AFFORDABLE HEALTHCARE: HR 3962

Below, is a report issued on the proposed Health Care Bill that the House passed last week. Without pictures and sarcastic commentary, I thought to just post it for discussion:

AMCP Releases Summary Of Key Provisions In H.R. 3962, 'Affordable Health Care Act For Americas'

The Academy has released a summary of key provisions of interest to managed care pharmacists in H.R. 3962, the "Affordable Health Care Act for America." These include provisions on Medicare Part D drug price negotiations, the Medicare Part D coverage gap, PBM disclosure, follow-on biologics and comparative effectiveness research. On Oct. 29, House Speaker Nancy Pelosi (D-CA) released H.R. 3962, which is the consolidation of the H.R. 3200 bills reported by three House committees: Energy & Commerce Committee; Ways & Means Committee; and Education & Labor Committee.

The following is an AMCP staff summary of some of the key provisions of interest to the Academy.

Medicare Part D - Drug Price Negotiation

The bill repeals current law and directs the Secretary of Health and Human Services (HHS) to negotiate drug prices with drug manufacturers in Medicare's Part D program. The bill retains the current law's prohibition on establishment of a national formulary.

Medicare Part D - Coverage Gap

Beginning with a $500 reduction in 2010, the bill eliminates the "doughnut hole" with a complete phase-out by 2019. The bill pays for the elimination of the gap with funds raised by requiring drug manufacturers to provide Medicaid rebates for drugs used by full dual eligibles. It also incorporates a voluntary agreement with the drug manufacturers to provide discounts of 50% for brand-name drugs used by Part D enrollees in the Part D "doughnut hole," beginning in 2010.

Public Health Insurance Plan

The bill establishes a new government-run health insurance plan within the exchange that would compete with private health plans. Under the government plan, among other requirements, the Secretary would be required to negotiate drug prices and establish a drug formulary. The public plan is provided startup administrative funding, it is required to amortize these costs into future premiums to ensure it operates on a level playing field with private insurers.

Health Insurance Purchasing Pool/Exchange

The bill creates a new marketplace called the national "Health Insurance Exchange," with an option for states that agree to meet federal standards to run their own exchange. People are eligible to enter the Exchange and purchase health insurance as long as they are not enrolled in employer sponsored insurance, Medicare or Medicaid. The Exchange is also open to businesses, starting with small firms (25 or fewer employees).

PBM Disclosure

The bill requires that PBMs that enter into contracts with plans that participate in the health exchange disclose certain financial information, including rebate information.

Repeal of the Antitrust Exemption for Insurers

The bill removes the antitrust exemption for health insurers and medical malpractice insurers with regard to price fixing, monopolization, and dividing territories. It retains the exemption with regard to exchange of certain information.

Follow-on Biologics

The bill authorizes FDA to approve follow-on biologic drugs. It would grant biologics manufacturers 12 years of exclusive use of their data before a follow-on biologic manufacturer could begin developing alternatives. [Note: The amendment is identical to a follow-on biologics amendment adopted by the Senate Health, Education, Labor and Pensions Committee.]

Comparative Effectiveness Research

The bill creates a new Center at the HHS Agency for Healthcare Research and Quality (AHRQ) to conduct, support and synthesize comparative effectiveness research (CER). It prevents the Center from mandating payment, coverage or reimbursement policies. Further, it ensures that research findings are not construed to mandate coverage, reimbursement, or other policies to any public or private payer.

Generic Exclusion Agreements

The bill prohibits brand name drug companies from settling patent litigation with generic competitors by paying them to delay marketing their products.

Medication Therapy Management Grants

The bill provides for two types of federal grants that would promote medication therapy management (MTM) services. The bill provides for: (1) grants to eligible entities to establish community-based, multidisciplinary teams to support primary care practices with the provision of "pharmacist-delivered medication therapy management services (including 'medication reconciliation"), as a component and (2) grants to eligible entities for the specific purpose of implementing pharmacist-delivered MTM services in the treatment of chronic diseases. [The provisions are similar to the provisions included in the Senate HELP Committee's health care reform bill.]

Sunshine Provisions

The bill includes requirements that manufacturers and distributors of covered drugs, devices, biological, or medical supplies under Medicare, Medicaid, or CHIP report to the HHS Inspector General information on their financial relationships with:

- Physicians, physician groups, and other prescribers
- Pharmacies and pharmacists
- Health plans, pharmacy benefit managers, and their employees
- Hospitals and medical schools
- Organizations that sponsor continuing medical education
- Patient organizations
- Professional organizations [The Senate Finance Committee bill only applies to physicians.]

Other Medicare Part D Changes

The bill makes various changes, technical and otherwise, to Medicare Part D, including elimination of vaccine coverage in Part D and provides for vaccine coverage under Part B, effective 2011.

Medicare Advantage Reforms

The bill reduces MA benchmarks to fee-for-service levels over three years, reaching equality of payment rates in 2013.

Center for Medicare and Medicaid Payment Innovation

The bill gives the Department of Health and Human Services broad authority to conduct demonstration projects of new payment models through a newly created Center.

Fraud, Waste and Abuse

The bill makes numerous changes to fraud and abuse laws, as well as enhances the authority of the HHS Inspector General. The bill includes new exclusion authority for obstructing an investigation or audit, new civil monetary penalties and exclusion from Medicaid or CHIP, if an entity owns, controls or manages an entity that is suspended, excluded or terminated from Medicaid or is affiliated with an individual or entity that has been suspended, excluded or terminated from Medicaid.

Conclusion

The Academy is closely monitoring health care reform developments and will do all it can to advocate for its positions as legislation moves forward on Capitol Hill. Please check http://www.amcp.org or your Daily Dose for updates.

Source
AMCP