U.S. House Passes Legislation to Address Prescription Drug Abuse Epidemic

On July 29, the House of Representatives approved by voice vote H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, sponsored by Representatives Tom Marino (R-PA), Marsha Blackburn (R-TN), Peter Welch (D-VT), and Judy Chu (D-CA).

H.R. 4709 aims to help prevent prescription drug abuse by establishing clear and consistent enforcement standards, and ensuring patients have access to needed medications by promoting collaboration between government agencies, patients, and industry stakeholders. This collaboration would allow stakeholders to consider abuse and access issues at the same time. Specifically, the bill will allow companies registered with the Drug Enforcement Administration (DEA) to submit corrective action plans to address DEA concerns, and clarify key terminology in the Controlled Substances Act to better delineate registrant responsibilities under the law.

The bill moved to the Senate and is pending before moving to the Senate Health, Education, Labor, and Pensions Committee. 

California Considering Bill to Allow Patients to Opt Out of Mandatory Mail-Order Filling

The California legislature is considering a bill, AB 2418, to allow patients to opt out of insurance requirements to refill certain prescriptions through mail order, rather than retail, pharmacies. For certain high-cost drugs, the bill would allow insurance carriers to require mail-order filling with no opt out provisions. According to the California Health Benefits Review Program at the University of California, 24 states currently prohibit or restrict mandatory mail-order requirements. AB2418 would also ensure enrollees may receive a partial prescription refill, at a prorated cost, in order to synchronize the individual’s prescriptions. Lastly, the bill would permit early refills of covered ophthalmic products at 70 percent of predicted days of use. 

The bill was introduced by Assemblywoman Susan Bonilla (D-Concord) and is supported by the California Pharmacists Association and the California Healthcare Institute. The California Assembly has passed AB2418, and the bill is being considered in committee in the Senate. 

Push for Pharmacist Provider Status

There has been an uptick in efforts to grant pharmacists provider status under the Medicare program. The National Association of Chain Drug Stores (NACDS) is advocating such an approach as a means to further an effort by the Senate Finance Committee to improve chronic care treatment for Medicare beneficiaries. Senate Finance Committee Chairman Ron Wyden (R-OR) has had a longstanding interest in improving treatment for chronic diseases, noting that 93 percent of Medicare spending is related to care for chronic diseases. The American Pharmacists Association (APhA) observes that the predicted provider shortage makes it the ideal time for pharmacists to be part of efforts to ensure patients have access to quality health care. 

NACDS has joined with APhA and other pharmacist groups to form The Patient Access to Pharmacists’ Care Coalition. The Coalition’s mission is to enact federal policy to “enable patient access to, and payment for, Medicare Part B services by state-licensed pharmacists in medically underserved communities.” As reported in an earlier newsletter, Representatives Brett Guthrie (R-KY), G.K. Butterfield (D-NC), and Todd Young (R-IN) have introduced H.R. 4190, legislation to give pharmacists provider status in medically underserved areas. The legislation currently has 94 bipartisan cosponsors.  While it is not anticipated that this legislation will become law in the current Congress, the push for provider status is building momentum. 

Public Support for Opening Preferred Pharmacy Networks

According to a recent poll sponsored by the National Community Pharmacists Association, 76 percent of likely voters would support opening preferred pharmacy networks in medically underserved areas. This survey demonstrates the public support for the Ensuring Seniors Access to Local Pharmacies Act, or H.R. 4577. This legislation, sponsored by Representatives Morgan Griffith (R-VA) and Peter Welch (D-VT), currently has 59 bipartisan cosponsors. 

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, counters with a July 22 Moran Company study, which concludes that the Ensuring Seniors Access to Local Pharmacies Act would increase Part D costs by $21 billion over 10 years, because prescription drug plans would need to include all pharmacies willing to accept the terms and conditions of preferred network contracts.Plans would therefore not be able to use the threat of exclusion to drive better deals from pharmacies. According to PCMA, H.R. 4577 would cover as many as 95 percent of Part D enrollees, driving up the cost of such a policy shift. There is not yet an official Congressional Budget Office score for the legislation. 

Earlier in 2014, the Centers for Medicare and Medicaid Services (CMS) included a proposal to open up all preferred pharmacy networks in a proposed Part D rule, but CMS later discarded the proposal and announced it would further analyze the proposed policy and review divergent stakeholder comments on the issue. 

Pharmacy Compounders Versus PBMs and Insurers

Pharmacy compounders have partnered with patient advocates and providers to form the Patients and Physicians for Rx Access, a coalition of more than 110 entities, to counter a growing trend by pharmaceutical benefit managers (PBMs) and insurers to limit coverage of compounded drugs. PBM Express Scripts will soon fully implement a policy to block coverage of more than 1,000 bulk ingredients “whose prices have been inflated but that provide no additional clinical benefit.” The policy will go into effect Sept. 15, although some Express Scripts clients have already indicated whether they wish to opt out or enroll in the policy at an earlier effective date. Express Scripts contends that it is reacting to the increasing costs of compounded drugs and cites an increase from $28 million on compounded drugs in the first quarter of 2012 to $171 million per quarter only two years later. According to the International Academy of Compounding Pharmacists, Catamaran, Optum, UnitedHealthCare, and some Blue Cross Blue Shield plans have adopted similar policies. 

In a more targeted effort to counter coverage restrictions, the United Compounding Network (UCN) was launched and will be comprised of the top one percent of compounding pharmacies or those meeting “the highest bar for quality and best practices” to negotiate reimbursement levels and provide specialized services such as standardized claims billing. UCN will be limited to compounders who meet specific accreditation requirements as well as the UCN’s code of ethics. Physician-owned pharmacies and pharmacies that compound in bulk without individual patient prescriptions will be excluded from participation. The UCN has not yet disclosed its charter members but a spokesperson expects the initial group to be comprised of between 10-20 compounding pharmacies.