "device" (not a roomful of people), and because inflicting billions of costs on the lab industry for millions of pages of paperwork was not the best ROI on improving lab quality.

Bump for FDA:  We've got a very active, strongly opinionated Republican administration that has newly thrown its weight behind the FDA LDT regulation.   (There's an alternative universe where they might not have, especially with the tsunami of anti-regulation moves).  

Is a Republican judge more likely to support a Republican agency supported by a Republican Department of Justice?   Maybe.   Hard to weight, but a factor now.

Bump for ACLA/AMP:  HHS and FDA are still being populated with executives, many from the Trump I administration, see an excellent open-access posting from AgencyIQ by Joshua Sztorc and Laura DiAngelo at LinkedIn.  

Under this theory, the support of the FDA LDT rule by DOJ in a recent oral hearing might be viewed as provisional, subject to review especially if FDA-DOJ lose the first round in court.

Pressure on Medicare Finances and Fee Levels

According to the AMA, practice costs have risen 60% since 2001, yet physician fees having risen only 10%.   This grim pressure seems positioned to continue.   Could Medicare fee for service shift into a zone where substantially fewer physicians except it (like Medicaid?)   That's a tough one, since Medicare patients are such a large part of the population needing healthcare.   But let's consider.

Two radical cracks could be balance-billing and concierge fees.  Since changes in the 1990s, balance-billing isn't allowed.  So somebody decides to change that. Such a change may seem radical, but we live in fast-changing times that see unexpected events.  

Similarly, concierge fees (like $500 per year) aren't allowed, but there are already some workarounds like providing non-covered "wellness support" or other extra-Medicare services.   Loosening up enforcement could occur.  If a practice has 500 patients, and adds a $500 fee, it's $250,000 gross.  See a long Chat GPT dialog on these topics here.

MolDx Z Codes as a National Code Set?

Why do we have ICD-10 codes for diagnosis and CPT codes for outpatient procedures?  It's in the Code of Federal Regulations, at 45 CFR 161.1002, called "Medical data code sets."  It dates back to the year 2000 (65 FR 50312).   

MolDx Z-codes are not part of this, as lab tests are today specified to be coded either under HHS HCPCS codes or AMA CPT codes - full stop.  However, in the space of a few months, CMS could issue a regulation and finalize it, that adds a pphrase about Z codes into these lines of regulations.   While this is only a pipedream, let's assume that Z codes could then be the primary codes for their services (making claims processing unexceptional) and let's assume that like the AMA, Palmetto could maintain full copyright control (or even set licenses).  Z codes would not have to be co-billed with 81479 any more, since they'd be primary 5-place codes, and AMA service fees would not apply, nor would AMA be able to make unexpected year-to-year policy changes as it can with PLA codes.   

CMS: Fossilized NCDs and 14 Day Rules

It's widely discussed now that CMS NCD 90.2 (regarding NGS testing in cancer) is badly out-of-whack and out-of-date.   And the bizarrely-worded and cryptic "14-day-rule" continues to be a mess, most severely for cancer inpatients.   (We can credit the first Trump administration for revising the 14-day-rule for outpatients.)   

Yet most stakeholders and experts will predict the timeline for changing any of this is years (or never).   Necessary changes would be only a few sentences long, and could be completed in months. Or maybe even faster under the March 3 decision at HHS pulling many decisions out-of-scope of the APA requirements for notice-and-comment (see opening of this blog.)

Chat GPT and Medicare Policy: Balance Billing, Concierge, Medicare Advantage by State

This is a historical question about the Medicare program for physicians, when did the Medicare part b program stop allowing balance billing? I think it might’ve been in the 1980s or 1990s, however, I do not know the history of this policy feature.

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The Medicare Part B program never fully banned balance billing, but significant restrictions were introduced in the 1980s and 1990s to limit how much physicians could bill above Medicare's allowed amount. Here’s a historical timeline of key balance billing restrictions:

1. 1984 – Participating Physician Agreements: Medicare introduced financial incentives for physicians to become participating providers, meaning they agreed to accept Medicare's approved amount as full payment (i.e., no balance billing).

2. 1989 – Omnibus Budget Reconciliation Act (OBRA 1989): This law introduced the "limiting charge" for non-participating physicians, capping how much they could balance bill. By 1993, the limit was set at 115% of Medicare’s approved amount for services.

3. 1990s – Expansion of Assignment and Limiting Charge Rules:

   • By the mid-1990s, more than 90% of physicians accepted Medicare assignment, meaning they agreed not to balance bill.
   • The limiting charge (115% of the Medicare fee schedule) was applied across nearly all non-participating physicians.

4. 1997 – Balanced Budget Act (BBA 1997): Introduced private contracting under Medicare, allowing physicians to fully opt out of Medicare and charge their own rates—though this required patients to pay 100% out-of-pocket, with no Medicare reimbursement.

Summary:

• Balance billing was never fully prohibited, but major limits were set in 1989 and 1993 with the 115% limiting charge.
• By the mid-1990s, most physicians took Medicare assignment, making balance billing rare.
• The 1997 Balanced Budget Act allowed full opt-out private contracting but required physicians to leave Medicare entirely for those patients.

Would you like more details on how this compares to today’s Medicare payment policies?

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Surely before the 1997 balanced budget act, a physician could have not had any kind of participation in Medicare?

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Yes, before the 1997 Balanced Budget Act (BBA 1997), physicians could choose not to participate in Medicare at all, but the framework was different from the formal “opt-out” process introduced in 1997.

Pre-1997 (Before Formal Opt-Out Rules)

• Physicians could refuse to accept Medicare assignment and instead balance bill patients directly.
• However, they were still subject to the "limiting charge" rules introduced in 1989, which capped how much they could bill above the Medicare-approved amount (115% by 1993).
• There was no formal way for a physician to completely sever ties with Medicare and enter into a private contract where they could charge unrestricted rates while still treating Medicare beneficiaries.

Post-1997 (Formal Opt-Out Option)

• The Balanced Budget Act of 1997 created an explicit opt-out provision.
• Physicians who opted out of Medicare entirely could enter into private contracts with Medicare patients.
• If a physician opted out, their Medicare patients had to agree to pay 100% out-of-pocket, and Medicare would not reimburse anything.
• Physicians had to renew their opt-out status every two years or revert to being subject to Medicare rules.

Key Takeaway

• Before 1997, physicians could avoid Medicare by not enrolling and refusing to accept assignment, but they were still subject to Medicare’s fee schedule if they treated Medicare patients.
• After 1997, the opt-out provision gave them a formal way to treat Medicare patients without any involvement with Medicare billing.

Would you like details on how this changed with later Medicare Advantage and concierge models?

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YES

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Post-1997: Evolution of Medicare Opt-Out and Alternative Models

After the Balanced Budget Act of 1997 introduced a formal opt-out option for physicians, several changes and alternative models emerged, including Medicare Advantage and concierge medicine. Below is an overview of these developments.

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1. Medicare Opt-Out Rules After 1997

• Physicians who opted out had to sign private contracts with their Medicare patients.
• Medicare would not reimburse the physician or the patient.
• The opt-out status had to be renewed every two years.
• Opting out applied to all Medicare patients (physicians could not selectively opt out for some and remain in for others).
• Most primary care and specialty physicians did not opt out, as it limited their patient base.

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2. Medicare Advantage (MA) Expansion

• Medicare Advantage (Part C) was introduced in the 1990s as a way for Medicare beneficiaries to enroll in private insurance plans that replaced traditional Medicare.
• Physicians who contracted with Medicare Advantage plans did not have to adhere to standard Medicare fee schedules. Instead, they negotiated private rates with the MA insurers.
• Balance billing was generally not allowed under Medicare Advantage plans, but out-of-network physicians could charge higher rates (if the plan covered out-of-network services).

Key Difference vs. Traditional Medicare:

• In traditional Medicare, non-participating physicians had to adhere to the limiting charge rule (115% cap).
• In Medicare Advantage, payment rates were negotiated with private insurers, and some plans had out-of-network coverage with different billing rules.

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3. Concierge Medicine and Medicare

• Concierge medicine became more popular in the 2000s and 2010s. Some concierge practices:
  • Accepted Medicare but charged membership fees for extra services (like same-day appointments or wellness programs).
  • Opted out of Medicare entirely and only saw private-pay patients.

Medicare’s Stance on Concierge Fees

• Physicians cannot charge extra fees for services that are already covered by Medicare (e.g., routine visits).
• However, non-covered services (such as extended visits, preventive counseling, or 24/7 access) could be billed separately.
• Fully opting out of Medicare allowed concierge physicians to set their own fees, but they could not submit any claims to Medicare.

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4. Direct Primary Care (DPC) and Medicare

• Direct Primary Care (DPC) is similar to concierge medicine but typically involves lower monthly fees and avoids insurance billing.
• Under current Medicare rules:
• DPC physicians must opt out of Medicare to charge a monthly retainer fee.
• Medicare patients in DPC practices cannot seek reimbursement from Medicare.
• There have been proposals to allow Medicare reimbursement for DPC models, but as of now, DPC remains an opt-out-only approach.

Final Takeaways

• Since 1997, physicians have had a formal way to completely opt out of Medicare, but it means no Medicare billing at all.
• Medicare Advantage offers a workaround where doctors negotiate rates with private insurers, rather than following strict Medicare rules.
• Concierge and DPC models have developed to provide private-pay options, but physicians must either stay within Medicare’s rules or fully opt out to operate independently.

Would you like further details on a specific model or a real-world case of how physicians navigate these options?

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It seems like physicians would be tempted to enter concierge services with monthly or quarterly additional fees, and simply have verbal handwaving to assert that this account for some kind of non-covered service, not part of traditional Medicare?

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Yes, that’s exactly what has happened in many cases. Concierge medicine models that continue participating in Medicare (instead of fully opting out) often rely on strategic workarounds to charge additional fees while staying compliant with Medicare rules.

How Some Physicians Navigate the Rules

Physicians cannot charge Medicare beneficiaries extra fees for covered services, but they can charge for additional benefits that they claim are not covered by Medicare. This has led to some creative (and sometimes legally questionable) approaches, such as:

1. "Wellness Programs" or "Executive Health Plans"

   • Physicians charge monthly or quarterly fees for services like:
     • Annual comprehensive wellness assessments
     • 24/7 physician access by phone or email
     • Extended appointment times
     • Same-day or next-day scheduling
   • These are often claimed as non-covered services, even though some overlap with standard Medicare-covered preventive care.

2. "Membership Fees" for VIP Access

   • Some concierge doctors charge retainer fees that supposedly cover "administrative services" like:
     • Expedited scheduling
     • Personalized health reports
     • Additional time for discussions beyond standard visits
   • This is a gray area—if the membership fee covers anything that should be billed to Medicare, it could trigger an audit.

3. Bundling Covered and Non-Covered Services

   • Some concierge practices structure their fees so that Medicare still pays for covered services, while the patient pays out-of-pocket for longer visits or extra care coordination.
   • The physician must separate out covered services and bill them to Medicare, avoiding overlap.

4. "Legal Handwaving" and Verbal Assurances

   • Many practices operate under informal, unwritten policies, assuring patients that the fee only covers non-Medicare services—but in reality, much of what patients pay for could arguably be Medicare-covered.
   • Some practices adjust their language (e.g., calling a concierge membership a "care enhancement fee" rather than a "medical service fee") to stay under the radar of regulators.

Medicare’s Stance and Enforcement

• CMS has warned against "double billing"—if a service is covered by Medicare, the patient should not be charged extra.
• The Office of Inspector General (OIG) has investigated concierge medicine practices to ensure compliance.
• However, enforcement is uneven—unless a practice blatantly bills Medicare and charges patients for the same service, it’s rare for CMS to aggressively intervene.
• Legal loopholes remain, and many physicians rely on legal counsel to structure their models carefully.

Why Many Doctors Are Tempted by Concierge Medicine

• Medicare reimbursement rates are low, and some physicians feel undervalued for the time they spend with patients.
• Concierge fees provide predictable revenue and help doctors reduce patient volume while maintaining income.
• Avoiding Medicare opt-out rules allows them to keep treating Medicare patients while collecting additional income from private fees.

Biggest Risk for Physicians?

• If Medicare finds out that a physician charged for a service that should have been covered, the doctor could face:
  • Fines, audits, or loss of Medicare participation.
  • Refund orders to reimburse improperly billed patients.
• Most practices operate in a gray zone, carefully wording their offerings to avoid clear violations.

Final Thoughts

Yes, many concierge practices engage in "verbal handwaving"—asserting that their fees are for extra, non-covered services while quietly benefiting from higher revenue per patient. However, because the rules aren’t always clear-cut, many walk a fine legal and ethical line without explicitly violating Medicare regulations.

Would you like examples of specific cases where CMS or the OIG cracked down on questionable concierge billing?

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YES

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​Yes, there have been instances where the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have taken action against physicians in concierge practices for improperly charging Medicare beneficiaries for services already covered by Medicare.​

Notable Enforcement Actions:

1. Dr. R. Douglas Thorsen (2003): Dr. Thorsen agreed to a settlement of $53,400 for allegedly charging Medicare patients an annual fee for services that were already covered by Medicare. ​Higgs Law+1crstoday.com+1

2. Dr. Lee R. Rocamora (2007): Dr. Rocamora paid a settlement of $106,600 to resolve allegations that he charged patients membership fees for services including comprehensive physical examinations and 24/7 access, which were considered Medicare-covered services. ​Higgs Law+1Little Health Law Blog+1

3. Heritage Medical Partners (2013): This South Carolina-based practice agreed to a settlement of $170,260 after being accused of charging Medicare beneficiaries annual fees for services already covered by Medicare. ​Higgs Law

OIG Guidance:

In March 2004, the OIG issued an alert reminding physicians that charging Medicare beneficiaries extra fees for services covered by Medicare violates Medicare assignment agreements. The alert emphasized that such practices could lead to civil monetary penalties and exclusion from federal health programs. ​Government Accountability Office+1crstoday.com+1Reuters+2Burr+2Government Accountability Office+2

Key Takeaways for Physicians:

• Compliance with Medicare Rules: Physicians participating in Medicare must not charge additional fees for services already covered by Medicare.​

• Clear Distinction of Services: Any membership or concierge fees should exclusively cover services not included in Medicare coverage to avoid potential violations.​

Physicians considering or currently operating concierge practices should consult legal experts to ensure their payment structures comply with Medicare regulations, thereby avoiding enforcement actions.

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But Medicare fees for physicians have been lagging further and further behind inflation, I believe they have been essentially flat for five years, or even gone down, we’re inflation has been up. With various changes in presidential administrations, more liberal approaches to concierge fees or balance billing might be seenas a political safety valve.

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Yes, Medicare physician fees have been stagnant or declining in real terms, while inflation and practice costs have risen significantly. This financial squeeze has led to increasing interest in concierge models, private contracting, and alternative payment structures as a way for physicians to stay financially viable.

Medicare Physician Reimbursement Trends

• Flat or Declining Reimbursement:

  • From 2018 to 2023, Medicare's physician fee schedule saw minimal increases, with some years even experiencing net cuts due to budget neutrality adjustments.
  • In 2024, Congress prevented a large cut but still implemented a 3.37% decrease in the conversion factor (the key payment formula component).
  • Inflation-adjusted physician payments under Medicare have dropped by nearly 20% since 2001.

• Contrast with Inflation:

  • General inflation (CPI) rose by over 20% in the last five years.
  • Medical practice costs (staff salaries, rent, malpractice insurance) have skyrocketed.
  • Hospital payments have generally increased, while physician payments have lagged.

Political Shifts and Potential Policy Loosening

Given these economic pressures, some policymakers might view concierge models and balance billing reforms as a "safety valve" to retain doctors in Medicare. Here’s how this could unfold under different political leaderships:

1. Liberal/Democratic Approaches (e.g., Biden Administration)

   • Historically opposed to balance billing, favoring stronger protections for Medicare patients.
   • May increase Medicare payments for primary care while limiting physician opt-outs or private contracting.
   • More likely to expand Medicare Advantage, as it allows physicians to negotiate private rates.

2. Conservative/Republican Approaches (e.g., Trump or GOP Congress)

   • More likely to loosen balance billing limits and encourage private contracting.
   • Could expand opt-out models or allow hybrid participation, where doctors can accept Medicare but bill more than the Medicare rate.
   • Might push block grant reforms to shift more Medicare funding to states, leading to regional variations.

Possible Reforms to Address Physician Payment Concerns

• Increase Physician Fee Schedule Payments (unlikely without bipartisan support).
• Allow Partial Opt-Outs (so doctors could balance bill some services but still participate in Medicare).
• Expand Private Contracting Rules (letting doctors contract privately while still treating Medicare patients).
• Higher Payment Incentives for Underserved Areas (to prevent physicians from leaving Medicare in rural areas).

Final Thoughts

Given rising costs and stagnant Medicare fees, there’s growing political pressure to give physicians more flexibility in billing—whether through concierge models, private contracting, or looser balance billing restrictions. However, these changes would likely depend on which party controls Congress and the White House.

Would you be interested in tracking any pending legislation or policy proposals in this area?

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While block grants for Medicaid funding have been discussed, block grants for Medicare funding would be a radical shift from the part part B national structure.

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You're absolutely right—block grants for Medicare would be a radical departure from the program's current national structure, whereas block grants for Medicaid have been a recurring policy proposal.

Why Medicare Block Grants Would Be a Radical Shift

• Medicare Part B is a National Program

  • Physician payments under Part B follow a national fee schedule set by CMS.
  • While there are geographic adjustments, the fundamental structure is federal and uniform, ensuring that Medicare beneficiaries nationwide get consistent physician reimbursement rates.

• Medicaid, in Contrast, is a State-Based Program

  • Medicaid is a joint federal-state program, so states already have flexibility in administration.
  • Block grant proposals for Medicaid suggest giving states a fixed lump sum and allowing them to decide how to allocate the funds.

• Applying Block Grants to Medicare Would Mean:

  • Decentralization—States or regional entities could set different Medicare payment policies, which could lead to unequal access to care.
  • Risk of Budget Cuts—If a block grant didn’t keep up with inflation or healthcare costs, states might cut physician payments or services.
  • Privatization or Alternative Payment Models—Some proposals could push more beneficiaries into Medicare Advantage or regional managed care plans.

Would a Medicare Block Grant Ever Be Proposed?

• Highly Unlikely Under a Democratic Administration

  • Democrats generally favor expanding Medicare’s scope, not restructuring it into state-controlled block grants.
  • Recent Democratic policies have focused on increasing Medicare benefits (e.g., drug price negotiation, dental/vision proposals).

• Could be Considered Under a Conservative/GOP Administration

  • Some conservative health policy experts support market-driven Medicare reforms, such as:
    • Premium support models (like vouchers for private plans).
    • State flexibility in Medicare Advantage rules.
    • Allowing states to pilot different Medicare payment structures.
  • However, block grants would likely face enormous political opposition from seniors and physician groups, making it a hard sell even for Republicans.

More Realistic Medicare Reforms Instead of Block Grants

If policymakers want more cost control without radical decentralization, they might propose:

1. Expanding Medicare Advantage (Part C) to cover more beneficiaries and encourage state-level flexibility.
2. Allowing more private contracting in Part B, enabling balance billing or hybrid opt-out options.
3. Experimenting with regional payment models, similar to Accountable Care Organizations (ACOs) but without full block grant structures.

Final Thought

Block grants for Medicaid have been debated for decades, but doing the same for Medicare Part B would be a fundamental overhaul—likely politically toxic due to Medicare's broad popularity. While a future conservative administration might explore regional Medicare payment reforms, a full block grant model would be extremely unlikely to gain traction.

Would you like insight into past Medicare reform attempts that came close to major structural changes?

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Changing the operation of Medicare advantage on a state to state basis is an interesting idea.

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Yes, modifying Medicare Advantage (MA) on a state-by-state basis could be a politically feasible way to introduce regional flexibility without fundamentally altering traditional Medicare (Parts A & B). While Medicare is a federal program, Medicare Advantage already operates through private insurers, which vary widely by state and even by county. Expanding state-level control over Medicare Advantage could allow for localized innovation, but it would also introduce risks and regulatory complexities.

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Ways Medicare Advantage Could Be Modified at the State Level

Here are some potential ways a state-based approach to Medicare Advantage could work:

1. State-Defined Plan Design Flexibility

   • States could be given the ability to adjust plan rules, including:
     • Extra benefits (e.g., social services, housing assistance, transportation).
     • Care coordination models (e.g., integrating MA plans with state-funded long-term care programs).
     • Prescription drug formularies beyond current federal Part D rules.

2. State-Level Premium Support for Medicare Advantage

   • States could experiment with Medicare premium subsidies, offering extra financial incentives for certain groups (e.g., low-income seniors, rural enrollees).
   • This could be structured like Medicaid "buy-in" programs, where states contribute to MA premiums for targeted populations.

3. State Negotiations with MA Insurers

   • Instead of relying solely on federal MA plan contracts, states could negotiate additional provider network requirements or reimbursement structures for MA insurers operating in their state.
   • Example: Some states might require higher rural reimbursement rates to encourage more physicians to accept Medicare Advantage.

4. Experimenting with State-Based Payment Models

   • Similar to how Medicaid managed care varies by state, Medicare Advantage plans could be structured with state-driven risk adjustment models.
   • A state might create specialized reimbursement formulas for high-cost populations (e.g., dementia patients, dual-eligibles).

5. More Aggressive Cost-Control Measures

   • Some states might want more control over Medicare Advantage costs, including:
     • Reference pricing (capping certain procedures at state-determined rates).
     • Stricter prior authorization rules (which some states might use to limit unnecessary spending).
     • Cost-sharing reforms (e.g., limiting out-of-pocket expenses for specific conditions).

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Potential Benefits of a State-Based Medicare Advantage System

• Allows for Innovation

  • States with unique healthcare challenges (rural access, high poverty rates, long-term care needs) could customize Medicare Advantage to better serve their populations.
  • Example: States like Minnesota and Oregon could integrate MA plans with local public health and social services.

• Could Address Physician Payment Issues

  • States could adjust reimbursement models to retain doctors in the Medicare system, preventing provider shortages.
  • Some states might increase MA reimbursement for specialists in high-need areas.

• Political Middle Ground

  • Instead of radical Medicare changes (like block grants or Medicare for All), this could be a moderate reform appealing to both parties:
    • Democrats could use it to expand benefits and care models in high-need states.
    • Republicans could use it to increase competition and reduce federal control over Medicare Advantage.

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Potential Risks and Challenges

• Fragmentation of the Medicare Market

  • Different MA rules in different states could create confusion for beneficiaries who move across state lines.
  • MA insurers might exit smaller states if they dislike state-specific rules.

• Potential for Lower Federal Oversight

  • If states had more control over MA, fraud or cost-cutting measures could vary widely, leading to inequities in patient care.
  • Some states might lower provider reimbursements too aggressively, leading to network shrinkage.

• Political and Legal Challenges

  • Medicare is a federal entitlement—any major state-based changes would require Congressional action.
  • CMS might resist giving states more control, fearing weakened national Medicare standards.

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Has This Been Tried Before?

• Medicare-Medicaid Integration in Some States

  • Certain states already integrate Medicare Advantage with Medicaid managed care, particularly for dual-eligible beneficiaries.
  • PACE (Program of All-Inclusive Care for the Elderly) is another example where state-administered Medicare-like programs have been piloted.

• State-Based Innovations in Medicare Supplement (Medigap) Plans

  • Some states (e.g., Massachusetts, Wisconsin, Minnesota) already have state-regulated Medigap plans, which function as secondary insurance for Medicare.

• Trump-Era Proposal for Medicaid Block Grants

  • Some conservative health policy experts have floated the idea of experimenting with Medicare state flexibility, but no state-based Medicare Advantage reforms were implemented at a large scale.

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Final Thoughts: A Potential Future Reform?

Giving states more control over Medicare Advantage is less extreme than block grants and could be politically viable—especially as a bipartisan compromise to address stagnant physician payments and rising Medicare costs.

Would you like to explore specific states that might be best suited for a Medicare Advantage state-based pilot program?

CCLA Notes mrd etc

 9-18-24 MolDX: Definition of Patients With and without Cancer

 

[Bruce Quinn – Bruce Quinn & Associates] Could MolDX please revisit its definitions of patients with cancer and patients without cancer?  For example, a patient has a cancer resection and gets a minimal residual disease plasma series.  At what point exactly does he become a patient without cancer and on surveillance testing that is outside NCD 90.2 because he "does not have cancer" anymore.  Also, what happens if a patient qualifies for a plasma series, but is positive on the first test?  It doesn't seem like further minimal residual disease tests would be of interest after that known early relapse.

 

Dr. Bien Willner elaborated on the issue: There has been ongoing discussion regarding the definition of patients with cancer versus those without cancer (in remission), particularly in relation to plasma tests under NCD 90.2.  The policy applies to patients with cancer, but there are specific criteria that must be met which have some inconsistency in the instructions provided.  Novitas has received different guidance than MolDX, apparently Novitas was told the NCD doesn’t apply to liquid biopsy tests.   MolDX understands that the NCD does apply to any next-generation sequencing test in cancer. 

 

For a patient to qualify under NCD 90.2, four key criteria must be met:

1. The patient must be undergoing treatment or planning for treatment.
2. The cancer must be advanced, including metastatic or recurrent.
3. The patient must not have been previously tested with that specific test or a test that has the same genetic content.
4. Some additional situations and interpretations are described below.

 

Targeted Therapy: Changes in genetic content can affect the patient's response to targeted therapy.  The patient must demonstrate an effective genetic change to qualify for targeted therapy.  All other requirements under NCD 90.2 must be met for coverage.

 

Recurrence: If a patient recurs, meaning there is a genetic change in the cancer, they may qualify for further testing under NCD 90.2.  Since they have cancer, they only qualify for one test.  However, one test may be priced as "bundles" to reflect comprehensive analysis over time.

 

Patients in Remission: A patient with no clinical, radiographic, or biological evidence of active disease, considered to be in remission or with a history of cancer, would fall outside of NCD 90.2.  

However, these patients still need monitoring, so they may require alternative coverage pathways.  

For further clarification, these definitions and criteria are detailed in the MolDX articles for comprehensive genomic profiling (CGP) and minimal residual disease (MRD).  There was a discussion about whether it is always clear how a “bundle” duration is described (is it 6, 12, or 18 months), and when rules for “a patient without evidence of cancer” start to apply instead. 

 

9-18-24 MolDX: Minimal Residual Disease (MRD) Technical Assessments (TA)

 

[Bruce Quinn – Bruce Quinn & Associates] MolDX now lists Z codes specific to indications, as well as specific to tests.  There seem to be many lung MRD tests listed in the DEX system, but none of them are covered yet. 

Can MolDX generally share what some of the challenges have been for labs submitting MRD TAs in the lung indication?   

Also, could you confirm whether or not a company should have a Z code prior to submitting a new TA for the first time?

 

Dr. Bien-Willner shared the following regarding the challenges with Technology Assessments (TAs).  One of the significant issues relates to Minimal Residual Disease (MRD) testing, for which TA applications are still relatively uncommon.  He confirmed that for lung cancer, there is currently no approved test available, making it essential to demonstrate clinical validity.  Specifically, the test must meet established criteria regarding advancements in radiographic and biological assessment.

 

There is a greater emphasis on surveillance in lung cancer.  The cadence of testing should align with CT imaging to accurately reflect the test's performance.  However, the current study design may lead to failure because it compares the test directly with radiological assessments.  For example, the MRD test and radiology test are both negative in January, and both positive in June.  This data does not document an advantage for the MRD test.

 

The goal is to ensure the test is superior, more accurate, and faster in identifying cancer.  If a patient is determined to be cancer-free, it is permissible to indicate that the test can be performed again for monitoring purposes.

 

The course of MRD testing does not have a definitive endpoint; according to the policy, if a patient has cancer, they are eligible for testing.  This process is structured around a series of defined time points.

 

[less certainty on this point --]   

CMS has clarified that Novitas is not required to apply NCD 90.2 for non-solid tumors, which provides additional flexibility in MRD coverage at that MAC.

 

Update to OPPS System for Radiopharma > $650

 Find it here:

https://www.cms.gov/files/document/r13032cp.pdf