PCORI Announces Two Funding Opportunities

This morning the Patient-Centered Outcomes Research Institute (PCORI) issued two funding announcements for a total of $68 million to support comparative effectiveness research.  Specifically, PCORI will fund $56 million to support up to eight Clinical Data Research Networks (CDRNs) that will develop the capacity to conduct randomized clinical studies and $12 million to support up to 18 Patient-Powered Research Networks (PPRNs) and “their progression toward a reusable, scalable, and sustainable research network.”  Letters of Intent are due June 19th and applications are due September 27th.

A press release about the announcement is available here.

Health Care Jurisdiction in the Senate

One of the more confusing aspects of following Congress can be determining which Committee has jurisdiction over the matters you are interested in.  This is particularly true when it comes to health care, as a number of committees have jurisdiction over different parts of the nation’s health care system.  This post is a short primer on how these matters are broken up among Senate Committees.  A primer on House Committees will be up in the coming days.

Under Senate Rule XVII, each measure is typically referred to only a single committee based on “the subject matter which predominates” in the legislation.  Provided below is information on each of the relevant Senate Committees, its leadership, and the matters it reviews.  Please note that this list is not intended to be exhaustive, as numerous other Committees – such as those with oversight of Department of Defense, Veterans’ Affairs or the State Department – have oversight of specific health programs within those agencies.  Rather, we are focusing on the matters most often affecting those within the health sphere: the funding and oversight of the Department of Health and Human Services. Continue reading

HHS Releases HIPAA and HITECH ACT Mega-Rule

Today, the Department of Health and Human Services released an omnibus rule making changes to the Health Insurance Portability and Accountability Act (“HIPAA”) regulations related to privacy and security.  The new final rule expands requirements beyond covered entities (health care providers, health plans, and entities that process health insurance claims) to business associates of covered entities in order to provide additional protections.  These changes represent some of the most significant changes to the rule since it was first implemented fifteen years ago.

This mega rule also seeks to finalize privacy and security regulations related to the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) as well as implement certain provisions of the Genetic Information Nondiscrimination Act of 2008 (“GINA”).

The final rule is effective on March 26, 2013; covered entities and business associates must comply with the rules by September 23, 2013.  Drinker Biddle & Reath is in the process of reviewing the 563-page final rule and will be releasing alerts and updates over the next few days. A copy of the rule can be found here.

The Democratic Platform – What it Means for Healthcare

As the Democrats prepare to open their National Convention this evening, the party has released its official 2012 party platform.  As with the Republican platform issued last week, it does not contain many surprises, but it is important to note the priorities each party has set heading into the election season.  Here’s a quick look at the major healthcare issues discussed.

Defense of the Affordable Care Act:  The platform notes that “over the determined opposition of Republicans,” Democrats “enacted landmark reforms that are already helping millions of Americans.”  Specifically highlighted are the ACA’s provisions allowing children to stay on their parents’ health insurance, requiring insurers to cover children with pre-existing conditions, prohibitions on caps for coverage, and cost-free preventative services.  The document warns that “Mitt Romney and the Republican Party would repeal health reform,” but promises that “we will continue to stand up to Republicans working to take away the benefits and protections that are already helping millions of Americans every day.”

Medicaid and Medicare:  Democrats promise to strengthen and expand Medicaid access for low-income and disabled Americans while explicitly opposing “efforts to block grant the program, slash its funding, and leave millions more without health insurance.

Similarly, the Democrats call Medicare a “sacred compact with our seniors” and vow to “adamantly oppose any efforts to privatize or voucherize Medicare.”

The platform does not lay out potential changes to either program other than touting those included in the ACA to “strengthen” each program.

Other Items of Note:  The platform also calls for investments in several sectors, including mental health services, HIV/AIDS funding, and programs to combat childhood obesity.  Democrats will also seek to provide additional sick leave for employees under the proposed Healthy Families Act and an expansion of the Family and Medical Leave Act.

Two Approaches to Health Care Spending in NEJM

The debate on health care spending and cost cutting ideas continues in the New England Journal of Medicine (NEJM).  Earlier this month, NEJM published two articles, which discuss two different approaches to addressing the rising cost of health care in America.

The first article, “A Systematic Approach to Containing Health Care Spending,” was authored by 23 health policy experts, including Zeke Emanuel, Donald Berwick, Tom Daschle and Peter Orzag.  The authors put forward several ideas about how they would reduce health care costs over the coming years including, alternatives to fee-for-service Medicare, an expanded use of competitive bidding within the Medicare system, price transparency for health care costs, a greater emphasis on using non-physician providers, and evidence-based clinical practice guidelines reduce the cost of defensive medicine.

The second article, written by Joseph Antos, Mark Pauly, and Gail Wilensky, is called, “Bending the Cost Curve through Market-Based Incentives.” In this article, the authors suggest that insurance subsidies that would enable beneficiaries to purchase their own insurance (one option of which would be traditional Medicare) is the best path forward—allowing for a competitive marketplace with fewer regulatory controls.

So, what do the two sides have in common?  Both articles place blame on the fee-for-service model of Medicare payment suggesting that it leads to waste in the system as providers are encouraged to use more services.  Likewise, both groups of authors suggest some type of bundling for Medicare services and both seem to favor a wider use of competitive bidding across Medicare services.

DBR Hosts Webinar on Value Based Purchasing

Today DBR’s own Julie Scott Allen and Matt Amodeo hosted a  Bloomberg BNA webinar entitled “Beyond ACOs: Value-Based Purchasing and Other Accountable Care Delivery Options.”  This 90-minute webinar featured discussions on:

  • The policy, politics, and economics of value-based purchasing – with a particular emphasis on the payment reform models called for under the Affordable Care Act (ACA);
  • The current political climate including deficit reduction efforts, looming SGR cuts, sequestration, and FY2013 federal budget activities;
  • Supreme Court’s decision on the constitutionality of the ACA and how it will likely affect value-based payment delivery models supported through the ACA;
  • Overview of the current Medicare delivery system reform programs and initiatives including the value-based purchasing program; hospital readmission reduction program; hospital-acquired condition penalty; bundled payment demonstration; bundled payment for care improvement initiative (BPCII); accountable care organizations (ACOs); and
  • Commercial market value-based purchasing models being tested across the country.

Previewing the Supreme Court’s Affordable Care Act Arguments

On March 26, the Supreme Court will start three days of oral argument on the health reform law (Affordable Care Act).  Rather than review all aspects of the health reform law, the Court’s review will focus on four specific questions, all of which have big implications for the millions of issues covered by the law.  The following is a brief review of the four key questions. Continue reading

Registry of Patient Registries Notice

Last week, the Agency for Healthcare Research and Quality released a notice announcing plans to create a “registry of patient registries” (RoPR) – or a centralized clearinghouse – that will be available to the public. The notice states “the purpose of the RoPR is to create a readily available public resource in the model of ClinicalTrials.gov to share information on existing patient registries to promote collaboration, reduce redundancy, and improve transparency in registry research.” The notice acknowledges the increase in patient registry research and states that the agency has learned from stake holders that the existing ClinicalTrials.gov site currently does not meet the patient registry research community’s needs. The agency is providing a 60-day comment period and the full notice can be found here. Comments are to be submitted to Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at: doris.lefkowitz@AHRQ.hhs.gov.

State of the Union and Health Reform

For some of us in Washington, watching President Obama’s State of the Union Address last night was about waiting to see what he would say about the health care law.  Given the law’s mixed reviews among Americans, it wasn’t too much of a surprise that the entire speech went by with almost no mention of health care.  Obama did make clear he would not go back to a time when insurance companies could cancel an individual’s coverage, but a larger defense of the controversial law was missing.

While this means that health care might not play a huge role in the Obama campaign’s platform for 2012, health reform is by no means a thing of the past.  The coming year promises to be an exciting one for the new law as the Supreme Court examines the constitutionality of the law and implementation of State Health Exchanges gets under way.  Undoubtedly, the law will continue to face a beating from the Republican presidential candidates as they make promises to repeal the law immediately upon taking office.

In the coming months, the talk in Washington will be about what happens if the law is repealed.  How much of the law will actually be thrown out  by the Supreme Court and  if the entire law is thrown out then what happens to the parts that have already been implemented.  It is hard to know the answers to these questions this early in the game, but it will an interesting year trying to figure it all out.