Washington Healthcare Update - July 20, 2015

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer's, Dementia, Falls Prevention... HHS OIG Report Finds Fraud Prevention System (FPS) Saved $453.9 Million in 2014

1. Congress

   House

   Federal "Right to Try" Bill Introduced in the House

   On July 9, Reps. Matt Salmon (R-AZ), Paul Gosar (R-AZ) and Marlin Stutzman (R-IN) introduced the Right to Try Act of 2015 (H.R.3012), to provide patients access to investigational drugs that have passed the Food and Drug Administration's (FDA) basic safety testing, but have not yet been fully approved. The bill parallels efforts in dozens of states, but goes even further by preventing the FDA from denying access for a terminally ill patient seeking an experimental therapy. While FDA's Compassionate Use program provides access to therapies still under evaluation, the application is seen by many patients and physicians as cumbersome and time consuming when a terminally ill patient often is diagnosed with months to live. Existing laws in some states reduce the often two- to four-month waiting period under the FDA's Compassionate Use down to two to four weeks, and eventually two to four days. During fiscal year 2015, the FDA approved 99.5 percent of the approximately 1,900 exception requests it received. The 21st Century Cures bill, which has passed the House, provides a different route by focusing efforts to improve FDA's existing expanded access program. The Cures provisions, authored by Reps. Michael McCaul (R-TX) and Michael Burgess (R-TX), would require drug companies to increase their transparency when making expanded access decisions.

   House Energy and Commerce Hearing Highlights Fraud and Lack of Oversight in the Medicare Part D Program

   On July 14, the House Energy and Commerce's Subcommittee on Oversight and Investigation held a hearing focused on Medicare Part D program integrity. This hearing was a result of the largest Medicare fraud takedown in history, which occurred last month when the Justice Department charged 243 individuals for participating in fraud schemes involving $172 billion in false Medicare billings. Also in June, the Department of Health and Human Services Inspector General (OIG) also issued a report highlighting fraud within the program, linking some of the fraud to the opioid abuse crisis. The Centers for Disease Control and Prevention issued a report about the growing use and abuse of prescribed painkillers as well. Several members noted that the Centers for Medicare and Medicaid (CMS) has failed to implement the nine recommendations from the OIG and has been too lenient in its oversight of the program. The members pressed Dr. Agrawal to give them a timeline for completion. Dr. Agrawal explained the technical challenges related to oversight, including that CMS cannot interfere with legitimate access to Part D services for beneficiaries. He stated that the CMS is moving as quickly as possible to implement the OIG suggestions and improve oversight of the Part D program. Ms. Maxwell of the OIG testified that CMS has made substantial improvements by closing the loopholes in prescriber screening standards. She noted that the plan sponsors also play a vital role in oversight of the program, but this does not negate the significance of CMS. Dr. Agrawal added that the CMS has been working with plan sponsors to identify Part D enrollees who have potential opioid overuse, but that there are still patients who genuinely need the drugs as part of their treatment.

   Witness List

   Ann Maxwell Assistant Inspector General Evaluation and Inspections Office of Inspector General U.S. Department of Health and Human Services

   Shantanu Agrawal, M.D. Deputy Administrator and Director Center for Program Integrity Centers for Medicare and Medicaid Services U.S. Department of Health and Human Services

   For more information and to view the hearing, please visit energycommerce.house.gov.

   GOP House Members Introduce Bill to Allow Provider Utilization of ICD-9 or ICD-10 Codes for Six-Month Transition Period

   Republican Reps. Marsha Blackburn (TN) and Tom Price (GA) have introduced H.R. 3018, the Coding Flexibility in Healthcare Act, which would allow providers to use either ICD-9 or ICD-10 for a 180-day transition period, as providers make the permanent transition to the new health coding system. It would also allow Health and Human Services (HHS) Secretary Sylvia Burwell to extend the glide path for an additional six months if she determines that providers need more time, and requires HHS submit to Congress a report assessing the impact of such ICD-10 code sets on health care providers no later than 90 days after the final implementation date. "With industry surveys indicating that critical provider partners are behind schedule in deploying billing and electronic health record software, it is clear that some physicians will have no way to submit ICD-10 codes for payment," Rep. Blackburn said in a press release. "For this reason, it is critical to establish a transition period which allows the healthcare industry to ease into compliance instead of 'flipping a switch' on Oct. 1st. Our legislation will provide stability to providers during this difficult transition period by establishing a period of 180 days where providers would be permitted to code in either ICD-9 or ICD-10." ICD-10 is a coding system that doctors and hospitals must use starting Oct. 1, 2015. It requires new software and all that entails for implementation. While larger doctor groups and hospitals are mostly ready, smaller and rural doctor practices need additional time for software vendors to have them up and running.

   Upcoming: House Energy and Commerce Oversight Subcommittee to Hold Hearing on ACA Exchanges

   The House Energy and Commerce Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), has scheduled a hearing for Friday, July 24, entitled "An Overdue Checkup: Examining the ACA's State Insurance Marketplaces." Subcommittee members will hear testimony from several states about their experiences implementing the Affordable Care Act (ACA). The hearing will be held at 9:15 a.m. in Room 2123 of the Rayburn House Office Building.

   The Majority Memorandum, a witness list and witness testimony will be available at energycommerce.gov as they are posted. A press release announcing the hearing can be found here.

   Senate

   Senate Reauthorizes Older Americans Act; Bill Heads to the House

   In a voice vote July 16, the Senate, without amendment, unanimously reauthorized the Older Americans Act, S. 192, a bill that funds programs such as Meals on Wheels, home care support and senior centers through 2018. Noteworthy changes to previous reauthorizations of the bill include the creation of a federal grant program for states to enhance elder abuse data collection; updates to the definitions of "adult protective services," "abuse," "exploitation and financial exploitation" and "elder justice"; and implementation of best practices in long-term care facility responses to elder abuse and neglect, including strengthening ombudsman programs that protect residents of nursing home and other long-term care facilities. The bill, which is sponsored by HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), Sen. Richard Burr (R-NC) and Sen. Bernie Sanders (I-VT), streamlines federal-level administration of programs, promotes effective use of transportation services and improves coordination between programs at the federal, state and local levels. The reauthorization also adjusts the formula that allots state grants to account for geographic changes in the older population.

   The Older Americans Act has been due for reauthorization since 2011 and has until this year been funded through continuing resolutions. The bill now moves for approval in the House of Representatives, where Reps. Bobby Scott (D-VA) and Suzanne Bonamici (D-OR) are sponsoring the House reauthorization bill.

   Bill Funding FDA Passes Out of Senate Appropriations Committee

   The Senate Committee on Appropriations approved the FY2016 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations bill on July 16 in a bipartisan 28-2 vote. The bill includes $148.3 billion for agricultural and rural development, food safety, public health and nutrition programs, and provides for FDA an additional $40 million over the previous fiscal year. The bill provides more than $2.6 billion in discretionary funding for the FDA, $40 million over the FY 2015 enacted level, and a $45 million increase was provided for food safety activities authorized in the Food Safety Modernization Act (FSMA), which is more than $60 million short of the President's Budget. The appropriators also provide a $3 million increase for antibiotic resistance research and programming, and an increase of $2 million for FDA's efforts under the Precision Medicine Initiative, which also fall short of the president's budget request. Overall, total FDA funding, including user fee revenues, is $4.6 billion, which is $116 million above FY 2015. Within this total, a $45 million increase is provided for food safety activities and a $5 million increase is included for medical product safety activities. Democrats worry the bill does not provide the requested funds for implementing the FDA Safety and Innovation Act, a bill that provides the oversight of drug compounding facilities and evaluates more sunscreens. A fact sheet containing a summary of the Senate's FY 2016 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations bill can be found here.

   Senate Companion for 21st Century Cures Bill Not Expected for Months

   The House's passage of the 21st Century Cures bill on July 10 has not jumpstarted the drafting of the Senate companion in...