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Pharmacy Compliance Question of the Week


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January 23, 2012

Question:

Can you provide a billing guideline for alpha 1–proteinase inhibitor?

Answer:

It is used to treat alpha 1–antitrypsin deficiency in people who have symptoms of emphysema. Assign HCPCS code J0256—injection, alpha 1–proteinase inhibitor (human), not otherwise specified, 10 mg. Bill one service unit for each 10-mg injection.

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January 16, 2012

Question:

My questions relate to the Medicare provider-enrollment change. Does this apply to pharmacies? And where can I find more information about it?

Answer:

Yes, it applies to pharmacies. The following links you directly to the article which addresses the Affordable Care Act related enrollment changes: https://www.cms.gov/MLNMattersArticles/downloads/MM7350.pdf. This article also clarifies the revalidation effort has been extended through 2015 instead of 2013. Providers and suppliers will be contacted by their Medicare administrative contractors (MACs) when they are required to revalidate.

Here’s another link for details about this: https://www.cms.gov/MLNMattersArticles/downloads/SE1126.pdf.

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January 9, 2012

Question:

We are a pharmacy, and I understand we must submit an application to Medicare to revalidate our enrollment. What is the deadline for us to submit this revalidation application? And where can we find more information about this?

Answer:

Medicare administrative contractors (MACs), including the National Supplier Clearinghouse (NSC), will notify each supplier to revalidate. Suppliers and providers including pharmacies should not submit a revalidation application until requested to do so by the MAC or the NSC. For the most current information, go to https://www.cms.gov/MedicareProviderSupEnroll/11_Revalidations.asp

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January 2, 2012

Question:

In the December 12 answer, you said that the threshold for packaging would be $75. Are there any drugs that are over the payment threshold and so separately paid?

Answer:

Currently, only the following code remains sepa­rately payable because its per-day cost is above the $75 threshold.

J2469    Injection palonosetron hydrochloride, 25 mcg

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December 26, 2011

Question:

When is the NDC code set used for reporting drugs and biologics on HIPAA transactions?

Answer:

The final rule adopting changes to the HIPAA Electronic Transactions and Code Set standards published in the Federal Register on February 20, 2003, does not adopt a standard for reporting drugs and biologics in HIPAA transactions other than those for retail pharmacies. Therefore, compliance permits the use of the HCPCS or NDC code set to meet business needs. In the absence of an adopted code set for drugs and biologics, the X12 implementation guides adopted as HIPAA standards must be consulted. If you currently use HCPCS to report drugs and biologics you may continue to do so. You may also use the NDC code set if you meet the conditions for use specified in the implementation guide/TR3 Report. The NDC code set must be used for reporting drugs and biologics on retail pharmacy transactions.

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December 19, 2011

Question:

Are there any 2012 changes to the way Medicare reimburses for drugs?

Answer:

Reimbursement in 2012 for pass-through drugs will be paid at a rate of the average sale price + 6 percent. If ASP data are not available, then CMS will base payment on the product’s wholesale acquisition cost. If ASP and WAC are unavailable, the average wholesale price will be used.

In 2012, most separately payable Part B drugs and biologicals without pass-through status administered in the hospital outpa­tient setting will be paid based on 104 percent of the manufacturer’s average sales price. CMS maintains that the most recently available claims data (2010) indicates that 104 percent of the ASP captures the drug-acquisition cost and associated overhead charges.

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December 12, 2011

Question:

For 2012, how will Medicare reimburse drugs with a per-day cost of $70 or less?

Answer:

Payment will continue to be packaged (and not separately payable) for drugs, therapeutic radiopharmaceuticals and biologicals when they have a cost per day that is less than or equal to $75. In 2012, this will include 5-HT3 antiemetics, which has been exempt from the packaging threshold requirement. Payment for these pharmaceuticals will be bundled with their associated procedure or treatment.

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December 5, 2011

Question:

Can all discarded drugs be billed to Medicare?

Answer:

In its 2012 work plan, the Department of Health & Human Services Office of Inspector General (OIG) explains the Medicare policy as follows.

If a provider must discard the remainder of a single-use vial or package of drugs after administering a dose or quantity, Medicare provides payment for the amount discarded and for the amount administered—up to the amount as indicated on the vial or package label. However, multiuse vials such as those used for supplying herceptin are not subject to payment for discarded drug or biological amounts. (See Medicare Claims Processing Manual, chapter 17, section 40, at http://www.cms.gov/Manuals/IOM/list.asp.)

In 2012, the OIG will continue to review whether Medicare payments related to the drug herceptin were appropriate. Providers must bill accurately and completely for services provided.

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November 28, 2011

Question:

Under the Medicare and Medicaid Electronic Health Records (HER) Incentive Program, who can enter medication orders in order to meet the measure for the computerized physician order-entry meaningful use objective? When must these medication orders be entered?

Answer:

According to the Centers for Medicare & Medicaid Services, any licensed healthcare professional can enter orders into the medical record for purposes of including the order in the numerator for the measure of the CPOE objective if they can enter the order per state, local, and professional guidelines. The order must be entered by someone who could exercise clinical judgment in the case that the entry generates any alerts about possible interactions or other clinical-decision support aides. This necessitates that CPOE occurs when the order first becomes part of the patient's medical record and before any action can be taken on the order. Each provider will have to evaluate on a case-by-case basis whether a given situation is entered according to state, local, and professional guidelines; allows for clinical judgment before the medication is given; and is the first time the order becomes part of the patient's medical record.

For more information about the Medicare and Medicaid EHR Incentive Program, go to http://www.cms.gov/EHRIncentivePrograms

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November 21, 2011

Question:

Where can we find the new HCPCS level II codes?

Answer:

These can be found at: http://www.cms.gov/HCPCSReleaseCodeSets/ANHCPCS/list.asp#TopOfPage.

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November 14, 2011

Question:

What is a self-administered drugs’ exclusion list?

Answer:

On no less than an annual basis, Medicare payers update and publish self-administered drugs’ exclusion lists, which include injectable drugs that they have determined are excluded when furnished incident-to a physician’s service on the basis that the drug is usually self-administered. Payers must also submit the lists to the Centers for Medicare & Medicaid Services, and the latest updates took effect in September. These lists are available on Medicare contractors’ web sites.

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November 7, 2011

Question:

How will pharmacy overhead be paid under the new 2012 OPPS rule?

Answer:

According to the final rule, Medicare will pay for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals, other than new drugs and biologicals that have pass-through status, at the average sales price (ASP) plus 4 percent.   

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October 31, 2011

Question:

Does Medicare cover the unlabeled use of a drug?

Answer:

Medicare may cover the unlabeled use of a drug or biological if the contractor determines its usage is medically acceptable. Contractors make these decisions on a case-by-case basis, and providers are required to indicate the unlabeled use in the comments section of the claim.  

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October 24, 2011

Question:

Can you tell me how to calculate the Medicaid drug-pricing rebate?

Answer:

The best source for this answer would be the website of the Centers for Medicare and Medicaid Services (http://www.cms.gov/). When you get there, go to the Medicaid tab at the top. If you do not find your answers within this section, you may call toll-free at 877-267-2323.

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October 17, 2011

Question:

Are there any new pass-through drugs this quarter?

Answer:

For this quarter, the two codes listed below have been given pass-through status (effective on October 1, 2011). The first listed is a new code:

C9286  Injection, belatacept, 1 mg
J0638 Injection, canakinumab, 1 mg

For more on the hospital outpatient prospective payment system update where this information appears, go to https://www.cms.gov/transmittals/downloads/R2296CP.pdf  

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October 10, 2011

Question:

We have patients who have commercial (third party) insurance. Are those patients eligible to receive 340B drugs, or is the 340B drug-pricing program just for the uninsured?

Answer:

The covered entity may use 340B drugs for all patients of the facility. For commercially insured
patients, the entity can bill the insurance company at the rate that they will pay. The 340B program law and guidelines do not dictate how the entity is to bill third parties or address
how reimbursement amounts are to be used. An entity should take its entire payer mix, including third-party insurance coverage, into account as they set sliding scale co-payment fees, and plan for other health care services.

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October 3, 2011

Question:

Can a single-roster claim be submitted containing information for both the pneumococcal and seasonal influenza virus?

Answer:

According to the Centers for Medicare & Medicaid Services, a separate roster claim needs to be prepared for the pneumococcal vaccine and the seasonal influenza virus vaccine. However, a provider may file an individual claim containing information for both types of vaccines.

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September 26, 2011

Question:

When will CMS implement the revisions related to the policy about drugs incident-to a physician’s service?

Answer:

October 1, 2011, is now the effective and implementation date for the revised Medicare policy for pharmacy billing for drugs provided incident-to a physician’s service.CMS announced this revision in Transmittal 2271 (issued July 1, 2011)—and this is at least the third time the date has been changed. For a copy of the above-mentioned transmittal, go to https://www.cms.gov/transmittals/downloads/R2271CP.pdf.

For those who don’t know, this policy relates to restrictions on pharmacy billing for drugs provided incident-to a physician’s service. It also reminds providers about the local payment determination limits for drugs that are not nationally determined. Transmittal 2271 includes comprehensive guidelines on when pharmacies, suppliers and providers may and may not bill Medicare Part B for drugs dispensed directly to a beneficiary for administration incident-to a physician service or furnished to a physician for administration to a Medicare beneficiary.

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September 19, 2011

Question:

How does the Medicaid program establish payment for prescriptions?

Answer:

Federal law dictates that Medicaid reimbursement for prescription drugs may not exceed the lower of (1) the estimated acquisition costs plus a dispensing fee or (2) the provider’s usual and customary charge to the provider for the drug. States have latitude in how they determine estimated acquisition cost. Typically, they base estimated acquisition costs on published average wholesale prices (AWPs) or wholesale acquisition costs (WACs). 

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September 12, 2011

Question:

When First DataBank stops publishing its average wholesale price data, how will states determine Medicare drug payments?

Answer:

According to a recently released Office of Inspector General study, many states remain undecided about how they will determine Medicaid drug reimbursement after First DataBank ceases to publish average wholesale price data.  OIG’s report—“Replacing Average Wholesale Price: Medicaid Drug Policy”—also reveals a patchy landscape of state reimbursement policies across the country. For details about this situation, see the OIG’s report at http://oig.hhs.gov/oei/reports/oei-03-11-00060.pdf

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September 5, 2011

Question:

Why doesn't the hospital outpatient prospective payment system (OPPS) recognize CPT codes 99605, 99606, and 99607, which describe medication therapy management (MTM) services provided by a hospital pharmacist?

Answer:

The Centers for Medicare & Medicaid Services state that it has no need under the OPPS to distinguish pharmacist-provided MTM services from those provided by other hospital staff, since the OPPS only makes payments for services provided incident to physicians' services. Hospitals may choose a variety of staffing configuration to provide those services, taking into account other relevant factors such as state and local laws and hospital policies.

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August 29, 2011

Question:

What is the current drug-packaging threshold?

Answer:

It is currently $70 per day. However, for 2012, the Centers for Medicare & Medicaid Services have proposed raising it to $80 per day. This means that drugs costing $80 or less would be packaged into the procedure with which they are billed and that more drugs will likely be packaged. Drugs costing more than $80 would be paid separately through their own APC.

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August 22, 2011

Question:

Does Medicare Part B cover outpatient prescription drugs?

Answer:

Medicare Part B covers only a limited number of outpatient prescription drugs. Covered drugs include injectable drugs administered by a physician; certain self-administered drugs, such as oral anticancer drugs and immunosuppressive drugs; drugs used in conjunction with durable medical equipment; and some vaccines.

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August 15, 2011

Question:

Can you provide some examples when a drug is not directly related and integral to a procedure or treatment and, therefore, it would not be considered a packaged supply?

Answer:

Examples include the following:

• Drugs given to a patient for their continued use at home after leaving the hospital would not be packaged.
• When a patient who is receiving an outpatient chemotherapy treatment develops a headache, any medication given for the headache would not meet the conditions necessary to be treated as a packaged supply.
• When patients undergoing surgeries need their daily insulin or hypertension medication, the medication would not be treated a packaged supply.

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August 8, 2011

Question:

Can hospitals bill Medicare patients when items are paid via APC?

Answer:

No, hospitals may not bill Medicare beneficiaries for items whose costs are packaged into the APC for the procedure. Here are examples of such items:

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August 1, 2011

Question:

Does the payment limit for J7197 include the clotting factor furnishing fee?

Answer:

No. The Centers for Medicare & Medicaid Services did previously include the clotting factor furnishing fee in the payment limit for J7197 (antithrombin III [human], per IU). However, it no longer includes it, and Medicare will not make separate payment for it. CMS clarifies this and more in transmittal R1839CP at http://www.cms.hhs.gov/transmittals/downloads/R1829CP.pdf.

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July 25, 2011

Question:

My question relates to billing for biologicals used in surgically implantable devices. Can you provide basic rules and a source for these?

Answer:

When the product is “solely surgically implanted or inserted,” report the appropriate code for the product—after you review the complete long descriptor. According to the Centers for Medicare & Medicaid Services, this guideline applies to products with and without pass-through status. Also, report units in multiples of the unit indicated in the code descriptor, not on the way the biological is packaged, stored, or stocked. If the biological has pass-through status, Medicare will make separate payment; otherwise, payment is packaged with the associated service.

In Transmittal 2234 (at http://www.cms.gov/Transmittals/downloads/R2234CP.pdf), CMS also says that when a code describes a product that may either be surgically implanted or inserted or otherwise applied, do not report separately the biologic’s code, unless it is separately payable and was used as an implantable device during a surgical procedure.

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July 18, 2011

Question:

What code should be used to report Provenge?

Answer:

Effective July 1, HCPCS code Q2043 should be used to report Provenge instead of C9273. Note that the same reporting instructions for retired code C9273 apply to Q2043.

Specifically, the phrase in the long descriptor “all other preparatory procedures” refers to the complete process of collecting immune cells from a patient during a non-therapeutic leukapheresis procedure. This includes sending the immune cells to the facility preparing the immunotherapy product to transporting the immune cells back to the site of service for administration to the patient.

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July 11, 2011

Question:

When is the NDC code set used for reporting drugs and biologics on HIPAA transactions?

Answer:

The final rule adopting changes to the HIPAA electronic transactions and code set standards published in the Federal Register on February 20, 2003, does not adopt a standard for reporting drugs and biologics in HIPAA transactions other than those for retail pharmacies. Therefore, it permits the use of any code set to meet business needs.

The Centers for Medicare & Medicaid Services state the following: In the absence of an adopted code set for drugs and biologics, the X12 implementation guides adopted as HIPAA standards must be consulted. If you currently use HCPCS to report drugs and biologics you may continue to do so. You may also use the national drug code (NDC) set if you meet the conditions for use in the implementation guide/TR3 Report. This code set must be used for reporting drugs and biologics on retail pharmacy transactions.

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July 4, 2011

Question:

What are the billing guidelines for hospital billing of blood-clotting factors in inpatient settings?

Answer:

Medicare pays for these but only if an ICD-9-CM diagnosis code for hemophilia is included on the bill. In transmittal R2193CP CMS revised the hemophilia diagnosis-code descriptions that will take effect on July 23, 2011. One of the listed hemophilia diagnosis codes must be listed on the bill. See the transmittal at www.cms.gov/transmittals/downloads/R2193CP.pdf for the codes.

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June 27, 2011

Question:

To which Medicare contractor would a claim be submitted when a pharmacy dispenses a drug that will be administered through implanted DME but a physician’s service will not be used to fill the pump with the drug?

Answer:

According to the Centers for Medicare & Medicaid Services, this situation you describe would be rare (http://www.cms.gov/transmittals/downloads/R2214CP.pdf). Nonetheless, CMS states that the claim should be submitted to the A/B Medicare administrative contractor (MAC) or carrier. The DME MAC, A/B MAC, or carrier will pay the pharmacy for these drugs, when Medicare policy considers them to be covered and reasonable and necessary. All bills submitted to the DME MAC, A/B MAC, or carrier must be submitted on an assigned basis by the pharmacy.

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June 20, 2011

Question:

Does Medicare cover Provenge?

Answer:

In a proposed decision memo, CMS indicated that it would cover on-label use of PROVENGE® (sipuleucel-T) under a national coverage determination (NCD). This drug is the only autologous cellular immunotherapy treatment for metastatic prostate cancer approved by the Food & Drug Administration. It is labeled for use in men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Coverage of off-label use would be determined by Medicare's local contractors.

For the proposed decision memo, go to http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx. On the right side of the page, under Quick Search, Document ID, enter CAG-00422N

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June 13, 2011

Question:

How are unused drugs associated with an NDC that contains several vials to be managed?

Answer:

According to the Centers for Medicare & Medicaid Services, packages containing multiple individual units of drug (like vial trays) may be split into quantities that are appropriate for a beneficiary’s dose. The remaining vials would be retained by the vendor. Consistent with Medicare billing rules, only the quantity actually administered to the Medicare beneficiary may be billed to Medicare by the vendor. The vendor claim would specify the HCPCS code for the drug and the number of units of the drug that were administered to the beneficiary.

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June 6, 2011

Question:

Does the payment limit for J7197 include the clotting factor furnishing fee as it previously did?

Answer:

No. Previously, the Centers for Medicare & Medicaid Services included the clotting factor furnishing fee in the payment limit for J7197—antithrombin III (human), per IU. Further clarification that the payment limit for J7197 does not include the clotting factor furnishing fee and that Medicare will not pay separately payment for it can be found at the following websites:

- http://www.cms.hhs.gov/mlnmattersarticles/downloads/MM6673.pdf
- http://www.cms.hhs.gov/transmittals/downloads/R1829CP.pdf

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May 30, 2011

Question:

Last week you explained how to determine payment for infliximab when it is administered in a privately owned physician’s office. What would be the method if administered in a hospital-owned clinic?

Answer:

The April Addendum B file on the CMS website shows that a 10-mg injection of infliximab (J1745) is reimbursed under the Medicare outpatient prospective payment system (OPPS) at a rate of $59.47 per 10 mg. The dose administered represents 20 billing units. Therefore, 20 billing units multiplied by $59.47 equals a total reimbursement payment of $1189.40.

Note that code J1745 has an OPPS status indicator of K, which means that it is not a pass-through drug. If it was a pass-through drug (with a SI of G), the reimbursement would be the same as that received in a private physician’s office (ASP + 6 percent).

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May 23, 2011

Question:

Can you tell me how to figure payment when 200 mg of infliximab (Remicade) is administered to a Medicare patient in a privately owned physician’s office?

Answer:

The Medicare billing unit for this drug is 10 mg. The dose administered represents 20 billing units. The reimbursement rate found in the April average sales price (ASP) file is $60.041 per billing unit. Therefore, the total reimbursement rate is 20 billing units multiplied by $60.041, which equals $1200.82.

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May 16, 2011

Question:

Can you explain how CMS calculates the average sales price?

Answer:

The average sales price (ASP) is calculated by dividing the manufacturer’s drug sales to all non-exempt purchasers representing all classes of trade in a calendar quarter by the total number of units sold. It does not include sales that are excluded from the calculated Medicaid best price or group purchasing organizations’ administration fees, nor does it include 340b prices.

The manufacturer must calculate its ASP every calendar quarter and submit it to the Centers for Medicare & Medicaid Services within 30 days of the close of the quarter. A drug’s ASP is used to determine the reimbursement rates of separately paid drugs in the outpatient setting. Under Medicare’s outpatient prospective payment system, current reimbursement of most separately paid drugs is based on a rate of ASP + 5 percent. Pass-through drugs are paid at ASP + 6 percent, as are drugs given in a private physician’s office.

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May 9, 2011

Question:

Does Medicare cover H1N1 vaccine code 90663?

Answer:

On December 31, 2010, the American Medical Association discontinued use of the H1N1 vaccine codes 90663 and 90470. Consequently, these codes aren’t covered under Medicare staring January 1, 2011. Instead providers should report the following codes, respectively: G9141 Influenza A (H1N1) immunization administration (includes the physician counseling the patient/family) G9142 Influenza A (H1N1) vaccine, any route of administration

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May 2, 2011

Question:

I heard that a new code must be used in place of C9278. Can you provide information about this?

Answer:

On April 1, the following code replaced C9278 (injection, incobotulinumtoxin A, 1 unit):
Q2040 injection, incobotulinumtoxin A, 1 unit

This information and more can be found at http://www.cms.gov/HCPCSReleaseCodeSets/02_HCPCS_Quarterly_Update.asp#TopOfPage.

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April 25, 2011

Question:

Are there any new pass-through drugs for OPPS this quarter?

Answer:

The Centers for Medicare & Medicaid Services granted this status to the following drugs under the outpatient prospective payment system, and, accordingly, Medicare will reimburse them at the average sales price plus 6 percent.

C9280 ---- Injection, eribulin mesylate, 1 mg
C9281 ---- Injection, pegloticase, 1 mg
C9282 ---- Injection, ceftaoline fosamil, 10 mg

This information can be found at http://www.cms.gov/Transmittals/downloads/R2174CP.pdf.

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April 18, 2011

Question:

What are Medicare’s requirements regarding the date of service for an injectable osteoporosis drug on a home health claim?

Answer:

The date of service for an injectable osteoporosis drug on a home health claim falls within the start and end dates of an existing home health episode if the claim contains the following:

• Type of bill 34x;
• HCPCS codes J0630, J3110, or J3490; and
• Covered charges corresponding to these HCPCS codes. For more on this, see http://www.cms.hhs.gov/mlnmattersarticles/downloads/MM6512.pdf or http://www.cms.hhs.gov/transmittals/downloads/R1818CP.pdf.

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April 11, 2011

Question:

Can a pharmacy submit a Medicare Part B drug claim to a Medicare administrative contractor (MAC) or carrier for a drug that has been administered through an implanted piece of durable medical equipment (DME)?

Answer:

The Centers for Medicare & Medicaid Services addresses this topic in transmittal R2115CP (http://www.cms.gov/Transmittals/downloads/R2115CP.pdf) where it says that a claim for a drug that has been administered through implanted DME should be submitted to a MAC/carrier not a DME MAC. According to CMS, “In the rare situation where a pharmacy dispenses a drug that will be administered through implanted DME and a physician's service will not be utilized to fill the pump with the drug, the pharmacy may bill the MAC/carrier…”

CMS also notes that pharmacies may not bill Medicare Part B for medications provided incident to a physician's service. These charges, if there are any, should be included on the physician's or other eligible health professional's bill and must represent their costs.

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April 4, 2011

Question:

Will Medicare Part B pay for a drug from a single-dose vial if it is administered to more than one beneficiary?

Answer:

Here’s what is stated in Chapter 17, Section 40 (Discarded Drugs and Biologicals) of the Medicare Claims Processing Manual: The "CMS encourages physicians, hospitals and other providers and suppliers to care for and administer to patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner."

In the 2011 Medicare physician fee schedule rule published November 29, 2010, CMS also stated that both the overfill policy and the discarded drug and biological policy would apply as providers are expected " to make good faith efforts to efficiently minimize the amount of discarded drug by facilitating clinically appropriate methods of administering the required dose to each beneficiary...." The appropriate use of drug products, including sterile products, depends on numerous factors, including, but not limited to the following: approved labeling, state law, the setting in which the product is prepared and used, how the product is stored, sterility, and chemical stability.

In an answer to a question about this, CMS stated, “We do not have the authority to regulate the practice of medicine or other health professions and our policies neither encourage or prohibit the administration of more than one dose from a single dose vial to one or more beneficiaries.”

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March 28, 2011

Question:

How are drug administration services and evaluation and management (E&M) visits billed on the same day of service defined?

Answer:

Here’s what the Medicare Claims Processing Manual (Chapter 12, Section 30.6.7, Paragraph D) states:

"Carriers must advise physicians that CPT code 99211 cannot be paid if it is billed with a drug administration service such as a chemotherapy or non-chemotherapy drug infusion service (effective January 1, 2004). The Centers for Medicare & Medicaid Services expanded this policy in the 2005 Medicare physician fee schedule final rule to also include a therapeutic or diagnostic injection code (effective January 1, 2005)."

Therefore, when a medically necessary, significant, and separately identifiable E&M service (which meets a higher complexity level than CPT code 99211) is performed, in addition to one of these drug administration services, the appropriate E&M CPT code should be reported with modifier 25. Documentation should support the level of E&M service billed. For an E&M service provided on the same day, a different diagnosis is not required.

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March 21, 2011

Question:

Does Medicare reimburse for code Q2040?

Answer:

Medicare payment will be available for code Q2040 (injection, incobotulinumtoxin A, 1 unit) for claims with dates of service on or after April 1. For this update, see transmittal R2147CP at http://www.cms.gov/transmittals/downloads/R2147CP.pdf or MM7299 at http://www.cms.gov/MLNMattersArticles/downloads/MM7299.pdf

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March 14, 2011

Question:

Are multi-use vials subject to payment for discarded amounts of drug or biological?

Answer:

No. Multi-use vials are not subject to payment for discarded amounts of drug or biological. For more on this, see http://www.cms.hhs.gov/mlnmattersarticles/downloads/MM5520.pdf and http://www.cms.hhs.gov/transmittals/downloads/R1248CP.pdf.

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March 7, 2011

Question:

Does Medicare pay ment code Q2040?

Answer:

The Centers for Medicare & Medicaid Services recently announced that payment will be available for this code (injection, incobotulinumtoxin A, 1 unit) for claims with dates of service on or after April 1. This information can be found at: www.cms.gov/transmittals/downloads/R2147CP.pdf.

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February 28, 2011

Question:

What is the Medicare policy on single-use vials and packages of drugs and biological?

Answer:

The Centers for Medicare & Medicaid Services recently amended Section 40 of Chapter 17 of the Medicare Claims Processing Manual to address single-use vials and packages of drugs and biologicals. It says that after administering a dose/quantity of the drug or biological to a Medicare patient, a physician, hospital or other provider must discard the remainder of a single-use vial or other single-use package, Medicare will pay for the amount administered and the amount discarded, up to the total amount of the drug or biological as indicated on the vial or package label.

See the following memos for more: http://www.cms.hhs.gov/mlnmattersarticles/downloads/MM5520.pdf and http://www.cms.hhs.gov/transmittals/downloads/R1248CP.pdf.

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February 21, 2011

Question:

Can physicians participate in both the CAP and ASP systems?

Answer:

No, physicians cannot participate in both the competitive acquisition program (CAP) for Part B drugs and biologicals and the average sales price (ASP) program for the same drugs in the same practice. However, all participating CAP physicians may continue to bill under the ASP methodology for drugs not included in the CAP, or in cases where a beneficiary requires a particular formulation of a drug that the approved CAP vendor does not supply, using the “furnish as written” process.

In addition, a physician who is a member of a group has reassigned his or her benefits to the group and bills using the group's PIN. If the group practice has elected to participate in the CAP, the physician cannot "buy and bill" separately from the group outside of the CAP. However, if a physician is a member of a group practice but does not reassign his or her benefits to the group and bills using his or her individual PIN, rather than the group’s PIN, the physician can make a determination about whether to participate in the CAP separate from that of the group.

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February 14, 2011

Question:

How should oral equivalent drugs that are filled at the pharmacy for take-home use be shown on the claim?

Answer:

According to directions from the Centers for Medicare & Medicaid Services, you should report one line item per prescription only for the quantity expected to be taken during the claim billing period.

For example, if a prescription for calcium was written on 4/15/11 for one pill taken three times daily for a period of 45 days, on the September claim the provider would report the national drug code (NDC) for calcium with the quantity 45 (15 days x 3 pills day). The remaining pills that would be taken in May should appear on the May claim. In other words, if the prescription was for a three-month supply, you would not put the entire three months on one month's claim. Only the amount that was taken in the month would be on that month's claim.

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February 7, 2011

Question:

Can Medicare be billed for drugs administered through durable medical equipment (DME)?

Answer:

Yes, claims for these drugs are generally submitted to the DME Medicare administrative contractors (MAC), and the DME MAC reimburses the pharmacy (after they determine if the drugs are covered and reasonable and necessary). One exception is that claims for drugs administered through implanted DME (such as an implanted infusion pump) must be submitted to the A/B MAC or local carrier. All bills submitted to the DME MAC must be submitted on an assigned basis by the pharmacy. For more on this, see Medicare Claims Processing Manual, Chapter 17, Section 50.B, at http://www.cms.gov/manuals/downloads/clm104c17.pdf.

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January 31, 2011

Question:

Why does CMS recommend that providers always submit codes even when they aren’t getting paid?

Answer:

CMS makes packaging determinations for drugs and biologicals annually based on charge information reported with specific HCPCS codes on claims. According to CMS, the accuracy of OPPS payment rates improves when hospitals report charges for all items and services that have codes, whether or not payment is packaged or not. CMS relies on hospital cost and charge information as it is reported through the claims data and cost reports.

As CMS states, “Precise billing and accurate cost reporting by hospitals allows CMS to most accurately estimate the hospital costs for items and services upon which OPPS payments are based.”

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January 24, 2011

Question:

My question is a follow-up to the January 3 answer regarding the ESRD drugs being bundled into a new PPS. Do you know if these drugs will be bundled into chemo infusions?

Answer:

No, they will not.

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January 17, 2011

Question:

When it comes to what’s called the incident-to benefit, does Medicare pay for oral drugs?

Answer:

On July 30, 2010, the Centers for Medicare & Medicaid Services expanded Medicare eligibility under the incident-to benefit to oral drugs, suppositories, and topical medications that are not usually self-administered. Previously, only injectable drugs, including intravenously administered drugs, were eligible for coverage. Medicare contractors, however, have discretion on determining whether a drug meets the incident-to benefit and are required to post their decisions on their Web sites.