You are here: Home / Archives for Legislation

States’ Debate on PPACA Implementation Puts Politics Above Practicality

May 21, 2013 by Leave a Comment

The debate over Medicaid expansion and cooperation with the health insurance marketplaces continues. These two provisions are key to the successful implementation of health insurance reform under the  Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148) and the Health Care and Education Reconciliation Act (HCERA) (P.L. 111-152).  Although some Republican governors reluctantly decided that Medicaid expansion was in their states’ best interests, other members of their own party are determined to see PPACA fail regardless of cost.

Republican Arizona Governor Jan Brewer has campaigned for expansion for months with little success. As the legislature debated on May 16, 2013, two leaders from her party legislators brought up competing proposals. Senate President Andy Biggs’ bill would direct  the state’s Medicaid agency, the Arizona Health Care Cost Containment System (AHCCCS) to apply for an extension of its existing waiver, which provides coverage to a limited number of adults with incomes at or below the federal poverty level (FPL). It also would appropriate about $135 million for services to childless adults. If the waiver extension is not approved, Biggs suggests funding care for the existing number of childless adults, but not expanding it, and paying for it with the state’s rainy day fund. Brewer, on the other hand, says that fund should be saved for a rainy day.

House Speaker Andy Tobin would put the question to the voters. It is reported that his bill would require a constitutional amendment to implement Medicaid expansion and stop the expansion if either federal  funding or state revenue is insufficient. Yet another proposal would simply drop the existing benefits for childless adults, causing about 60,000 people to lose their coverage. Brewer calls that alternative “morally repugnant.” The debate is expected to be contentious. And Arizona can’t pass a budget until it is resolved.

The Florida legislature ended the session without passing any legislation on the Medicaid expansion. So the debate there is over for the year unless Governor Scott calls a special session. One interesting wrinkle in the argument might be worthy of attention. The House Republicans proposed, as an alternative to the Medicaid expansion, a bill that would have provided for a subsidy for the purchase of limited coverage from a state-operated marketplace for a premium of $25 per month. But the House members are eligible for comprehensive health insurance available to all state employees, for which they pay $8.34 per month for individual coverage, or $30 for family coverage. In 2012, they voted to keep this privilege.  It is reported that the Senate voluntarily gave  up the discount; now they pay the same premium as rank-and-file state employees: $50 per month for individual coverage or $180 per month for family coverage.

About half the states chose not to establish their own health insurance exchange, now called marketplace, under PPACA. A few have gone even farther down the road of resistance. In Missouri, voters passed a ballot measure that bars the establishment of a state exchange unless either the legislature or the voters have passed a law authorizing it. What’s more, no state employee may “provide resources or assistance of any kind” to the establishment of an exchange by the federal government without statutory authorization unless specifically required to do so under federal law. And any taxpayer has standing to sue to enforce the law.

Filed Under: Health care spending, Health Insurance Exchange, Legislation, Medicaid, Medicaid, News, State Level, Uninsured

Senate Bill Would Tighten Requirements for Compounding Pharmacies

May 1, 2013 by

On Friday, April 26, 2013, the Senate Committee on Health, Education, Labor and Pensions (HELP) began to consider a draft bill to increase the regulation of compounding drugs. Under the proposed legislation, mixing, reconstituting, or other activities performed according to the manufacturer’s directions would not be considered compounding. The bill would distinguish between traditional compounders, who compound drugs to fill orders for identified patients, and compounding manufacturers, who prepare drugs for shipment in interstate commerce. The requirements would apply to compounded drugs for human beings or animals. The HELP committee is accepting comments on the proposed bill at compounding@help.senate.gov until 6:00 pm on May 3, 2013.

Traditional Compounders

The bill would amend sec. 503A of the Food, Drug and Cosmetic Act (FD&C Act) to define traditional compounders as licensed physicians or veterinarians or pharmacists who prepare limited quantities of a drug for an identified patient; the pharmacists must be working in a licensed pharmacy. A traditional compounder may only compound drugs on receipt of a prescription for an identified individual patient. If there is an established relationship between the physician or patient and the compounding pharmacist, the drug may be prepared before the prescription is presented. When drugs are compounded for animals, the identified patient may be a specific herd or flock.

Compounding Manufacturers

The amendment to FD&C Act sec. 503A would define compounding manufacturers as entities that compound sterile drugs without a prescription order and introduce the drugs into interstate commerce or who repackage sterile drugs by pooling them or using single-dose vials. Entities that are part of a health system and prepare drugs in accordance with FD&C Act sec. 506F, who prepare drugs to be dispensed within the system and otherwise meet the definition of a traditional compounder, will not be considered compounding manufacturers.

New requirements would be imposed on compounding manufacturers. They will be required to register with the Secretary of the Food and Drug Administration (FDA) and to pay establishment fees beginning in fiscal year (FY) 2015. The establishment fee will be $15,000 per establishment for FY 2015 and will be adjusted thereafter. Small businesses will pay one-third of the fee. The FDA will charge compounding manufacturers reinspection fees. They also will have to submit reports to the FDA every six months listing the identification number, strength, and quantity of the drugs they have sold. Compounding manufacturers must be supervised by a licensed pharmacist. In addition, a compounding manufacturer who becomes aware of a serious adverse experience under FD&C Act sec. 505-1(b) must report it to the Secretary within 15 calendar days and must maintain records for ten years.

FDA’s Duties

According to the draft bill, the FDA would be required to promulgate regulations designating acceptable bulk drugs and the applicable standards and identifying complex dosage forms or biological that may not be compounded. In promulgating regulations, the Secretary must publish a notice of proposed rulemaking and allow at least 60 days for comment; the agency may not use an interim final rule. The final rule must be published at least 30 days before its effective date.

Filed Under: Drugs, Food & Drug Administration, HHS, Legislation, News

Senate Finance Committee Chairman Baucus to Retire in 2014; Tavenner Approved as CMS Administrator

April 26, 2013 by

Senate Finance Committee Chairman Max Baucus, D-Mont., a senior Democrat on the panel since 2001, will not seek re-election in 2014, he announced on April 23. The same day, the Finance Committee approved Marilyn Tavenner to become the next administrator of CMS. Tavenner has been acting CMS administrator since 2011. The agency has not had a permanent administrator since September 2006. The full Senate must now vote to approve Tavenner’s appointment.

Baucus’ Role

The Senate Finance Committee is responsible for most of the health care legislation that moves through the Senate. Baucus was responsible for writing much of the Patient Protection and Affordable Care Act (P.L. 111-148) and ensuring that there were 60 votes to pass the Senate. If the Democrats maintain control of the Senate after the 2014 midterm elections, the chairmanship would shift to Sen. Ron Wyden, D-Ore. Ranking member Orrin G. Hatch, R-Utah, would take the reins if Republicans control the Senate.

In a statement, Baucus said that in the remainder of his term, “I will continue to work on simplifying and improving the tax code, tackling the nation’s debt, pushing important job-creating trade agreements through the Senate, and implementing and expanding affordable health care for more Americans.”

Sen. Charles E. Grassley, R-Iowa, who served as chairman and ranking member alongside the Montana lawmaker, said he and Baucus have been very close professionally during their years in the Senate. “We ran the Finance Committee for 10 years together, and every bill except for three or four was bipartisan,” said Grassley. “The Senate will be worse off as a deliberative body when Senator Baucus leaves.” Grassley extolled Baucus as a lawmaker who sought to produce legislation through “comity and consensus.”

Tavenner’s Priorities

In her testimony before the Finance committee on April 9, Tavenner said that her three primary focuses were (1) to run CMS like a business and act like a business partner with beneficiaries, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and employees; (2) to implement legislation to ensure that all Americans have affordable healthcare care coverage; and (3) to use the tools Congress has granted the agency to reduce overall costs of care and improve the delivery of health care, such as new payment strategies connected to performance, innovative new models of care, and enhanced tools to combat fraud.

Filed Under: Centers for Medicare and Medicaid, HHS, Legislation, News
«Older Posts