The Pharmacy and Medically Underserved Areas Enhancement Act of 2015 (H.R. 592/S. 314)

Pharmacy and Medically Underserved Areas Enhancement Act of 2015:

HCC is committed to helping get The Pharmacy and Medically Underserved Areas Enhancement Act of 2015 (H.R. 592/S. 314) passed. The bill would amend title XVII (Medicare) of the Social Security Act to cover Pharmacist services. This would allow Pharmacists to help fill some gaps in the health care system in providing much needed patient care services to Florida’s neediest and underserved communities. To make this happen we all need to show our support!

I would like to share parts of a recent email that was received from Scott Tomerlin, the President-elect for the Florida Pharmacy Association. In it Scott shares several statistics that you may find to be helpful:

– 30 out of 67 Florida counties include areas designated as “medically underserved”

– Florida will be short 7,000 doctors by 2025, with 253 active physicians per 100,000 residents as of 2012 according to the Association of American Medical Collages.

– Southwest Florida is of 3 regions in the state where medical demand is expected to exceed supply by the highest amounts 10 years from now.

– For every $1 that is invested in Pharmacists provided services, a return on investment of $4 is realized in health care savings.

– In Florida alone, there are over 19,900 Pharmacists ready to help.

As Scott points out, while we can all agree that supply and demand changes for Pharmacists and the job market has shifted dramatically, this bill has the potential to be a viable step to help create more demand for Pharmacist provided services. We know the positive impact of Pharmacists provided services in the health care setting, and certainly those patients that receive these services do, but do our Legislators? How will they ever know if we sit silently on the sideline and wait for others to dictate the direction of our profession?

A Special Thanks to those Legislators in our state that have already co-sponsored this legislation, as well as those constituents in their district whom have reached out to those members. Currently, there are 161 Cosponsors (8 in Florida) in the U.S. House of Representatives and 22 Cosponsors (0 in Florida) in the U.S. Senate.

Current H.R. 592 Co-Sponsors (Florida) as of July 15, 2015 (and date of co-sponsorship)

Rep. Hastings, Alcee L. [D-FL-20]
02/02/2015

Rep. Jolly, David W. [R-FL-13]
02/03/2015

Rep. Ross, Dennis A. [R-FL-15]
02/10/2015

Rep. Murphy, Patrick [D-FL-18]
02/26/2015

Rep. Bilirakis, Gus M. [R-FL-12]
03/23/2015

Rep. Curbelo, Carlos [R-FL-26]
04/13/2015

Rep. DeSantis, Ron [R-FL-6]
07/07/2015

Rep. Nugent, Richard B. [R-FL-11]
07/07/2015

Current S. 314 Co-Sponsors (Florida)
None!!

If you do NOT see your representative on this list, we urge you to contact them today!
How do you contact them?

Use the FPA direct link to CAPWIZ – This will allow you to send an email to your local Congressman to urge them to co-sponsor the bill: http://www.capwiz.com/pharmview/state/main/?state=FL

Now is the time that we act, not react, to what is happening around us in the Practice of Pharmacy and Health Care in general. I ask with the strongest urgency that you reach out TODAY to your local legislator to co-sponsor H.R. 592/S. 314 “Pharmacy and Medically Underserved Areas Enhancement Act of 2015”.

Please keep in mind – the legislators that you have voted in office are there to represent you and your interests – your beliefs, morals and ideals just to name a few. I would hope you would consider YOUR Profession of Pharmacy that you practice to be of utmost concern as you are interacting with your legislator. (and eventually voting for in the polls!).

Bob Miller
7/22/2015


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FDA Announces Deadline Delay in Drug Supply Chain Integrity Act (DSCSA)

Drug Supply Chain Integrity Act (DSCSA):

The FDA announced yesterday that it has delayed taking any action regarding dispensing pharmacies in relation to the Drug Supply Chain Integrity Act (DSCSA) deadline that had been scheduled to go into effect on July 1st, 2015. What is now being called the “Track and Trace” enforcement of the Drug Supply Chain Integrity Act has been delayed until a new November 1st, 2015 deadline. In a new guidance document released yesterday, the FDA has basically given pharmacies another four months to get into compliance with the new requirements. Be advised that along with the announced delay was a “warning” from the FDA that there will be no more delays and all requirements must still be met under the law for pharmacies to be in compliance by the new deadline. It must also be noted that the newly released guidance does not extend the July 1 deadline for the requirement that pharmacists must provide this product tracing information to a subsequent owner, which includes pharmacy-to-pharmacy transfers, except for a specific patient need. The FDA further clarifies in its guidance that “if a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information.” It is further noted that a “subsequent owner” does not include a patient.

As previously stated, pharmacies will be required to collect and keep records of what is being dubbed the “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after the new November 1st deadline. It is also important to note that covered pharmacies must also have systems in place to segregate and investigate any drugs purchased or received after the deadline. This part of the law is specifically aimed at the compounding and specialty pharmacies that have been at the center of national attention since concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts.

Some other aspects of the DSCSA to consider include:
– When ownership of a pharmacy changes, or the prescription files are transferred to another pharmacy, the pharmacy will need to provide the 3T information to the new owner or pharmacy receiving the transferred prescription files.
– Product returns also are addressed in the DSCSA law. In this respect, pharmacies cannot view the DSCSA as only requiring the passive receipt of information from suppliers or manufacturers.
– Records and information will need to be retained for at least 6 years, so pharmacies also need to deal with this additional and significant record-keeping responsibility.

This law applies to almost every pharmacy in the country. The only exclusions are licensed health care practitioners (such as physicians) who dispense medication as part of their medical practice.

Any pharmacy that has not yet begun considering the impact of the DSCSA on its business should do so immediately. Pharmacies that do not currently have systems in place to ensure compliance with the laws requirements should take steps to develop appropriate policies and procedures, train their pharmacists on the new systems, and be prepared for the July 1st deadline for receiving and providing 3T information. HCC is here to help you prepare for the DSCSA requirements. Healthcare Consulting is a full service Pharmacy Consulting firm that has been in business for over 25 years. HCC has been helping pharmacies plan, prepare and deal with critical business issues such as new DSCSA law since 1989. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts! Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miller
7/14/2015


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URAC Accreditation – Pharmacy Consulting by HCC Gets Client Accredited

HCC Client Gets URAC Accreditation:

In our last post we shared how a South Florida client recently requested Healthcare Consultants to provide Pharmacy Consultation assistance in regards to obtaining VIPPS accreditation. Additionally the client asked HCC to assist in obtaining URAC accreditation. Once again HCC provided our client an Experienced Consultant Pharmacist to assist with the mounds of paperwork and discovery required. As with the VIPPS accreditation, upon completion of the assignment we received correspondence from our client that everything was in order and approved.

URAC is an independent, nonprofit organization, that is well-known for promoting healthcare quality through its accreditation, education, and measurement programs. URAC promotes pharmacy quality through accreditation for pharmacies to validate their commitment to quality and accountability. URAC’s Pharmacy Quality Management Accreditation products offer prestige for an organization and demonstrate a commitment to quality and safety. These accreditations ensure that the pharmacy operates up to national standards and participates in continuous quality improvement-oriented processes that enhance operations and compliance. URAC’s Pharmacy Quality Management Accreditation products are a critical seal of approval for employers, consumers, regulators, and providers. They show that an organization ensures access to drugs and pharmacies, provides for medication management and safety, and that contract terms and pricing structures are clear. Employers, consumers, regulators, and health plans rely on URAC for identification of the pharmacies that demonstrate the highest standards in PBMs, specialty pharmacies, and health plans. HCC clients that obtain URAC accreditation consistently report their value in improving operations and enhancing regulatory compliance activities.

URAC’s Pharmacy Quality Management Accreditation Suite includes the following products:
– Community Pharmacy Accreditation
– Drug Therapy Management
– Mail Service Pharmacy Accreditation
– Pharmacy Benefit Management Accreditation
– Specialty Pharmacy Accreditation
– Accreditation for Workers’ Compensation and Property and Casualty Pharmacy
– Benefit Management Accreditation

If you are considering obtaining URAC accreditation, we urge you to contact Healthcare Consultants today! HCC is a full service Pharmacy Consulting firm that has been in business for over 25 years helping pharmacies plan, prepare and deal with business issues. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts. Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miller
7/14/2015


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VIPPS Accreditation – Pharmacy Consulting By HCC Gets Client Approved 

HCC Pharmacy Consulting Client Receives VIPPS Accreditation:

Recently a South Florida client requested Healthcare Consultants to provide Pharmacy Consultation assistance in regards to obtaining VIPPS accreditation. HCC provided our client an Experienced Consultant Pharmacist to assist with the mounds of paperwork and discovery required. After we completed the assignment, we received correspondence from our client that everything was in order and approved.

VIPPS (also known as The Verified Internet Pharmacy Practice Sites) accredits online pharmacies that dispense prescription drugs. VIPPS requires an Internet pharmacy to comply with the licensing and survey requirements of its state and each state to which it dispenses pharmaceuticals. VIPPS-accredited pharmacies meet nationally endorsed standards of pharmacy practice, and they demonstrate compliance with standards of privacy and authentication and security of prescriptions, adhere to quality assurance policy, and provide meaningful consultation between patients and pharmacists.

VIPPS pharmacy sites display the VIPPS Seal on their websites and offers a client a way to be verified as legitimate. The Seal is a key benchmark for consumers to measure the quality of a pharmacy’s practice, and by clicking on the VIPPS Seal, they are able to access verified information about the pharmacy.

Here is a quick overview of the VIPPS Accreditation Process:
– Submit an application, required documentation, and specified fees to NABP
– NABP reviews policies and procedures to ensure adherence to VIPPS criteria
– NABP verifies the pharmacy’s license status
– NABP performs an on-site survey

VIPPS Accreditation Maintenance Overview
– Once accredited, an annual review and three-year reaccreditation are performed.
– To ensure continued compliance, all VIPPS-accredited sites are surveyed once every three years.
– Policies and procedures may be required to be submitted and re-reviewed as part of annual compliance requirements, reaccreditation, or if the scope of the pharmacy changes (ie, ownership, location, types of products offered).

If you are considering obtaining VIPPS accreditation, we urge you to contact Healthcare Consultants today! HCC is a full service Pharmacy Consulting firm that has been in business for over 25 years helping pharmacies plan, prepare and deal with business issues. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts. Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miller
7/14/2015


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Pharmacy Consulting – What Does King vs. Burwell Decision Mean to Pharmacies?

What King vs. Burwell Decision Means to Pharmacies:

Last week the U.S. Supreme Court voted in favor of upholding one of the primary tenets of the Affordable Care Act in the King vs. Burwell decision. This is the second ruling by the Supreme Court that was in favor of President’s Obama’s health care law. It basically preserved the rights of an estimated 6.4 million US citizens to retain the tax subsidies that help them afford health insurance. It is also seen as a major defeat for the law’s republican opposition, who have been attempting to undermine the law since it went into effect in 2010. The case centered on whether middle and low-income adults who purchased health insurance were entitled to subsidies based on the language of the law that says tax credits are only to be distributed for marketplaces “established by the state.” Many organizations and individuals had feared that there could be chaos in the health insurance market if the Supreme Court had ruled differently. Had the court shot down the tax subsidies, most feared that only the sickest would actually enroll for health insurance, resulting in premiums “skyrocketing” and causing more individuals to dropping their health insurance.

The question many have been asking is how does the ruling affect the Pharmacy profession? The answer is that most are in favor of the decision as it seems to enhance the role of Pharmacists in providing healthcare to patients and stabilizes the pharmacist’s role as a provider of healthcare information and consultant. Here are the responses to the ruling by many Pharmaceutical organizations and associations:

The National Association of Chain Drug Stores (NACDS) noted that pharmacists can play a role in improving patients’ health insurance comprehension. “Pharmacy remains committed to helping patients understand their coverage, which has been a priority throughout the roll-out of exchange-based insurance, as well as to maximizing the valuable role of pharmacies in today’s evolving health care delivery models,” the NACDS wrote. The NACDS also called for pharmacy Medicaid provisions of the ACA to be implemented, allowing for more access to pharmacist-provided patient care.

The Academy of Managed Care Pharmacy CEO Edith A. Rosato, RPh, IOM, praised the King v. Burwell decision, referencing a Kaiser Family Foundation estimate that 6.4 million individuals would have lost subsidies worth $1.7 billion per month if the court had ruled in favor of the plaintiffs. In addition, premiums for subsidized enrollees could have seen massive increases. “Whatever one’s view of the ACA, there’s no denying that this decision has averted significant disruption to the health care marketplace,” Rosato wrote.

The American Society of Consultant Pharmacists (ASCP) does not foresee any changes to the consultant pharmacy profession and long-term care industry as a result of the ruling, but did recognize that the decision adds more certainty to the future of the nation’s health insurance system. “The decision allows our members to continue efforts to work with other professions in the health care arena to deliver higher quality, more cost-effective care to the nation’s seniors,” the ASCP said in a statement.

International Academy of Compounding Pharmacists executive vice president and CEO David G. Miller, RPh, said he also does not expect any changes for the compounding community as a result of the King v. Burwell decision.

Both the Generic Pharmaceutical Association (GPhA) and the International Pharmaceutical Federation (FIP) expressed positive outlooks from the ruling.

As always HCC is here to help you. Healthcare Consulting is a full service Pharmacy Consulting firm that has been in business for over 25 years. HCC has been helping pharmacies plan, prepare and deal with critical business issues since 1989. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts! Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miller
6/30/2015


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Compounding Pharmacy Consulting – NIH Pharmacy Shuts Down

NIH Pharmacy Shuts Down:

Compounding pharmacies are once again under scrutiny on a national level as The National Institutes of Health (NIH) suspended all operations of its Clinical Center Pharmaceutical Development Section (PDS) last Thursday. The pharmacy, located at the NIH clinical center in Bethesda, Md., was shut down after the discovery of a fungus contamination in two vials of albumin being used in cancer treatments. Six cancer patients had already been administered treatments from the same batch and so far none have developed any signs of infection or become ill. Additionally, the NIH will be notifying almost 250 other patients involved in 46 studies that may be potentially affected. Patients travel from almost everywhere in the United States to participate in experimental therapies taking place at the NIH. The NIH facility acts partly as a compounding pharmacy, making special orders of medications that aren’t routinely available elsewhere.

Of greater concern is the fact that a complaint about the NIH pharmacy had already led the Food and Drug Administration to inspect the facility in May. Inspectors documented numerous problems, including flaws in air handling systems, insufficient employee training and lack of compliance with standard operating procedures. Concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts. In that case which drew a substantial amount of national media attention, 48 patients actually died and up to 14,000 people may have received the contaminated injections.

The biggest questions facing the NIH are all based around the issues of compliance regarding adherence to established policies and procedures. Various studies to date have shown that many compounding pharmacies have been slow to react to the newest guidelines of US797 regarding compliance. The most often cited reasons include:
– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes

A quote from Leigh Briscoe-Dwyer, the chief pharmacy and medication safety officer at North Shore-Long Island Jewish Health System really gets to the heart of the matter. “Because this is the NIH, the expectation is that standards are higher than you would expect from other sites,” Briscoe-Dwyer said. “It shows that no one is immune to failing to adhere to standard operating procedures. All of us involved in pharmacy need to pay attention. If it can happen at NIH, it can happen anywhere.”

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.

Bob Miller
6/18/2015


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