Legislative Updates
**organized from most current to oldest**
Legislative 101: 6 Protected Cases
2) Anticonvulsants
3) Antipsychotics
4) Antiretrovirals
5) Antineoplastics
6) Immunosuppressants
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
HR 592 and S. 314
DEA’s Disposal of Controlled Substances
H.R. 4190
H.R. 1024 and S. 557: Medication Therapy Management Empowerment Act of 2013
Amendment of the Controlled Substances Act
S. 1493: Medicare Efficient Drug Dispensing Act of 2013
DEA’s rescheduling of Hydrocodone Combination products
Legislative 101: 6 Protected Cases
- What are the 6 Protected Classes?
2) Anticonvulsants
3) Antipsychotics
4) Antiretrovirals
5) Antineoplastics
6) Immunosuppressants
- What’s important about this?
- These are therapeutic classes for which Part D plans must cover all available products with very few exceptions
- Changes proposed by CMS
- Allow plans to exclude protected class drugs from their formulary
- Allowing plans to use prior authorizations and step therapy for protected class drugs
- Summary: AKA “any willing pharmacy” legislation. Allows community pharmacies in medically underserved areas to be in all Medicare drug plan networks. Improved access and better care for patients while preventing loss of business for pharmacists.
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
- Summary: Guideline by the FDA that prohibits pharmacies from repackaging medications unless they are prescribed for a specific patient.
- Impact on LTCFs: This creates operational issues for long term care facilities. On May 20th a joint bill was sent to the FDA requesting for the following: allowance of medication emergency supplies, exemption for remote facility, and allowance of repackaged drugs in case of undistributed demand
HR 592 and S. 314
- Summary: To amend the Social Security Act to allow coverage of pharmacy services. These bills are reintroduced versions of HR 4190 House of Representative and Senate bills, respectively.
- ASCP will work with PAPCC (Patient Access to Pharmacists’ Care Coalition) to ensure the success of these bills
- If these bills pass, it will encourage pharmacists to provide MTM.
DEA’s Disposal of Controlled Substances
- Summary: The DEA published their final rule about disposal of controlled substances on September 9th, 2014. The DEA has the authority to regulate mail-back programs, take-back events and secured onsite disposal receptacles for disposal of controlled substances in order to prevent injury or death from unsanctioned use of controlled substances and to prevent buildup of unwanted controlled substances at these sites. In their final rule they outlined new disposal options, these options were voluntary. New options laid out in the final rule are effective as of October 9th, 2014.
- Impact on LTCFs: Long term care facilities are able to continue their current disposal practices as long as they are compliant with state and federal regulations. LTCFs can implement a new disposal method outlined in the final rule if they see fit.
H.R. 4190
- Summary: To amend the Social Security Act to allow coverage under the Medicare program for pharmacist services. Will allow for pharmacist-provided services to be reimbursable under Medicare Part B.
- ASCP’s stance: ASCP supports H.R. 4190 and advocating for this legislation through their grassroots advocacy initiative.
- Impact on students/pharmacy: H.R. 4190 will push the pharmacy profession to focus on delivering more comprehensive medication management services.
H.R. 1024 and S. 557: Medication Therapy Management Empowerment Act of 2013
- Summary: To amend Part D of the Social Security Act to provide access to medication therapy management programs for Medicare part D eligible individuals with a single chronic disease.
- ASCP’s stance: We support the effort to extend MTM services to patients with a single chronic disease because this will make it easier for seniors to receive MTM services.
- Impact on students/pharmacy: H.R. 1024 and S. 557 will give pharmacist more opportunity to provide clinical services to their patients. This might require extra qualifications on the pharmacist end to provide such services. For students this would mean learning more about MTM in school
Amendment of the Controlled Substances Act
- Summary: ASCP supports amending the Controlled Substances Act to allow pharmacist to dispense controlled medication to long term care and hospice patients based on chart orders. ASCP also wants to amend the act to allow nurses to have more power in prescribing controlled medication in long term care facilities. ASCP believes that these amendments will allow patients in senior facilities to receive their medications more efficiently and will help eliminate drug misuse and abuse.
- Impact on students/pharmacy: This amendment will allow long term care pharmacist to have more control over their patient’s health care.
S. 1493: Medicare Efficient Drug Dispensing Act of 2013
- Summary: To amend part D of the Social Security Act to require prescription drug plans that will encourage the use of efficient dispensing techniques that will reduce waste of outpatient prescription drugs in long-term care facilities.
- Impact on students/pharmacy: This amendment will allow long term care pharmacist to have more control over their patient’s health care.
DEA’s rescheduling of Hydrocodone Combination products
- Summary: The DEA published their final rule rescheduling hydrocodone combo products to Schedule II on August 22, 2014 in hopes to decrease prescription drug abuse. This rule is effective as of October 6th, 2014.
- ASCP’s stance: Though ASCP supports the DEA in its effort to solve the problem of prescription drug abuse they believe that it will have adverse effects on long term care facilities.
- Impact of LTCFs: Increased regulation of hydrocodone and hydrocodone combinations will delay access to these medications making it harder to treat long term care patients in a timely fashion.