Knowledge Base Category -

Did You Know?

On November 6, 2023, the Office of Inspector General (OIG) released General Compliance Program Guidance (GCPG).

Per the OIG’s announcement, “the GCPG is a reference guide for the health care compliance community and other health care stakeholders. The GCPG provides information about relevant Federal laws, compliance program infrastructure, OIG resources, and other items useful for understanding health care compliance. The GCPG is voluntary guidance that discusses general compliance risks and compliance programs. The GCPG is not binding on any individual or entity.”

You can download the complete guidance or  individual sections.

Why it Matters?

The OIG first published compliance program guidance documents (CPGs) in 1998. Historically, guidance has been published in the Federal Register. However, moving forward, updates or new guidance will no longer be published in the Federal Register.

GCPG

The GCPG guidance applies to all individuals and entities involved in the health care industry and addresses:

• Key Federal authorities for entities engaged in health care business.
• The seven elements of a compliance program,
• Adaptations for small and large entities, other compliance,
• Other compliance considerations, and
• OIG processes and resources.

Moving forward, the OIG anticipates updating the GCPG as changes in compliance practices or legal requirements may warrant.

ICPGs

Starting in 2024, the OIG will begin publishing industry specific CPGs (ICPGs) that “will be tailored to fraud and abuse risk areas for each industry subsector and will address compliance measures that the industry subsector participants can take to reduce these risks. ICPGs are intended to be updated periodically to address newly identified risk areas and compliance measures and to ensure timely and meaningful guidance from the OIG.”

Moving Forward

Ultimately, the goal of both guidance documents (GCPG and ICPGs) “has been, and will continue to be, to set forth voluntary compliance guidelines and tips and to identify some risk areas that OIG believes individuals and entities engaged in the health care industry should consider when developing and implementing a new compliance program or evaluating and updating an existing one.”

I encourage you to take the time to read this latest guidance, pay close attention to the information in the blue boxes and tips throughout this document. For example, in the “Auditing and Monitoring” section of this document an OIG tip reminds providers that “Medicare requires, as a condition of payment, that items and services be medically reasonable and necessary. Therefore, entities should ensure that any claims reviews and audits include a review of the medical necessity of the item or service by an appropriately credentialed clinician. Entities that do not include clinical review of medical necessity in their claims audits may fail to identify important compliance concerns relating to medical necessity.”

Finally, if you are not already signed up for the OIG newsletter, I encourage you to do so. You can sign up on the website by scrolling to the bottom of page and clicking “Subscribe to Our Newsletter.”  

Did You Know?

Effective October 1, 2023, the Alphabetic Index to the code book changed how we are to code elevated Troponin level again.

Why It Matters?

Prior to October 1, 2023, the Alphabetic Index led coders to assign R77.8, Other Specified Abnormalities of Plasma Protein, for an elevated Troponin level, while the advice from Coding Clinic, 2Q 2019, page 6 instructed coders to use R79.89, Other Specified Abnormal Lab Findings of Blood Chemistry. Even though the code book instructions take precedence over Coding Clinic advice, this confused many coders and caused coding errors when coding this condition.

What Can I Do?

Inform coders that the Alphabetic Index has now changed and that R79.89, Other Specified Abnormal Lab Findings of Blood Chemistry is the correct code for an elevated Troponin level.

Resources:

Coding Clinic, 2Q 2019, page 6

Alphabetic Index from the code book, 10/01/2023

CMS issued the CY 2024 OPPS/ASC Final Rule on November 2, 2023. You can read about changes to the Inpatient Only (IPO) Procedure List and ASC Coverage Procedure List (CPL) in a related article in this week’s newsletter. This article highlights additional topics that historically our clients have reached out to us to learn about.

OPPS Remedy for 340B-Acquired Drug Payment Policy

On July 7, 2023, CMS published a proposed rule, referred to as “remedy proposed rule” to address reduced payment amounts to 340B hospitals for CYs 2018 through 2022 and to comply with the statutory requirement to maintain budget neutrality. The “remedy proposed rule” proposed changes to the calculation of the OPPS conversion factor beginning in CY 2025.

The 340B final remedy was also issued on November 2^nd. In this final rule, CMS finalized their proposed methodology of estimating the reduction in drug payments to affected 340B covered entity hospitals in CY 2018 through September 27, 2022, and will make total lump sum payments in the amount of $9.004 billion.

CMS will be issuing instructions to the MACs to issue a one-time lump sum payment to the affected hospitals within 60 calendar days of the MAC’s receipt of the instructions.

Based on updated analyses, the final rule Addendum AAA was updated with new hospital-specific payment amounts and accounts for all payment activity that has happened since the proposed rule was issued. Updated claims data reflects that affected hospitals received approximately $10.6 billion less in 340B drug payments (including money that would have been paid by Medicare and money that would have come from the beneficiaries as copayments) than they would have for drugs provided in CY 2018 through September 27, 2022, had the 340B policy not been implemented.

“The amounts included in Addendum AAA are the amounts that hospitals will receive, except that payment amounts may be affected by MACs continuing to follow normal accounting processes for collecting repayment amounts stemming from provider-specific overpayment obligations, adjustments resulting from errors identified through the lump-sum technical correction process described below, as well as other unique situations such as provider bankruptcy or payment suspension, any of which may impact the provider’s net payment amount.”

Unfortunately, the lump sum payments do not include interest and CMS is following budget neutrality requirements to make these payments. This means that “beginning in CY 2026, we will reduce all payments for non-drug items and services to all OPPS providers, except new providers (hospitals with a CMS CCN effective date of January 2, 2018, or later), by 0.5 percent each year until the total estimated offset of $7.8 billion is reached. We currently estimate that the payment decrease will be completed after approximately 16 years. To implement this reduction and exception for new providers, we are finalizing the proposed regulation text changes at § 419.32(b)(1)(iv)(B) as proposed, except for changing the implementation date of the 0.5 percent reduction from CY 2025 to CY 2026.”

CMS notes in the 340B remedy final rule that “generally the impact of that annual 0.5 percent reduction to the OPPS conversion factor on individual providers, as well as categories of providers, will depend on the percentage of their OPPS payments that are conversion factor-based, and in most cases will be a decrease of slightly less than 0.5 percent of overall OPPS payments.”

Beneficiary Cost Sharing

CMS noted in the final rule that commenters overwhelmingly supported their proposed approach and rationale for accounting for beneficiary cost sharing. They finalized their “policy to account for beneficiary cost sharing as proposed. We will exercise our authority under section 1833(t)(2)(E) of the Act (42 U.S.C. 1395l(t)(2)(E)) to make adjustments “as necessary to ensure equitable payments,” to pay the full $9.0 billion difference, including $1.8 billion, an amount that is approximately equivalent to what affected 340B covered entity hospitals would have collected from beneficiaries for these 340B-acquired drugs if the 340B Payment Policy had not been in effect from CY 2018 through September 27, 2022, so that affected 340B covered entity hospitals are paid the approximate amount they would have been paid in full without application of the 340B Payment Policy.”

340B Modifiers “JG” and “TB”

The Inflation Reduction Act of 2022 expanded the provider types that must report one of these modifiers no later than January 1, 2024, to now include critical access hospitals, Maryland All-Payer or Total Cost of Care Model Hospitals, and Non-excepted off-campus provider-based departments (PBD).

In the CY 2023 OPPS/ASC final rule, CMS maintained the requirements that 340B hospitals report one of two modifiers, “JG” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes, or “TB” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes for select entities.

In the CY 2024 OPPS/ASC proposed rule, CMS notes they “now believe utilizing a single modifier will allow for greater simplicity, especially because both modifiers are used for the same purpose: to identify separately payable drugs and biologicals acquired under the 340B program.”

CMS is proposing that all 340B covered entity hospitals would report the “TB” modifier effective January 1, 2025, even if the hospital previously reported the “JG” modifier. The “JG” modifier will remain effective through December 31, 2024. Beginning January 1, 2025, the “JG” modifier would be deleted.

CMS notes hospitals currently using the “JG” modifier could choose to continue to use it in CY 2024 or choose to transition to the “TB” modifier during that year.

Did you Know?

November is Lung Cancer Awareness Month and annually the American Cancer Society has designated the third Thursday of November as the Great American Smokeout®.

Why it Matters?

In June of this year HHS published a request for information in the Federal Register seeking input on the Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation to guide the Department’s efforts to sustain and strengthen existing programs and drive further progress toward smoking cessation, with an emphasis on serving populations and communities disproportionately impacted by smoking-related morbidity and mortality. Comments had to be submitted by July 30, 2023. https://www.federalregister.gov/documents/2023/06/30/2023-13928/request-for-information-draft-hhs-2023-framework-to-support-and-accelerate-smoking-cessation

In a related Fact Sheet, HHS noted that “smoking causes approximately 30 percent of all cancer deaths in the nation – making it the largest single driver of cancer deaths in America…the Biden-Harris administration has made it a priority to reach the Cancer Moonshot goal of reducing cancer mortality by 50% within 25 years. Driving progress towards smoking cessation is essential to achieving this goal.”

What Can I Do About It?

For health care providers, know what resources are available for your patients.

Counseling to Prevent Tobacco Use

This service falls in the benefit category of additional preventive services. National Coverage Determination (NCD 210.4.1) Counseling to Prevent Tobacco Abuse details the covered indications for this service. Specifically, CMS covers this service for outpatient and hospitalized patients with Medicare Part B who meet the following criteria:

• The patient uses tobacco, regardless of whether they exhibit signs and symptoms of tobacco-related disease,
• The patient is competent and alert when counseling is delivered, and
• The counseling is provided by a qualified physician or other Medicare-recognized practitioner.

Counseling Frequency

Medicare covers two cessation attempts per year and each attempt may include a maximum of four intermediate or intensive sessions, with the patient getting up to eight sessions per year. There is no copayment, coinsurance, or deductible for the patient.

Medicare Transmittals & MLN Articles

September 19, 2023: MLN MM13166: ICD-10 & Other Coding Revisions to National Coverage Determinations: October 2023 Update

Relevant NCD coding changes in related Change Request 13166 include:

• NCD 20.20: External Counterpulsation Therapy (ECP) for Severe Angina, effective August 7, 2023,
• NCD 90.2: Next Generation Sequencing (NGS), effective August 7, 2023, and
• NCD 210.1: Prostate Screening Tests, effective October 1, 2023.

https://www.cms.gov/files/document/mm13166-icd-10-other-coding-revisions-national-coverage-determinations-october-2023-update.pdf

October 11, 2023: MLN MM13381: Update for Blood Clotting Factor Add-on Payments

In this MLN article, CMS advises IPPS hospitals to make sure your billing staff knows about additional diagnosis codes eligible for blood clotting factors, and adjustment of certain claims with the added codes. https://www.cms.gov/files/document/mm13381-update-blood-clotting-factor-add-payments.pdf

October 12, 2023: Transmittal 12299: An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring, and (2) Expanding Coverage of Colorectal Screening

Transmittal 11865 issued February 16, 2023 has been rescinded and replaced by Transmittal 12299 to provide clarification on CMS policy and related claims processing instructions for their approach to colonoscopies within the context of a complete colorectal cancer screening. Specifically, this CR is amended to remove the requirement that contractors shall return to provider / return as un-processable certain screening colonoscopy claims that do not include the KX modifier. https://www.cms.gov/files/document/r12299bp.pdf

October 19, 2023: MLN MM13365: Medicare Deductible, Coinsurance, & Premium Rates: CY 2024 Update

CMS advises providers to make sure your billing staff knows about the CY 2024 Medicare Part A and Medicare Part B deductible and coinsurance rates, and Part and Part B premium amounts. https://www.cms.gov/files/document/mm13365-cy-2024-update-medicare-deductible-coinsurance-premium-rates.pdf

Coverage Updates

October 13: NCD 220.6.20 Beta Amyloid PET in Dementia and Neurodegenerative Disease Final Decision Memo

CMS announced a final decision removing this NCD and now permitting Medicare coverage determinations to be made by the MACs. Removing the NCD also removes the current limitation of one PET beta-amyloid scan per lifetime from the coverage requirements.

It has been thirteen years since CMS published the first Medicare Quarterly Compliance Newsletter in 2010.  At that time, this Medicare Learning Network® (MLN) educational product was meant “to help providers understand the major findings identified by Medicare Claims Processing Contractors, Recovery Auditors, Program Safeguard Contractors, Zone Program Integrity Contractors, and other governmental organizations such as the Office of Inspector General.”

In the second edition of this newsletter CMS indicated that it was “designed to help FFS providers, suppliers, and their billing staffs understand their claims submission problems and how to avoid certain billing errors and other improper activities, such as failure to submit timely medical record documentation, when dealing with the Medicare FFS program.”

Thirteen years later, the newsletter is published twice a year instead of quarterly, and there have been additions to who is reviewing records (i.e., Noridian as the current Supplemental Medical Review Contractor (SMRC) and Livanta as the National Medicare Claim Review Contractor for short stay reviews (SSRs) and higher-weighted DRG (HWDRG) reviews nationally).

CMS announced the release of the September 2023 newsletter in the October 5, 2023 edition of MLN Connects. This edition of the newsletter includes guidance from the Comprehensive Error Rate Testing (CERT) and the Recovery Auditor program.

CERT: Hospital Outpatient Services

The CERT guidance affects physicians, non-physician practitioners (NPPs), and providers who bill 12x-19x. For 2022, the CERT reported an improper payment rate of 5.4% for hospital outpatient services. While the error rate is relatively low, it equates to a projected improper payment of $4.4 billion.

Ninety-one percent of the improper payments were attributed to insufficient documentation. CMS notes that “hospital outpatient claims with insufficient documentation errors most commonly were due to a missing order, missing provider’s intent to order, or inadequacies (that is, required elements are missing) with an order.”  An example of a missing order or provider’s intent to order is in the newsletter as well as links to resources to help avoid errors when billing hospital outpatient services.

Recovery Auditor Review 0210: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements

The Recovery Auditor guidance affects outpatient hospitals, ambulatory surgical centers (ASCs), and professional services. The problem cited related to this RAC topic is that providers should know the documentation and medical necessity requirements when billing for this service.

The CPT code for this procedure 64582 (Open implantation of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array) became effective January 1, 2022 and CMS approved this RAC topic for review on June 7, 2022.

There are very specific indications that must be met for this procedure to be covered (i.e., beneficiary must be 22 years of age or older with a body mass index less than 35, and Shared Decision-Making (SDM) must occur between the beneficiary, sleep physician, and qualified otolaryngologist (if they are not the same).

CMS recommends that providers review coverage indications, limitations, and medical necessity requirements in Local Coverage Determinations (LCDs) and related Local Coverage Articles (LCAs) for billing and coding guidance.

The September Medicare Provider Compliance Newsletter includes links to a National Government Services, Inc. (NGS) LCA and a Palmetto GBA LCD. If neither one of these Medicare Administrative Contractors (MACs) is your MAC, you can find a listing of all MACs that have published an LCD and related LCA on the RAC approved topic description for recovery auditor review 0210 on the CMS webpage.   

CPT Code 64582 by the Numbers

With this being a relatively new CPT code and RAC approved topic, I turned to our sister company, RealTime Medicare Data (RTMD), to quantify actual claims volume and payment for this service. The following data represents Medicare Fee-for-Service paid claims data available in RTMD’s database for all U.S. States and D.C. for calendar year 2022.

Hospital Outpatient Setting

• Claims volume: 5,632
• Sum of CPT Paid: $113,462,444.15
• Average Payment: $20,146.03
• Top five states performing this procedure in the hospital outpatient setting: Florida, Texas, Arizona, South Carolina, and Indiana

   

  ASC Setting

• Claims Volume: 1,052
• Sum of CPT Paid: $5,207,088.00
• Average Payment: $4,949.70
• Top five states performing this procedure in an ASC: Texas, Illinois, New Jersey, New Mexico, and Washington

In addition to ensuring that documentation in the medical record supports indications, documentation requirements, and coding and billing guidance, CMS recommends that you respond to RAC review requests promptly and completely. While this seems obvious, no/insufficient documentation continues to be cited as a cause for claim denials. For this reason, make sure you have processes in place to ensure record requests from contractors make it to the right person and/or department in your hospital, you send all documentation needed to support the service provided, and the review contractor receives the record in a timely manner. 

Social factors can have a positive and negative impact on our health and our general outlook on life. Hospitals have been tasked with assessing and identifying social factors that impact a patient’s health and well-being. Once identified, hospitals are taking action to mitigate the negative impact of social factors that are contributing to wide health disparities and inequities.

This article will review Social Determinants of Health (SDOH), Health Related Social Needs (HRSN), and Social Drivers of Health (SDOH).

Social Determinants of Health (SDOH)

HHS Health People 2030 National Health Initiative

The U.S. Department of Health and Human Services through their Healthy People 2030 national health initiative defines SDOH as being “the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” They group SDOH into the five domains of economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context.  

SDOH can negatively impact our health especially as we age. Collectively, the U.S. population is getting older, in fact “people aged 65 years and older made-up 17 percent of the population in 2020. By 2040, that number is expected to grow to 22 percent. An aging population means higher use of health care services and a greater need for family and professional caregivers.”

To learn more about how the Healthy People 2030 initiative is addressing SDOH and available resources, visit the initiative website at https://health.gov/healthypeople/priority-areas/social-determinants-health.

SDOH and ICD-10-CM Z Codes

ICD-10-CM Z codes are found in Chapter 21: Factors Influencing Health Status and Contact with Health Services (Z00-Z99). The SDOH codes are a subset of this chapter and range from Z55 – Z65 and are used to document SDOH data (i.e., housing, food insecurity, lack of transportation).

CMS recently published information about a new CMS infographic to help you understand and use Z codes to improve the quality and collection of health equity data in the September 14, 2023 edition of MLN Connects (https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-mlnc#_Toc145581413).

ICD-10-CM Official Guidelines for Coding and Reporting Documentation Tips Regarding SDOH Z Codes

• Code assignment may be based on medical record documentation from clinicians involved in the care of the patient who are not the patient’s provider (i.e., Social Workers, Case Managers, or Nurses).
• Patient self-reported documentation may be used when the information is signed-off by and incorporated into the medical record by either a clinician or provider.
• SDOH codes should be assigned only when the documentation specifies that the patient has an associated problem or risk factor. For example, you would not use ICD-10-CM code Z60.2 (Problems related to living alone) without documentation of a risk or unmet needs for assistance at home.

   

  Z Codes IPPS FY 2024 Change in Severity Designation

  In the 2024 IPPS Final Rule, CMS recognized that homelessness is an indicator of increased resource utilization in the acute inpatient hospital setting. Therefore, they finalized the proposal to change the severity designation for three codes to a CC (comorbidity) for the purposes of MS-DRG assignment:

• Z59.00: Homelessness, unspecified,
• Z59.01: Sheltered homelessness (due to economic difficulties, currently living in a shelter, motel, temporary or transitional living situation, scattered site housing, or not having a consistent place to sleep at night), and
• Z59.02: Unsheltered homelessness (residing in a place not meant for human habitation, such as cars, parks, sidewalks, or abandoned buildings (on the street)).

CMS noted in a FY 2024 IPPS Final Rule fact sheet that as SDOH codes are increasingly added to billed claims, they plan “to continue to analyze the effects of SDOH on severity of illness, complexity of services, and consumption of resources.”

Did You Know?

There is a new code to assign for Encounter for Screening for COVID-19.

Why It Matters?

Prior to October 1, 2023, coders assigned code (Z20.822) for contact with and (suspected) exposure to COVID-19, for COVID-19 screening, per the federal Public Health Emergency (PHE).  However, as of May 11, 2023, the federal PHE expired.  Therefore, the new code is to be assigned beginning with all encounters on or after October 1, 2023.

What Can I Do?

Stay abreast of all new ICD-10-CM codes and guidelines and new Coding Clinic references.

References

Coding Clinic for ICD-10-CM/PCS, Second Quarter 2012, Page 3

Coverage Updates

September 6, 2023: National Coverage Determination (NCD) Dashboard

CMS released an NCD dashboard that was last updated on August 23, 2023. This document details the seven accepted NCD requests that are on the CMS Wait List, the four open NCD topics currently undergoing a National Coverage Analysis (NCA) with opportunities for public comment, and the two NCDs finalized in the past twelve months. Links to all thirteen topics are included in this document. https://www.cms.gov/files/document/ncd-dashboard.pdf

COVID-19 Update

September 11, 2023: FDA Approves and Authorizes Updated COVID-19 Vaccines

The FDA has approved an update COVID-19 vaccine that was developed to target current circulating variants. The updated mRNA vaccines for 2023-2024 were manufactured by ModernaTX Inc. and Pfizer Inc. and have been updated to include a monovalent (single) component that corresponds to the Omicron variant ZBB.1.5. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating

September 14, 2023: Special MLN Connects: COVID-19 Updated mRNA Vaccines for Patients 6 Months or Older

CMS issues a special MLN Connects announcing the FDA’s approval of updated vaccines noting that the CDC recommends everyone 6 months and older get an updated COVID-19 vaccine. Also includes in this announcement are six new CPT codes effective September 11, 2023 for the vaccine and administration of the vaccine. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-oce

Other Updates

September 14, 2023: MLN Connects: Social Determinants of Health Resources

In this edition of MLN Connects, CMS let providers know about a new CMS infographic to help you understand and use Z codes. They also included links to additional resources.

As a reminder, effective October 1, 2023, CMS finalized their proposal to change the severity level designation for diagnosis codes Z59.00 (Homelessness, unspecified), Z59.01 (Sheltered homelessness), and Z59.02 (Unsheltered homelessness) from NonCC to CC. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-mlnc

September 19, 2023: CMS Requires States to Pause Disenrollments and Reinstate Coverage for Impacted Individuals

Did You Know?

Effective October 1, 2023, there is a new Place of Service (POS) Code 27 – “Outreach Site/Street.” This POS is defined as “a non-permanent location on the street or found environment, not described by any other POS code, where health professionals provide preventive, screening, diagnostic, and/or treatment services to unsheltered homeless individuals.”

In the August 10^th Transmittal 12202, CMS indicated that “Medicare has not identified a need for this new code. However, in order to comply with HIPAA and its goals of promoting administrative simplification, contractors are to accept claims containing this new code in accordance with its effective date. Medicare contractors shall therefore implement the systems and/or local-contractor-level changes needed for Medicare to return as unprocessable claims with the new code should it appear on a Medicare claim.”

Why it Matters?

On September 20, 2023, CMS rescinded Transmittal 12202 and replaced it with Transmittal 12254 indicating that the transmittal has been revised to “align with broader CMS efforts to address economic, social, and other obstacles impacting Medicare beneficiary healthcare access by revising the IOM as well as the policy section and business requirements 13313.2.”

The policy note has changed to indicate that “Contractors are to accept claims containing this new code in accordance with its effective date. Medicare contractors shall therefore implement the systems and/or local-contractor-level changes needed for processing claims with the new code should it appear on a Medicare claim.”

What Can I Do?

Make sure key stakeholders at your facility are aware of this change to the new POS Code 27.

Resources

August 10, 2023 Transmittal 12202: New Place of Service (POS) Code 27 – “Outreach Site/Street” https://www.cms.gov/files/document/r12202cp.pdf