Physicians and Dentists – Know the Hidden Costs of Your Technology/Marketing Contracts

Many website design and development contracts as well as marketing and electronic medical records agreements (“technology contracts”) contain onerous terms and layers of user fees. If a physician or a dentist (“provider”) decides to part ways with the vendor under a technology contract the transition may be costly or cost prohibitive. One of the best ways providers can protect themselves against a slue of additional costs and concerns about possible loss of data is to have the contract reviewed by a healthcare attorney before signing on the dotted line.

Thinking “it’s not a big deal” providers sometimes pay little attention to technology contracts or the legal ramifications of onerous terms may not be evident without legal analysis. But once the relationship has soured they may look for ways to end an unfavorable relationship and move forward without disrupting their workflow while keeping the website running.

Often providers come to us with such questions after the technology contract is well underway. Our evaluation often leads to shock and disappointment as providers discover numerous additional costs and fees as well as other onerous terms embedded in the technology contract. The typical reaction is:

“I already paid them so much money and I still have to pay?”

“It is a website designed for my practice, how is it that I don’t have control over it?”

Based on the contracts we evaluated post-signing there are many problematic terms hidden in microscopic font that become controlling when providers are looking to end a problematic relationship. Equally important to understand is what is included in the fees providers pay for the services and if there are any exclusions that would require additional provider fees. For example, will the website meet or exceed the standards of ADA accessibility requirements or will the provider incur additional costs?

Likewise, it is important to know if the provider’s website or marketing is exposing them to disciplinary Board action or lawsuits and liability from potential patients or their respective Boards for misleading information and marketing.

Technology contracts contain many important and unique terms that may be costly and either prevent a provider from moving to a company of their preference or be so cost prohibitive that, despite being dissatisfied, a provider remains tethered to their existing technology contract for the foreseeable future.

An analysis by a healthcare attorney prior to signing a technology contract can alert a provider to problematic terms and either lead to a contract negotiated with more favorable terms or give the provider an opportunity to find a technology/marketing company that better suits their marketing and legal needs.

If you have questions about your technology contract please contact our office.

OIG Looks to Remove a Safe Harbor for Certain Drug Rebates; Proposes Two New Ones

In a newly proposed rule the Office of the Inspector General (“OIG”) is proposing to exclude from the discount safe harbor certain types of remuneration offered by drug manufacturers to Part D plan sponsors and Medicaid MCOs that may pose a risk to the Federal health care programs and beneficiaries. The OIG is also proposing to add two new safe harbors. The first would protect certain manufacturer point-of-sale reductions, and the second would protect certain fixed service fees that manufactures pay to pharmacy benefits managers for services rendered to the manufacturer that meet specific criteria.

Citing various ways that the current rebate system works to the disadvantage of beneficiaries, and the Federal health care programs, the OIG proposed amending the rebates safe harbor. Under the proposal the safe harbor regulation would be amended so that it would not protect price reductions paid by manufacturers to plan sponsors under Medicare Part D or Medicaid MCOs, either directly or through pharmacy benefits manager (“PBMs”) acting under contract with either, unless the reduction in price is required by law (e.g., rebates under the Medicaid Drug Rebate
Program). The proposed rule would define “plan sponsor under Medicare Part D” to include the sponsor of a prescription drug plan and a Medicare Advantage organization offering a Medicare Advantage prescription drug plan.

OIG is also proposing a new safe harbor that would protect a manufacturer point-of-sale reductions in price on prescription pharmaceutical products to a plan sponsor under Medicare Part D, a Medicaid MCO, or a PBM acting under contract with either. Under the proposal, the reduction in price would have to be set in advance with the plan sponsor under Medicare Part D, a Medicaid MCO, or a PBM. According to the proposed rule, the “set in advance” would mean that the terms of the reduction in price would be fixed and disclosed in writing to the plan sponsor under Medicare Part D or the Medicaid MCO by the time of the initial purchase. OIG has indicated that it intends for this new safe harbor to protect reductions in price for prescription pharmaceutical products without regard to what phase of the benefit the beneficiary is in. Like the current discount safe harbor, OIG proposes for this new safe harbor to exclude from protection price reductions offered to one payor but not to Medicare or Medicaid.

Additionally, the OIG is proposing a new safe harbor to protect certain fixed service fees that pharmaceutical manufacturers pay to PBMs for services rendered to the manufacturers that “relate to PBMs’ arrangements to provide pharmacy benefit management services to health plans.” This safe harbor would protect only a pharmaceutical manufacturer’s payment for those services that a PBM furnishes to the pharmaceutical manufacturer, and not for any services that the PBM may be providing to a health plan. OIG is interpreting the phrase “services that relate to” as those services rendered to manufacturers that depend on or use data gathered by PBMs from their health plan customers (whether claims or other types of data). One example of that would be PBMs that provide services for pharmaceutical manufacturers to prevent duplicate discounts on 340B claims. While the OIG is not proposing to define “pharmacy benefit management services,” it is interpreting the phrase to refer to “services such as contracting with a network of pharmacies; establishing payment levels for network pharmacies; negotiating rebate arrangements; developing and managing formularies, preferred drug lists, and prior authorization programs; performing drug utilization review; and operating disease management programs.”

OIG is soliciting comments on its proposed changes which are due on April 8, 2019.

If you have any questions regarding the proposed rule or have other health law related questions, please contact us.

Recent Expansion of Scope of Practice for Dental Hygienist in New Jersey

The New Jersey Board of Dentistry (Board) recently expanded the scope of practice of licensed dental hygienists, limited registered dental assistants in orthodontics and registered dental assistants. Effected providers should become familiar with these expanded parameters. 

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Expanding Role of Pharmacists and Certified Medical Assistants in New Jersey

The New Jersey Board of Pharmacy and the New Jersey Board of Medical Examiners recently adopted new regulations and amended existing ones that effect the way providers practice. The changes concern pediatric immunizations performed by pharmacists and the administration of subcutaneous and intramuscular injections and venipunctures by certified medical assistants. We briefly summarize these recent changes below. 

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CMS Proposes Sweeping Changes to E/M Service Codes and Telemedicine

The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule that, if codified, would bring about sweepings revisions to many Medicare payment policies under the physician fee schedule. Among many other changes CMS is proposing to simplify the documentation requirement for evaluation and management (E/M) code levels 2 through 5 but also proposes a flat fee for those levels of services. These and certain other proposed policy changes are briefly summarized below. 

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New York Dentists Face New Dental Anesthesia Requirements

New sweeping regulations went into effect on July 1, 2017 for dental anesthesia services in New York. The regulations, among other things, would require dentists to meet specific practice requirements, maintain more exacting records than previously required and complete additional and specific continued education courses. The regulations will also impose more stringent requirements on dentists providing dental sedation to patients 12 years old and younger. Below is a brief summary of the new requirements. 

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NYS OMIG Focuses on Compliance, Fraud, Waste & Abuse and Detection

New York State Office of the Medicaid Inspector General (OMIG) annual 2018-2019 Work Plan highlights three areas of concern for the agency: (1) provider compliance; (2) identifying and addressing fraud, waste and abuse in the program; and (3) improving methods of detecting fraudulent activities.

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CERT Audit Finds Insufficient Documentation Results in Improper Payments

Recent analysis by the Comprehensive Error Rate Testing (CERT) initiative of physical therapy claims revealed that insufficient documentation contributed to improper payments issued to providers.

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Pharmacies Beware of Potential Gabapentin Reporting Requirements

The Division of Consumer Affairs (Division) is proposing to amend the Prescription Monitoring Program (PMP) rules to require New Jersey licensed pharmacies and registered out-of-State pharmacies to electronically transmit information to the Division about prescriptions filled for gabapentin.

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NJ’s New Rules for Companion Service

The New Jersey Division of Consumer Affairs (“Division”) recently proposed amendments and a new rule to implement a 2014 law concerning health care service firms.

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NY’s OMIG Finds Basic Compliance Program Gaps

The Bureau of Compliance (BOC) within the New York State Office of the Medicaid Inspector General (OMIG) recently performed an assessment of providers’ compliance programs. The results indicate that providers sometimes fail in relatively less complicated and readily addressable ways.

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New Jersey Places New Limitations on Opiod Prescriptions

Several of New Jersey’s professional licensing Boards recently adopted new controlled dangerous substance prescription requirements. Prescribers should be aware of the changes to avoid running afoul of the new regulations. 

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New Blanket Waivers for Electronic Prescribing Approved in NY

In recognition of limitation of certain electronic prescribing software the NYS Health Commissioner approved a new blanket waiver for electronic prescribing requirements. 

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Billing for Dually Eligible Beneficiaries

The Centers for Medicare & Medicaid Services (CMS) has once again issued guidance reminding providers that federal law bars Medicare providers from billing a Qualified Medicare Beneficiaries (QMB) under any circumstances.

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NY Watchdog Releases Its Annual Fraud Fighting Plan

The New York State Office of the Medicaid Inspector General (OMIG or agency) has recently issued its 2017-2018 Workplan. The Workplan identifies key areas of OMIG’s focus impacting health care providers and suppliers.

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Recent Medicare Program Changes

Providers, suppliers and their billing staff need to be aware of the following recent changes to the Medicare program.

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OIG’s Strengthens its Exclusion Authorities

The Office of Inspector General (OIG) recently published a final rule that implements OIG’s expanded statutory exclusion authority. The final rule included a number of provisions that impact providers and suppliers.

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NJ Dentist Beware – When Administering Botox May Lead to Board Troubles

Scope of practice matters and New Jersey dentists who fail to comply with the requirements for administering injectable pharmacologics such as Botox or Restylane may be subject to discipline.

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NJ’s Medicaid Watchdog Expands Audit and Exclusion Efforts

A recent report from the New Jersey Office of the State Comptroller indicates an expansion of the efforts of its Medicaid Fraud Division (MFD) to investigate fraud, waste and abuse in the New Jersey Medicaid Program. The report also highlights MFD’s expanded effort to exclude providers from the Medicaid Program.

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Late Breach Notification Leads to Half a Million Dollar HIPAA Settlement

Failure by a covered entity to timely report a breach of protected health information (PHI) resulted in the first of its kind settlement in the amount of $475,000.

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