Paycheck Protection Program Expanded in COVID Relief Bill
Congress passed an end of year COVID relief bill in December that President Trump signed into law. While it did not include all of NCPA’s priorities, it did include new funding for the paycheck protection program. Additionally, small businesses may qualify for a second loan. To help pharmacists understand what is included in this relief bill, there is a video featuring Scotty Sykes, CPA, and NCPA also has a summary of the bill available. You can read NCPA’s statement on the package here.
Democrats Sweep Georgia Runoffs
to Take Control of the U.S. Senate
This week, Democrats Raphael Warnock and Jon Ossoff defeated Senators Kelly Loeffler (R-Ga.) and David Perdue (R-Ga.) in Georgia’s U.S. Senate run-off elections. The dual wins have given Democrats control of the Senate as they will control 50 seats with Vice President-elect Kamala Harris able to serve as the tiebreaker after Jan. 20. By gaining control of the Senate, Democrats will fully control the levers of power in Washington. The Georgia victories will elevate Sen. Chuck Schumer (D-N.Y.) to Majority Leader and Sen. Ron Wyden (D-Ore.) to Chairman of the powerful Senate Finance Committee. Sen. Mike Crapo (R-Idaho) will serve as the committee’s Ranking Member. Sen. Patty Murray (D-Wash.) is likely to become Chairwoman of the Senate Health, Education, Labor and Pensions (HELP) Committee. It remains to be seen which Republican will serve as the Ranking Member.
NCPA, 65 Pharmacy Organizations
Urge Insurance Officials to Rein in PBMs
NCPA spearheaded the effort in commenting on a draft of model PBM legislation from the National Association of Insurance Commissioners and 65 pharmacy organizations signed on in support. For more than a year, NCPA has been leading a coalition of pharmacy organizations to provide insights to NAIC while it develops the model. The comments urge NAIC to address various PBM practices that raise drug costs and interfere with patient access to community pharmacy services. Given the recent Supreme Court decision clarifying states’ authority to regulate PBMs, state legislators will be looking to NAIC for ideas on how to rein in the unregulated middlemen.
NCPA Releases Summary and Highlights
of Rebate Rule for Community Pharmacy
NCPA is providing members with a summary of the HHS Office of Inspector General final rule “Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees” more commonly known as the “rebate rule.” The rule will take effect on January 1st, 2022 and modifies existing antikickback statute safe harbors to make any rebates or renumeration provided by manufacturers to PBMs for drugs under Medicare Part D flow to patients at the point of sale. Additionally, the HHS OIG creates a “chargeback” process to ensure pharmacy is made whole as a result of the transaction. The HHS OIG did not modify DIR as jurisdiction with that issue lies with CMS. NCPA will continue to work with our partners and coalitions, as well as CMS, to ensure there is a seamless implementation.
NCPA Comments to CMS on Policy and Regulatory Revisions
in Response to COVID-19
In response to the fourth interim final rule CMS has issued on the COVID-19 public health emergency (PHE), NCPA submitted comments focused on the need for CMS to: align Medicaid reimbursement rates with Medicare’s administration fee for the COVID-19 vaccine; provide the option for pharmacists and pharmacies to submit claims for COVID-19 vaccine reimbursement, preferably through the medical billing pathway or existing processes via the NCPDP Telecommunication Standard; create a direct pathway for pharmacists to bill for evaluation, specimen collection, and other related services for patients who come to their pharmacies; and provide flexibility related to new COVID-19 diagnostic test price transparency requirements.
Coronavirus Paid Sick Leave and Expanded Family/Medical
Leave Requirements Expired December 31, 2020
The paid sick leave and expanded family and medical leave requirements under the Families First Coronavirus Response Act (FFCRA) expired on December 31, 2020 (see NCPA member summary of the FFCRA here). The Consolidated Appropriations Act of 2021 (see member summary of the CAA here) extended employer tax credits for paid sick leave and expanded family and medical leave voluntarily provided to employees until March 31, 2021, however the FFCRA leave entitlements were not extended, and employers are no longer legally required to provide such leave. For the most up to date information regarding FFCRA, please be sure to check the U.S. Department of Labor Wage and Hour Division questions and answers page here.
NCPA Offers Comments on PBM Transparency Standards
in Proposed Rule Governing the Exchanges
In response to the CMS Notice of Benefit and Payment Parameters for 2022 and PBM Standards proposed rule, NCPA urges CMS to shed light on PBM practices and increase transparency of data reported to CMS by PBMs. The rule also proposed a definition of prescription drug rebates and other price concessions which could have a large impact moving forward. NCPA highlighted areas in our comments where additional guidance or clarification is needed. Read the comments here.
NCPA Provides Comments on HHS Regulatory Relief Initiatives
Recently, NCPA submitted comments to HHS on two Requests For Information (RFI) regarding general regulatory relief and changes undertaken as a result of COVID-19. As part of their ongoing “Patients Over Paperwork” initiative, HHS is interested in addressing duplicative, restrictive, contradictory, unnecessary or overly burdensome regulatory requirements. In the comments, NCPA requested HHS finalize the proposed rule on DIR fees and finally resolve the largest outstanding regulatory issue facing pharmacy. In the more specific request for information, HHS sought information on whether certain temporary relaxations, suspensions, or expansions of different authorities or requirements granted during the PHE ought to be made permanent. NCPA provided detailed comments to HHS on specific provisions which might be permanently implemented, modified for future use, or terminated as unnecessary at the end of the PHE.
CMS Finalizes Rule for Part D Plans
on Electronic Prior Authorization Standard
On December 31st, 2020, CMS published a final rule which named the required standard for electronic prior authorization for Part D plans. The rule provides that prescription drug plans are required to support the electronic prior authorization transaction standard in NCPDP’s SCRIPT Standard Version 2017071. While plans may choose to implement the standard earlier, CMS will not be enforcing the standard prior to January 1, 2022.
HHS: States Can Do More to Contain Costs for Specialty Drugs
According to a report from the Office of the Inspector General at HHS, states can do more to implement greater oversight of Medicaid spending on specialty drugs. The report found no standard definition of “specialty drug” and that many states are not aware of the cost management strategies used by managed care organizations to contain specialty drug costs. The OIG recommends CMS work with states to expand alternative reimbursement models, provide acquisition cost data for a broader range of specialty drugs, and conduct greater oversight of MCO management of specialty drugs. Read the report here.
NCPA Engages NAMD and NGA on COVID-19 Vaccine
Administration Fee and Billing Pathway Options
NCPA submitted letters to the National Association of Medicaid Directors(NAMD) and the National Governors Association (NGA) advocating for an equitable and sustainable reimbursement for COVID-19 vaccine administration and we recommended suggestions for billing pathways. We ask governors and their Medicaid directors to align Medicaid reimbursement rates with Medicare’s administration fee for the COVID-19 vaccine and allow pharmacists to submit claims for COVID-19 vaccine administration as other licensed practitioners.
NCPA Comments to DEA on Suspicious Orders Proposed Rule
NCPA submitted comments to the Drug Enforcement Administration (DEA) in response to their proposed rule on Suspicious Orders of Controlled Substances, which contains several proposed revisions to regulations relating to suspicious orders of controlled substances, including: a new two-option system to report orders received under suspicious circumstances (ORUSCs); new recordkeeping requirements related to ORUSCs; new definitions to support the new suspicious order monitoring framework; and an amendment to DEA regulations to require dispensers that distribute pursuant to the “five percent rule” to design and operate a suspicious order monitoring system.
CMS’s Coverage and Reimbursement of Vaccines,
Vaccine Administration, and Cost Sharing
under Medicaid, CHIP, and BHP Toolkit
The Centers for Medicare & Medicaid Services’ (CMS) released an updated toolkit - Coverage and Reimbursement of Vaccines, Vaccine Administration, and Cost Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program. This update provides additional guidance on vaccine administration reimbursement and details the review process states can utilize to adjust vaccine administration reimbursement rates in their state plan. As for now, pediatric vaccines once approved, will go through the current COVID-19 program and not through the Vaccines for Children Program. Click here for an update to the NCPA summary.
Michigan SB 920 Becomes Law
Michigan Senate Bill 920 has been enacted granting new authorities to pharmacists while requiring provisions for compounding pharmacies. The bill authorizes emergency 60-day refill (non-controlled drugs) if ongoing patient care would be interrupted. It also allows temporary operation of a pharmacy in a location not designated on the pharmacy license, authorizes a pharmacist to dispense and administer a drug as needed to treat COVID-19, authorizes therapeutic substitution for drugs subject to critical shortage, allows oversight of pharmacy staff remotely through real-time, continuous audio-visual camera system; mandates a pharmacist on staff for a pharmacy technician to compound and requires out of state pharmacies to hold accreditation from a national organization approved by the board of pharmacy to deliver sterile compound medications in the state.
NCPA’s Summary of NIH’s Vaccine Communication Report
The NIH released a report outlining evidence-informed communication strategies in support of national COVID-19 vaccine distribution efforts. The report highlights coordinated communication with consistent messaging focusing on what, who, and how to address different health literacy levels within the population while prioritizing equity. Pharmacies are identified as critical partners and health care extenders in communication efforts regarding COVID-19 vaccinations. Click here to view NCPA’s summary.
HHS OGC Issues Advisory Opinion
on Contract Pharmacies in 340B
On December 30th, 2020, the HHS Office of General Counsel issued an advisory opinion on the status of contract pharmacies within the 340B program. The OGC concluded the pharmacies are acting as agents of the covered entities and manufacturers are obligated to provide drugs at the 340B prices. However, the advisory opinion does not have the force of law but does establish the interpretation of the law for the Department should manufacturers continue to limit shipments of drugs to contract pharmacies. NCPA will communicate with manufacturers to see what, if any, changes they will be undertaking as a result of the opinion as well as continue to develop and implement our own policy solutions as part of the NCPA 340B Task Force.
CDER Small Business and Industry Compliance Conference
Webinar on Compounding Topics
On January 14th, 2021, from 9:00AM to 3:30PM, CDER Small Business & Industry Assistance will be hosting a webinar on a wide range of topics related to CDER compliance, including compounding, which might be of interest to you and your pharmacy. Registration is free and will include presentations from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. Presenters will discuss questions from the audience after each presentation. Additionally, this webinar has been approved for certain continuing education credits. For a complete agenda and registration, please visit the webinar website.
NCPA State Legislative Activity Update
NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Click each issue for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.
NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC.