House Action on Drug Pricing Bill
Delayed Until December
A House vote on H.R. 3, the Lower Drug Costs Now Act; Speaker Nancy Pelosi’s (D-Calif.) drug pricing bill, has been pushed back until December (click here to view the NCPA summary). The Congressional Budget Office (CBO) needs more time to analyze the bill to provide an official score, and that process will not be completed in time for the House to vote on the measure before it adjourns for its Thanksgiving recess. Once taken up, it is expected to pass the house on a party line vote, but Senate Majority Leader Mitch McConnell (R-Ky.) is not expected to bring it to the Senate floor for consideration.
Texas Pharmacists Urge Sen. Cornyn
to Support Pharmacy DIR Fee Reform
As part of its Fix DIR campaign, the NCPA Advocacy Center targeted Sen. John Cornyn (R-Texas) in October to provide support for pharmacy DIR reform. Cornyn was one of a handful of members of the Senate Finance Committee who had not publicly committed to fixing DIR. NCPA was able to get a number of local papers to run letters to the editor that were submitted by NCPA members calling on Cornyn to do the right thing. Cornyn noticed, and he responded with a letter of his own in which he noted his own efforts to bring down drug prices. Getting a U.S. senator to respond like that is pretty rare in politics, so this is a great case study in the power of grassroots activism and NCPA’s influence.
CMS and HHS OIG Move to Reform AKS and Stark
HHS released two proposed rules on October 9, 2019 to modernize and clarify the regulations that interpret the Federal Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law). The proposed rules are part of HHS’ regulatory sprint to remove potential regulatory barriers to care coordination and value-based care. Of particular concern to community pharmacy is OIG’s proposal to exclude pharmacies from protection under the newly proposed value-based enterprise (VBE) safe harbors. OIG is considering whether to exclude all pharmacies, or only compounding pharmacies, from the definition of VBE participant, or from specific safe harbors in AKS. The agency acknowledges that some pharmacies have the potential to contribute to the type of beneficial value-based arrangements; however, OIG is concerned that because pharmacies primarily provide items, their participation in value-based arrangements may not further care coordination. A detailed summary of the proposals are available here. NCPA will be submitting comments to inform OIG, in particular, of beneficial arrangements pharmacies may want to undertake and to assert that pharmacies should be included under the VBE safe harbor.
NCPA Sends Comments Supporting Michigan’s Proposal
to Reform Medicaid Pharmacy Benefits
This week, NCPA submitted comments to Michigan’s Medical Services Administration in support of a proposal that would carve pharmacy benefits out of the Medicaid Managed Care program. Michigan proposed the change because it found that the move “will result in cost savings” and “result in significantly streamlined administration” of Medicaid benefits. In its comments, NCPA applauded the state for taking steps that will increase patient access to pharmacy services, save taxpayer money, and result in competitive pharmacy reimbursements that are tied to NADAC plus a professional dispensing fee.
President Trump Nominates Dr. Stephen Hahn to Head FDA
Last Friday, the White House announced that President Trump intends to nominate Dr. Stephen Hahn, Chief Medical Officer of the MD Anderson Cancer Center in Houston to be FDA Commissioner. Hahn, who has never held a government position, would replace Scott Gottlieb who stepped down from the positon in April. If confirmed by the Senate, Hahn will be faced with several critical issues related to vaping, opioids and prescription drug importation.
Court Overturns Final Rule Regarding
Conscientious Objection of Care by Healthcare Providers
This week, a U.S. district court in Manhattan ruled that HHS' recent final rule regarding the conscientious objection of care by healthcare providers for religious or moral beliefs lacked statutory authority to be promulgated, violated the Civil Rights Act of 1964, and did not follow proper rule-making procedures under the Administration Procedures Act. The final rule was titled "Protecting Statutory Conscience Rights in Health Care" and would have allowed medical providers to refuse care if the care conflicted with the provider's religious or moral convictions. The final rule would have also allowed those providers to decline to refer patients to another provider who did not have a religious or moral objection. NCPA will continue to actively monitor developments on this final rule as the administration may choose to appeal the court's decision in the near future.
CMS Issues Physician Fee Schedule Final Rule
Aiming to Reduce Clinician Burden
Last week, CMS issued a final rule, the Physician Fee Schedule (PFS) and Quality Payment Program (QPP) Final Rule, aiming to reduce clinician burden, ensure appropriate payment under the PFS, and enable them to provide their patients with high quality care. CMS updated "burdensome and overly complicated" billing requirements for Evaluation and Management (E/M) services that will take effect on January 1, 2021. CMS is also increasing payment for office and outpatient E/M visits and providing enhanced payments for certain types of visits. The final rule also improves the QPP by including a simpler way for clinicians to participate in the Merit-based Incentive Payment System (MIPS). In the proposed rule, CMS stated that an Opioid Treatment Program (OTP) must maintain and submit to CMS a list of all physicians and other eligible professionals (as defined in the Social Security Act) who are legally authorized to prescribe, order or dispense controlled substances on behalf of the OTP. Pharmacists are not enumerated as other eligible professionals. In the final rule, CMS reiterated that pharmacists do no qualify as eligible professionals, but revised the statute to include pharmacists within the scope of the list requirement for OTPs. Therefore, pharmacists can continue ordering, prescribing, or dispensing for coverage on behalf of the OTP.
USP Issues FAQs on Compounding Appeals
USP recently posted an FAQs document on Compounding Appeals to clarify enforcement of Chapters <795>, <797>, <800>, and <825>. As stated in previous NCPA communications, <795>, <797>, and <825> are being postponed until further notice due to pending appeals. USP states that <800> is not subject to any appeals, and therefore will still become official on Dec. 1. However, during the postponement of <795> and <797>, <800> is informational and not compendially applicable because <800> is not referenced in any other official chapters.
<800> will become compendially applicable once revisions to <795> and <797> include a reference to <800>. Reference in <795> and <797> to <800> would make <800> compendially applicable only to the extent to which <795> and <797> apply. State regulators may still choose to enforce <800> regardless of the pending appeals. For more information about whether your state will be enforcing <800>, please contact your state board of pharmacy.
CMS Finalizes DMEPOS Proposals for CY 2020
CMS issued a final rule to update Medicare payment policies for CY 2020 for renal dialysis services paid under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and modify Medicare payment for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS).The final rule is effective January 1, 2020. In our comments to the proposed rule, NCPA asked CMS to ensure that the responsibility of providing face-to-face encounter documentation falls upon the treating practitioner and not community pharmacists who may dispense DMEPOS. In its response, CMS agreed that the beneficiary’s practitioner is charged with creating the documentation of the face-to-face encounter; however, CMS stated that additional documentation requests are generally sent to the entity requesting Medicare payment. CMS also finalized a methodology for determining the fee schedule amounts for new DMEPOS items and services. Lastly, the final rule developed one “Master List” which serves as a library of items from which an item may be selected to be subject to face-to face encounter and written order prior to delivery and/or prior authorization requirements. NCPA will continue to monitor any DMEPOS payment changes as it affects community pharmacy.
MedPAC Holds Monthly Meeting
on Medicare Part D and MA Quality
This week, the Medicare Payment Advisory Committee (MedPAC) held its monthly public meeting with sessions on redesigning the Medicare Advantage (MA) quality bonus program and restructuring Part D, focusing on low-income subsidy (LIS) beneficiaries. The topic of discussion surrounding MA quality was that the current program has many flaws due to excessive measures, poor implementation, and high costs. A redesigned MA-Value Incentive Program would be patient-oriented, score a small set of measures, and encourage care coordination across providers. The session on restructuring Part D focused on considerations for plans serving LIS beneficiaries, asserting that risk adjustment would be an essential element of a redesigned Part D benefit. The Commissioners pointed out there is currently a skew in DIR that is allocated back to plans, and that misallocation needs to be fixed. NCPA continues to monitor MedPAC’s meetings and seeks opportunities to address the committee on issues pertaining to community pharmacy.
NCPA Comments on Texas Board of Pharmacy Proposal
Eliminating Pharmacist-to-Tech Ratio
This week at the Texas Board of Pharmacy hearing, NCPA commented on a proposal to eliminate the pharmacist-to-technician ratio (currently 1:4). While commending efforts to enhance patient care via enhanced utilization of technicians and addressing manpower issues, NCPA recommended that the board take a stepwise approach to ensure adequate supervision and training of technicians, ultimately protecting public health and safety.
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. Linked below are reports 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