Category : Pharmacy News


Pharmacy News: Omnibus HIPAA and How it Impacts you — Part II

In my last blog post, I informed you of changes to HIPAA and how it will be enforced.

Here are some of the specific changes in the  Omnibus HIPAA Final Rule and that impact you as a pharmacy owners:

  1. Security Rule—You must now make sure your business associates, anyone with whom you legally share individuOmnibus HIPAA changesally identifiable PHI, are compliant with the Security Rule and have policies and procedures in place to ensure the confidentiality, integrity, and availability of electronic Protected Health Information (PHI). While you’re at it, conduct an evaluation of your own Security Compliance Program, paying close attention to your Risk Analysis, Risk Management, Disaster Recovery, and Contingency Plans. A pilot audit program found that pharmacies were often deficient in these areas.
  2. Breach Notification—The standard for deciding whether one must issue a Breach Notification was changed from risk of harm to the patient to risk that the PHI was compromised. If your risk analysis determines that the PHI was possibly released inappropriately, you must: 1) Notify the patient within 60 days of discovery. 2) Notify HHS within 60 days for breaches of 500 or more patients. 3) Notify HHS of all breaches within 60 days of year’s end. 4) Notify a prominent media outlet in your area for breaches of 500 or more patients.
  3. Privacy Rule—This is where the majority of changes were made. Your Notice of Privacy must now: 1) State that you are required to get patient authorization for certain uses and disclosures (e.g. psychotherapy notes, marketing, sale of PHI, and other uses and disclosures not described in the Notice). 2) Include an opt-out statement in your fundraising statement. 3) Notify patients that they may restrict disclosures to health plans for services paid for out of pocket. 4) State that patients will be notified of any PHI breach. Offsite records must now be provided within 30 days of patient request, rather than 60 (with a 30-day time extension provision, as before). If patients request their PHI in an electronic format that you can provide, you must provide it electronically.

Also, there are changes to disclosure rules for the PHI of deceased persons and for proof of immunization to schools. You may continue to disclose PHI to individuals who were authorized to receive it before the patient’s death, and you must protect the PHI for 50 years or until you destroy those records. Proof of immunization may be disclosed to schools with a verbal request of a patient, parent, or person acting in loco parentis; document the request and the submission.

Want more information on the changes put in place by Omnibus HIPAA?

View the PRS webinar: HIPAA 2013: Don’t Panic. Be Prepared.

Looking for an answer to Omnibus HIPAA Compliance for your pharmacy?  

Visit the PRS website @ or contact 1-800-338-3688 to speak with a Specialist.



Pharmacy News: Medicare Re-Enrollment

calendarPharmacy Owners: Did you know that within the next 2 years you will be required to re-enroll with Medicare?

Read on to see how this will affect your pharmacy.

Between now and March 2013, your MAC will be sending you a revalidation request, so watch the mail for your notification!

When you receive the re-validation (re-enrollment) request, providers and suppliers, you have a limited amount of time to submit completed enrollment forms. Although you may be thinking, I should just take care of this now,  according to CMS, you shouldn’t submit your Medicare re-enrollment until you are requested by your DME-MAC.  BE SURE that you follow the directions in your letter to stay in compliance with the request.

It is extremely important that you take care of your re-enrollment in a timely manner.  Why? If you don’t, you will lose your Medicare number, whether you care Accredited or not.  And the process of getting it back could take up to ONE YEAR!  This could mean a loss of not only DME sales, but your customers could take their other prescription and OTC business elsewhere.  DON’T LET THAT HAPPEN TO YOU!

If you have  questions on Medicare Re-enrollment, give Palmetto (NSC) a call at 1-866-238-9652.


Pharmacy News: Medicare Enrollment Revalidation

r252188_1038084medicare1Pharmacies have lost their Medicare numbers because they didn’t revalidate their enrollment when notified.

Don’t Let It Happen to You!

Recently, a few pharmacies have come to my company asking for help because they did not revalidate their Medicare enrollment when the National Supplier Clearinghouse sent them a Revalidation Letter. As a result, their Medicare numbers were revoked.

You may remember from my October 28, 2011 blog posting that all pharmacies with Medicare provider numbers are going to have to re-enroll, or re-validate, their provider information within the next two years. Recently, CMS extended this revalidation period to 2015.

The pharmacies asking for help, claim that they did not receive their revalidation notification.

Be sure you haven’t missed this important communication from the NSC before it is too late. CMS has published all of the facilities to whom they’ve sent Revalidation Letters. Go to:

You can search the list to see if your facility is on it.

If you don’t file your re-enrollment documents correctly, completely, and on time, there’s not much you can do to speed up your reinstatement. If you can prove that your number was revoked in error, and you’ve appealed unsuccessfully to the NSC, you might ask your member of Congress to intervene.

Harry Lattanzio | PleaseNoteDon’t be confused by the word “revalidation.” Accredited pharmacies need to revalidate their DMEPOS Accreditation before it expires. This is entirely separate from the necessity forall Medicare suppliers to revalidate their enrollment when CMS tells them to.


Pharmacy News: HIPAA Compliance Can No Longer Be Ignored.

hP2-300x225Can you believe that it has been almost a decade since the HIPAA laws were put into effect?

And like many pharmacy owners, has your HIPAA Policy and Procedure manual  sat on your book shelf and collected dust?

Well things are changing, and NOW is the time to make sure you have reviewed your HIPAA Policy and Procedure Manual, make all the necessary updates and amendments and, most importantly, be sure you are following the Policies and Procedures laid out in the Manual.

Why?  One word — AUDITS.

As part of the American Recover and Reinvestment Act of 2009(ARRA), specifically the HITECH Act, the Office of Civil Rights (OCR) is required to perform periodic audits of a covered entities HIPAA Compliance Program. To accomplish this, the OCR has contracted with KPMG LLP (KPMG) to conduct performance audits of covered entities, including pharmacies. As part of the initial pilot audit program, KPMG will be auditing a total of 150 covered entities this year between June and October.

According to KPMG, “the objective of the Performance Audits is to 1) analyze the key processes, controls or policies relative to selected requirements of the Rules as specified in an audit protocol established by the OCR, and 2) to provide our observation.” These audits will be performed both on-site and off-site.

Based on notices already sent out by KPMG, the on-site audits could take up to a week and will be scheduled with you or your staff. During the on-site audits, KPMG will:
• Meet with key members of your organization responsible for your HIPAA Compliance.
• Collect verbal and documented information related to your HIPAA Compliance.

Prior to an on-site audit occurring and to assist with the smoothness of the audit, KPMG does request that no later than 15 days after their documentation request is received, you provide them with certain documentation related to your compliance.

Please remember that KPMG is acting on behalf of the U.S. Department of Health and Human Services (HHS) and as such will not enter into any non-disclosure agreements with a covered entity.

Stay tuned as I cover the basics of HIPAA Compliance in the weeks to come.


Pharmacy News: New York Medicaid Hoping to Move to AAC-Based Reimbursment

reimbursement-2As you are probably aware, especially if you are a New York based pharmacy,  New York Medicaid is looking to move to a AAC based reimbursement model for some Prescription Medication.

To help mold this pricing, New York Medicaid is asking a random sampling of Pharmacies on a monthly basis to submit an AAC Pricing Survey.   This survey will ask for similar information as the initial AAC Survey that are due in January 2013, however the date ranges will be dependent upon the date you receive the Survey Request.

Do you need more information on why the AAC Survey is required by New York Medicaid? Please visit these websites:


Pharmacy News: NSC Site Visit vs Accreditation Survey

Compliance-ChecklistDo you know the difference between an NSC Site Visit and an Accreditation Survey?

As a Medicare Part B Supplier you will go through periodic onsite surveys by the National Supplier Clearinghouse and your Accreditation Organization. These two types of surveys are separate and distinct from one another and not allowing either to take place could have negative effects on your ability to bill Medicare.


No worries, many Medicare Part B Suppliers are because they have so many different surveyors coming in to their locations.

The Accreditation Organization Survey will verify that you are following all of the policies and procedures required by them to remain in good standing.

The National Suppler Clearinghouse (or NSC Site Survey)will verify that you are abiding by the 30 Medicare Supplier Standards (always refer to CMS/Palmetto for the current version). This survey can be conducted to all Medicare Part B suppliers, whether you are Accredited or not. They will be specifically asking for several policies and forms, including:

  1. Beneficiary Complaints.
  2. A Model Warranty Form can be found on the NSC Website.
  3. A “Capped Rental, Inexpensive or Routinely Purchased Items Notification” form can be found on the NSC Website.

To ensure your continued ability to bill Medicare for DMEPOS and prevent you from being removed from the Medicare program, it is critical that you allow them to conduct their survey. The NSC site visitor is not affiliated with your accreditation organization. They will identify themselves and present you with a Site Visit Acknowledgement Form. For more information or with questions, visit the NSC Web site – or contact NSC Customer Service – (866) 238-9652, M-F 9:00 am – 5:00 pm, ET.


Pharmacy News: Mail Order and Blood Glucose Testing Supplies

mailboxAre you confused about what is considered  Mail-Order for glucose testing supplies for the 2013 Competitive Bidding?

Let’s see if I can sort through it with you.

When it comes to Blood Glucose Testing Supplies, Medicare considers mail order to be “any items shipped or delivered to the beneficiary’s home, regardless of the method of delivery.” This includes delivering to your patient’s home with your own vehicle.

So, what that means is with National Competitive Bidding for Blood Glucose Testing Supplies starting in 2013, pharmacies will no longer be able to deliver Blood Glucose Testing Supplies unless they are selected as a Mail Order Competitive Bidding Winner for Blood Glucose Testing Supplies.

Of course, many Pharmacy Organizations are asking Medicare to change the delivery rule, but as of July 2012, Medicare is still maintaining that all methods of delivery to the beneficiary’s home is considered “mail-order”.


Pharmacy News: The Affordable Care Act

health-care-reformThe Affordable Care Act and What It Means for Your Exemption from DMEPOS Accreditation.

The Supreme Court ruled 5–4 in favor of the constitutionality of the Affordable Care Act.  While there is much I could say about the entire law, I am not here to give my political views. Let me instead focus on what it all means for your pharmacy business.

As we know, and I have stated many times in past entries, the clause that allows many independent pharmacy owners to be exempt from DMEPOS Accreditation is a part of the Affordable Care Act.

Does Your Pharmacy Meet the Exemption Requirements?

First, if you are still questioning whether or not you qualify for an exemption from the current accreditation requirements and standards, it’s best to either seek legal counsel and/or contact Palmetto for information (their phone number is 866-238-9652). Be aware that you may be under a false assumption that you do qualify for the exemption. Please be sure for yourself before you count on this.

If You Meet the Requirements, What’s Next?

You are not automatically exempted. You are required to submit to National Supplier Clearinghouse a letter of attestation developed by the DME MACs. In this letter you attest that your pharmacy is exempt from the accreditation requirement because your total DMEPOS billings to Medicare have been less that 5 percent of your total pharmacy sales for the past three calendar or fiscal years and that your pharmacy has been a Medicare DMEPOS Supplier for over five years without any unrescinded adverse actions.

Regardless of whether your pharmacy qualifies for, files for; then, receives acceptance from the NSC for the exemption, you must, as always, comply with the Medicare DMEPOS Supplier Standards. So, having Policies and Procedures in place is very important. The supplier standards are published in CFR 42 424.57 (c).

business-decisionDoes Taking the Exemption Make Good Business Sense?

Please remember, many private, third-party insurance companies do require that suppliers obtain accreditation in order to bill for DME products. Also, many state Medicaid programs require accreditation for DME suppliers, and it’s not clear at this point if they will follow suit with any exemptions.

You may want to ask yourself, especially since you have already gone through the accreditation process, if you should keep your accreditation. With accreditation, you are sure to be compliant with all of the Supplier Standards, and you will meet any requirements that private, third-parties or Medicaid programs have.

There are also networks and buying groups out there who cater to accredited pharmacies. They offer enrollment to insurance plans that may be closed to  you if you are not accredited.

Weighing all of your options can be confusing at first, but there are resources to help—National Supplier Clearinghouse, CMS, and consultants can work with you to reach the right accreditation decision for your pharmacy.


Pharmacy News: The Election and Healthcare

ballot_box1_EV0PWith an election year coming up, a lot of things could change; especially in the pharmacy world.

When I talk to my clients about this, mainly those who are thinking about not re-validating their DME Accreditation, I tell them they should really think before writing that letter to take the exemption.


  1. We DON’T know what the future may hold for pharmacy owners. The healthcare bill could be repealed, taking the exemption option off the table.
  2. The hard work is already done! Yes, I understand there is a fee involved in re-validating, but look back to #1, if healthcare is repealed then you will not only have the fee to pay, but will have to redo all the work.
  3.  Exemption (and I have talked about this before, a few times actually) does not apply to third party insurers and state Medicaid programs who, following an industry trend, are requiring suppliers to obtain accreditation in order to bill. Many of these plans, including Security Blue in PA, HEALTHFirst in MD and more, currently require accreditation.

So, be compliantbe accredited, and be connected, so you are always be ahead of any changes that could happen.


Pharmacy News: DME Accreditation Exemption

chain_clipboard1What do the chains know about DME Accreditation and the Exemption that you don’t?

Walgreen’s, Rite Aid, CVS, Kroger’s, Safeway, Publix and a host of others have already said NO to taking the DME accreditation exemption offered by CMS, which would have saved them millions of dollars.

Why would they do that?

The answer is simple.

They spent the money to become accredited knowing that a growing number of third party insurance providers and state Medicaid programs are requiring accreditation.
Therefore, they get a big return on investment with the increase in prescription and total store sales from new DME customers.

As Independent pharmacy owners, we need to be prepared to protect our customer base.
Don’t put yourself in the position of having to turn away DME customers because you cannot bill their insurance and risk losing their prescription business as well.

By renewing or acquiring DME accreditation and saying no to the exemption, you will remain strong in your overall offerings against the chains, while maintaining complete Medicare compliance in case the exemption ever goes away.