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Nov. 30 — The House passed the 21st Century Cures Act Nov. 30 by a vote of 392 to 26. It now moves to the Senate for consideration.
The bill (H.R. 34) contains a wide-ranging health package on biomedical innovation, Medicare payments, and mental health. The legislative package is part of an amendment introduced in an already passed bill that would strengthen the nation’s tsunami warning system.
“This is going to be a game changer for patients and for their families,” House Speaker Paul Ryan (R-Wis.) said during a Republican press conference the morning of the vote. “It will fundamentally transform the way we treat and cure diseases in this country.”
Some Democratic lawmakers expressed reservations about the bill, but many said the benefits outweighed their concerns.
The Senate is expected to vote on the bill as early as Dec. 5. President Barack Obama supports the bill, according to an administration statement of policy the White House released Nov. 29.
An earlier version of 21st Century Cures passed the House in July 2015.
While the bill has a wide range of support from Republicans and Democrats as well as industry and patient groups, the bill has also taken hits from both sides. Senate Republican leaders have put their support behind the bill, but there’s growing opposition to it among progressive lawmakers and uncertainty whether some conservatives will back the legislation.
Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have decried the bill as handing out shortcuts to drug companies, and Warren in particular said the bill’s revised numbers for agency funding don’t provide enough money for new medical research.
Warren’s colleagues, Sens. Jeff Merkley (D-Ore.) and Richard Durbin (D-Ill.), joined her on the Senate floor Nov. 30 to criticize the bill. However, Durbin acknowledged he will likely vote to pass the legislation.
The Progressive Change Campaign Committee, a long-time Warren supporter and fundraising group founded by organizers with MoveOn.org, Nov. 30 was urging Democrats to vote against the biomedical innovation package. The group, in an e-mail, called it “an opportunity for Democrats to send a signal about how they will fight bad deals in the post-Trump-election.”
Sen. Charles Schumer (D-N.Y.) told reporters he’s still uncertain he’ll support passage of the bill. He said he was pleased with the recent changes to the legislation made by the House but he’ll likely seek further changes.
However, Sen. Chris Murphy (D-Conn.) urged Democrats to vote for the bill. With Senate Health, Education, Labor and Pensions ranking member Patty Murray (D-Wash.) able to remove provisions that would have altered how drug and device manufacturers report certain payments to doctors under the Physician Payments Sunshine Act, there’s no reason for Democrats to oppose it, Murphy told reporters.
The conservative Heritage Foundation opposes the bill because it contains too much spending, calling it a “Christmas Tree, loaded with handouts for special interests, all at the expense of the taxpayer.”
Conservatives in the Senate opposed the original Cures bill in 2015 because it included mandatory spending increases for the NIH and the FDA. Some, like Sen. Lisa Murkowski (R-Alaska), were against using the Strategic Petroleum Reserve to pay for the budget increases.
The new version of the bill also uses money from sales of oil from the Strategic Petroleum Reserve, but less than the original. A spokesperson for Murkowski said the senator was still reviewing the bill.
At its base, 21st Century Cures is a bipartisan biomedical innovation bill to spur new medical treatments by addressing the systemic causes for why developing a new drug costs $1 billion, takes more than a decade and fails about 90 percent of the time. Cures would provide about $4.8 billion for the National Institutes of Health and $500 million for the Food and Drug Administration through a 10-year “Innovation Fund” to boost funding for precision medicine, the cancer moonshot, and brain research, all of which are major research initiatives started by the Obama administration.
“This bill, which expedites the approval of drugs and devices, includes figuratively billions for additional health research, so we can find the cures and answers to what patients are demanding today,” House Energy and Commerce Chairman Fred Upton (R-Mich.), who has been leading the Cures effort with Rep. Diana DeGette (D-Colo.), said.
“This is a watershed moment in this country for biomedical research in the United States,” DeGette said in her floor speech.
Rep. Rosa DeLauro (D-Conn.), ranking member of the appropriations health panel that oversees the NIH’s budget, said the bill would implement “weak and dangerous” standards for approving new drugs and devices.
“In its attempt to speed up the drug and device approval process, this legislation neglects the very people who clinical trials are meant to help—the patients,” DeLauro said in her floor speech. “This legislation is the wrong path forward and I strongly oppose it.”
The bill also would provide $1 billion in grants to states to curb opioid addiction.
The 2015 bill that passed the House only contained the biomedical innovation provisions and would have provided almost double the money for the NIH and $50 million more for the FDA through a mandatory funding stream.
The legislation would also exempt more hospitals from Medicare’s controversial site-neutral payment policy.
Site-neutral payments are set to take effect at some hospital outpatient departments Jan. 1, 2017. The payment policy means certain items and services provided by some hospital off-campus outpatient departments will no longer be paid under the hospital outpatient prospective payment system, which has higher reimbursement rates than the Medicare physician fee schedule.
The Centers for Medicare & Medicaid Services, in a final payment rule published in the Nov. 14 Federal Register, specified that site-neutral payments would apply to hospital-owned physician practices acquired or opened since Nov. 2, 2015, and that are located farther than 250 yards from a hospital’s main campus. The Bipartisan Budget Act (BBA) of 2015 required the CMS to adopt the policy.
Congress included the site-neutral payment policy in the 2015 law to discourage hospitals from acquiring doctors’ offices in order to receive the higher rate under Medicare’s payment system for physicians.
The latest Cures legislation would exempt hospital outpatient departments that are defined as “mid-build” prior to Nov. 2, 2015, a summary of the bill said.
In addition, the bill would define mid-build as a provider that had a binding written agreement with an outside, unrelated party for the actual construction of the hospital outpatient department before Nov. 2, 2015, according to the summary.
Provisions in the Cures legislation also say the CMS can adjust for a patient’s socioeconomic status when accounting for readmissions.
The CMS lowers Medicare payments to hospitals if patients are readmitted within 30 days after being discharged. Hospital industry groups have long advocated that the CMS needs to account for a patient’s socioeconomic status when determining readmission penalties.
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