Oral Parity Update 2013: Federal Edition

by Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

The good news: oral parity legislation has already passed in almost half of the states. The bad news: the laws vary from state to state, and 27 states still have no law at all.

The solution: HR 1801, the bipartisan Cancer Drug Coverage Parity Act, introduced recently by U.S. Representatives Brian Higgins (D-NY) and Peter King (R-NY).

Currently, most IV-infused chemotherapies are covered under the medical benefit component of a health insurance plan, while orally administered drugs fall under the prescription drug benefit, which often carries a very high patient-cost-sharing component. The Higgins-King bill would eliminate the cost-sharing disparity by requiring insurance companies to cover orally administered prescription drugs at a cost no less favorable than their infused counterparts. Legislation such as this is particularly important as the oncology drug development pipeline increasingly consists of oral anti-cancer medications. Some estimates are that over the next decade the oncology pipeline will include up to 30% oral anti-cancer drugs.

So why is ACCC pushing for oral parity legislation at both the federal and state level? The answer is simple: we want to achieve parity across every state as quickly as possible. While federal legislation is preferable because it would negate the need for individual state laws and would cover every patient equally from coast to coast, the current political climate on Capitol Hill is such that legislation regulating insurance companies can be unpopular and difficult to move through both houses of Congress.  In fact, Representative Higgins introduced this same bill in the last Congress, but the legislation never made it through committee or to the House floor for a vote. Additionally, companion legislation must be introduced and passed in the Senate before the bill can become law. ACCC continues to work with other organizations to identify a Senate sponsor for a companion bill.

State legislation, on the other hand, generally moves faster due, in part, to the fact that most state legislatures are only in session for a portion of the year. Over the past five years, 23 states plus Washington, DC, have been able to pass their own oral parity bills while Congress has been unable to pass one. For this reason, ACCC will continue to advocate for oral parity with a two-pronged approach until every patient in the U.S. has access to the most appropriate anti-cancer medication at the most appropriate time. Please visit the ACCC Legislative Action Center for more ways to get involved in this issue and others impacting cancer care. ACCC will keep members current on HR 1801, as well as progress on state-level legislation.

Two New Bills Support Quality Oncology Care

by Matt Farber, MA, director, Provider Economics and Public Policy, ACCC

In the past week, two bills important to oncology care have been introduced in the United States Congress. The first, introduced  by Reps. Israel (D-NY) and Tiberi (R-OH), is HR 1661.  This bill would provide reimbursement for a one-hour chemotherapy teaching session by nurses in the physician-office setting.  This legislation has been introduced in previous Congresses, with the primary support of the Oncology Nursing Society (ONS).  ACCC has supported this legislation in the past and will be supporting it again this year.

The second bill is the “Patient Centered Quality of Life Act” (HR 1666).  This bill would support the growing demand for palliative care, which is specialized medical care that focuses on care coordination and relief from pain, stress, and other symptoms of treatment for a life-threatening disease such as cancer. The bipartisan bill, co-sponsored by Reps. Cleaver (D-MO) and Bachus (R-AL), would facilitate and expand federal research into palliative care; support training for nurses, nurse practitioners, and other allied health professionals to effectively practice palliative care; and convene health professionals, patients, public and private payers, and state and federal health officials for a national summit to develop tools and model best practices for providing palliative care.

Both pieces of legislation support oncology care and would improve the overall quality of care that patients receive.  These bills address issues that have been identified as key to ensuring quality care as part of ACCC’s Grassroots Advocacy Campaign. ACCC is working with advocacy organizations, such as ONS, the American Cancer Society Cancer Action Network (ACS CAN), and other organizations to increase the support for these bills.  We encourage you to write and call your elected officials and ask them to support these important measures. Visit ACCC’s Legislative Action Center.

Turn Up the Volume on Sequester’s Impact on Cancer Centers

By Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

Yesterday, Congresswoman Renee Ellmers (R-NC) introduced a bill that would eliminate the sequester on chemotherapy drugs that must be administered in the physician office setting (HR 1416).  It would also direct Medicare to repay providers for any reduced payment since April 1.

As you know, as part of the sequester, on April 1 the Centers for Medicare and Medicaid Services (CMS) reduced Medicare reimbursement for all drugs and services by 2%.  As providers begin feeling the impact from claims submitted April 1 or later, some are being forced to turn patients away.  Cancer care providers are impacted disproportionally because of the way care is reimbursed.  In addition to services, the 2% sequester cuts are applied to drugs, which have fixed costs. Given the high cost of cancer care therapies, the sequester is putting many cancer care providers underwater.

The cancer care community is working diligently to remove the sequester from all drugs, or cancer drugs, at a minimum.  Congress recognizes that such cuts restrict providers’ ability to care for cancer patients.  Therefore, ACCC supports HR 1416, the “Cancer Patient Protection Act” that would eliminate chemotherapies from the 2% sequester on Medicare.

We must raise the volume on how these cuts are impacting care! ACCC is joining with various state oncology societies and other organizations to send a letter to members of Congress. Please take a few minutes to send your own letter using ACCC’s template.  We are also signing on to a petition that will go to President Obama urging him to exempt cancer drugs from the sequester.  We invite you to sign the petition as well.  ACCC will continue to keep members informed of developments with the sequester.

The Ripple Effect: Sequester’s Impact on Cancer Care

by Matt Farber, Director of Provider Economics & Public Policy, ACCC

According to a front page article in today’s Washington Post, the 2% cut to Medicare reimbursement is already having an effect on oncology offices across the country.  The article states that some practices have made the difficult decision to cut back on the number of Medicare patients they see, and one hospital has stated that they are preparing for an increase in Medicare patients.

The 2% cut to Medicare reimbursement affects all services billed to Medicare, including E&M codes, chemotherapy administration, hydration, and drugs and their overhead costs. Because many oncology drugs are reimbursed under Medicare Part B, the reduction in drug reimbursement from ASP+6% to ASP+4.3% is having a deleterious effect.

Prior to the sequester, providers were reimbursed average sales price (ASP)+6% for drugs covered under Medicare Part B. The “plus” percentage helps cover pharmacy overhead costs such as mixing, storage, and disposal. With the drop in reimbursement to ASP+4.3%, physicians are not being reimbursed enough to cover their costs related to the purchasing and delivering these drugs.

The best way to push back against these cuts is to raise the volume with lawmakers about the effect these cuts are having on cancer patients and their providers. ACCC would like to know if you have made any changes to your practice due to the sequestration. If you have, please contact Matt Farber at mfarber@accc-cancer.org.

Let’s work together to try and solve this issue.

Congress Passes Budget Stopgap – Some Help for NIH, FDA

by Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

Yesterday, Congress passed legislation to keep the federal government funded through September. In a rare act of bipartisanship, Congress avoided the potential government shutdown with a 318-109 vote in the House and a 73-26 vote in the Senate. The measure now awaits President Obama’s signature.

Even though this legislation funds federal agencies through September, the impact of the sequester is still very real. Medicare, the National Institutes of Health (NIH) , the National Cancer Institute (NCI), and the Food and Drug Administration (FDA) are all seeing significant cuts. However, this budget deal does provide supplemental funding to NIH of about $70 million to offset some of the cuts to research and clinical trials and an additional $74 million to the FDA, which may help the agency adhere to its current drug approval timeline—certainly bright spots in the gloomy sequester landscape.

It is important to note, though, that this is a pivotal year for implementation of the Affordable Care Act (ACA), which could lead to problems in an already too-tight budget. More states than previously expected have elected to let the federal government run their health insurance exchanges. This makes budgeting for these costs more difficult than initially predicted, and could lead to underfunding of the exchanges.

Certainly more debate on the federal budget and funding for healthcare reform is to come. As always, ACCC will keep its members updated on new developments.

Capitol Hill Day Kicks Off ACCC Meeting

Neither snow, nor rain… kept ACCC members from walking the halls of Congress for ACCC’s Capitol Hill Day on March 6. Braving the wintery mix dubbed the “snowquester,” an intrepid band of more than 50 ACCC members visited with Senators, Congressmen, and healthcare legislative aides to discuss issues key to ensuring access to quality care such as elimination of the sequester, fixing the SGR formula, ensuring oral parity, resolving drug shortages, and other concerns affecting the delivery of cancer care in their states.

From first timers to Capitol Hill Day veterans, participants reported that the legislators they met with were engaged and eager to learn more about the issues.

“They are looking to us as cancer experts and as a resource, and they know ACCC,” said Brendan Fitzpatrick, MBA, Alamance Regional Medical Center, Alamance Cancer Center, Burlington, North Carolina.

“They were really receptive,” said Fuad Hammoudeh, St. Vincent Hospitals and Health Care Center in Indianapolis, Indiana. He noted that the visits with legislators were an opportunity to educate on multiple issues and respond to questions.

In visits with newly elected legislators ACCC members were able to talk about how issues such as oral parity, lack of codes for chemotherapy teaching, and the oncology medical home affect patients with cancer.

“They are looking for answers,” said ACCC President George Kovach, MD.

“This is just the beginning. There are so many opportunities to get involved.”

ACCC makes it easy for members to become involved in this important advocacy work. Learn more at www.accc-cancer.org/getinvolved.

The Sequester Strikes: What It Means for Cancer Care

by Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

By now, we all know how we got here. The failure of the 2011 Congressional “Super Committee” to compromise on a deficit reduction pulled the trigger on a process called “sequestration,” which requires approximately $85 billion in federal spending cuts to domestic programs over the next  seven months, and more than $1 trillion in budget reduction over the next 10 years.

While the sequester was originally designed as a blunt tool so devastating that no one in Congress would allow it to happen, we now know that the sequester  will go into effect today—at least for the short term.  Everyone in the cancer care community has been bracing for across-the-board funding cuts to go into effect March 1 for at least one month while lawmakers work toward a budget agreement to replace the continuing resolution that expires at the end of March and address the sequester.

Even if the cuts only last one month, there are things ACCC members need to know. Here are the top 3 ways the sequester will impact the provision of cancer care:

1. Medicare Reimbursement will be cut by 2%.  This means you will only receive 98% of what you bill to CMS for your Medicare patients.  The cut is not just on drugs; it includes overhead and anything else billed to Medicare.  This could be devastating for ACCC members with a high proportion of Medicare patients. On March 1, CMS stated that the 2% cuts to Medicare providers is scheduled to begin on April 1, 2013.

2. Funding for Research to groups like the National Institutes of Health (NIH) and the National Cancer Institute (NCI) will be slashed under the sequester.  NIH could see more than an 8% budget reduction, which would mean a loss of $2 billion in funding.  These cuts will have a significant impact on clinical trials, as well as other research projects.

 3. Drug Approvals by the Food and Drug Administration (FDA) could also be slowed as a result of decreased funding.  The oncology drug approval process is generally about 10 months faster than the process for non-oncology drugs.  However, with the FDA facing a reduction in staff or staff furloughs, it will become very difficult for the agency to continue to approve new potentially lifesaving therapies quickly.

These reimbursement and funding cuts are serious and will have a long-lasting effect on your ability to treat patients battling cancer.  Because of this, ACCC has worked with other organizations to place this ad inside the Beltway to urge Congress to avoid cuts to cancer care.

Click image to enlarge.

It is vitally important for you to reach out to your members of Congress to let them know how the sequester will impact you and your ability to treat Medicare patients.

ACCC members will carry this message to the halls of Congress next week as part of the ACCC Capitol Hill Day on March 6, where more than 130 meetings will be held with Representatives and Senators from across the country to raise awareness of the issues facing community oncology, including the sequester.  Visit the ACCC Grassroots Advocacy Campaign page to learn how you can get involved.

Next week’s Capitol Hill Day is part of the ACCC 39th  Annual National Meeting, March 6-8, in Washington, DC, with sessions focused on economics, policy, and the business of delivering quality cancer care. If you can’t make it to DC, join us by following our meeting sessions on Twitter (@ACCCBuzz) by searching for hashtag #ACCCmtg.

Congressional Action on Prompt Pay Discount

By Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

A new bill to eliminate the prompt pay discount has been introduced in the House of Representatives by Congressman Ed Whitfield (R-KY), along with 31 other bi-partisan co-sponsors.  A bill number will be assigned to the “Prompt Pay Bill” next week; stay tuned for an update from ACCC.

As you already know, most manufacturers extend a discount (about 2 percent of the cost of the drug) to distributors who pay promptly for the product (the “prompt pay discount”).  Traditionally, this discount is not passed on to the end purchasers—cancer care providers.  Because these discounts are calculated into the average sales price (ASP) formula, providers end up with an artificially reduced ASP reimbursement.  Excluding prompt pay discounts would align Medicare reimbursement with current Medicaid reimbursement methodology, which excludes prompt pay discounts from the calculation of average manufacturers price (AMP) and ensures fair and accurate reimbursement for physicians and clinics.

ACCC’s Grassroots Advocacy Campaign has identified key issues that may impact oncology care in 2013 and beyond.  Elimination of the prompt pay discount is an issue that is part of ACCC’s effort to create appropriate reimbursement for oncology care.

The 113^th Congress is off to a strong start with respect to policy issues surrounding community cancer care.  With two bills being floated to permanently fix the sustainable growth rate (SGR) formula, and now the introduction of a bill to eliminate the prompt pay discount, this is the time to reach out to your members of Congress.  Let them know that you support the bills that protect your ability to care for patients battling cancer.  It takes just 5 minutes to contact your Congressional office.  Find out who to call and what to say here.

SGR Progress?

by Sydney Abbott, JD, Manager, Provider Economics and Public Policy, ACCC

Could new developments surrounding the sustainable growth rate be a sign that a permanent solution to this long-time reimbursement issue is near?

The Congressional Budget Office (CBO) has lowered the expected 10-year cost to replace the sustainable growth rate (SGR) formula from $245 billion down to $138 billion, a reduction of more than 40 percent. In its annual report on the federal budget and economy issued Feb. 5, CBO attributed the significant decrease in cost to the slow down in healthcare spending in recent years. This is largely due to the decreased use of medical services as a result of the recession, as well as the more efficient and appropriate use of medical procedures and other delivery system changes.

Meanwhile on Capitol Hill, in a bi-partisan effort, Representatives Allyson Schwartz (D-PA) and Joe Heck (R-NV) have reintroduced the Medicare “doc-fix” bill without the war savings offsets seen in the previous bill to attract more support. The Schwartz/Heck bill will eliminate the present fee-for-service system in favor of a system developed and tested by the Centers for Medicare & Medicaid Services (CMS) over the next five years. Physicians opting to remain with the current system would face increasing cuts to reimbursement, unless they are close to retirement.

Additionally, Kevin Brady (R-TX), is expected to introduce an alternative legislation that would allow for the continued use of the fee-for-service system on a modified basis by offering additional reimbursement for providers increasing efficiency. Congressman Brady’s proposal is also designed to encourage physician involvement in the replacement payment mechanism.

While we still await the introduction of Brady’s bill, the fact that both parties agree that the SGR must be fixed is promising. While Congress must still find a way to pay for the repeal, the lowered CBO score makes this task more palatable.  With all the talk around the SGR in Congress, now is the time to reach out to your representatives and encourage them to act on this issue. Let them know why it is important to you and your patients that the SGR be repealed and permanently fixed. Visit ACCC’s Legislative Action Center for tools to help you make your voice heard.

Shedding Light on the Sunshine Act Final Rule

By Sydney Abbott, JD, Manager of Provider Economics and Public Policy, ACCC

The Centers for Medicare & Medicaid Services (CMS) just  released the much-anticipated final rule on the Sunshine Act, which is designed to illuminate the relationship between providers and drug and device manufacturers.  Starting August 1, pharmaceutical companies must begin collecting data on certain payments and transfers of value made by companies to physicians and teaching hospitals.  Providers will have 45 days to review the accuracy of these data. Then, beginning September 30, 2014, the data will be made publicly searchable by CMS.

With the release of this final rule, there are a few things ACCC members should be aware of:

1. Meals, gifts, and other transfers of value will be reported, unless they are under $10 and the aggregate amount is less than $100 for the calendar year.  Buffet meals, snacks, soft drinks, coffee, or other food made generally available at conferences and events where it is difficult to identify who has partaken in the offering is not reportable.

2. Medical research payments will be reported by drug and device companies to CMS, but publication of these data may be delayed.  Publication will be delayed when made in connection with research or in the development of a new drug, device, biological, or in clinical investigations.

3. Payments and other compensation for speaking at a continuing medical education (CME) event do not have to be reported, so long as the event is accredited, the manufacturer does not select the speaker, and the manufacturer does not pay the speaker directly. A pharmaceutical or device company may make a grant to the hospital where a physician works to host a continuing medical education (CME) program, but that grant would be reported and disclosed to the public if it were made to a teaching hospital or to another entity at the request of a teaching hospital.

4. Some healthcare providers have written agreements with pharmaceutical companies to serve on scientific advisory boards. Written agreements providing reasonable compensation and reimbursement in connection with bona fide advisory board services are still permissible, but they will be reported and made public.

While the federal Sunshine Act may change healthcare providers’ interactions with drug and device manufacturers, it is certainly not the first law of its kind. Seven other states (California, Connecticut, Massachusetts, Minnesota, Nevada, Vermont, and West Virginia) and the District of Columbia already have laws on the books that impose marketing restrictions and disclosure requirements on manufacturers’ interactions with providers and institutions. The laws vary in scope, but all place reporting responsibility and restrictions on manufacturers.

ACCC remains on the forefront of this developing issue.  As always, we will keep our members updated on the application of the Sunshine Law.

The final rule can be downloaded here.