NCPA Asks Lawmakers To Reconsider 21st Century Cures Draft Provisions

The National Community Pharmacists Association is asking House lawmakers to reconsider or change provisions in their draft 21st Century Cures bill, including measures to lock beneficiaries into specific pharmacies for obtaining certain drugs, suspend pharmacies’ Part D payments when there is suspicion of fraud and require e-prescribing for Part D drugs.

“There is widespread, bipartisan support for taking steps to realize more cures through the development of new medication and NCPA applauds that work. However, the legislation being drafted includes several provisions that appear unrelated to drug development that may inadvertently undermine patient access to prescription drugs today as well as the ability of community pharmacists to serve them,” NCPA CEO Douglas Hoey says in a statement.

The 21st Century Cures draft bill released by House Energy & Commerce Chair Fred Upton (R-MI) late last monthincludes a wide range of provisions on drug development, anti-fraud proposals and CMS reimbursement. Rep. Diana DeGette (D-CO), who spearheaded the initiative alongside Upton, did not endorse the draft because it was incomplete but said she fully stands behind the work done so far.

NCPA says it is concerned about the pharmacy lock-in program laid out by the draft bill, which the group says would lock into a pharmacy or pharmacies Medicare beneficiaries who need coverage of certain classes of drugs that are frequently abused. The community pharmacists say this would would presumably affect all beneficiaries who are looking to obtain these schedule II, III, IV and V drugs.

“While we share the common goal of cracking down on the endemic prescription drug abuse problem in the United States, we have serious concerns with this approach,” NCPA says in its Feb. 10 comment letter to Upton.

Beneficiary lock-in programs are used in commercial and Medicaid plans, and tend lock high risk beneficiaries in to a certain pharmacy or pharmacies for drugs that could be abused like opioids. Ways & Means health subcommittee Chair Kevin Brady (R-TX) also included a beneficiary lock-in proposal that targets high risk beneficiaries in his program integrity bill introduced late last year. Stacy Sanders, federal policy director at the Medicare Rights Center, previously told Inside Health Policy that Brady’s bill includes more-developed beneficiary protections than the 21st Century Cures draft and gives clearer direction to the agency about stakeholder involvement. The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, has been supportive of lock-in pharmacy proposals.

NCPA says that “at the forefront of prevention efforts must be a focus on reducing the inappropriate prescribing or the overprescribing of controlled substances and the prevention of ‘doctor shopping,’” because patients cannot get a drug from a pharmacy without first obtaining a prescription.

Rather than a pharmacy lock-in policy, NCPA says the group would “support carefully constructed prescriber lock-in policies; as this is the root cause of many patients being able to obtain multiple prescriptions for the same or similar medications leading to overuse and possible diversion.”

NCPA says it has concerns around pharmacy lock-in policies that let drug plans choose a pharmacy for beneficiaries. Under this approach, a plan could assign beneficiaries to a pharmacy in which the plan has a commercial or financial interest, including a mail-order pharmacy, NCPA says, which is a concern for community pharmacists.

The community pharmacists say CMS already has criteria in place to identify high-risk Part D beneficiaries, and the agency should build off that program before giving plans the authority to create and operate lock-in programs. However, former CMS Medicare chief Jon Blum previously expressed interest in a lock-in policy, and the administration’s fiscal 2016 budget also includes a lock-in proposal. HHS’s budget in brief says that the agency’s overutilization program can identify results from inappropriate activity, but there’s not much CMS can do on a preventive basis with that program.

NCPA also raises concerns with a provision in the draft cures bill that gives plans the ability to suspend payments to pharmacies pending an investigation of fraud. The definition of a “credible allegation of fraud” includes complaints made on the 1-800-Medicare hotline, and NCPA says that shouldn’t be the case.

“Certainly, a faceless allegation made on a 1-800 phone number should not automatically be considered ‘credible’ and be sufficient to suspend payment to a Medicare Part D provider — which could result in disruptions in the access to needed medications,” NCPA says.

The community pharmacists say they oppose giving Part D plans the “unilateral authority to suspend payment” because doing so could limit patient access to needed medications. NCPA says CMS’ guidance from 2011 that says plans can withhold payment on claims they suspect to be fraudulent already provides plans the necessary tools for blocking fraudulent claims.

NCPA also says that e-prescribing should not be required, as suggested by the 21st Century Cures draft.

“Until systems are widely in place to implement this provision, NCPA opposes mandated use, as this will place undue burdens on physicians, pharmacies, and create serious access concerns for patients,” NCPA says.

CMS’ e-prescribing incentives ended in 2013 and 2014 was the last year those participating in the eRx Incentive Program faced cuts. CMS notes in its website that electronic prescribing is still part of the meaningful use of electronic health records program. – Michelle M. Stein (

See the original article on the Inside Health Policy website.