House Subcommittee Hearing on Drug Pricing

The House Energy and Commerce Health Subcommittee held a hearing this week examining policies allowing the Secretary of Health and Human Services (HHS) to negotiate prices in the Medicare Part D program, placing inflation caps on pharmaceutical products, limiting the use of citizen petitions at the Food and Drug Administration (FDA), capping seniors' out of pocket costs in Medicare Part D, and ending "pay for delay" arrangements between branded drug companies and generic competitors. Health Subcommittee Chairwoman Anna Eshoo (D-CA), Committee Chairman Pallone Jr. (D-NJ), and other Committee Democrats expressed strong support for allowing the HHS Secretary to negotiate prices within the Medicare Part D program and the need to cap out of pocket expenses for seniors in Part D. Rep. Peter Welch (D-VT) highlighted the need to finalize pharmacy DIR reform as a part of any drug pricing package, and Rep. Buddy Carter (R-GA) commented on the role that PBMs play in raising drug costs and the need to rein in their practices.

Congresswoman Diana Harshbarger: PBMs Bear Responsibility
for Increased Health Care Costs

This week the House Labor and Education HELP subcommittee held a hearing focusing on H.R. 3 and the responsibility of pharmaceutical manufacturers on the cost of prescription medications. Congresswoman Diana Harshbarger (R-TN), one of two pharmacists in Congress, emphasized the fact that more responsibility needs to be put on PBMs in regards to increased prescription drug costs. Congresswoman Harshbarger went on to point out the negative impact PBMs are having on patient access because they are putting community pharmacies out of business. Please see Congresswoman Harshbarger go after the PBMs during this hearing. Her remarks can be found here starting at timestamp 1:26:10.

NCPA Comments to FinCEN on Beneficial Ownership
Reporting Requirements

NCPA submitted comments in response to the Financial Crimes Enforcement Network (FinCEN), part of the Department of the Treasury, advance notice of proposed rulemaking (ANPRM) on the implementation of the Corporate Transparency Act (CTA), which was enacted into law as part of the National Defense Authorization Act for FY 2021. The CTA would require corporations, limited liability companies, and similar entities to report certain information about their beneficial owners, defined as “the individual natural persons who ultimately own or control the companies.” This new reporting requirement represents a shift in the regulatory burden from large financial institutions to small businesses. Additionally, under current law that information is held securely by financial institutions and can only be accessed by law enforcement agencies via a judicial subpoena or warrant; the elimination of this requirement would allow not only domestic law enforcement, but foreign governments, to obtain this information via undefined protocols. NCPA highlighted the financial burden of regulatory compliance for NCPA members and requested that FinCEN remove from the ANPRM several items based on their lack of authority, detail the protocols they will implement to authenticate requests for beneficial ownership information, and delay implementation of the new reporting requirements until the end of the COVID-19 public health emergency.

HRSA Announces New COVID-19 Vaccine Program
for Underinsured

On May 3, 2021, HRSA announced a new program – the COVID-19 Coverage Assistance Fund (CAF)- to cover the cost of administering COVID-19 vaccines to patients with health insurance, but that insurance does not cover vaccination fees or covers them with cost-sharing. This program seeks to address the need for providers to be compensated for vaccinating underinsured patients and will reimburse providers at the increased national Medicare rate or patient costs for administration for those with some coverage. HHS views CAF as closing the final payment gap for the general public and removes any reimbursement issues for providers for administering vaccines approved by the FDA. Providers will need to enroll in the CAF portal, which takes three to five days, prior to submitting claims. HRSA expects properly submitted claims to be paid within 15 days. For more information on how to process these claims and login and use the online system, please see the CAF portal guide.

NCPA Submits Comments on Proposed Changes to HIPAA

NCPA submitted comments to HHS on proposed modifications to the “Privacy Rule” issued pursuant to the Health Insurance Portability and Accountability Act (HIPAA) and the HITECH Act. NCPA provided comments on the provisions that would have the greatest impact on community pharmacy – positive developments such as the inclusion of pharmacists as providers for purposes of HIPAA and changes which will reduce the regulatory costs and burdens while upholding the spirit of protecting patient information. NCPA also supported changes to the Notice of Privacy Practices (NPP) such as ending the written acknowledgement requirement which permits pharmacists more time to spend serving patients. However, there were a few negative proposals – such as an expansive definition of electronic health records and reducing the time to respond to patient health information requests. NCPA will continue to communicate with HHS on how these issues arising under HIPAA impact community pharmacy.

HHS OIG Releases Study on Use of Antipsychotics
in Nursing Homes

This week, the HHS Office of Inspector General, which has oversight of CMS, released a study on the proper monitoring of the prescribing of antipsychotic drugs in nursing homes. The report found that the data used by CMS in Minimum Data Set – self reported by the nursing homes – was insufficiently capturing actual antipsychotic prescriptions when compared to Medicare claims. This data inconsistency meant the quality measure intended to monitor the drugs was inaccurate. This is the first of two reports that OIG will be releasing this year on antipsychotic prescriptions – this first report was requested by CMS, and NCPA’s Long-Term Care Division is awaiting the report originating from last year’s Congressional request that should arrive this Fall. NCPA’s LTC Division will continue to work with our partners in Project Pause, an ad hoc coalition of national patient and professional organizations advocating on clinical care LTC issues, to work with CMS to appropriately determine antipsychotic drug use in long-term care settings. NCPA’s LTC Division is a membership division within NCPA that advocates on behalf of and provides dedicated business resources for independently owned LTC pharmacies. Visit www.ncpa.org/LTC to join today.

Study: Lack of Pharmacy Access an Often Overlooked
Contributor to Health Disparity

Black and Latino neighborhoods in the 30 most populous U.S. cities had fewer pharmacies than white or diverse neighborhoods, according to new research from the University of Southern California. Pharmacies are vital points of care for essential health services, and these “pharmacy deserts” affect nearly 15 million people. “Traveling a mile to get your prescription medications may be convenient for people that own a car. Traveling a mile, or even half a mile, may be difficult for people who live in low-income neighborhoods and don’t drive, particularly older adults who rely on walking or public transportation,” said Dima Mazen Qato, associate professor at the USC School of Pharmacy and senior author of the research paper. Read more about the research here.

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. The weekly update is intended exclusively for the recipient and is not for external distribution.