This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls...  Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay” Practices by Pharmaceutical Companies...  The Government Accountability Office (GAO) Releases Report on Private Health Insurance Premiums and Plan Availability for Individuals

1. Congress

House of Representatives

Senate

2. Administration

3. State Activities

4. Regulations Open for Comment

5. Reports

1. Congress

House

House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls

On Sept. 11, 2015, the House Energy and Commerce Committee’s Health Subcommittee held a hearing, entitled “Strengthening Medicaid Program Integrity and Closing Loopholes,” to discuss six bills related to improving Medicaid program integrity and closing eligibility loopholes in the program.

Witness List

John Hagg 

Director of Medicaid Audits 

Office of Inspector General 

U.S. Department of Health and Human Services

Nico Gomez 

Chief Executive Officer 

Oklahoma Health Care Authority

Trish Riley 

Executive Director 

National Academy for State Health Policy 

Commissioner 

Medicaid and CHIP Payment and Access Commission

The bills discussed included:

A background memo on the legislation can be found here.

For more information, or to view the hearing, visit energycommerce.gov.

House Judiciary Subcommittee Holds Hearing on ACA’s Effect on Competition in Health Care

The House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law held a hearing Sept. 10 entitled “The State of Competition in the Health Care Marketplace: The Patient Protection and Affordable Care Act’s (ACA) Impact on Competition.”

Congressional Republicans blame the ACA for mergers and consolidations by hospitals, pharmaceuticals and insurers. This consolidation in the marketplace, Republicans contend, is costing consumers money and choice. This hearing was spurred by the proposed Aetna-Humana and Anthem-Cigna insurance mergers. The witness from America’s Health Insurance Plans testified that the mergers will result in better health care quality and lower costs for consumers. American Hospital Association (AHA) President Richard Pollack and Barbara McAneny, a member of the American Medical Association’s (AMA) Board of Trustees, testified against the merger. Pollack, however, also stated that consolidation among providers is a necessary reaction to the ACA’s focus on population health management and the transition to value-based care. The hearing is the first in a series the committee plans to hold to examine competition within the hospital, insurance and physician marketplaces.

Witness List

Thomas L. Greaney 

Professor of Law 

St. Louis University School of Law

Mr. Richard (Rick) J. Pollack 

President and CEO 

American Hospital Association

Barbara L. McAneny, M.D. 

Member of the Board of Trustees 

American Medical Association

Scott Gottlieb, M.D. 

Resident Fellow 

American Enterprise Institute

Dan Durham 

Executive Vice President 

Strategic Initiatives, American Health Insurance Plans

For more information or to view the hearing, visit judiciary.house.gov.

Federal Judge Allows House Republicans’ Obamacare Lawsuit to Proceed

U.S. District Court Judge Rosemary M. Collyer ruled Sept. 9 that a lawsuit can move forward that challenges aspects of the “cost-sharing reductions” in the Affordable Care Act (ACA). The suit, bought by House Republicans, claims that healthcare reform’s subsidies that lower deductibles, copayments and other out-of-pocket charges for marketplace enrollees with incomes below 250 percent of the poverty line cannot be paid to the insurers that deliver these benefits because Congress has not appropriated the money for those payments. The judge’s decision only rules on the question of standing, and the judge has not yet made any decisions on the merits of the case. The Obama Administration maintains that the spending is mandatory, much like Social Security payments, and does not require separate appropriations. The judge also ruled, however, that House Republicans cannot move forward with another significant component of their lawsuit — challenging the changes the Department of Health and Human Services (HHS) made to the employer mandate and other provisions.

The White House issued a statement saying that the Justice Department intends to seek an appellate review of the judge’s “unprecedented” decision.

House Passes Prescription Drug Monitoring and Newborn Opioid Response Bills

On Sept. 9, the House of Representatives unanimously passed two bills to give state officials and medical practitioners nationwide more tools to address the opioid abuse epidemic. The National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 (H.R.1725), authored by Rep. Ed Whitfield (R-KY), would reinstate federal funding to states to establish, implement and improve prescription drug monitoring programs to help screen and treat those addicted or at risk of becoming addicted. The second bill, the Protecting Our Infants Act of 2015 (H.R. 1462) sponsored by Rep. Katherine Clark, would direct the U.S. Department of Health and Human Services (HHS) to identify and make available best practices for the diagnosis and treatment of neonatal abstinence syndrome (NAS), to evaluate and coordinate federal efforts to research and respond to NAS, and to assist state health agencies with their data collection efforts. If passed by the Senate, it would become the first law to address newborns exposed to opioid use. Both proposals have companion bills in the Senate, which have not yet been scheduled for consideration.

Push by Conservative House Republicans to Shut Down Federal Government over Planned Parenthood Funding Grows

Despite warnings from House and Senate leadership about the political consequences of shutting down the government, the House Freedom Caucus, which includes 40 Republican members, announced its opposition to any spending measure that continues funding for Planned Parenthood. The fiscal year ends on Sept. 30, and Congress will need to provide a short-term spending bill to keep the federal government operating. Without such a bill, the government will shut down. Planned Parenthood receives $500 million annually in federal funding to provide women with health care services. A Senate effort to defund Planned Parenthood failed earlier this summer.

Senate

Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay” Practices by Pharmaceutical Companies

On Sept. 9, Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) reintroduced legislation, the Preserve Access to Affordable Generics Act. This legislation would make it illegal for brand-name drug manufacturers to use anticompetitive pay-off agreements (also known as “pay for delay”) to keep generic equivalents off the market. Sens. Klobuchar and Grassley introduced similar legislation last Congress following a resurgence of patent settlement agreements. “These agreements disrupt the current law that was put in place to speed generic drugs getting to the market. In addition, they force consumers to pay more for their medicines, and add an exorbitant burden to the deficit,” Grassley said in a press release. A report from the Federal Trade Commission (FTC) in December 2014 identified 29 potential pay-for-delay settlements involving 21 different branded pharmaceutical products, with combined U.S. sales of approximately $4.3 billion.

2. Administration

Centers for Medicare and Medicaid Services (CMS) Announces Plan to Address Health Equity in Medicare

On Sept. 8, CMS’s Office of Minority Health (CMS OMH) unveiled a new plan to address health equity in Medicare. The CMS Equity Plan for Improving Quality in Medicare (CMS Equity Plan for Medicare) is a plan that focuses on six priority areas and aims to reduce health disparities in four years. The Equity Plan focuses on Medicare populations that experience disproportionately high burdens of disease, lower quality of care and barriers to accessing care. These include racial and ethnic minorities, sexual and gender minorities, people with disabilities and those living in rural areas. The plan includes the following priorities:

  • Priority 1: Expand the Collection, Reporting and Analysis of Standardized Data
  • Priority 2: Evaluate Disparities Impacts and Integrate Equity Solutions Across CMS Programs
  • Priority 3: Develop and Disseminate Promising Approaches to Reduce Health Disparities
  • Priority 4: Increase the Ability of the Health Care Workforce to Meet the Needs of Vulnerable Populations
  • Priority 5: Improve Communication and Language Access for Individuals with Limited English Proficiency and Persons with Disabilities
  • Priority 6: Increase Physical Accessibility of Health Care Facilities

A press release on the new plan can be found here. To learn more about the six priorities visit cms.gov.

Centers for Medicare and Medicaid Services (CMS) Quarterly Enrollment Snapshot: 9.9 Million Consumers Enrolled on the Exchanges

In a Sept. 8 press release, CMS announced that as of June 30, about 9.9 million consumers had enrolled in coverage on health insurance marketplace exchanges, had paid their premiums and had an active policy. These numbers are consistent with the Department of Health and Human Services’ (HHS) effectuated enrollment target of 9.1 million for the end of 2015. There were 7.2 million consumers with effectuated enrollments at the end of June 2015 through the 37 Federally-Facilitated Marketplaces (including State Partnership Marketplaces) and supported State-based Marketplaces (collectively known as HealthCare.gov states) and 2.7 million through the remaining State-based Marketplaces. Of those with active Marketplace enrollments at the end of June, about 84 percent of, or more than 8.3 million, consumers were receiving an advanced premium tax credit (APTC). The average APTC for those enrollees who qualified for the financial assistance was $270 per month.

The announcement noted that as of June 30, 2015, the Marketplace had ended 2015 coverage for approximately 423,000 consumers who failed to produce sufficient documentation on their citizenship or immigration status and had adjusted APTC and/or CSRs for about 967,000 households.

Medicare Advisory Commission (MedPAC) Holds September Public Meeting; Commissioners Discuss Post-Acute Care Payment, Medicare Advantage Star Ratings among Other Items

MedPAC, an appointed commission that advises Congress on Medicare policy, held its monthly meeting Sept. 10-11 to discuss a number of items to be included in its annual report to Congress. The commission discussed developing a unified payment system for post-acute care, reviewed a preliminary analysis of Medicare Advantage and encounter data, and was briefed on factors affecting variation in Medicare Advantage plan star ratings. They also were briefed on Medicare drug spending issues and payments from drug and device manufacturers to physicians and teaching hospitals. Additionally they discussed trends in emergency medicine leading to the growth of free-standing emergency departments as well as off-campus hospital emergency departments.

For more information and a copy of MedPAC’s September meeting agenda visit medpac.gov.

3. State Activities

Michigan Sent the Centers for Medicare and Medicaid Services (CMS) a Controversial Proposal to Update Its Medicaid Expansion Model

On Sept. 1, Michigan sent to CMS proposed updates for the state’s Section 1115 waiver. The proposal would require Medicaid beneficiaries with incomes above the federal poverty level (FPL), and who have enrolled in the program for at least two years, to buy a private insurance plan through HealthCare.gov or start contributing up to 7 percent of their income to remain in the program. As the program currently operates, implemented through a 2013 state law that expanded the state’s Medicaid program (Healthy Michigan) under the Affordable Care Act (ACA), beneficiaries with incomes between 100 to 138 percent of the FPL pay between 3 to 5 percent of their income for premiums and cost-sharing. CMS must respond to the state by December 2015. If the CMS rejects the waiver, the state must terminate its Medicaid expansion program by April 30, 2016. Healthy Michigan has approximately 600,000 state residents enrolled.

4. Regulations Open for Comment

Department of Health and Human Services (HHS) Proposes Updates to “the Common Rule”

HHS and 15 other agencies released a notice of proposed rulemaking Sept. 2 for the Common Rule, the existing regulatory framework to transparency and oversight for scientific research involving human subjects. The proposed changes are to address the substantial changes that have occurred within scientific research. Current regulations have been in place since 1991 and are followed by 18 federal agencies. Proposed updates to the rule include:

  • Strengthened informed consent provisions
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research
  • New data security and information protection standards
  • Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies
  • Requirement, in most cases, to use a single institutional review board for multisite research studies
  • Application of rule to clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding from a Common Rule agency for research involving human participants.

In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public’s input on updating the Common Rule. The proposed rule issued reflects input and requests comments for HHS to consider as it drafts the final rule. HHS will take public comment on the proposed rule until Dec. 7.

For a press release detailing changes to the rule visit hhs.gov.

Department of Health and Human Services (HHS) Releases Proposed Rule on Health Equity

On Sept. 3, HHS issued a proposed rule, Nondiscrimination in Health Programs and Activities, to advance health equity and reduce disparities in health care. The proposed rule establishes that the prohibition on sex discrimination includes discrimination based on gender identity. It also includes requirements for effective communication for individuals with disabilities and enhanced language assistance for people with limited English proficiency. The proposed rule applies to Health Insurance Marketplaces, any health program that HHS itself administers, and any health program or activity any part of which receives funding from HHS, such as hospitals that accept Medicare patients or doctors who treat Medicaid patients. Finally, the proposed rule extends these nondiscrimination protections to individuals enrolled in plans offered by issuers participating in the Health Insurance Marketplaces and explicitly bars any marketing practices or benefit designs that discriminate on the basis of race, color, national origin, sex, age or disability. Section 1557 of the Affordable Care Act (ACA) extended civil rights protections banning sex discrimination to health programs and activities. Previously, civil rights laws enforced by HHS’s Office for Civil Rights (OCR) barred discrimination based only on race, color, national origin, disability or age. The rule will be published in the Federal Register on Sept. 8, and is open for public comment through Nov. 6, 2015.

For more information, including a fact sheet and Frequently Asked Questions, visit hhs.gov.

Internal Revenue Service (IRS) Proposed Rule Mandates Employer Health Plans Offer Hospital and Physician Services

The IRS released a proposed rule Aug. 31 that would require employer health plans to offer substantial coverage for inpatient hospital services and physician services. The Affordable Care Act requires employer health plans to be at least 60 percent of the minimum value standard. News reports uncovered the fact that employer plans could do so without providing hospital or physician coverage.

The preamble of the proposal points out that while large group plans are not required to cover the ACA’s Essential Health Benefit, a plan that does not cover hospital and physician services “does not meet a universally accepted minimum standards of value expected from and inherent in any arrangement that can reasonably be called a health plan and that is intended to provide the primary health coverage for employees.”

Under the proposed rule, an employer group health plan must, to meet the minimum value standard (MSV) and avoid a penalty, meet or exceed an actuarial value standard of at least 60 percent coverage including substantial coverage for doctor and hospital services. The proposed rule provides a transition period for employers that have previously offered non-compliant coverage prior to Nov. 4, 2014. The proposal aligns IRS and Department of Health and Human Services (HHS) policies. The ACA compels employers who do not meet the affordability and MSV thresholds to pay a penalty of $3,000 for each worker that receives a tax credit. The IRS proposed rule, published in the Federal Register Sept. 1, also says that any employee offered a non-compliant plan would not be prevented from receiving premium tax credits. IRS is taking comments on the proposed rule until Nov. 2, 2015.

Centers for Medicare and Medicaid Services (CMS) Issues FY 2016 Final Inpatient and Long-Term Care Hospital Policy and Payment Changes

CMS issued a final rule on July 31, 2015, to update fiscal year (FY) 2016 Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS).

For hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and demonstrate meaningful use of certified electronic health record technology, the increase in rates is 0.9 percent. This is calculated from a hospital market basket update of 2.4 percent adjusted by -0.5 percent for multi-factor productivity and an additional adjustment of -0.2 percent in accordance with requirements of the Affordable Care Act and further adjusted by - 0.8 percent for a documentation coding recoupment adjustment required by the American Taxpayer Relief Act of 2012.

Hospitals that do not successfully participate in the Hospital IQR program and do not submit the required quality data will be subject to a one-fourth reduction of the market basket update. In addition the law required that the update for any hospital that is not a meaningful user of electronic health records will be reduced by one-half of the market basket update in FY 2016. Other payment adjustments will include continued penalties for readmissions, a continued -1 percent penalty for hospitals in the worst-performing quartile under the hospital acquired condition reduction program and continued bonuses and penalties for hospital valued-based purchasing.

Medicare Disproportionate Share Hospital (DSH) payments will also change. CMS is distributing an estimated $6.4 billion in uncompensated care payments in FY 2016, a decrease from FY 2015, which is attributable to the continued declines in the number of uninsured.

The rule contains a number of other policy changes. A fact sheet on the final rule can be found here. The final rule will be published in the Federal Register on Aug. 17, 2015. Comments may be made on the final rule and are due to CMS by Sept. 29, 2015, and the rule is effective Oct. 1, 2015.

Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats

FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.

More information on FDA’s decision can be found in the agency’s press release.

5. Reports

Department of Health and Human Services Office of the Inspector General (OIG) Report: Washington State Did Not Suspend Medicaid Payments to Some Providers with Credible Allegations of Fraud

In a report released Sept. 8, OIG found that Washington state did not always suspend Medicaid payments to providers with credible allegations of fraud, in accordance with the Affordable Care Act (ACA). The Washington Health Care Authority (WHCA) did not suspend Medicaid payments to 48 of the 81 providers with credible fraud allegations that the OIG reviewed. The OIG also found that the state agency repeatedly failed to suspend payments because it did not follow WHCA’s existing policies and procedures, and that the state’s Department of Social and Health Services (Health Services) did not have any written policies and procedures in place to suspend Medicaid payments to providers when there were credible allegations of fraud. Furthermore, the OIG reported, WHCA did not follow its policies and procedures to report to the Centers for Medicare and Medicaid Services (CMS) the summary information on good-cause exemptions, which may be used when law enforcement requests that a payment suspension not be imposed or that other remedies more effectively or quickly protect Medicaid funds.

In its recommendations, OIG suggested that WHCA follow its existing policies and procedures to ensure that it suspends Medicaid payments with credible allegations of fraud. Moreover, OIG recommends that WHCA ensure Health Services has adequate policies and procedures in place to suspend Medicaid payments to providers and improve reporting of summary information on good-cause exemptions to CMS. It was also recommended that Health Services mandate that officials report summary information on payment suspensions.

Substance Abuse and Mental Health Services Administration (SAMHSA) Releases Results of 2014 National Survey on Drug Use and Health

On Sept. 10, SAMHSA released its annual survey of mental health and substance abuse issues, just as federal lawmakers are considering comprehensive reform. The survey shows trends in the behavioral health of people aged 12 years and older and includes data from about 67,600 people. The SAMSHA report found some areas of progress, particularly among teens. For example, the percentage of adolescents aged 12 to 17 who were current (past month) tobacco users declined by roughly half, from 15.2 percent in 2002 to 7 percent in 2014. Similarly, the level of adolescents engaged in illegal alcohol use in the past month dropped from 17.6 percent to 11.5 percent over the same period. The population of current nonmedical users of prescription pain relievers decreased from 3.2 percent in 2002 to 1.9 percent in 2014 among adolescents aged 12 to 17.

SAMSHA found that in 2014, 27 million people had used an illicit drug in the past 30 days (10.2 percent of population), up from 9.4 percent in 2013, which was attributed mostly to rising rates of marijuana use. Although the survey shows nonmedical pain reliever use continues to be the second most common type of illicit drug use, the percentage of people aged 12 or older in 2014 who were current nonmedical users of pain relievers (1.6 percent) was lower than in most years since 2002, and about the same as in 2013. Current heroin use increased from 0.1 percent (in 2013) to 0.2 of the population in 2014. That is a 100 percent increase.

The Government Accountability Office (GAO) Releases Report on Private Health Insurance Premiums and Plan Availability for Individuals

GAO released a report Sept. 9 that examined variation in the health plan options and premiums available to individuals under the Affordable Care Act (ACA), and how the options available in 2014 compared to those in 2015.

The GAO concluded that individual market consumers generally had access to more health plans in 2015 compared to 2014 in most of the 1,886 counties (representing 28 states) GAO studied. Consumers in most of the counties analyzed had six or more plans to choose from in three of the four health plan metal tiers (bronze, silver and gold) in both 2014 and 2015, and the percentage of counties with six or more plans in those metal tiers increased between 2014 to 2015.

The review found that in 2014 and 2015 the lowest-cost plan available in a county was available on an exchange in most counties. For example, among the 1,886 counties analyzed, GAO found that the lowest-cost silver plan for a 30-year-old was available on an exchange in 63 percent of these counties in 2014 and in 81 percent of these counties in 2015 — an increase of 18 percent.

GAO also found that the range of premiums — from the lowest to highest cost — differed considerably by state. An interactive graphic reporting by state and county the minimum, median and maximum premium values for all individual market plans (either on or off the exchange) and for exchange-only plans is available at gao.gov.