Malecki Brooks Ford Law Group, LLC

Malecki Brooks Ford Law Group, LLC Malecki Brooks Ford Law Group, LLC 2026-08-05T18:07:24Z https://www.mbhealthlaw.com/feed/atom/ WordPress /wp-content/uploads/sites/1504063/2024/05/cropped-ID-image-2-32x32.jpg On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[DEA Impersonation Scams Targeting Healthcare Providers]]> https://www.mbhealthlaw.com/?p=51136 2026-08-05T18:07:24Z 2026-08-04T20:31:13Z

We want to ensure our clients are aware of an ongoing scam where fraudsters impersonate the Drug Enforcement Administration (DEA) to target physicians, pharmacists, and other DEA registrants. The DEA has issued repeated public warnings about this scheme, and it continues to evolve. Here’s what to watch out for and what to do if you're contacted.

What's happening

Scammers are contacting healthcare providers by phone and by letter, sometimes even on official-looking Department of Justice letterhead. These letters and messages falsely claim that the recipient is under investigation, typically for unlawful prescribing or distribution of controlled substances. Both DEA-registered and non-registered physicians have been targeted. The goal of the fraudsters is to obtain personal or financial information, or to extort a payment. These callers attempt to sound credible by:

Using the real names of well-known DEA officials, retired agents, or local police officers
Providing a fake badge number, often recited immediately at the start of the call
Referencing your National Provider Identifier (NPI) number or state license number, information that is publicly available, not proof the caller is legitimate
Claiming patients have made accusations against you, or that your DEA registration or medical license is under investigation
Using an urgent, aggressive tone and threatening arrest, prosecution, imprisonment, or revocation of your DEA registration or medical license

Eventually, callers ask for sensitive information such as a Social Security number, date of birth, bank account details. They may even demand payment to resolve the supposed “investigation.”

What the DEA actually does and doesn't do

The DEA has confirmed the following, which should help you recognize a scam call or letter immediately:

The DEA does not call registrants about investigations. Legitimate DEA personnel will only notify someone of an investigation or legal action in person or by official letter.
The DEA will never demand money, gift cards, wire transfers, or any other form of payment over the phone.
The DEA will never ask for your Social Security number, date of birth, or other sensitive personal information by phone.
The DEA does not investigate or revoke medical licenses. That authority belongs to state medical boards. A caller who threatens to “revoke your medical license” is not from the DEA.
DEA personnel are titled Special Agents or Diversion Investigators, not “officers.” A caller who identifies themselves as an “Officer” with the “DEA Drug Enforcement Administration” (a redundant phrase a real agent would not use) is a red flag on its own.

What to do if you receive one of these calls or letters

Do not engage. Do not confirm your identity, provide any personal or professional information (including your DEA registration number, NPI, Social Security number, date of birth, or banking details), or make any payment.
Do not call back any number the caller provides. If you want to verify a communication, look up the DEA's number independently rather than using contact information supplied in the suspicious call or letter.
Hang up or set the letter aside and contact our office if you're unsure if the communication is legitimate. We're glad to help you evaluate it before you respond.
Report the incident. You can report scam calls to the FBI's Internet Crime Complaint Center at ic3.gov, to the Federal Trade Commission at reportfraud.ftc.gov, and to the DEA's Diversion Control hotline at 1-877-792-2873.

If you’ve already shared information or made a payment

If you provided a Social Security number, bank account information, or other sensitive data, or sent a payment, act quickly:

Contact your bank or credit card issuer immediately to flag the account and, if you shared a card number, treat it as lost or stolen.
Consider placing a temporary credit freeze with the three major credit bureaus to prevent new accounts being opened in your name.
Visit identitytheft.gov for a personalized recovery plan.
Let our office know. Depending on what was disclosed, there may be additional steps worth taking to protect your DEA registration, NPI, and professional standing.

Related risks to consider

Treat your DEA registration number and NPI as sensitive credentials, not public reference numbers, even though both can be looked up online. If you ever notice prescribing activity you don't recognize under your name or registration, contact us right away, this could implicate your DEA registration and requires prompt attention. Some physicians have also reported a related scam involving callers who claim to be with the Centers for Medicare & Medicaid Services (CMS), demanding medical records or payment of an alleged Medicare debt. The same rule applies: legitimate government agencies do not demand immediate payment or sensitive information over the phone.

Key considerations before forming your PLLC

Before you move forward with starting a PLLC, you should think about several important factors. Your malpractice insurance needs may change based on your business structure. You will also need to make sure you keep proper licensing with the Illinois Department of Financial and Professional Regulation. Additionally, forming a PLLC involves ongoing tasks you must complete:

Filing yearly reports with the state
Keeping separate business bank accounts
Keeping detailed business records
Following proper business rules

These requirements take time and attention beyond your patient care duties.

Moving forward with confidence

Choosing the right business structure for your medical practice is a major decision that could affect your financial future and professional liability. While a PLLC offers potential benefits for Illinois physicians, the formation process and ongoing tasks deserve careful thought. You are not alone in working through these complex decisions. Talking with professionals who understand both Illinois business law and healthcare rules can provide helpful guidance tailored to your specific situation. Taking the time to explore your options carefully now can help you build a strong foundation for your practice's future success.]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[CAN YOU KEEP A SECRET? JUST SIGN HERE.]]> https://www.mbhealthlaw.com/?p=51066 2026-07-07T19:38:46Z 2026-07-07T19:38:46Z

What the Taylor Swift/Travis Kelce wedding can teach us about NDAs As an attorney I am used to dealing with confidential information. So much so that I am conditioned to treat just about everything as confidential, including what comes and goes in my personal life. If a friend tells me something, I presume it’s confidential until told otherwise. Conversely, I don’t presume that what I tell people will be kept confidential, so I carefully choose when to share private information, limiting those disclosures. This approach has worked for me professionally and personally for a long time, and I never gave it much thought. Last weekend, I kept checking my phone for updates on the secret Swift-Kelce wedding because I'm a huge fan of Taylor Swift and admire her talent and business savvy. I was hoping—and frankly expecting—that I would catch a glimpse of the secret event. I told myself that surely there would be something shared with their fans, a photo of them, the décor, something. And that’s when I thought: Did the nondisclosure agreements (NDAs) that the guests and staff reportedly signed really work? It certainly looks like they did. Taylor Swift and her husband may have started a trend by bringing the legality of an NDA into a social context. It’s such an interesting concept that I am unable to “shake it off.” Is it too crazy to consider using NDAs in our personal relationships? For example, if I tell my close friend a secret and tell her not to repeat it, do I just trust that she won’t, or do I ask her to sign an NDA? Would I sue her if she violates? What about asking her to sign an NDA about our friendship in general and consider everything confidential unless otherwise stated? The questions are endless but not entirely unreasonable. But before I start drafting NDAs for my friendships, though, it's worth stepping back to look at what an NDA is, when they are typically used in a legal setting, and what can happen if someone violates or “breaches” the NDA.

What is a Nondisclosure Agreement (NDA)?

In general, a Nondisclosure Agreement (NDA) is a formal, enforceable contract. It is designed to ensure that confidential information remains private. As a contract, it defines the responsibilities of the parties involved and provides legal remedies if the agreement is violated.

When is an NDA appropriate?

Typically, NDAs are used in business situations to protect the confidential information of parties to a transaction. This could include information shared by one party with another party that is trying to determine whether/how to proceed with a transaction. If you are thinking about buying a business and want to review information pertinent to that before you commit, an NDA would be appropriate for you to review and possibly sign, subject to the advice of your attorney.

If you “spill the beans” and violate an NDA, what are the legal consequences?

Technically, the legal complaint against you would be for a “breach of contract.” If you are found to be in breach, you could be liable for monetary damages caused by your breach. If disclosure of confidential information caused harm to another party to which you promised confidentiality, you could be liable to pay those damages. Whether or not Taylor and Travis have started a new trend, the legal value of an NDA, lies more in the threat of a lawsuit and less in trusting the people we let in. So the next time a friend tells me something in confidence, I'll keep presuming it's private. But we all might start wondering if we need better terms. Dinner at my house? For further information contact: Melinda Malecki mmalecki@mbhealthlaw.com ]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[Understanding ‘for cause’ and ‘without cause’ terminations]]> https://www.mbhealthlaw.com/?p=51044 2026-04-28T05:48:43Z 2026-04-28T05:48:43Z

end the relationship at any time if the reason is not illegal. This issue appears often in physician and provider agreements, especially when contracts include termination clauses that shape job security. So what does this mean when you review your terms?

Distinguishing for cause and without cause termination

The type of termination clause sets the level of protection in your agreement, which directly affects your position. “For cause” termination depends on specific reasons listed in the contract, such as policy violations, conduct issues or defined performance concerns. These terms can limit when an employer may end the agreement. “Without cause” termination allows either party to end the relationship without giving a reason, which reflects the at-will nature of many Illinois jobs. However, a contract may change that default by requiring cause or setting conditions. The difference often centers on whether the employer must justify the decision.

Assessing contract terms that define notice and risk

Certain contract terms outline the steps and conditions tied to ending the agreement, which often affect timing and planning. Review these key provisions:

Notice period length
Cure period for alleged issues
Definition of cause in the agreement
Impact on pay and benefits
Patient transition responsibilities

Each term can influence stability, which means small wording differences may affect your position.

When does a termination clause raise concern?

A termination clause raises concern when the language allows sudden separation without clear timing or defined steps, which can disrupt your role and patient care. You might notice this during contract review when notice terms, listed causes or cure periods do not align. At that point, it helps to pause, compare those sections closely and consider how each term affects your schedule, income flow and patient handoffs if the relationship ends.]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[How much negotiating is too much on your employment agreement?]]> https://www.mbhealthlaw.com/?p=51014 2026-02-24T10:58:14Z 2026-02-24T10:39:14Z

You might feel tempted to sign your first medical job offer as soon as it hits your inbox, especially after years of training, debt and exams. The firm McDonald Hopkins shares some thoughtful cautions about how far you may want to push in negotiations and where to ease up, which you can read more about here.

Why new physicians often hesitate

Many new physicians feel grateful for an offer and worry that negotiating could make the employer lose interest. You might also assume that a contract is standard and therefore fair, or that the employer knows what is reasonable. These assumptions can discourage you from raising important points. At the same time, failing to address key concerns could affect your schedule, compensation and long-term options.

Signs you may be pushing too hard

Negotiation can be productive, but it is possible to overextend. You might be moving into “too much” negotiation if you notice:

Requesting changes to almost every section of the agreement instead of focusing on top priorities
Sending long lists of edits in multiple rounds without distinguishing what matters most
Insisting on terms that are far outside local or specialty norms, especially regarding salary or call duties
Ignoring clear signals that the employer has reached its limit on certain issues

Focusing on a few core concerns often allows you to protect your interests without creating unnecessary friction.

Areas worth focusing on

Most new physicians benefit from concentrating on terms that influence daily work and long-term risk. Key areas may include:

Compensation structure and realistic earning potential over time
Call schedule, clinic hours and expectations for weekends or holidays
Non-compete clauses or other restrictions on working elsewhere afterward
Malpractice coverage, including responsibility for tail coverage
Termination provisions and required notice to leave

Spending your negotiation energy on these points can make it easier to accept less negotiable clauses. You might also explore revisiting certain terms after working in the position for a period, instead of attempting to secure every change upfront.

How to negotiate without straining relationships

Tone can matter as much as content. Employers often respond better when you remain polite, curious and clear about your priorities. You could express excitement for the position while noting a desire to ensure a fair arrangement on key points. Framing discussions as questions rather than demands can help maintain goodwill. It may also help to consult with an experienced healthcare attorney to review the agreement. They can provide perspective on what is realistic in your market and help you balance thoroughness with approachability.

Finding a balanced approach

Your first employment contract can shape your income, schedule and options for years. Taking a measured approach that mixes reasonable negotiation with realistic expectations can help you accept an offer that protects your interests, supports your goals, and begins your working relationship on a positive note. A thoughtful approach can make signing your first contract feel more like a strategic choice rather than a leap of faith.]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[4 ways you can beat impostor syndrome during contract negotiations]]> https://www.mbhealthlaw.com/?p=50994 2026-03-12T20:47:02Z 2025-12-22T16:36:34Z

As a woman in medicine, you may face contract negotiations while battling self-doubt. This is where impostor syndrome can make you feel unworthy of a better deal, even when the offer is unfavorable or below market value. Too often, physicians feel that they do not deserve to or are afraid to try to negotiate a better deal than what is initially presented. The good news is that you can overcome these feelings. Here are four ways to negotiate with confidence:

1. Highlight your brand

First, recognize the value you bring to the table. Whether it is your specialized skills, unique experiences, or a high demand for your role, these attributes are your leverage in negotiations. Imposter syndrome hits women hard, especially during high-stakes moments like contract negotiations. Do not let self-doubt overshadow your accomplishments. Think about how your expertise can help grow your employer's practice. When you own your strengths, you build a stronger case for better terms.

2. Don’t be afraid to be difficult

Once you know your worth, make sure others hear it too. Many women hesitate to push back during negotiations because they worry about seeming difficult. However, very rarely will an employer back out of an offer if demands are well thought out and reasonably justified. Research compensation data through professional associations. Come prepared with facts. Speaking up is not aggressive, it is professional.

3. Fight for what matters to you

Of course, compensation is just one piece of the puzzle. If parental leave is important to you, it should be discussed and addressed in writing, preferably in the final employment contract. The same applies to flexible scheduling, PTO policies or call schedules. Write down your priorities beforehand. Then advocate for them directly.

4. Get professional legal help

Finally, consider bringing in an expert. Understanding physician contracts and employment agreements on your own is a daunting task. Just as patients trust you with their health, you should trust a legal professional with your contract. An attorney can advocate for fair compensation, meaningful benefits and work conditions that align with industry standards. The cost of a contract review is often smaller compared to the risks involved. You protect your patients every day. Now, let a professional legal help protect your career.]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[Key Open Questions and What Providers and Suppliers Should Be Doing Now]]> https://www.mbhealthlaw.com/?p=50992 2025-12-17T21:51:25Z 2025-12-17T21:51:25Z

In our earlier article, we broke down the key elements of Final Rule CMS–1828–F and what it means for the future of the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). But as many in the industry have pointed out, understanding the rule itself is only half the story. After years without a fully active bidding cycle, CMS has laid out a renewed framework, yet many details remain unresolved. image of a statoscope

As organizations assess these changes, new questions emerge about how they will be implemented. Ahead of the next competitive bidding cycle, stakeholders are trying to balance what CMS has finalized with what remains unclear. The return of competitive bidding arrives at a moment when hospitals, clinics, and suppliers are facing increased cost pressures, renewed CMS oversight, and growing patient demand for chronic-use products. Understanding what CMS–1828–F includes and what it leaves unaddressed is essential as organizations prepare for a reimbursement and regulatory environment that may look considerably different by 2028. Bid evaluation criteria present additional unknowns. While CMS updated pricing methodologies and bid ceilings, the agency has not specified how non-price factors—such as supplier capacity, geographic coverage, financial stability, or historical performance—will influence bid scoring. Stakeholders also want to know whether CMS intends to maintain broad supplier networks or adopt a more limited set of contract suppliers, as this decision will have direct implications for market competition and beneficiary access.

Questions Leaders Should Be Asking Now

When organizations evaluate how to prepare for CMS–1828–F, leadership teams should:

Assess their dependency on categories likely to enter competitive bidding

Evaluate whether existing suppliers have the capacity for national or regional distribution under RID-CBP
Understand the financial impact of potential 10%–20% reimbursement changes
Develop transition plans for chronic-use patient populations who may be required to switch suppliers

Addressing these issues early allows organizations to identify vulnerabilities, anticipate market changes, and build informed strategies before CMS releases additional guidance. In its recent Q&A resource, CMS addressed questions about the shift to annual accreditation surveys under CMS–1828–F, offering added clarity on survey expectations, timing, and year-round documentation requirements. While the guidance allows accreditation organizations to streamline certain reaccreditation elements for consistently compliant suppliers, CMS makes clear that the annual cycle will be treated as a full survey—not a scaled-down or abbreviated review. This clarification is particularly important for smaller suppliers and federally funded clinics that may have limited administrative capacity. The Q&A reiterates the need for continuous readiness, robust internal monitoring, and consistent adherence to quality and performance standards. The release of this resource signals CMS’s intention to implement uniform oversight practices while minimizing disruption during the transition to more frequent survey intervals.

Implications for Federally Funded Clinics

Federally funded health centers, including Federally Qualified Health Centers (FQHCs), rural health clinics, and public hospitals, may be disproportionately affected as CMS–1828–F is implemented. These providers serve high volumes of patients who rely on chronic-use supplies, often within constrained budgets and tightly managed supply chains. Supplier consolidation, narrower contract networks, and increased oversight could disrupt access and influence referral patterns, requiring clinics to reassess supplier relationships to maintain continuity of care for medically underserved populations.

Uncertainty Around Product Categories

A central area of uncertainty involves which product categories CMS plans to include in the upcoming bidding round. Although CMS–1828–F identifies several categories that could be competitively bid—such as continuous glucose monitors, insulin pumps, urological and ostomy supplies, hydrophilic catheters, and multiple off-the-shelf orthotic products—the agency has not confirmed which will ultimately appear on the final category list. For suppliers, this uncertainty may require preparing bids across multiple categories, adjusting inventories, or making early decisions about entering or exiting specific product lines. For hospitals and clinics, the stakes involve continuity of care and procurement strategy, because category selection directly affects which items may require contracting with competitively bid suppliers and how patient access could shift in the next cycle.

Operational Details for RID-CBP Remain Undefined

The operational framework for the Remote Item Delivery Competitive Bidding Program (RID-CBP) introduces a second layer of ambiguity. While the rule enables CMS to conduct bidding at a regional or national scale for items shipped directly to beneficiaries, it does not outline the performance standards or operational expectations suppliers will need to satisfy. Requirements related to delivery timeliness, documentation of shipment and receipt, inventory thresholds, and logistics capabilities have not yet been defined. Without clarity on these benchmarks, suppliers cannot fully assess whether they can or should participate in RID-CBP, nor can hospitals and clinics evaluate which suppliers are best positioned to meet patient needs under this emerging delivery model.

What These Unknowns Could Mean for the Market

Information on timing, exceptions, continuity-of-care expectations, and CMS support for transition logistics is unclear. While CMS has indicated that a transition period will occur once new contracts take effect, little detail is available on how beneficiaries, particularly those using chronic, high-utilization items, will be guided through supplier changes. Providers and suppliers alike require this information to plan patient communication, training, and access strategies. These uncertainties suggest a period of significant transition and adjustment for the DMEPOS sector. The shift toward national or regional bidding under RID-CBP may advantage suppliers with large-scale logistics infrastructure, potentially accelerating consolidation in the supplier market. New product categories, especially those with high utilization, may see downward pressure on reimbursement once Single Payment Amounts (SPAs) are established, influencing pricing strategies and product availability. Provider–supplier relationships are also expected to evolve as organizations evaluate whether current partners intend to bid, have the operational capacity to meet updated requirements, or are likely to secure contracts. Smaller suppliers may face challenges with annual accreditation, expanded financial reporting, and more complex logistics, while larger suppliers may pursue expansions or mergers to strengthen their competitive position. As the industry awaits additional details, CMS–1828–F clearly signals a significant shift in the competitive bidding framework. We encourage healthcare providers and suppliers to closely monitor CMS updates, engage early with emerging implementation requirements, and proactively address open questions ahead of the next competitive bidding round, expected no later than 2028. Early internal planning, supplier evaluations, and compliance readiness will be critical to navigating these forthcoming changes with greater clarity and confidence.]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[The End-of-Life Options for Terminally Ill Patients Act]]> https://www.mbhealthlaw.com/?p=50990 2026-01-26T18:13:51Z 2025-12-16T14:38:17Z

Illinois’ End-of-Life Options for Terminally Ill Patients Act image of a doc with a pen and notebook

(Please note: This Article has been updated and supersedes the original version previously published in the MBF newsletter. Revisions include clarification regarding the Right of Conscience Act, the duties of a health care entity that declines to provide aid in dying services, and enhanced definitions.) On December 12, 2025, Governor Pritzker signed Public Act 104-0441, the End-of-Life Options for Terminally Ill Patients Act, also known as “Deb’s Law” (“Act”). The Act does not go into effect until September 12, 2026. This delay in the effective date gives affected health care entities (“HCEs”) and health care professionals (“HCPs”) time to become familiar with the Act and to develop policies, procedures and forms to implement their obligations under the Act. This article provides a brief summary of some key provisions of the Act. The Act imposes obligations and confers rights on health providers regardless of whether they choose to participate in the new care option described in the Act. The Act provides a new option for end-of-life care that supplements existing care options such as palliative care, pain control, comfort care and hospice services, endeavoring to enable patients to choose an end-of-life experience that is aligned with their individual beliefs and values. The new option, referred to as “aid-in-dying” (“AID”), allows a “qualified patient” as defined in the Act, who has been diagnosed with a terminal illness expected to cause death within six months, to request that the patient’s attending physician prescribe medications that will likely result in the qualified patient’s death (“AID medications”), for self-administration by the patient. A “qualified patient” is an adult Illinois resident with mental capacity as defined in the Act who has satisfied the requirements of the Act to request a prescription for AID medications. The Act prescribes that a request for AID medications be directed to the attending physician, defined as the physician with primary responsibility for the care of the qualified patient and the treatment of the patient’s terminal illness. The request must be made both verbally and in a written document substantially in the form set forth in the Act. With certain exceptions, the patient must repeat the verbal request after waiting at least five days. After receiving the request, the attending physician must request an evaluation by a consulting physician for written confirmation that the patient has the required mental capacity and has a terminal illness with a prognosis of six months or less to live. If the attending physician or the consulting physician has any concerns regarding the patient’s mental capacity, the patient must be referred to a licensed mental health practitioner, as defined in the Act, for an evaluation and written determination whether the patient has the required mental capacity or suffers from a psychological or psychiatric disorder causing impaired judgment. Assuming that all requirements of the Act are met, the attending physician may prescribe, and a pharmacy may dispense, AID medications for self-administration by the patient. The Illinois Healthcare Right of Conscience Act applies to and is incorporated into the Act. HCEs may decline to provide AID services, and may restrict their employed or contracted HCPs from providing them while engaged in work for the HCE. HCPs may also decline to participate in AID services. HCEs may not restrict their HCPs from providing AID services in a practice setting independent of the HCE. HCEs must cooperate with a requested transfer of care and may not restrict their HCPs from providing information to patients about AID services or community resources. The Act contains numerous definitions, detailed requirements and additional provisions not described in this summary. The Illinois Department of Public Health and the Department of Veterans Affairs are authorized to promulgate rules to assist in the implementation and administration of the Act. In ascertaining their rights and obligations, providers should carefully examine the full text of the Act and any rules that are issued. Future articles are planned that will summarize specific aspects of the Act in greater detail and discuss some of the issues and steps that an affected provider should consider. ]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[CMS–1828–F: CMS Finalizes Significant Updates to the Competitive Bidding Program]]> https://www.mbhealthlaw.com/?p=50987 2025-12-08T21:29:11Z 2025-12-08T21:24:18Z

Key Considerations for Healthcare Organizations and DMEPOS Suppliers It has been several years since the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) was fully active, and the healthcare community has been watching closely to see how CMS would reshape the program moving forward. With the release of Final Rule CMS–1828–F, CMS has introduced the most significant updates to CBP in more than a decade, marking a pivotal moment for providers, patients, and the healthcare industry at large. image of a federal building

Given the long time-gap since the last major bidding round, we reviewed the final rule, listened to experts in the field, and have summarized the key updates, compliance implications, and action items you should be aware of as CMS prepares for the next CBP cycle. We’ll look at how the rule modernizes key components of the program, reshapes price-setting, revises supplier obligations, and updates bidding and contracting requirements. These changes will have substantial implications for both federally funded private healthcare facilities and DMEPOS suppliers.

Overview of the Competitive Bidding Program

CBP establishes market-based pricing for specific categories of DMEPOS items by requiring suppliers to submit bids and awarding contracts to those offering competitive rates that meet quality and accreditation standards. Historically, the program applied to define Competitive Bidding Areas (CBAs) and was designed to achieve cost savings, reduce improper payments, and maintain supplier quality. Final Rule CMS–1828–F reaffirms these goals but implements several structural and operational changes that will influence how suppliers participate and how healthcare organizations access bid products competitively.

Major Changes Introduced in CMS–1828–F

Creation of the Remote Item Delivery Competitive Bidding Program (RID-CBP)

CMS–1828–F establishes a new bidding model for items primarily distributed through shipment rather than in-person delivery. This allows CMS to group specific categories into regional or national bidding pools, to reflect current distribution practices and create a framework for competitive bidding items that have been handled outside the traditional CBA structure.

Expansion of Product Categories

CMS–1828–F broadens the scope of the CBP to include additional, high-volume items such as:

Continuous glucose monitoring (CGM) systems
Insulin pumps (transitioned to a rental category due to ongoing servicing needs)
Urological and ostomy supplies
Hydrophilic urinary catheters
Off-the-shelf (OTS) orthotic braces, including upper-extremity, knee, and back supports

Revisions to Single Payment Amount (SPA) Calculations

CMS–1828–F makes several essential updates to the methodology used to establish payment rates: Lead Items

Payment amounts for lead items in each product category will now be based on the 75th percentile of all winning bids, replacing the prior approach that relied on the highest accepted bid.

Non-Lead Items

For all non-lead items, CMS will apply ratios derived from the 2015 CBA-specific fee schedule, rather than using a national average as was done in 2021. This shift introduces more localized pricing and may lead to greater regional variation.

Determination of Contract Awards

CMS–1828–F modifies how CMS will award contracts by:

Reducing the requirement for CMS to award ten or more contracts per product category, giving CMS greater flexibility to adjust the number of contract suppliers as appropriate.

This flexibility allows CMS to tailor supplier numbers to product needs, market dynamics, and anticipated beneficiary demand.

Updated Bid Limits and Conditions for Awarding Contracts

The final rule establishes more precise parameters for how bid ceilings will be set Items Newly Introduced into CBP

Bid ceilings for items being included for the first time will be tied to the current unadjusted fee schedule amount.

Items Previously Competitively Bid

Bid limits will be set at the most recent SPA plus 10 percent.
If more than one year has passed since the SPA was in effect, CMS will use the inflation-adjusted SPA plus 10 percent.

In all cases:

Bid limits may never exceed the original, unadjusted fee schedule rate, ensuring that competitive bidding does not create higher-than-usual results in pricing above the fee schedule

Financial Documentation Requirements

CMS–1828–F simplifies the types of financial documentation required for bidding entities: Suppliers must provide either:

A business credit report with a numerical score from one of CMS’s designated credit reporting agencies; or
If such a score is unavailable, a business credit report showing insufficient data plus a personal credit report with a numerical score for the entity’s Authorized Official or Delegated Official listed in the Provider Enrollment. Chain and Ownership System (PECOS).

Additionally:

For each CBA bid placed, a $50,000 bid surety bond must be submitted. This bond is specific to CBP requirements and is in addition to any bond required for Medicare billing privileges.
New Contract Clause for Public Health Emergency (PHE) Situations

CMS–1828–F introduces a new provision that allows CMS to unilaterally modify or terminate supplier contracts if a public health emergency (PHE) creates conditions warranting a temporary return to standard fee-for-service rules. This clause provides CMS with operational flexibility during emergencies but also requires suppliers to be prepared for abrupt contractual adjustments.

Legal and Compliance Implications of CMS–1828–F

CMS–1828–F introduces annual reaccreditation, more specific financial documentation requirements, and updated contract provisions, thereby increasing CMS oversight of suppliers. These updates are expected to lead to more frequent audits, closer examination of operational and billing documentation, and evaluation of supplier performance indicators such as delivery reliability, financial stability, and capacity to meet program requirements. The rule modifies several components of the bidding and contracting framework.

Contract awards are no longer required to meet a set minimum number per product category
Bid ceilings are recalibrated based on the fee schedule or SPA history
Bidding may occur on a regional or national basis through RID-CBP.

These changes could affect the number of suppliers participating in specific categories, the competitive landscape, and the availability of items for beneficiaries who rely on frequently replenished products. Healthcare organizations may need to review supplier agreements and assess potential impacts on product sourcing and patient continuity of care. Financial impacts arise from the updated SPA methodology—using the 75th percentile for lead item payments and CBA-specific ratios for non-lead items—as well as the new bid limit calculations tied to either current fee schedule rates or prior SPAs. These revisions may affect reimbursement rates and require adjustments in procurement budgets. At the same time, enhanced accreditation and financial reporting requirements may increase suppliers' administrative workload, influencing operational planning and cost structures. The introduction of the Remote Item Delivery Competitive Bidding Program (RID-CBP) adds further operational specifications, including expectations for delivery timeliness, shipment and receipt documentation, inventory adequacy, and the capacity to support regional or national distribution. These requirements may influence which suppliers qualify for future contracts and may necessitate updates to how healthcare organizations evaluate vendor performance.

Looking Ahead

CMS anticipates initiating the next round of competitive bidding no later than 2028, with additional technical and procedural guidance expected in the coming years. In preparation, hospitals and clinics should reassess their supplier networks, evaluate continuity-of-care procedures, and plan for potential patient transitions involving high-volume or frequently replenished products. DMEPOS suppliers will need to prepare for updated bidding obligations, ensure adherence to revised financial documentation standards, manage the new annual reaccreditation cycle, and assess their readiness to support regional or national distribution under the Remote Item Delivery Competitive Bidding Program. Compliance and legal teams should monitor forthcoming CMS guidance, track any litigation related to CMS–1828–F, and review internal processes to ensure alignment with evolving requirements. Final Rule CMS–1828–F substantially reconfigures the DMEPOS Competitive Bidding Program by introducing new pricing methodologies, expanding product categories, revising bidding requirements, and strengthening oversight provisions. Adapting to these changes will require coordinated planning among healthcare providers and suppliers to ensure compliance, maintain reliable beneficiary access to essential items, and preserve operational stability as the next competitive bidding cycle approaches.]]> On Behalf of Malecki Brooks Ford Law Group, LLC <![CDATA[Compliance as a Catalyst: Safeguarding Financial Integrity and Patient Access in Healthcare ]]> https://www.mbhealthlaw.com/?p=50985 2025-11-11T21:16:00Z 2025-11-11T21:16:00Z

In today’s healthcare environment, the message from federal authorities is clear: fraud will be detected, and violators will be held accountable. Enforcement actions underscore the urgency for hospitals, providers, and suppliers to invest in robust compliance programs. But compliance isn’t just about avoiding headlines—it’s about building a resilient, ethical organization that protects patients and preserves financial integrity. image of a checklist

Why Compliance Matters More Than Ever

Healthcare organizations and suppliers face complex billing systems, evolving regulations, and increased scrutiny from agencies such as the Department of Justice (DOJ) and the Office of Inspector General (OIG). Without a strong compliance framework, even well-intentioned providers and suppliers can find themselves entangled in costly investigations.

A well-designed compliance program:

Promotes accurate billing and coding

Ensures patient access to medically necessary services

Detects and prevents fraudulent activity

Builds a culture of transparency and accountability

Compliance as a Strategic Investment

Organizations that prioritize compliance:

Reduce legal and financial risk

Strengthen payer relationships

Enhance patient trust and access

Stay out of the headlines—and off enforcement radars

Real-World Consequences of Noncompliance

Recent enforcement actions show that weak compliance programs can lead to staggering financial losses, criminal charges, and public exposure:

DME Fraud Case (Raju Sharma) Summary: The owner of two DME companies pleaded guilty to conspiracy to commit healthcare fraud in a scheme that billed Medicare for $29.6 million, which resulted in reimbursement payments of $15.8 million. The companies utilized telemarketing operations to target Medicare beneficiaries and generate orders for medically unnecessary durable medical equipment (DME) for patients who had not received proper medical evaluations.

Legal Issue: This activity fraudulently used practitioners’ national provider identifiers (NPIs) without the providers' knowledge or consent, and violated the Anti-Kickback Statute, as marketing companies were paid per order placed. Penalties: The Court issued a seizure warrant for luxury goods purchased using these funds, including Ferraris, a Mercedes-Benz, and Rolex watches. Sharma could face up to 10 years in prison, fines, and restitution payments for the $15.8 million in reimbursement payments.

National Health Care Fraud Takedown Summary: The DOJ charged 324 defendants in schemes involving $14.6 billion in intended loss. The defendants included doctors, nurse practitioners, pharmacists, and other licensed professionals.

Legal Issue: The schemes included submission of fraudulent claims to Medicare for DME products, wound care, genetic testing, and other medically unnecessary treatments provided in connection with kickbacks. The Takedown also included an illegal drug trafficking scheme, which involved the diversion of prescription opioids. Penalties: $245 million in seized assets, including cash, vehicles, and cryptocurrency. Civil settlements totaling $34.3 million with 106 defendants. Suspension or revocation of billing privileges for 205 providers. These cases demonstrate that fraud can originate from both individual providers and corporate entities—and that the government is equipped to respond with aggressive enforcement and asset recovery. Compliance isn’t a cost center; it’s a strategic asset that protects your mission, your margins, and your reputation. Above all, compliance protects patients. ]]>