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Washington Highlights: November 6, 2009

House Poised for Vote on Health Care Reform

The House of Representatives moved closer to a floor vote on health care reform when Energy and Commerce Committee Chair Emeritus John Dingell (D-Mich.) Nov. 3 filed a manager's amendment to the Affordable Health Care for America Act (H.R. 3962) [see Washington Highlights, Oct. 30]. House leadership had promised members at least 72 hours to review the amendment before floor consideration of the bill would begin. Upon release of the amendment, Majority Leader Steny Hoyer (D-Md.) stated that the House Leadership was "continuing to discuss this legislation with our Members" and expected to "bring it to the floor once we have consensus and in keeping with our 72 hour pledge."

The House Rules Committee was scheduled to meet Nov. 6 to establish guidelines for floor debate on H.R. 3962, further indicating that House leadership hoped to schedule a final vote on H.R. 3962 in the following days.

In anticipation of a floor vote, the AAMC Nov. 2 sent a letter to House leadership and key committee chairs applauding their progress. The letter highlights the importance of additional investments in the physician workforce and a repeal of the sustainable growth rate (SGR) used to calculate Medicare physician payments. The letter also praises House leaders for excluding an independent Medicare commission from their bill, "given the potential for unintended consequences … if Medicare payment policy is changed without adequate Congressional review."

Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

Len Marquez, Director
AAMC Government Relations
lmarquez@aamc.org
(202) 862-6281

Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418

House Democrats Introduce Physician Payment Legislation

House Energy and Commerce Committee Chair Emeritus John Dingell (D-Mich.), along with Ways and Means Committee Chair Charles Rangel (D-N.Y.), Energy and Commerce Chair Henry Waxman (D-Calif.), and Education and Labor Committee Chair George Miller (D-Calif.), Oct. 29 introduced legislation to avert the scheduled 21.2 percent reduction in calendar year (CY) 2010 Medicare physician payments. Health Subcommittee Chairs Pete Stark (D-Calif.), Frank Pallone (D-N.J.), and Robert Andrews (D-N.J.), also sponsored the Medicare Physician Payment Reform Act of 2009 (H.R. 3961).

The stand-alone bill is based on provisions that were approved as part of the House "tri-committee" bill on health care reform (H.R. 3200). Estimated to cost $210 billion over 10 years, H.R. 3961 eliminates the accumulated "Sustainable Growth Rate (SGR) deficit" associated with the CY 2010 cut and "rebases" Medicare physician payments using 2009 expenditures. In CY 2010, it establishes a conversion factor update based on the Medicare Economic Index. In CY 2011 and subsequent years, the bill establishes two distinct "service categories" that will have separate conversion factors and target growth rates:

  • "Evaluation and Management" services (target growth rate of GDP per capita, plus 2 percent)
  • All other services (target growth rate of GDP per capita, plus 1 percent)

Before holding a final House vote on the new SGR bill, House leaders plan to add statutory "PAYGO" provisions to H.R. 3961. The language would put into law the requirement that Congress must fully offset any new spending, but the requirement would not apply to the SGR fix. The House approved legislation (H.R. 2920) that accomplished similar goals in July [see Washington Highlights, July 24], but the Senate has not acted on the bill.

Currently, PAYGO is in place as a rule that can be waived by Congress. While enacting PAYGO is among the House leadership's top priorities, several key Senate Democrats are likely to oppose a PAYGO bill that excludes the SGR fix.

Information:
Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

CMS Releases 2010 Medicare OPPS Final Rule

The Centers for Medicare and Medicaid Services (CMS) Oct. 30 released the calendar year (CY) 2010 Medicare outpatient prospective payment system (OPPS) final rule on the CMS Web site. The final rule includes a 2.1 percent inflation update in base payments for hospital outpatient services. The changes will take effect Jan. 1, 2010.

In response to comments and meetings with the AAMC and others, in the final rule CMS makes changes in the requirements for physician supervision of hospital therapeutic services that are less restrictive than what was proposed. CMS now defines "direct supervision" to mean that the supervising physician or non-physician practitioner providing hospital outpatient therapeutic services can be present anywhere on the same campus of the hospital, as long as he or she is immediately available to furnish assistance and direction throughout the performance of the procedure. While CMS does not define "immediately available," the preamble states that this would not include, "for example, performing another procedure or service that" could not be interrupted.

CMS finalizes its proposal not to include any additional measures in the current Hospital Outpatient Quality Data Reporting Program (HOP QDRP). Hospitals will continue to submit data (where applicable) on the current eleven required measures. CMS will proceed with its plans to report publicly the Outpatient Measures on Hospital Compare in 2010. The agency also will implement a new validation process designed for the chart-abstracted measures for CY 2011. The results of the new process will not affect the CY 2011 payment determination.

CMS will not expand the current Hospital Acquired Conditions (HAC) program to the OPPS at this time. The agency will utilize the results from the impact study on the inpatient program before making any determinations about its expansion to the outpatient setting.

CMS finalizes its proposal to continue to pay for separately payable drugs and biologicals at the current rate. Specifically, payment for the acquisition and overhead cost of these products will be equal to the average sales price (ASP) plus 4.0 percent, a rate that is 2.0 percentage points lower than the payment received when these drugs are furnished in physicians' offices, currently ASP plus 6.0 percent. According to CMS, the ASP plus 4.0 percent rate is based on a new methodology; if it had not applied the new methodology, separately payable drugs and biologicals would be reimbursed at ASP minus 3.0 percent.

The final rule will be published in the Federal Register Nov. 20.

Information:
Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498

Jennifer Faerberg, Director, Health Care Affairs
AAMC Health Care Affairs
jfaerberg@aamc.org
(202) 862-6221

CMS Releases Final 2010 Physician Fee Schedule

The Centers for Medicare and Medicaid Services (CMS) Oct. 30 published the Medicare 2010 Physician Fee Schedule final rule with comments. CMS revised the expected 2010 update for physician services from a decrease of 21.5 percent (as listed in the proposed rule) to a 21.2 percent decrease. Although the update formula has produced negative updates since 2002, Congress has approved legislation annually to prevent the cuts from being implemented. Changes in the rule are effective Jan. 1, 2010.

The agency finalizes its proposal to remove physician administered drugs from the update calculation. This change affects the 2010 rates, but will reduce the number of years physicians are projected to receive a negative update.

The rule finalizes several proposals to modify relative value units (RVUs), which are the base units for physician payments. All RVU changes must be budget neutral. Among the changes are the elimination of consultation codes with resulting increases in payments for new and established office visits and for initial hospital and nursing facility visits.

CMS also will begin using new practice expense data and finalizes a proposal to increase the utilization rate for expensive diagnostic equipment (over $1 million) from 50 percent to 90 percent; the increased utilization rate does not apply to therapeutic equipment. CMS will phase in these changes over four years.

The rule modifies the proposed implementation of a Medicare Improvements for Patients and Providers Act (MIPPA, P.L. 110-275) provision that requires the establishment of a "special payment rule for teaching anesthesiologists." For services furnished on or after Jan. 1, 2010, the provision allows payment under the regular fee schedule for the teaching anesthesiologist's involvement in training residents in either a single case or in two concurrent cases, which is similar to the way teaching surgeons are paid. CMS will allow different anesthesiologists in the same group practice to be considered "teaching physicians" for purposes of meeting the requirement that the teaching physician be present for all key or critical portions of the service.

The rule also finalizes several proposed changes to the Physician Quality Reporting Initiative (PQRI) and the Electronic Prescribing Incentive Program, such as including a group reporting option, allowing data submission from electronic health records, and streamlining the reporting process for e-prescribing.

The final rule will be published in the Federal Register Nov. 25. CMS will accept comments on a limited number of sections of the final rule through Dec. 29.

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490

Mary Patton, Senior Specialist
AAMC Health Care Affairs
mpatton@aamc.org
(202) 862-6297

Department of Education Publishes Final Rules on Higher Education Reauthorization

The Department of Education Oct. 27-29 published in the Federal Register four sets of final rules for the federal student loan programs authorized under Title IV of the Higher Education Act. The new regulations incorporate many of the changes made under the Higher Education Opportunity Act (HEOA, P.L. 110-315), and reflect recommendations of the AAMC.

With regard to medical school financial aid, the regulations:

  • Amend the calculation of monthly payments under the Income-Based Repayment (IBR) program to adjust for spouses who both elect IBR
  • Increase graduate student annual and aggregate loan maximums in the Perkins Loan Program from $6,000 to $8,000, and from $40,000 to $60,000, respectively;
  • Describe the required content for "codes of conduct" and require institutions to develop and adopt such codes;
  • Require institutions to report on reimbursements received for certain service on lender advisory boards;
  • Require institutions to describe for prospective and enrolled students the terms and conditions of the loans students receive under the Federal Family Education Loan (FFEL), Direct Loan, and Perkins Loan programs;
  • Eliminate the requirement that borrowers make ''written'' requests to obtain a forbearance on their Perkins Loan;
  • Reduce from 12 to nine the number of consecutive on-time, monthly payments a borrower must make to rehabilitate a defaulted Perkins Loan; and,
  • Modify the entrance and exit counseling requirements.

The regulations are effective July 1, 2010.

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

HHS Office of Civil Rights Releases HIPAA Enforcement Rule

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) Oct. 30 issued an interim final rule to conform the enforcement of Health Insurance Portability and Accountability Act (HIPAA) privacy regulations with statutory revisions made in the American Recovery and Reinvestment Act (ARRA, P.L. 111-5) [see Washington Highlights, Feb. 13]. The rule becomes effective Nov. 30, and applies to violations occurring on or after Feb. 18, 2009.

The rule amends HIPAA enforcement regulations to:

  • Significantly increase civil monetary penalties for established HIPAA violations;

  • Establish a tiered penalty structure based on categories of violations; and,

  • Revise limitations on the secretary's authority to impose civil monetary penalties for established violations.

HIPAA covered entities can be penalized for four categories of HIPAA violations, with minimum individual penalties ranging from $100 to $50,000:

  • The lowest penalty applies to entities that are not aware of or would not have known about a violation despite "the exercise of reasonable diligence," and starts from $100 for each violation.

  • The minimum penalty for each violation due to reasonable cause (and not willful neglect) is $1,000.

  • In cases where willful neglect is established, but corrected within the required period of time, the minimum penalty for each violation is $10,000.

  • For a violation due to willful neglect that is not corrected by a covered entity up to 30 days after discovery of the violation, the minimum penalty for each violation is $50,000.

For the first three categories of violations, the rule sets the maximum monetary penalty for each violation at $50,000. For all categories, the rule also establishes an annual penalty cap for multiple, identical violations at $1.5 million.

In each case, the secretary will consider the appropriate penalty category depending on the nature and extent of the violation, the resulting harm, and other factors such as the covered entity's history of prior compliance and financial condition.

ARRA also revised HIPAA by striking the affirmative defense for violations in which the covered entity did not know, or by reasonable diligence would not have known of the violation. Such violations are now punishable under the first tier of penalties. Additionally, the HIPAA subsection that provides an affirmative defense for a 30-day time period of correction now requires the covered entity to demonstrate that the violation was not due to willful neglect. A covered entity can minimize or avoid imposition of a civil monetary penalty if it corrects the violation within 30 days of discovery.

HHS will accept public comments on the new regulations until Dec. 29.

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490

Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134

President Signs Ryan White HIV/AIDS Program Reauthorization Bill

President Obama Oct. 30 signed into law legislation extending the Ryan White HIV/AIDS program through fiscal year (FY) 2013. The program, which provides health care and other assistance to low-income AIDS and HIV patients, previously was set to expire that same day.

The Ryan White HIV/AIDS Treatment Extension Act of 2009 (P.L. 111-87) authorizes $2.35 billion to fund medications, health care, and other support services in FY 2010, with increases in funding each year through FY 2013, when it will reach $2.7 billion. The legislation, which has had strong bipartisan support from its inception, removes the previously included "sunset" provision, which would have repealed the law on Sept. 30, 2009. Other changes include a requirement that states adopt name-based reporting for patients by FY 2013 and the inclusion of a national HIV testing goal of 5 million tests per year.

The legislation also contains an additional provision, Part G, that concerns notifications for emergency responders of possible exposure to infectious disease. Under Part G, medical facilities must notify emergency responders if the victim of an emergency transported to the facility was deemed to have an airborne infectious disease. The bill requires that the notification take place within 48 hours after the determination is made and also provides a mechanism for emergency responders concerned about possible exposure to request a determination from the treating facility.

The Senate approved the measure by unanimous consent Oct. 19, with the House voting Oct. 21 to approve the bill under suspension of the rules, 408-9.

Information:
Shannon Curtis, Legislative Analyst
AAMC Government Relations
scurtis@aamc.org
(202) 828-0558

Senate Panel Approves Biological Weapons Bill

The Senate Homeland Security and Governmental Affairs Committee Nov. 4 approved, 8-1, a bill that would expand the Department of Homeland Security's regulatory authority of biomedical research by directing the department to create a new designation of dangerous "tier I" select agents, require further registration of labs and facilities, and require extended background checks.

Committee Chair Joe Lieberman (ID-Conn.) and Ranking Member Susan Collins (R-Maine) introduced the Weapons of Mass Destruction Prevention and Preparedness Act of 2009 (S. 1649) Sept. 8 [see Washington Highlights, Sept. 11]. The committee proceeded with a two-part mark-up of the legislation that began Oct. 28, despite concerns from committee member and Armed Services Committee Chair Carl Levin (D-Mich.) that affected agencies had not had ample opportunity to comment on the bill and that the bill would diminish the role of the Department of Health and Human Services in dealing with human pathogens. Sen. Levin cast the lone dissenting vote against the legislation.

At the mark-up, the committee adopted a substitute amendment sponsored by Chairman Lieberman that reportedly made mostly technical changes to the bill.

Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488

On the Hill …

House Democrats boosted their majority to 258-177, after special elections that allowed them to hold a northern California seat and take over a traditionally Republican seat in New York.

California voters Nov. 3 elected Lt. Gov. John Garamendi (D) to fill the seat vacated by former Rep. Ellen Tauscher (D), who was sworn in as Under Secretary of State for Arms Control and International Security June 27.

A special election in New York determined Democrat Bill Owens as the successor to former Rep. John McHugh (R), who was sworn in as Secretary of the Army Sept. 21.

On the Agenda in Washington

Nov. 10: Genomic Medicine Program Advisory Committee Meeting
8:30 a.m.; Hamilton Crowne Plaza, 1001 14th Street NW
The VA Genomic Medicine Program Advisory Committee will meet and discuss optimal ways for VA to incorporate genomic information into its health care program while applying appropriate ethical oversight and protecting the privacy of Veterans. The committee also will discuss ways to enhance development of tests and treatments for diseases particularly relevant to Veterans.

Nov. 12-13: Primary Care Medicine and Dentistry Training Meeting
8:30 a.m.; Hilton Washington DC/Rockville, Executive Meeting Center, 1750 Rockville Pike, Rockville, Md.
The HRSA Advisory Committee on Training in Primary Care Medicine and Dentistry will meet to hear presentations and work on reports.

Nov. 12-13: NIH Scientific Management Review Board Meeting
Nov. 12: 1 p.m.; Nov. 13: 8:30 a.m.; NIH Campus, Building 31, 6th Floor, Conference Room 6, Bethesda, Md.
The NIH Scientific Management Review Board will meet to receive a presentation and to discuss updates from SMRB working groups: Deliberating Organizational Change and Effectiveness; NIH Intramural Research Program; and Substance Use, Abuse, and Addiction.

Nov. 12-14: NHSC Advisory Committee Meeting
Nov. 12: 3 p.m.; Nov. 13-14: 8:30 a.m.; Hilton Washington DC/Rockville, Executive Meeting Center, 1750 Rockville Pike, Rockville, Md.
The HRSA National Advisory Council on the National Health Service Corps will meet to hear updates from the Agency and the Bureau of Clinician Recruitment and Service, discuss recruitment strategies for the NHSC, and address current workforce issues.

Nov. 13: Healthcare Research and Quality Advisory Committee Meeting
9 a.m.; AHRQ, Eisenberg Conference Center, 540 Gaither Rd., Rockville, Md.
The AHRQ National Advisory Council for Healthcare Research and Quality will meet Nov. 13. The agenda will include report from the subcommittee on Child Health Insurance Program Reauthorization Act (CHIPRA) Quality Provisions, and discussion of the Patient Safety and Medical Liability Reform Demonstration Project.