IN THE NEWS:

Rx trends 2015: Managing the newly insured

If its goal of expanding health coverage to more Americans is fully realized, the Affordable Care Act could end up pulling as many as 30 million more people into the ranks of the newly insured. That means rising prescription counts and more patients at pharmacy counters and in drug store aisles, but it also poses challenges in managing and educating patients about their benefits. January 29, 2015. Read more

Many Americans must work more due to gap in the ACA

For some Americans, the Affordable Care Act doesn’t mean access to healthcare, simply because they fall into an income gap that prevents enrollment. February 2, 2015. Read more

The coming wave of biosimilars: What’s it going to take to win?

Marketing a biosimilar brings a unique set of challenges, the most fundamental of which feels like a contradiction: On the one hand, success depends on proving similarity; on the other you’ve got to differentiate to win. January 15, 2015. 

For most hospitals, penalties wipe out quality bonuses

Medicare will award quality bonuses to the majority of hospitals it assesses, but in most cases, other penalties will offset those gains, Kaiser Health News reports. January 22, 2015. Read more

BCBS: Huge variation in medical costs shows need for price transparency

The costs for knee and hip replacements—the two fastest-growing medical treatments in the country—vary by more than $20,000 from one place to another, demonstrating that insurers should develop price transparency tools so consumers can shop for the best prices, according to a new report from the Blue Cross Blue Shield Association. January 22, 2015. Read more

LTC pharmacy group wants fair dispensing fees

The newly-formed Senior Care Pharmacy Coalition (SCPC), a group of independent long-term care pharmacies, plans to work with U.S. Congressional leaders to reintroduce the Medicare Efficient Drug Dispensing Act. January 23, 2015. Read more

340B program demands compliance; are you ready?

Given the complex requirements of the federal 340B Drug Pricing Program, chief pharmacy officers and other stakeholders need to dedicate resources to manage its complex components, according to Christopher A. Hatwig, the president of Apexus, the prime vendor for 340B participants. January, 2015. Read more

DIRECT FROM WASHINGTON

2015 is proving to be an active year from a healthcare legislative perspective

Affordable Care Act (ACA) enrollment and congressional outlook

On Feb. 4, Health and Human Services Secretary Sylvia Burwell testified before the Senate Finance Committee and reported that nearly 7.5 million consumers selected a plan or were automatically re-enrolled through the HealthCare.gov platform, and another 2.4 million people have enrolled on the state exchanges, for a total of almost 10 million Americans enrolled since Nov. 15, 2014. During the hearing, several senators pressed Secretary Burwell on the administration’s planning should it lose the King v. Burwell case scheduled to be argued before the Supreme Court. Secretary Burwell responded that she is focused “on completing and implementing the law” and indicated that the Administration believes the Supreme Court will uphold the ACA’s tax credits. The King v. Burwell case centers on the question of whether the ACA allows for federal subsidies to purchase insurance on both federal and state-run health exchanges. If the Supreme Court rules that the law did not authorize subsidies for insurance purchased on federal exchanges, five million people who bought through the federal exchanges may lose their tax credits and likely their health insurance coverage. 

On Feb.3, by a vote of 239-186, the House approved H.R. 596, a bill to repeal the ACA. The bill calls for House committees to develop health law replacement alternatives and is a posturing step toward possible action on any health care overhaul adjustments. Republican majorities are working on an ACA alternative, and on Feb. 5, Senate Finance Chairman Orrin Hatch (R-UT), Senate Finance Committee member Richard Burr (R-NC), together with House Energy and Commerce Chairman Fred Upton (R-MI) released their proposal. It would remove the individual and employer mandates, as well as some of the coverage rules, in the ACA. Their replacement would offer tax credits instead of subsidies to purchase insurance and would retain the ability of  young adults to stay on a parent’s plan until age 26, and aim to ensure that those with pre-existing conditions not be denied coverage. It is unclear whether Republican majorities in the House and Senate will pursue a budget process known as reconciliation, which requires a simple majority of 51 votes instead of three-fifths (or 60), as a vehicle to repeal or repeal and replace portions of the ACA. The President has vowed to veto any repeal legislation. 

Legislation reintroduced to expand pharmacists’ role

Legislation to recognize pharmacists as providers in medically underserved areas has been reintroduced in the 114th Congress. On Jan. 28, Congressmen Brett Guthrie (R-KY), G.K. Butterfield (D-NC), Todd Young (R-IN), and Ron Kind (D-WI) have reintroduced “The Pharmacy and Medically Underserved Areas Enhancement Act,” or H.R. 592. Senate companion legislation, S. 314, was introduced on Jan.29 by Senators Charles Grassley (R-IA), Sherrod Brown (D-OH), Mark Kirk (R-IL), and Bob Casey (D-PA). 

As with the legislation introduced last Congress, H.R. 592/S. 314 would recognize pharmacists as providers in designated medically underserved areas and would allow them to be paid under Part B for certain services, including immunizations, diabetes screenings, cardiovascular screenings, behavioral therapy, and cholesterol tests. House bill sponsor Congressman Guthrie noted: “Whether it’s to inquire about medication, potential side effects, or discussing other ailments and complications, many patients depend on their local pharmacists.” According to Senator Grassley, “A lot of people in rural Iowa have easier access to a pharmacist than a doctor.” He added “Where that pharmacist is licensed to provide a service that could have been provided by a doctor, Medicare ought to pay the pharmacist for it.”

Governors urge larger role for pharmacists

In a paper titled “The Expanding Role of Pharmacists in a Transformed Health Care System” released Jan.13, the National Governors Association (NGA) urges states to expand the role of pharmacists in delivering care, including amending state laws and regulations to recognize pharmacists as providers. The NGA recommends integrating pharmacists into health care provider teams, such as chronic-care delivery teams, to ensure that they play a key role in medication therapy management. The paper reports that California, Montana, New Mexico, and North Carolina have established an advanced practice pharmacy designation to expand the scope of practice for pharmacists, allowing them to provide care directly to patients. In addition, Minnesota, Mississippi, and Ohio include team-based care models that incorporate medication therapy management pharmacy services. The NGA recognizes that the role of the pharmacist is evolving and notes that “administrative barriers and lack of flexibility limit pharmacists from practicing to the top of their professional training and education.”

Legislation to combat prescription drug abuse moving through Congress

Already in this Congress, the “Ensuring Patient Access and Effective Drug Enforcement Act of 2015,” or H.R. 471, was reintroduced, was the subject of a Jan. 27 House Energy and Commerce Subcommittee on Health hearing, and was approved by the Health Subcommittee Feb. 4. 

Similar to the legislation of last Congress, this bill will create a more transparent process to address the diversion of controlled substances and aims to foster a more collaborative working relationship between industry stakeholders and regulators, in order to fight abuse and diversion of prescription drugs. The bill provides for DEA-registered companies to submit corrective action programs in response to any agency concerns, so that abuse and diversion concerns are addressed in a manner that minimizes any supply chain disruptions, which might impact patient access to necessary medications.

The Senate bill has not yet been introduced. 

Generic drug payment legislation introduced

Congressmen Doug Collins (R-GA) and Dave Loebsack (D-IA) introduced “The MAC Transparency Act,” or H.R. 244, Jan. 12. The legislation would require pharmacy benefit managers (PBMs) to update their “maximum allowable cost” or “MAC” benchmarks for generic drugs every seven days. Timely pricing updates will ensure that pharmacists are not caught in the middle when PBMs wait weeks or months to update the reimbursement benchmarks while drug prices may surge in a very short time frame. H.R. 244 would ensure that these MAC benchmarks more accurately reflect market costs and enable pharmacists to know the source by which the PBM sets reimbursement. 

Prescription drug importation bill reintroduced

Senators John McCain (R-AZ) and Amy Klobuchar (D-MN) reintroduced The Safe and Affordable Drugs from Canada Act of 2014, or S. 122. The legislation would require the Secretary of Health and Human Services to promulgate regulations within 180 days of enactment, to permit individuals to import a prescription drug for personal use from approved pharmacies in Canada into the United States. Senator Klobuchar commented that the legislation was important both to assist individuals with finding less expensive drugs than are available in the United States, as well as to pressure pharmaceutical companies to lower their prices. 

Pharmacists ask for oversight hearing on Aetna’s Part D plan

The National Community Pharmacists Association (NCPA) is calling for congressional hearings to investigate how incorrect information about participating pharmacies was posted on Medicare Plan Finder. During the 2014 Medicare open enrollment period for 2015 year plans, Aetna provided inaccurate information regarding which pharmacies were in-network, and that information was circulated to beneficiaries. The information was not corrected until after the annual open enrollment period had ended. According to the NCPA, Medicare beneficiaries enrolled in the Aetna Part D plans who found in January that their pharmacy was not in network “may feel like the victims of a bait-and-switch.” Approximately 400,000 beneficiaries are affected. The Centers for Medicare and Medicaid Services (CMS) has worked with Aetna to expand its pharmacy networks on a temporary basis, through at least Feb. 28, to ensure beneficiaries are not turned away at the pharmacy they believed to be in-network. However, after Feb. 28, beneficiaries will need to work from a more restricted list of pharmacies or switch to a new plan. CMS has sent Aetna a warning letter asking it to come up with a corrective plan and has indicated that it reserves the right to impose additional enforcement actions. The NCPA has asked CMS, going forward, to require all insurers to post accurate information on their Plan Finder website at least 15 days prior to the start of Medicare open enrollment as well as inform local pharmacists regarding whether they are in or out of a particular company’s network. 

FDA compounding meeting

On Feb. 23-24, the FDA’s Pharmacy Compounding Advisory Committee will hold its first meeting to evaluate proposed criteria for developing the list of bulk substances that may be used to compound drug products as well as to discuss six substances nominated for inclusion on the list. The six substances nominated for inclusion are: cantharidin, diphenylcyclopropenone, piracetam, silver protein mild, squaric acid dibutyl ester and thymol iodide. 

NASPER reauthorization hearing

On Jan. 27, the House Energy and Commerce Subcommittee on Health held a hearing on public health legislation which focused on draft legislation to reauthorize the National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act. This legislation is expected to be introduced in the near future by Congressman Ed Whitfield (R-KY) in the House and by Senator Jeanne Shaheen (D-NH) in the Senate.