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“He’s making a list and he’s checking it twice.” Are you a list maker like Santa? If so, you probably have more lists at this time of the year than usual – gift lists, shopping lists, decorating to-do lists, and family/social gatherings lists. Can you handle one more list? There is a list of requirements and information for Medicare coverage of lung cancer screening by Low Dose CT.

Medicare recently added a new preventive service for Medicare beneficiaries through the National Coverage Determination (NCD) process that allows coverage of additional preventive services that are reasonable and necessary for the prevention or early detection of illness or disability. Medicare now covers lung cancer screening by Low Dose Computed Tomography (LDCT). This is an important preventive service since lung cancer was expected to claim over 158,000 lives in the United States in 2015.

A new HCPCS procedure code to bill Medicare for this service was finally announced in the 2016 OPPS Final Rule. Providers also need to carefully review the numerous requirements of the NCD and the claim processing instructions. Medicare summarizes all of these requirements in MLN Matters Article MM9246. Review our list of 8 issues concerning LDCT lung cancer screening to make sure you know what needs to be checked off when providing this service.

1.Dates

Lung cancer screening by LDCT is covered annually for services performed on and after February 5, 2015. The implementation date is January 4, 2016. This means Medicare will begin processing claims with the new HCPCS codes on and after this date. Timely filing limits will apply so claims must be submitted within one year of the date of service. So if your facility began providing this service last February, you will need to hurry after the first of 2016 to get your claims to Medicare before your time runs out.

2.Patient Coverage Criteria

• Age 55-77 years
• Asymptomatic (no signs or symptoms of lung cancer)
• Tobacco smoking history of at least 30 pack-years (one-pack year = smoking one pack (20 cigarettes) per day for one year)
• Current smoker or one who has quit within last 15 years
• Receives a written order provided at
• a lung cancer screening counseling and shared decision making visit for the first screening
• any appropriate visit with a practitioner for subsequent screening

3.Written Order Requirements

Written orders for lung cancer LDCT screenings must be appropriately documented in the beneficiary’s medical records, and must contain the following information:

• Patient’s date of birth
• Number of actual pack-year smoking history
• Current smoking status and the number of years since quitting for former smokers
• Statement that patient is asymptomatic
• NPI of ordering practitioner

4.Counseling and Shared Decision Making Visit

The lung cancer screening counseling and shared decision making visit may be billed by a hospital on a type of bill 12x, 13x, or 85x (CAH). The counseling visit must:

• Be furnished by a physician or qualified non-physician practitioner (meaning a Physician Assistant (PA), Nurse Practitioner (NP), or Clinical Nurse Specialist (CNS) and
• Include all of the following elements:
• Determination of beneficiary eligibility including age, absence of signs or symptoms of lung cancer, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting;
• Shared decision-making, including the use of one or more decision aids, to include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure;
• Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of co-morbidities, and ability or willingness to undergo diagnosis and treatment;
• Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions; and,
• If appropriate, the furnishing of a written order for lung cancer screening with LDCT.

5.Other Coverage Requirements

The NCD also contains specific requirements for eligibility criteria for the reading radiologist and the radiology imaging facility. The imaging facility criteria include data submission to a CMS-approved registry.

6.HCPCS Codes

• G0296 –Counseling visit to discuss need for lung cancer screening (LDCT) using low dose CT scan (service is for eligibility determination and shared decision making)
• G0297 –Low dose CT scan (LDCT) for lung cancer screening

7.Diagnosis and Diagnosis Code Required for Coverage

Personal history of tobacco use/personal history of nicotine dependence

• ICD-9 code V15.82 (for dates of service from February 5 – September 30, 2015)
• ICD-10 code Z87.891 (for dates of service on and after October 1, 2015)

8.Hospital Payment and Waiver of Co-insurance/Deductible

Lung cancer screening provided in a hospital outpatient setting is paid under OPPS and there is no beneficiary deductible or co-payment. The unadjusted Medicare payment amount for 2016 is $69.65 for G0296 (counseling visit) and $112.49 for G0297 (LDCT scan).

9.Frequency

LDCT for lung cancer screening is covered once per year. At least 11 full months must elapse from the date of the last screening.

The links to the actual transmittals that are listed in the MLN Matters Article do not appear to be working. You can find the full transmittals at: CMS Transmittal R3374CP and CMS Transmittal R185NCD . So get busy checking off that list! 

Dilemma:What are the ICD-10-PCS codes for the following procedures?

CLINICAL HISTORY: A 72-year-old man with known PAD of his right lower extremity, status post right fem-pop and subsequent intervention.

The patient was counseled as to risks, benefits and alternatives of the procedure. After yielding a full and informed consent, he was brought to the cath lab where he was prepped and draped in the usual fashion.

Initially, a short 4-French sheath was introduced in the left common femoral artery using modified Seldinger technique. We went in with a 4-French universal flush catheter and engaged the right common iliac artery. We advanced a Glidewire Advantage into the right profunda and subsequently exchanged for a 6 x 45 cm destination sheath which we put in the distal right common femoral artery. We then took angiograms confirming occlusion of the right fem-pop stent with distal reconstitution of the popliteal artery by profunda collaterals with 3-vessel runoff below the knee.

We then used a Glidewire Advantage and a Quick-Cross catheter to blunt dissect through the occluded segments of the fem-pop graft. We were able to easily reconstitute into the distal true lumen, which we confirmed through a test injection. Due to the ease of traversing this occluded segment of the fem-pop, I was concerned of a significant thrombus burden. We therefore exchanged out for a 5-mm filter wire and performed AngioJet thrombectomy along the entire course of the graft. There was still occlusion at the proximal portion due to a proximal cap lesion. We therefore performed laser atherectomy of the entire graft with a 2.0 Turbo Elite laser paying particular attention to the previously stented segments of the proximal and distal ends. We subsequently ballooned with a 5 x 300 mm Pacific balloon. This did restore flow down the graft. There were still some issues at the stented segments with significant stenosis proximally and in the distal stented segment near the anastomosis. We therefore used a 6 x 120 balloon distally, this was a drug-eluting balloon. We then used a 6 x 80 mm drug- eluting balloon proximally. There was still hazy area with restricting flow down the graft in the very proximal portion of the graft at its anastomosis. I therefore elected to place a 9 x 20 mm self-expanding stent back into the common femoral across the profunda. We ballooned this with a 6 x 80 a drug- eluting balloon, the old balloon, and then took wire out shots. Initially there was some slowish flow due to the filter being clogged. We ended up capturing the filter and taking a subsequent angiogram which showed brisk flow down the leg with preserved 3-vessel runoff below the knee. The patient was given a 300 mg Plavix bolus. We did use Angiomax as the anticoagulant and an ACT was checked to ensure adequacy during the procedure.

PROCEDURES PERFORMED

1. Right lower extremity angiography.
2. Primary thrombectomy of the right fem-pop graft.
3. Laser atherectomy, balloon angioplasty and stenting of the right fem-pop graft.

Solution:

• 04CK3ZZ – for extirpation of the femoral artery. (AngioJet thrombectomy & laser atherectomy)         
• 047K3ZZ – for dilation with Pacific balloon
• 047K3Z1 – for dilation with drug-eluting balloon           
• 047K3D1 – for dilation with drug-eluting balloon and stent placement
• The angiograms cannot be coded without further clarification of what type of contrast was used, if applicable, and whether or not fluoroscopy was used.

Resource(s):

• Coding Clinic ICD-10-CM/PCS, 1Q 2015, page 36
• ICD-10-CM and ICD-10-PCS Coding Handbook, by Nelly Leon-Chisen, RHIA

The Final Rule for the Comprehensive Care for Joint Replacement (CJR) Model was released on November 16, 2015 and published in the Federal Register on November 24, 2015. Unlike the proposed January 1st start date, the final rule start date is April 1, 2016 and is most definitely not an April Fool’s Day Joke. The model will include five (5) Performance Periods that will run through December 31, 2020. CMS has indicated that through an impact analysis they “expect the CJR model to result in savings to Medicare of $343 million over the 5 performance years of the model.”

Participating hospitals need to familiarize themselves with several new terms specific to the CJR Model as provided in Table 1.

Table 1: Key CJR Model Terms and Acronyms

‍CJR Model: Key Aspects

• For the first time, hospitals in selected MSAs are required to participate. CMS indicates that they “have designed the CJR model to require participation by hospitals in order to avoid the selection bias inherent to any model in which providers may choose whether to participate. Such a design will allow for testing of how a variety of hospitals will fare under an episode payment approach, leading to a more robust evaluation of the model's effect on all types of hospitals.”

• Eligible beneficiaries who elect to receive care at these hospitals will automatically be included in the model. Patients cannot opt out of this model.

• Participant hospitals will be required to supply beneficiaries with written information regarding the design and implications of this model as well as their rights under Medicare, including their right to use their provider of choice.

• Unlike the Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA) 30 Day Readmission Measure, this model will include LEJR procedures that result from hip fracture treatment rather than limiting the model conditions to only elective THA and TKA.

• CMS finalized the inclusion of any lower extremity joint procedure that results in discharge from MS-DRG 469 or 470, including ankle replacement; lower leg, ankle, and thigh reattachment; and hip resurfacing procedures. CSM acknowledges that while this volume of patients is likely to be small at any one hospital, these beneficiaries may also benefit from care redesign resulting in improved care coordination and quality that are goals of this model.

Payment

• During the performance years CMS will continue paying hospitals and other providers and suppliers according to the usual Medicare FFS payment systems.

• The Repayment requirement will not begin until Performance Year 2 (Episodes that end between January 1, 2017, and December 31, 2017).

• After the completion of a performance year, the Medicare claims payments for services furnished to the beneficiary during the episode, based on claims data, will be combined to calculate an actual episode payment. The amount of this calculation, if positive, will be paid to the participant hospital. This payment will be called a reconciliation payment. If negative Medicare will require repayment of the difference between the actual episode payments and the CJR target price from a participant hospital if the CJR target price is exceeded.

• CMS will limit how much a hospital can gain or lose based on its actual episode payments relative to target prices.

Payment and Pricing: Link to Quality

Hospitals will be assigned a composite quality score annually based on their performance and improvement on the following 2 quality measures:

1. Hospital Level Risk Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TAK) measure (NQF #1550); and
2. Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure (NQF #0166)

CMS intends to publicly report this information on the Hospital Compare website. Participating hospitals who successfully submit voluntary THA/TKA patient-reported outcomes and limited risk variable data will receive additional points for their composite quality score.

Program Waivers

“CMS finalized the proposal, without modification, that waivers of Medicare program rules would apply to the care of beneficiaries who are in CJR model episodes at the time the service is furnished to the beneficiary under the waiver, even if the episode is later canceled. This policy would include circumstances where a beneficiary's care is ultimately excluded from the CJR model due to a change in the beneficiary's coverage during the episode.”

CMS proposed and finalized three specific waivers of Medicare Program Rules. “The purpose of such flexibilities would be to increase LEJR episode quality and decrease episode spending or internal costs or both of providers and suppliers that results in better, more coordinated care for beneficiaries and improved financial efficiencies for Medicare, providers, and beneficiaries.”

• Home Visits Waiver
  CMS finalized their proposal, “without modification, to waive the "incident to" direct physician supervision requirement set forth at § 410.26(b)(5), to allow a CJR beneficiary who does not qualify for home health services to receive up to 9 post-discharge visits in his or her home or place of residence any time during the episode following discharge from an anchor hospitalization.”

• Billing and Payment for Telehealth Services Waiver
  CMS finalized without modification to waive the geographic site requirement and the originating site requirement to permit telehealth visits to originate in the beneficiary’s home or place of residence. Under this waiver, telehealth could not be a substitute for in-person home health services paid under the home health prospective payment system. Services must be furnished in accordance with all other Medicare coverage and payment criteria and the facility fee paid by Medicare to an originating site would be waived if the service was originated in the beneficiary’s home.

• Skilled Nursing Facility (SNF) Waiver
  Beginning in performance year 2, the CJR model waives the SNF 3-day rule for coverage of a SNF stay following the anchor hospitalization. A condition to using this waiver is that the beneficiary must be transferred to SNFs rated 3-stars or higher for at least 7 of the previous 12 months on the CMS Nursing Home Compare website. CMS will post the list of qualified SNFs quarterly to the CMS website.

Beneficiary Choice and Beneficiary Notification

CMS finalized the proposal to require that participant hospitals notify beneficiaries of the requirements surrounding the model at the point of admission to the hospital. Additional detail to the content, timing and form of the notification specified in the final rule includes:

• Participant hospitals will be required to provide beneficiaries on admission with a general notice of the existence of the model and of certain beneficiary rights.

• “Participant hospitals must require as a condition of any sharing arrangement that the collaborators must notify beneficiaries of the existence of a sharing arrangement. We are modifying our regulations to specify that, in the case of physicians, this notification must occur at the point of the decision to proceed to surgery, or, in the case of other collaborators, prior to the furnishing of the first service provided by the collaborator that is related to the joint replacement.”

• As part of discharge planning, participant hospitals “must inform beneficiaries of all Medicare participating PAC providers/suppliers in an area but may identify those providers/suppliers that the hospital considers to be preferred…..the participant hospital must also as part of this specific second notice inform the beneficiary of providers/suppliers with whom a sharing arrangement exists.”

• Participant hospitals will be required to reference the most recently published CMS list of SNFs which qualify for the waiver of the 3-day rule.

Participant hospitals have from today until March 31, 2016 to plan for an April 1st, 2016 implementation date of this model. MMP strongly encourages participant hospitals to not only read the Final Rule but become very familiar with the information available on the CJR Web page.

Hospitals are constantly being scrutinized to ensure they are following Federal rules and regulations for billing, coding, referrals, etc. In addition to the host of Medicare claim reviewers, there are also those entities that are specifically looking for fraud and abuse, such as the Zone Program Integrity Contractors (ZPICs) and the Office of Inspector General (OIG). When the rules are unclear or the issue is not specifically addressed, some hospitals prefer to “err on the side of caution” just to make sure there is no chance of bad consequences in the future. Such has been the case with the issue of billing Medicare patients for the self-administered drugs (SADs) they receive as hospital outpatients.

Most SADs are not covered under Medicare Part B but are covered under Medicare Part D. Since most hospital pharmacies do not participate in Medicare Part D, this leaves the Medicare patient liable for the self-administered drugs they receive while a hospital outpatient. Since Medicare does not regulate the billing by hospitals of non-covered drugs to Medicare beneficiaries, their only advice for hospitals has been: “a hospital’s decision not to bill the beneficiary for non-covered drugs potentially implicates other statutory and regulatory provisions, including the prohibition on inducements to beneficiaries, section 1128A (a) (5) of the [Social Security] Act, or the anti-kickback statute, section 1128B (b) of the Act.” This statement is enough to make a hospital nervous for sure.

So until the end of October 2015, the question remained, does CMS require hospitals to bill and collect (or make good faith efforts to collect) their usual and customary charges for SADs that are not covered by Medicare Part B (Noncovered SADs) to comply with OIG’s fraud and abuse authorities? And the answer is …No.

On October 29, 2015, the OIG issued a policy statement assuring hospitals they would not be subject to administrative sanctions for discounting or waiving amounts Medicare beneficiaries may owe for self-administered drugs (SADs) they receive in outpatient settings when those drugs are not covered by Medicare Part B. This is good news for hospitals – it will relieve the time and resources for submitting bills to patients and will allow hospitals to avoid the negative patient perception that results from such bills.

The OIG does include some conditions for this exemption from their general policy*:

• This Policy Statement applies only to discounts on, or waivers of, amounts Medicare beneficiaries owe for Noncovered SADs that the beneficiaries receive for ingestion or administration in outpatient settings;
• Hospitals must uniformly apply their policies regarding discounts or waivers on Noncovered SADs (e.g., without regard to a beneficiary’s diagnosis or type of treatment);
• Hospitals must not market or advertise the discounts or waivers; and
• Hospitals must not claim the discounted or waived amounts as bad debt or otherwise shift the burden of these costs to the Medicare or Medicaid programs, other payers, or individuals.

*(Ordinarily routine discounts and costs waivers of amounts owed by Medicare beneficiaries would potentially implicate the Federal anti-kickback statute, the civil monetary penalty and exclusion laws related to kickbacks, and the Federal civil monetary penalty law prohibiting inducements to beneficiaries.)

This OIG policy statement does not require a hospital to waive the amounts owed by Medicare beneficiaries for SADs. It is still the hospital’s decision whether to waive these charges or to bill the patient. At least now, hospitals will no longer feel obligated to bill the patient to prevent getting in trouble with the government.

Composite is defined as something made up of several parts or elements and comprehensive is including all or nearly all elements of something. These definitions are spot on regarding the reclassification of payment for observation services from a composite payment to a comprehensive payment as announced in the 2016 Outpatient Prospective Payment System (OPPS) Final Rule. This is one of the most significant changes found in this year’s final rule. In this article we discuss the reality of the changes with observation payments and other updates from the Final Rule.

Observation Comprehensive Payment

Under the current composite payment method for observation services, the observation payment is combined with the payment for high level ED visits, clinic visits, or direct referral when the observation services meet certain criteria. Other separately billable services are paid according to OPPS guidelines. This means payment for some services is packaged - most clinical laboratory services (since 2014), routine x-rays and some other minor diagnostic services (since 2015), and some minor procedures such as breathing treatments (since 2015). More extensive services, such as injections and infusions, CTs and MRIs, and separately payable drugs are paid separately from the composite payment.

Things change under the Comprehensive Observation APC. In keeping with the Medicare criteria for comprehensive APCs, payment for all adjunctive services is bundled into the comprehensive payment. This means no separate payment for injections, infusions, CTs, or MRIs, – just the one comprehensive observation payment amount of approximately $2174 (Medicare unadjusted payment rate) for the entire episode of care. There were also some changes to the criteria for eligible observation services. The comprehensive observation APC is paid when there is:

• At least eight hours of observation services (no change)
• Observations services in conjunction with any ED visit level (change from only high level ED visits), clinic visit level, or direct referral to observation
• No surgical procedure on the claim with a status indicator of “J1” or “T” (change from “T” status procedure on the day of or day before obs)

When these criteria are not met, observation services are packaged and there is no separate or additional payment for observation.

Since the Comprehensive Observation is for a combination of services which differs from the criteria for other comprehensive services which are based on a primary service, CMS created a new status indicator for Observation of “J2.” Nine other “J1” Primary Service Comprehensive APCs were also added in the final rule for device-intensive procedures.

Lung Cancer Screening by Low-Dose CT

Medicare issued a National Coverage Determination (NCD) for lung cancer screening by low-dose CT on February 5, 2015. Providers have been anxiously awaiting Medicare guidance on how to bill for this service, specifically what CPT or HCPCS code to report. In the OPPS Final Rule, CMS created new HCPCS code G0297 to report this service on and after January 1, 2016. At that time, they will accept claims for dates of service on and after February 5, 2015, so if you have already been providing this service and holding your claims you can submit them after the first of the year and receive payment. The Medicare unadjusted payment rate for G0297 is $112.49. Timely filing rules do apply so be sure to submit claims before a year has passed since the date of service.

Clinical Laboratory Services

There is good news related to lab services and then there is some really bad news. Let’s get the bad news out of the way first. CMS finalized a reduction of 2.0 percentage points to the CY 2016 conversion factor. This reduction was due to an error CMS made in calculating the impact of lab packaging in 2014. In combination with other financial adjustments for the year, the bottom line is a -0.3% reduction in OPPS payments overall for 2016.

Clinical lab services continue to be packaged in 2016 with the exceptions of molecular pathology codes and preventive services. In fact they will now be packaged per claim instead of per date of service, but I doubt this will be a significant impact. The good news is that CMS created new status indicator “Q4” for lab services so that lab payments will automatically receive separate payment if they are the only type of service reported on the claim. This means laboratories will no longer have to report the L1 modifier when only lab services are performed. The L1 modifier can still be used when lab services are unrelated to other outpatient services on the claim (ordered by a different physician for a different diagnosis), but not having to use it for lab-only outpatient claims should result in a lot less time and effort expended by hospital staff.

Increased Packaging

Since so many minor services have already been packaged in previous years, there was only a minimal increase in packaging of services for 2016. This year CMS is packaging three more APCs:

• Level 4 Minor Procedures will be S, T, V packaged with a status indicator of “Q1”
• Level 3 and Level 4 Pathology will be T packaged with a status indicator of “Q2”

Other Issues

Other issues addressed in the OPPS final rule include:

• Numerous additional requirements for hospitals to bill and receive payment for Chronic Care Management (CCM) services, CPT code 99490.
• Removal of seven procedures from the inpatient only list (vagus nerve blocking therapy, spine surgery procedures and penile implants). Carotid artery stenting remains on the inpatient only list.
• Payment reduction for CT scans (5% in 2016; 15% in 2017) if CT scanner does not meet the NEMA Standard XR-29-2013. Providers are to report new modifier “CT” if the CT scanner does not meet the standards in order to receive the appropriately reduced payment.

The reality of OPPS payment policies is increased packaging in the form of more comprehensive APCs, including an observation C-APC and increased packaging of services. CY 2016 also includes an overall reduction in payment due to adjustments for this and that, including a big adjustment for miscalculation of lab packaging payments. Sometimes the reality is just too real.

New “Exception” to the 2-Midnight Rule

Just 40 days prior to the 2014 Final Rule going into effect we released an article titled Inpatient Status: To Be or Not to Be, That is the Question. Since that time, through sub-regulatory guidance CMS has indicated that there may be “unforeseen circumstances” or “exceptions” where even though a beneficiary’s stay is not 2-Midnights that inpatient may still be appropriate.

• CMS defines “unforeseen circumstances” as when a beneficiary’s stay is shorter than the physician’s expectation of at least 2 midnights and “the patient may still be considered to be appropriately treated on an inpatient basis for payment purposes, and the hospital inpatient payment may be made under Medicare Part A.” Examples provided by CMS include unforeseen: death, transfer to another hospital, departure against medical advice, clinical improvement, and election of hospice care in lieu of continued treatment in the hospital.
• CMS has also acknowledged that there is the possibility of an “exception” to the 2-Midnight Rule where an inpatient admission would be reasonable in the absence of an expectation of a 2 midnight stay. Prior to the CY 2016 Outpatient Prospective Payment (OPPS) Final Rule, CMS had only identified one “exception.” The exception is mechanical ventilation initiated during the present visit.

CMS finalized a second “exception” to the 2-Midnight Rule in the CY 2016 OPPS Final Rule released October 30, 2015. CMS indicated in the Final Rule that “after consideration of the public comments we received, we are finalizing, without modification, our proposal to revise our previous “rare and unusual” exceptions policy to allow for Medicare Part A payment on a case-by-case basis for inpatient admissions that do not satisfy the 2-midnight benchmark, if the documentation in the medical record supports the admitting physician’s determination that the patient requires inpatient hospital care despite an expected length of stay that is less than 2 midnights.”

Challenge for Hospitals

With this new “exception,” to be or not to be an inpatient continues to be the question. Unfortunately, CMS provides no examples of what they would consider to be such an exception. What we do know is this:

• Records will be considered on a case-by-case basis.
• Documentation in medical records must support the admitting physician’s determination that the patient required inpatient hospital care absent the expectation of a 2-Midnight stay.
• CMS has indicated that factors relevant to determining whether or not the inpatient stay would be nonetheless appropriate for Part A payment include:
• The severity of the signs and symptoms exhibited by the patient;
• The medical predictability of something adverse happening to the patient; and
• The need for diagnostic studies that appropriately are outpatient services, that is, their performance does not ordinarily require the patient to remain at the hospital for 24 hours or more).
• One final challenge is making sure you have an appropriately authenticated inpatient order in the record prior to the patient being discharged.

1-Day Short Stay Hospital Volumes

From the implementation of the 2-Midnight Rule through September 30, 2015 short-stay reviews have been a review focus of Medicare Administrative Contractors (MACs) through the Probe and Educate Program. As of October 1, 2015 the short-stay review responsibility has shifted to the Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs). But before I get ahead of myself, let’s look at the numbers.

Has the implementation of the 2-Midnight Rule impacted the volume of 1-Day short stays?

To answer this question, I needed to ask two more questions.  

• Has there been a significant difference in 1-day stays prior to the implementation of the 2-Midnight Rule vs. after October 1, 2013?
• What is the percentage of 1-day short stays compared to a hospital’s total inpatient volume for our client base?

To find answers, I looked to our sister company RealTime Medicare Data (RTMD). RTMD collects over 680 million Medicare claims annually from 23 states and the District of Columbia, and allows for searching of over 5.1 billion historical claims. By accessing this data base I analyzed 1-Day Short Stay paid claims data for several hospitals within the MMP footprint. Specifically, I chose 1-day short stay claims with dates of service January 1, 2013 through June 30, 2013 which pre-dated implementation of the 2-Midnight Rule and January 1, 2015 through June 30, 2015 to compare the same six months after implementation of the 2-Midnight Rule. What I found was that while not all hospitals realized a decrease in 1-day stays, collectively there was a 2.87% decrease in 1-Day Short Stays compared to overall inpatient volume as depicted in Table 1.

Table 1

 I do not believe there should be a 1-Day Stay volume benchmark for all hospitals to strive for. I do believe that if physician documentation in your medical records supports the need for an inpatient admission, then the volume of 1-day short stays at your hospital will be what it should be. On the other hand, if you are an outlier above or below an “average” this may be a reason to take a closer look at these claims.

Medical Review Responsibility Change effective October 1, 2015

As previously mentioned, the BFCC-QIO’s have assumed responsibility for the short-inpatient stay medical review process. This transition, while outlined in the CY 2016 OPPS Proposed Rule, was not a proposal and subsequently occurred October 1, 2015.

CMS indicated in the CY 2016 OPPS Final Rule that “Under the new short-stay inpatient medical review process that we adopted beginning on October 1, 2015, BFCC-QIOs began to transition to reviewing a sample of post-payment claims and making a determination of the medical appropriateness of the admission as an inpatient.

QIOs will conduct “Revised Determination Reviews” (42 CFR 405.980) on hospital short-stay Medicare Part A claims. QIOs will conduct patient status reviews to determine the appropriateness of Medicare Part A payment for these short-stay inpatient hospital admissions, in accordance with section 1862(a)(1)(A) of the Act. In conducting these reviews, QIOs will use the information documented in the patient’s medical record, and may use evidence-based guidelines and other relevant clinical decision support materials as components of their review activity (we refer readers to 42 CFR 476.100 relating to setting standards for QIO reviews).

Comment: Several commenters stated the need for transparency and for more detailed information regarding the types of claims that would be subject to QIO review, claim sample sizes, the frequency of reviews, the claim look back periods, ADR limits, and administrative burden.

Response: We will address the technical medical review questions posed by commenters in subregulatory guidance.

We expect to release this information on the CMS Web site at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs/index.html?redirect=/qualityimprovementorgs/, no later than December 31, 2015.”

There are five BFCC-QIO Service Areas in the country. Most of the MMP footprint is located in an area where KEPRO is the BFCC-QIO. On September 30, 2015 KEPRO provided a Two-Midnight Short-Stay Reviews webinar. Short-stay review guidance provided in this session is outlined in Table 2.

Table 2

Resources

• Link to display copy of the CY 2016 OPPS Final Rule: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-27943.pdf

• Link to CY 2016 OPPS Final Rule in the November 13, 2015 Federal Register:http://www.gpo.gov/fdsys/pkg/FR-2015-11-13/pdf/2015-27943.pdf

• Link to KEPRO Two-Midnight Short-Stay Reviews webpage: https://www.keproqio.com/twomidnight/Default.aspx

Sometimes things in life are so complex that it becomes hard to understand them, let alone implement them or apply them in a practical manner. In healthcare, Medicare often seems to be the king of complexity. When reading Medicare regulations, sometimes the more you read, the more confused you become. You may find solace in this quote from Tom Peters, American author on business management practices – “If you’re not confused, you’re not paying attention.”

In August 2013, Medicare approved new coverage guidelines for the insertion of single and dual chamber permanent cardiac pacemakers. In summary, permanent pacemakers are covered for documented non-reversible symptomatic bradycardia due to either sinus node dysfunction or second and/or third degree atrioventricular block. National Coverage Determination (NCD) 20.8.3, as explained in MLN Matters Article MM9078 and the associated transmittals, also includes a list of conditions that are non-covered although some of these conditions will not prohibit coverage if the patient also has a covered condition (see – it’s already confusing). After a long wait, CMS finally released complex claims processing instructions for this NCD in February 2015. And they were complex – you must have one of these diagnosis codes, these diagnosis codes are ok but only with one of these other diagnosis codes, use the KX modifier on all claims, some coverage is at the discretion of the Medicare Administrative Contractor (MAC) – maybe too complex. Hospitals from all around the nation soon began reporting problems in getting their Medicare pacemaker claims to process.

Due to these claim processing issues, CMS rescinded and replaced the original transmittals on October 26, 2015. The revised transmittals instruct MACs to implement the NCD at the local level until CMS is able to revise the formal claims processing instructions. Providers may have to wait and see what edits, if any, their MACs put in place for these claims. However, all aspects of the NCD policy remain in effect.

So how should hospitals proceed in the mean time? Hospitals should

• Review and understand the pacemaker NCD,
• Only bill Medicare for permanent pacemaker insertion when the conditions of the policy are met,
• Submit claims with appropriate diagnosis and procedure codes,
• Seek guidance from your MAC about any other claim requirements,
• Monitor claims to make sure they are processing and paying appropriately and
• Watch for future communications from the MAC and/or CMS concerning claim requirements for pacemaker insertions.

Another complex NCD was also in the news recently. On October 30, 2015, the Department of Justice (DOJ) announced 70 settlements with 457 hospitals in 43 states for more than $250 million related to cardiac devices that, according to the DOJ, were implanted in Medicare patients in violation of Medicare coverage requirements. This issue involved implantable cardioverter defibrillators, or ICDs. Per the DOJ announcement:

“Medicare coverage for the device, which costs approximately $25,000, is governed by a National Coverage Determination (NCD). The Centers for Medicare and Medicaid Services implemented the NCD based on clinical trials and the guidance and testimony of cardiologists and other health care providers, professional cardiology societies, cardiac device manufacturers and patient advocates. The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. The medical purpose of a waiting period -40 days for a heart attack and 90 days for bypass/angioplasty - is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary. The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions. The Department of Justice alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the NCD.”

The lesson to be learned here is that your hospital, as a provider, must follow Medicare coverage requirements at the national (NCD) and local (LCD) level even when these requirements are complex, confusing, or just plain onerous. If your hospital fails to do so, it risks non-payment, recoupment, and/or penalties. 

Dilemma:

How do you know when to use plain radiography vs. fluoroscopy and which type of contrast should be used when coding coronary angiograms in ICD-10-PCS?

Solution:

Use fluoroscopy for the 3rd character (Root Type), per instructions in the ICD-10-PCS Coder Training Manual, 2016, Instructor’s Edition.  
The catheter is threaded into the heart using an x-ray machine that produces real time pictures which is fluoroscopy.  Then the catheter tip is moved into different positions such as the arteries and heart chambers while the physician is watching on a computer monitor.

The type of contrast dye will be low osmolar. Listed below are a few of the Low Osmolar Contrasts:

• Omnipaque
• Visipaque
• Isovue

Resource(s):

• ICD-10-PCS Coder Training Manual, 2016,
• Instructor’s EditionWikipedia 

“Hospital discharge planning is a process that involves determining the appropriate post-hospital discharge destination for a patient; identifying what the patient requires for a smooth and safe transition from the hospital to his/her discharge destination; and beginning the process of meeting the patient’s identified post-discharge needs.”- Pub. 100-07, State Operations Manual, Appendix A- Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Rev. 149, 10-09-15)

Whether true or not it seems the longer I work in health care the more it becomes apparent that when CMS makes “suggestions for process changes” sooner or later suggestions become requirements. Flash back to May 17, 2013 when CMS released updates to Appendix A of the State Operations Manual providing revised interpretive guidelines for the Discharge Planning Conditions of Participation (CoPs) at 42 CFR 482.43. Notably, this revision included “blue boxes” that CMS indicated displayed “successful practices currently found throughout the industry in the area of care transitions.”

Fast forward to October 29,2015 when CMS announced proposed revisions to the discharge planning requirements that hospitals, including long-term care hospitals (LTCHs), Inpatient Rehabilitation Facilities (IRFs), Critical Access Hospitals (CAHs), and Home Health (HH) agencies must meet in order to participate in the Medicare and Medicaid program. Several of the “blue boxes” are now being proposed as requirements.

While there are other proposals being made, this article focuses on the proposed changes specific to Discharge Planning in the Acute Care Hospital setting.

PROPOSED RULE BACKGROUND

Legislative History

The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) requires the standardization of Post-Acute Care (PAC) assessment data that can be evaluated and compared across PAC provider settings, and used by hospitals, CAHs, and PAC providers, to facilitate coordinated care and improved Medicare beneficiary outcomes.

CMS notes that they are currently developing additional public guidance and that many of the PAC provisions are being addressed in separate rulemakings. More information can be found on the CMS website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html .

This Proposal would implement the discharge planning requirements mandated in section 1899B(i) of the IMPACT Act by modifying the discharge planning or discharge summary Conditions of Participation (CoPs) for hospitals, CAHs, IRFs, LTCHs, and HHAs. The IMPACT Act identifies LTCHs and IRFs as PAC providers, but the hospital CoPs also apply to LTCHs and IRFs since these facilities, along with short-term acute care hospital, are classifications of hospitals. All classifications of hospitals are subject to the same hospital CoPs. Therefore, these PAC providers (including freestanding LTCHs and IRFs) are also subject to the proposed revisions to the hospital CoPs.

PROVISIONS OF THE PROPOSED REGULATIONS

Hospital Discharge Planning

The Medicare CoPs and Conditions for Coverage (CfCs) set forth the federal health and safety standards that providers and suppliers must meet to participate in the Medicare and Medicaid programs. The purposes of these conditions are to protect patient health and safety and to ensure that quality care is furnished to all patients in Medicare and Medicaid-participating facilities. In accordance with section 1864 of the Act, CMS uses state surveyors to determine whether a provider or supplier subject to certification qualifies for an agreement to participate in Medicare. However, under section 1865 of the Act, providers and suppliers subject to certification may instead elect to be accredited by private accrediting organizations whose Medicare accreditation programs have been approved by CMS as having standards and survey procedures that meet or exceed all applicable Medicare requirements.

The current hospital discharge planning requirements at §482.43, “Discharge planning,” were originally published on December 13, 1994 (59 FR 64141), and were last updated on August 11, 2004 (69 FR 49268). Under the current discharge planning requirements, hospitals must have in effect a discharge planning process that applies to all inpatients. The hospital must also have policies and procedures specified in writing.

CMS believes that providing more specific requirements to hospitals on what actions they must take prior to the patient’s discharge or transfer to a PAC setting will lead to improved transitions of care and patient outcomes.

CMS is proposing to revise the existing requirements in the form of six standards at §482.43. The following tables highlight the proposed requirements for each of the six standards.

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Considerations for Hospitals

While not all inclusive, should this Proposed Rule be finalized, here are some things to think about and questions that will need to be asked and answered.

• These proposals will require collaboration from several professionals/departments within the Hospital (Hospital Medical Staff, Nursing Leadership, Case Management, Social Services, Quality, IT, Pharmacy, Physical and Occupational Therapy, Dietician).
• Issues to think about if this Proposed Rule is Finalized:
• What is our current Policy and Procedure for Discharge Planning?
• How are we going to incorporate Discharge Planning for the Outpatient Population?
• Standard 3: Discharge Planning Process (Proposed §482.43(c)(1)) “would require a registered nurse, social worker, or other personnel qualified in accordance with the hospital’s discharge planning policy, to coordinate the discharge needs evaluation and the development of the discharge plan.” Does our discharge planning policy identify the professionals that can initiate this process?
• Where do we find and who in the hospital would be involved in providing data on Quality Measures and Data on Resource Measures to the patient, their families, or their caregiver’s/support person?
• For those interested in learning more about the IMPACT Act, CMS held an MLN Connects® National Provider Cal regarding the IMPACT Act of 2014 and Data Standardization. The slide presentation can be accessed at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2015-10-21-Post-Acute-Care-Presentation.pdf . CMS also has a webpage dedicated to information about the IMPACT Act and Cross Setting Measures at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html.
• Related to §482.43(d)(3), who would be responsible for sending follow-up information to the practitioner(s) responsible for follow-up care? How would you ensure a discharge summary be available within 48 hours of the patient’s discharge?
• Who will be responsible for the post-discharge follow-up process for patients being discharged to home? What will this process look like?

While, this article highlights proposals specific to Hospital Discharge Planning be mindful that this proposed rule also includes:

• Proposals for Home Health Agency Discharge Planning;
• Information Collection Requirements (ICRs) for hospital, HH and CAH discharge planning; and
• A Regulatory Impact Analysis.

MMP strongly encourages key stakeholders within your facility to read the proposed rule and submit comments. CMS has provided four was to submit comments. This information can be found on pages 1-3 of the display copy of the Proposed Rule.    

Resources

Link to CMS Press Release – Discharge Planning Proposed Rule Focuses on Patient Preferences:

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-10-29.html

Link to display copy of Proposed Rule: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-27840.pdf

This document was scheduled to be published in the Federal Register on 11/03/2015 and available online at http://federalregister.gov/a/2015-27840. There is a 60 day comment period on the proposed rule.

When you hear the word compliance, what comes to mind? The word compliance can and does actually bring to mind a varying degree of answers depending on who you were to ask in the hospital. For Example:

• A Hospital Compliance Officer among other things thinks about the fall release of the Office of Inspector General’s (OIG) annual Work Plan to guide compliance efforts for the coming year. .
• A Case Manager thinks about what is a compliant inpatient status order, does the Physician documentation support a 2-Midnight expectation, is my patient going to be compliant with his/her discharge plan instructions with a goal of preventing a 30-Day Readmission?
• For the Coder, with I-10 finally being implemented, he or she is dealing with compliance with the new coding system and I-10 Coding Clinics.
• A Clinical Documentation Specialist most likely thinks about a compliant query process.
• Infection control promotes compliance with best practices to prevent adverse outcomes for the patient.
• The billing department wants to be compliant while getting a “clean bill” out the door for payment for services rendered by the hospital.

While this is not an exhaustive list of healthcare providers who strive for compliance, it is clear that compliance is a very real concern and desired outcome and at the end of the day, each caregiver wants to “get it right” while providing the best care possible to the patient.

The Health Care Compliance Association (HCCA) defines compliance as being “the process of meeting the expectations of others. More specifically, it is the process of helping our health care professionals understand and meet the expectations of those who grant us money, pay for our services, regulate our industry, etc.” This is where MMP shines by living our mission of “Making HealthCare Make Sense.” This is what we enjoy. This is why when asked I tell people that my hobbies are my husband, my cats and reading the Federal Register.

Our Wednesday@One Newsletter already includes in our production schedule a coverage update the second week of the month and a Medical Review update the third week of each month. This week we are excited to debut a new monthly article the fourth week of each month to be known as The Making HealthCare Make Sense Spotlight. This month we begin by spotlighting free resources available to you on your compliance journey. The use of the term journey is very deliberate as the one thing that you can count on in healthcare is change and that is what makes your career a constant journey.

OIG Compliance Education Materials: Compliance 101:

The OIG developed the resources found on this web page to “help health care providers, practitioners, and suppliers understand the health care fraud and abuse laws and the consequences of violating them. These compliance education materials can also provide ideas for ways to cultivate a culture of compliance within your own health care organization” (http://oig.hhs.gov/compliance/101/).

Medicare Learning Network® (MLN) Provider Compliance page

The MLN Provider Compliance Page “contains educational products that inform health care professionals on how to avoid common billing errors and other improper activities when dealing with various CMS Programs. CMS’ claim review program’s overall goal is to reduce improper payment error by identifying and addressing coverage and coding billing errors. Since 1996, CMS has implemented several initiatives: to prevent improper payments before a claim is processed; and to identify, and recoup improper payments after the claim is processed” (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/ProviderCompliance.html).

Examples of useful resources on this web page include:

• Provider Compliance Educational Products pdf,
• Fraud and Abuse Educational Products pdf,
• Provider Compliance MLN Matters® Articles pdf; and
• Archive of Medicare Quarterly Provider Compliance Newsletters.

Office of Civil Rights

As a Business Associate we take our HIPAA responsibilities very seriously. The Office of Civil Rights (OCR) has an entire Web page devoted to Health Information Privacy. This web page provides you with information to understand HIPAA Privacy, current enforcement activities and much more. (http://www.hhs.gov/ocr/privacy/index.html).

As we begin this series of articles, we welcome feedback and recommendations for future articles by you our reader. I also encourage you to read the related article in this week’s newsletter, Resources for your Hospital Compliance Plan.