July 2024 - Newsletter

Included in this newsletter

1. CMS Preparing to Close Program that Addressed Medicare Funding Issues Resulting from Change Healthcare Cyber-Attack
2. R.J. Hedges & Associates Appoints a New President
3. ISMP Issues Call to Action to Prevent Errors With Automated Dispensing Cabinets
4. FDA Approves Expanded Age Indication For RSV
5. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season
6. HIPAA Compliance Changes
7. HHS Announces Cost Savings for 64 Prescription Drugs
8. DME JD Associations Communication
9. R.J. Hedges & Associates Office Address
10. Moving Sale: Hazardous Drug Spill Kits
11. Enforcement
12. R.J. Hedges & Associates renews Strategic Partnership and Certified Consultant status with ACHC
13. R.J. Hedges & Associates achieves Certified Product status with ACHC for Non-Sterile Compounding Compliance Program
14. New & Updated Policies & Procedures
15. New & Updated Forms and Support Documents
16. Meet our Staff – Judy

CMS Preparing to Close Program that Addressed Medicare Funding Issues Resulting from Change Healthcare Cyber-Attack

The Centers for Medicare & Medicaid Services (CMS) announced that payments under the Accelerated and Advance Payment (AAP) Program for the Change Healthcare/Optum Payment Disruption (CHOPD) concluded on July 12, 2024.  Launched in early March, the CHOPD payments were designed to ease cash flow disruptions experienced by some Medicare providers and suppliers, such as hospitals, physicians, and pharmacists, due to the unprecedented cyberattack that took health care electronic data interchange Change Healthcare offline in February.  See more...

R.J. Hedges & Associates Appoints a New President

On July 1, 2024, Becky Templeton was named as the new and second President of R.J. Hedges & Associates.  Becky has been instrumental working behind the scenes in the company, working with vendors, operations, the Compliance Portal, and many podcasts and trainings for the past 10 years.

Due to some health issues, Jeff Hedges founder and former President, will be taking a step back but will continue to work part-time and serve as Chief Executive Officer. Jeff commented, “Our company is a fine-tuned compliance company, and the staff has been doing most of the work and support for our clients.”  Jeff will concentrate on technical writing and is looking forward to spending more time with his family and grandchildren.

ISMP Issues Call to Action to Prevent Errors With Automated Dispensing Cabinets

The Institute for Safe Medication Practices (ISMP) recently issued a call to action for standardization and smart logic to reduce the risk of drug name selection errors with automated dispensing cabinets (ADCs).  Since 2019, ISMP has recommended the use of at least the first five letter characters of a drug name during ADC searches.  Some ADCs now have configurable search functions, but more needs to be done.  "Requiring a five-character minimum remains a valuable interim strategy for reducing the risk of drug name selection errors with ADCs, and ISMP continues to support its use," said ISMP President Rita K. Jew, PharmD, MBA, BCPPS, FASHP.  "However, a more comprehensive approach, including dynamic search function capability, is needed to truly mitigate risks."  The organization's safe practice recommendations include urging vendor support for dynamic function and standard medication names.  For health care organizations, ISMP recommendations include requiring indications for certain override medications; analyzing workflow and conducting a failure mode and effect analysis to identify and manage possible obstacles before implementing a five-character search requirement; and using simulation to educate staff before implementing any drug name search changes.  Additionally, ISMP recommends establishing a feedback mechanism to get input from frontline staff before implementing any changes in drug name searches and staying informed about vendor updates.

FDA Approves Expanded Age Indication For RSV

GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.  In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old.  Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions.  RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.

CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season

Regardless of prior immunization status, CDC is calling for individuals aged 6 months or older to receive COVID-19 and influenza vaccines that have been reformulated for the 2024-25 virus season.  While recipients of 2023-24 COVID-19 vaccines were more insulated from acute infection and hospitalization than non-recipients, CDC notes that the level of protection wanes over time.  Read more…

HIPAA Compliance Changes

 We have begun updating the HIPAA Compliance Program with the new 2024 HIPAA statutes.  One of the biggest impact changes are related to patient requests.  The Privacy Rule has permitted the Covered Entities to respond to a patient request within 30 days.  This requirement has been reduced to 15 days.  We will continue to provide updates as files and items are update.  If any actionable items are needed, they will be included in our Task Lists.

HHS Announces Cost Savings for 64 Prescription Drugs 

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today announced that some Medicare enrollees will pay less for 64 drugs available through Medicare Part B.  The drugs will have a lowered Part B coinsurance rate from July 1, 2024 – September 30, 2024, since each drug company raised prices faster than the rate of inflation.  Read More…

DME JD Associations Communication

Noridian’s Medicare DME Provider Outreach and Education Department has put together a compilation newsletter of recently published information.  There are some very helpful articles that our DMEPOS providers may find helpful.  This Newsletter includes: (Link to Document)

• Glucose Monitors for Insulin Treated Beneficiaries
• Requesting Claim Examples
• Medicare Claims Processing Manual Update: Gap-Filling DMEPOS Fees CR 13617
• Prior Authorization for Replacement of Power Mobility Devices - Effective June 2, 2024
• Paper Claim Submission Tip
• eMDR via the Electronic Submission of Medical Documentation System – Revised
• Clarification on Ostomy Supply HCPCS A4436 and A4437
• Medicare Beneficiary Identifier (MBI) Replacement for Lost or Stolen Cards

R.J. Hedges & Associates Office Address

Did you know our company started as a fully remote company back in 2006?  We were ahead of our time!  In 2016, we purchased our office space at 163 9th St, New Florence, PA and enjoyed many events and meetings over the last 7+ years.  Since most of our employees opted to remain virtual after the pandemic, we have made the decision to go fully virtual again and allow all our employees to work remotely.  Our mailing address will remain PO Box H, New Florence, PA 15944.  You will not see any changes in your level of service, but you may hear kids and pets in the background. 😊

Moving Sale: Hazardous Drug Spill Kits

R.J. Hedges & Associates is having a Moving Sale for our Hazardous Drug Spill Kits.  These kits can be used for Hazardous Drugs, Hazardous Chemicals, and Bio-Hazards containment and cleanup. Get yours while they last for $65.00 + shipping.  Email sales@rjhedges.com or order online https://www.rjhedges.com/usp-800-hazardous-drugs-compliance-retail-pharmacies.

Enforcement

• Pharmacy Owner Sentenced for Paying Illegal Kickbacks and Engaging in a Money Laundering Conspiracy
• Pharmacy Owner Sentenced for $1M Health Care Fraud Scheme
• Pharmacy Owners Sentenced for $18M COVID-19 Health Care Fraud and Money Laundering Scheme

R.J. Hedges & Associates renews Strategic Partnership and Certified Consultant Status with ACHC

ACHC Certified Consultants are trained in ACHC Accreditation Standards, survey approach, and processes to better prepare their healthcare clients for the accreditation survey. Each ACHC Certified Consultant has demonstrated a commitment to providing quality consulting services by attending a comprehensive training course and completing a competency assessment.  ACHC does not provide guidance for operating as a consultant and does not endorse any specific consultant or consulting firm. Using any consultant or consulting firm listed in this resource does not guarantee accreditation by ACHC. Organizations seeking consultants are encouraged to properly vet the consultant or agency using interview questions and requests for referrals in determining whether to use the services of that consultant.” https://www.achc.org/certified-consultants/

R.J. Hedges & Associates achieves Certified Product status with ACHC for Non-Sterile Compounding Compliance Program

ACHC standards were incorporated within the R.J. Hedges & Associates Compounding Program in the Fall 2023 release. In Spring 2024 R.J. Hedges & Associates became the first company to have an ACHC Product Certification for their Compounding Compliance Program. This means that clients utilizing their program will benefit from the evaluation and review process that has verified the program is in compliance with ACHC’s requirements for the Non Sterile Compounding section of the ACHC standards. R.J. Hedges & Associates clients will receive a discount code for ACHC accreditation, and can expect a shorter time-frame to have applications prepared and reviewed.  Learn more here 

"The ACHC review process was extremely helpful, solidifying and verifying our Policies and Procedures. It identified areas for additional policies to meet ACHC’s requirements and expand our Non-Sterile Compounding Program. We are thrilled to be the first to receive ACHC Product Certification for Non-Sterile Compounding. This milestone will help our clients expedite accreditation, bypassing part of the review process since our P&Ps are already verified. We appreciate ACHC’s assistance and discount for our clients. While not an endorsement, we are pleased with this certification and look forward to future collaboration”

-Becky Templeton-

R.J. Hedges & Associates President

New and Updated Policies & Procedures

New and Updated Forms & Support Documents

Meet our Staff- Judy

Judy is a proud mother of two children, five grandchildren, and two great-grandchildren. Her son Philip, wife Bronwyn, and their two sons reside in Georgetown, PA. Apollo, 17, balances high school and college at the Aviation Academy, aspiring to be an air traffic controller, while Ares, 11½, is a lively spirit advancing in karate, just like his mom, a 3rd-degree black belt.  Her daughter Lisa lives in Bakersfield, CA, Lisa has a stepdaughter, Ashlee, with two children, making Judy a great-grandmother, though she humorously insists she’s not old enough for that title yet. Thomas, Judy's grandson, aspires to be a NASCAR mechanic, and Timothy serves as a Navy cook stationed in Norfolk, VA, with sea assignments in Bahrain.

Judy loves reading, sewing, knitting, and traveling. Her adventures have taken her around the USA, on mission trips to Honduras, and to far away places like Prague, London, Stonehenge, Germany, Austria, and Italy.

Judy participates in her church bell choir, the New Florence Women’s Club, the Red Hats Society, and a retired home health nurses' lunch group, staying connected and active in her community.

At RJ Hedges & Associates, Judy keeps immunization standing orders updated according to CDC and ACIP standards, reviews product descriptions and HCPCS codes, ensures compliance with pharmacy rules, updates the travel program, sources SDS sheets, and serves as a resource for staff and pharmacies.

Judy's extensive experience and dedication make her an invaluable asset to our team. Her blend of professional expertise, adventurous spirit, and family values enriches our work environment and inspires us all.